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13 Drugs Facing FDA Approval Decisions

Here is the updated list of drugs facing FDA approval decisions.
Publish date:

) -- For FDA drug approval decision junkies, October is your World Cup.

By my count, U.S. regulators will issue approval decisions on 13 different drugs during October, making it the busiest month on the FDA calendar by a large margin. The summer -- when news flow in the biotech sector slows down and investor interest wanes -- is a good time to start thinking about the uptick of biotech catalysts in the fall.

For this June update to my regular FDA regulatory calendar, I've highlighted the 13 drugs (impacting 19 different companies) awaiting approval decisions in October. Stocks are listed in chronological order, starting with the earliest FDA approval decision date.

Read on.

Johnson & Johnson

(JNJ) - Get Report

Nucynta for moderate to severe chronic pain

Approval decision date:

Oct. 1

This is a extended release formulation of Nucynta with certain abuse-resistant properties. An immediate-release version of the painkiller was approved in 2008.

Javelin Pharmaceuticals

Dyloject for acute moderate-to-severe pain in adults

Approval decision date:

Oct. 3

If approved, Dyloject will be the first IV non-steroidal anti-inflammatory drug (NSAID) marketed in the U.S. as a single agent for the management of acute moderate-to-severe pain in adults since ketorolac in 1990. The active ingredient in Dyloject is diclofenac sodium, a widely prescribed oral NSAID.

The acquisition of Javelin by

is currently stalled and heading to court.

Human Genome Sciences

Zalbin for hepatitis C

Approval decision date:

Oct. 4

Zalbin is a longer-acting formulation of interferon that can be dosed as infrequently as every two weeks for the treatment of hepatitis C. Currently approved long-acting interferons require once-weekly dosing.

Alexza Pharmaceuticals

AZ-004 for agitation in patients with schizophrenia or bipolar disorder

Approval decision date:

Oct. 11

AZ-004 is an inhaled formulation of the generic antispsychotic drug loxapine, intended for the rapid treatment of adults with schizophrenia or bipolar disorder.

will market AZ-004 in the U.S. and Canada, if approved.

Jazz Pharmaceuticals

(JAZZ) - Get Report

JZP-6 for fibromyalgia

Approval decision date:

Oct. 11

JZP-6 contains the same active ingredient as Xyrem, which Jazz currently markets in the U.S. as a treatment for excessive daytime sleepiness and cataplexy in adult patients with narcolepsy.

(ALKS) - Get Report

Vivitrol for opioid addiction

Approval decision date:

Oct. 12

If approved, Vivitrol will be the first long-acting, non-narcotic treatment for patients addicted to opioids. Alkermes currently sells a version of Vivitrol for alcholol dependence.

Amylin Pharmaceuticals

(ALKS) - Get Report

Eli Lilly

(LLY) - Get Report

Bydureon for diabetes

Approval decision date:

Oct. 22

This is the second FDA review cycle for Bydureon, a once-weekly injectable drug for diabetes.

Arena Pharmaceuticals

(ARNA) - Get Report

Lorcaserin for obesity

Approval decision date:

Oct. 22

Lorcaserin is one of three obesity drugs currently under review by the FDA. While not confirmed, an FDA advisory panel is expected to review lorcaserin at a meeting scheduled for Sept. 15-16.

Protalix BioTherapeutics

(PLX) - Get Report

Uplyso for Gaucher's disease

Approval decision date:

Oct. 27

Protalix was forced to submit additional Uplyso manufacturing data to the FDA, delaying the drug's approval.

(PFE) - Get Report

is Protalix's marketing partner for Uplyso, which will compete for Gaucher's patients with

Cerezyme and

Vpriv, both already approved.

(VVUS) - Get Report

Qnexa for obesity

Approval decision date:

October 28

The FDA has scheduled an advisory committee meeting on July 15 to review Qnexa's safety and efficacy as a weight-loss drug. The FDA's review of Qnexa will be posted to the agency's web site on July 13 or 14.

Bristol-Myers Squibb

(BMY) - Get Report

Onglyza/metformin for diabetes

Approval decision date:

Oct. 29

Onglyza/metformin is a once-daily fixed dose combination of two drugs to treat diabetes patients.

VIAject for diabetes

Approval decision date:

Oct. 30

VIAject is a fast-acting insulin analogue designed for absorption into the bloodstream faster than currently marketed rapid-acting insulins.

Avanir Pharmaceuticals

Zenvia for pseudobulbar effect

Approval decision date:

: Oct. 30

FDA rejected Zenvia in 2006. Avanir conducted a new phase III study using a lower dose of the drug and resubmitted it to the FDA for another review.

-- Reported by Adam Feuerstein in Boston.

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Adam Feuerstein writes regularly for TheStreet.com. In keeping with TSC's editorial policy, he doesn't own or short individual stocks, although he owns stock in TheStreet.com. He also doesn't invest in hedge funds or other private investment partnerships. Feuerstein appreciates your feedback;

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Used Chevrolet Cheyenne

Chevrolet Cheyenne 150

The Chevrolet Cheyenne belongs to the second generation of General Motors’ C/K full-size pickup truck series. The C/K pickup series were launched in 1967, and it was in 1971 when the Cheyenne first appeared as an additional trim package in the Chevrolet series.

GMC also produced the same trim in its lineup and called it the Sierra. Comfort and body accents were the main enhancements that went into the Chevrolet Cheyenne such as more padding and insulation, more stylish interiors, chrome trim, carpet, tailgate trim, and upper and lower side molding.

Factory-installed AM/FM radios also made their first appearance in these pickup trucks. There is also a concept car called the Chevrolet Cheyenne which was unveiled in the 2003 North American International Auto Show. This pickup truck sports some innovations not yet applied to production vehicles such as side access doors to load and unload cargo. It has a supercharged 6L V8 engine capable of 500 hp.

Estimated Price Range for Used Chevrolet Cheyenne: $2,000-$30,000
Estimated MPG for Chevrolet Cheyenne: 22 City/33 Hwy
Below are Pre-Owned Chevrolet Cheyenne from Ebay:

[phpbay keywords=”Chevrolet Cheyenne ” num=”5″ siteid=”1″ sortorder=”BestMatch” templatename=”default” paging=”false” category=”6001″]

Chevrolet Cheyenne Commercial

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Fans attending UEFA Euro 2020 matches in Romania will be required to present proof of their COVID-19 status before entry.

The Romanian Football Association (FRF) has issued a series of rules for spectators visiting Bucharest’s National Arena for the four games it is staging. After proving their status, all fans above three years old can only enter the stadium with both a valid match ticket and a wristband provided by organisers that confirms they are vaccinated or have tested negative.

Romanian officials have identified four categories of people who will be allowed to attend, which is led by those who provide proof of a full SARS-CoV-2 vaccination, completed a minimum of 10 days earlier.

Others allowed entry include those showing proof of a negative PCR test within 72 hours of kick-off and those who can show proof of a previous COVID-19 infection. The final group is those showing a negative rapid antigen test that has been carried out at most 24 hours before the start of the match.

While all Euro 2020 venues across Europe have rules regarding social distancing and the wearing of masks, only Bucharest and Amsterdam have outlined plans to require spectators to prove their COVID status, while St Petersburg requires a body temperature check.

In a statement, FRF outlined how ticket-holders must visit one of the Euro 2020 accredited medical centres in Bucharest to provide documentation or take a test in the hours leading up to the match. Once they have proved they are vaccinated or have tested negative, the ticket holder will receive an access bracelet from a volunteer.

Officials warned that once removed from the hand, the wristband destroys itself and is no longer valid for access to the stadium.

“Access is based on the ticket and the bracelet,” an FRF spokesperson said in a statement. “Just one of these elements is not enough. The spectator must also have the identity card with which he reserved his ticket.

“Access bracelets are different from match to match. They have safety and inscription elements specific to each match. Ticket holders must go through the procedure of obtaining the access bracelet for each match, if they have tickets for several matches in Bucharest. No bracelets are released at the same time for several matches.”

Across the Euro 2020 host venues, fans have been allocated 30-minute time slots to arrive and told to keep a distance of at least 1.5m from other fans.

Fans are advised: “Don’t shake hands. Avoid hugs, high-fives and any close contact with others.”

Image: Mihai Petre / This file is licensed under the Creative Commons Attribution-Share Alike 3.0 Unported license / Cropped to size


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Know phenomenon of online qq poker agent sites activity betting

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Online qq poker agent

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Related Post


text:
The methamphetamine crisis silently burns in the background. – Scientific Inquirer

Public attention has been drawn to the 'Opioid Addiction" drugs which are legally prescribed for pain management.  The misuse of these useful medications was fueled by overzealous prescribing by physicians and marketing by unscrupulous pharmaceutical companies.

Several large previously reputable pharmaceutical companies (privately owned) were brought down by the opioid scandal (Purdue), and a rich philanthropic family's wealth destroyed by multiple large judgments (states) who sued for damages for medical treatments and therapy for addicted patients.  This will serve as a warning to those in the future who plan to profit from marketing dangerous and/or addicting drugs.

There are also many other non-opioid compounds that are used by patients who seek highs or other body experience, ranging from nitrous oxide to sniffing glue or other volatile compounds.  Many have serious effects on other body systems such as the heart, liver, and kidneys.

Methamphetamine, the chief ingredient for 'crack' is easily manufactured from some legal prescriptions including many over-the-counter cold remedies.  It became so well known that retail pharmacists no longer place them on open shelves, and although unregulated by the Drug Enforcement Agency (DEA) keeping them under lock and key elsewhere. The key ingredient, Sudafed is a main ingredient for nasal decongestants and is nonaddictive. Its main danger is the combination of readily available supply and dangerous side effects when concentrated into 'crack"

Desoxyn Methamphetamine

Blu Crystal Meth

The methamphetamine crisis silently burns in the background. – Scientific Inquirer


text:
Department Press Briefing – March 5, 2021

Ned Price, Department Spokesperson

Washington, D.C.

1:49 p.m. EST

MR PRICE: Good afternoon, everyone. Just two very quick things at the top. One, happy Friday to everyone. Number two, we’re sorry for getting started a couple minutes late here. But with that, we will take questions. Operator, do you want to repeat the instructions for questions?

OPERATOR: Sure. And once again, if you have a question, press 1 then 0 at this time.

MR PRICE: We’ll go to the line of Matt Lee.

QUESTION: Hi there. Can you hear me?

MR PRICE: We can.

QUESTION: Happy Friday.

MR PRICE: Happy Friday.

QUESTION: I wanted to ask you – they’re very brief, and I have three separate topics. One, on Burma, are you expecting anything more today or over (inaudible).

MR PRICE: Matt, we may have now lost you. We seem to have lost the line of Matt Lee. I did hear him say – mention Burma, so let me just take the opportunity to say a few words on that topic before we move on.

I would want to reiterate just how appalled we are by the horrific violence that’s been perpetrated against the people of Burma, again in response to nothing other than their peaceful calls to respect their rights and to restore the democratically elected civilian government. We condemn Burmese security forces’ brutal killing of unarmed people, their attacks on journalists and activists, their ongoing unjust detention, including of those journalists.

We call on all countries again to speak with one voice to condemn the military’s brutal violence against its own people, to promote accountability for the military’s actions that have led to the loss of so many lives. In close coordination with our partners and our allies, we have made clear to the military that violence against the people of Burma is unacceptable. The people of Burma have spoken out against the military coup and they are peacefully protesting and expressing their aspirations for, again, nothing more than a return to democracy and the rule of law. The United States stands with them, and we continue to work with our allies and partners around the world to speak and to act with one voice and in one motion.

We will go to the line of Will Mauldin. Oh, our phone died. Operator, you there?

OPERATOR: Yes, I am.

MR PRICE: Oh, great. Okay. We’re still live. Do we have – do you have Will Mauldin on the phone?

OPERATOR: No. So once again, if you have a question, please re-press 1 then 0. And then, I’m sorry, who would you like to take now?

MR PRICE: Do we have the line of Will Mauldin from The Wall Street Journal?

OPERATOR: I do not see his line open.

MR PRICE: Okay. We’ll go to the line of Shaun Tandon.

QUESTION: I hope you can hear this one. I wanted to ask you about the situation in Hong Kong. The – in China, of course, you might have seen that there has – there’s been a move to look at lawmakers, to have approval over lawmakers there. I wanted to see if you have any comments on that, and are there any actions the United States will take in return? Thanks.

MR PRICE: We do have a comment there. The United States condemns the PRC’s continuing assault on democratic institutions in Hong Kong. At the March 5 National People’s Congress opening session, NPC Standing Committee Vice Chairman Wang Chen previewed a series of quote-unquote “reforms” to Hong Kong’s electoral system. These are a direct attack on Hong Kong’s autonomy, Hong Kong’s freedoms, and the democratic processes, limiting participation, reducing democratic representation, and stifling political debate in order to defy the clear will of the people of Hong Kong and to deny their voice in their own government and governance.

If implemented, these measures would drastically undermine Hong Kong’s democratic institutions, and they run directly counter to the Basic Law’s clear acknowledgment that Hong Kong elections should progress towards universal suffrage. We call on the PRC to uphold its international obligations and commitments, and to act consistently with Hong Kong’s Basic Law. We’ve said this from the start, that the United States stands together with the people of Hong Kong, the people of Hong Kong who are seeking nothing more than the universal rights to which they are owed and should be guaranteed.

We will go to the line of – well, it looks like we may have Will Mauldin again.

OPERATOR: And pardon me, at this time I do not see his line on my —

MR PRICE: All right. I’m sorry, Will. We’re having trouble. We’ll go to the line of Cindy Saine.

OPERATOR: And again, I’m sorry, I don’t have her name, either.

MR PRICE: Okay. How about the line of Laura Kelly?

QUESTION: Hello? I hope you can hear me.

MR PRICE: We can, yes.

QUESTION: Okay. Great. Thank you. I’m going to ask a question on China, if that’s all right. Secretary of State Blinken has said that he believes what is taking place in Xinjiang against Uyghur Muslims amounts to genocide, and said that the State Department is focused on a number of things in response. Are these measures that have already been taken enough, or is the State Department looking to take more action?

MR PRICE: Well, you are precisely right. The Secretary of State has made the determination that the People’s Republic of China has committed crimes against humanity and genocide in Xinjiang. The then Secretary-Designate Blinken spoke to his determination vis-a-vis genocide during his confirmation hearing. The department has previously spoken to the determination regarding crimes against humanity in the same region.

Look, our charge at the moment is to rally our likeminded partners and allies around the world – that includes in the Indo-Pacific, that includes in Europe, it includes in all regions of the globe – to stand, to speak with one voice, and to condemn the human rights abuses that are taking place in Xinjiang, the repression that has taken place there, the repression – going back to the last question – that is taking place in Hong Kong and elsewhere. That’s precisely what we’re doing.

There will be – we will have more to say on this. I don’t think anyone is satisfied yet with the international response to what has taken place in Xinjiang, and that’s precisely why we are in many ways galvanizing the world, galvanizing collective action to make clear that these sort of abuses against human rights in Xinjiang and elsewhere will not be tolerated.

We’ll go to the line of Jiha Ham with VOA.

QUESTION: Hello? Can you hear me?

MR PRICE: Yes, go ahead.

QUESTION: Okay, hi. Is – there are a media reports that Secretary Blinken is visiting Japan and South Korea this month. What will he be discussing during this visit? What would be the main agenda, I mean? So – and also, why has the Secretary chosen to visit this area first?

MR PRICE: Well, we don’t have any travel to confirm or speak to at this time. But what I would say more broadly is that we have signaled our deep commitment to the Indo-Pacific region. You have seen Secretary Blinken, you have seen President Biden, you have seen others in this administration speak to their counterparts in the region. For his part, Secretary Blinken has met with the Quad as an entity virtually, of course. We have spoken to the fact that this region is an extraordinarily important one for the United States, for our own interests, for our values as well. We see it as pivotal. And so we will continue to engage with institutions, with partners in the region. And if we have more to say on how precisely we’ll do that going forward, we’ll let you know.

We’ll go to Muhammed Elahmad.

QUESTION: Hi, Ned. Hi, everyone. Happy Friday. I hope you can hear me well.

MR PRICE: We can, yes. Go ahead.

QUESTION: Yes. I have two questions about Iran and Yemen. According to Iranian news reports citing one Iranian official, the U.S. Government agreed to release frozen Iranian assets in the Commercial Bank of Iraq. So do you have anything to say about this? Do you confirm or deny those reports? And also, I’m – on Yemen, I’m wondering if the special envoy to Yemen, Mr. Timothy Lenderking, is still in the region. I believe he was supposed to return two days ago to Washington. If yes, can you give us an update about his latest meetings there, and how long that he plans to stay in the region? Thank you.

I have other questions that I would save for later when you change subjects. Thanks.

MR PRICE: Okay. Thank you very much. So on your first question, I believe you are referring to reports about Iraq’s electricity waiver. When it comes to that, we don’t have any updates to offer. As I understand it, Iraq’s 90-day electricity waiver remains valid. We are not aware of any interruptions when it comes to that. When it comes to Timothy Lenderking, Special Envoy Lenderking, he does remain in the region. As of today, he is in Riyadh. I believe he returned to Riyadh earlier this week. As we said earlier this week, on his now second trip to the region, Special Envoy Lenderking has engaged with counterparts in all of the GCC countries. He has visited every GCC country except for Bahrain. On the way over to the Gulf, he made a call, spoke to Bahrain’s foreign minister.

All part of the effort that this administration has prioritized, to bring a diplomatic, durable solution to this grueling conflict in Yemen. Special Envoy Lenderking is working closely with UN Special Envoy Martin Griffiths. Everything Special Envoy Lenderking is doing is intended to support the work of UN Special Envoy Martin Griffiths. I don’t have any firm details for you as to how much longer the special envoy will remain in the region, but whether he is in the region or whether he is back here, he will remain engaged in this important work.

We’ll go to Will Mauldin.

QUESTION: Hello, can you hear me?

MR PRICE: Yes, now we can.

QUESTION: Okay, great. Yeah, I just wanted to ask about State Department employee Freddy Klein, Federico Klein, who was arrested in connection with the Capitol riot, and whether – what – whether you have a comment on that. Does it mean anything for political versus career appointees or whether there are any other similar actions pending? Thanks.

MR PRICE: Can you hear me?

OPERATOR: Yes, we can hear you.

MR PRICE: I’m sorry, did you hear that last answer about Mr. Klein?

OPERATOR: No, we did not.

MR PRICE: Very sorry about that. Okay, so to the question, we do not have a specific comment on Mr. Klein. This is a matter that’s being investigated by the FBI, and they are the appropriate agency to answer questions specific to the charges. I believe the Department of Justice will be in a position to provide more details on those charges today.

Generally speaking, Mr. Klein served as a Schedule C presidential employee at the Department of State from 2017 until his resignation in January. He worked as a staff assistant with the transition team and as a special assistant in the Bureau of Western Hemisphere Affairs, but we of course wouldn’t comment on any pending criminal charges.

I’m very sorry for the technical issues we’re having today. We’ll try to go to the line of Cindy Saine.

QUESTION: (Inaudible) statement on the former Ukrainian official Kolomoyskyy – is it unusual to designate a former public official as an oligarch? And could you please elaborate a bit about what specific corrupt acts he committed during his time as governor? Thank you.

MR PRICE: Well, thanks for the question, and I imagine you saw the statement from the Secretary on this matter. Today the Secretary did announce the public designation of Ihor Kolomoyskyy due to his involvement in significant corruption. Today’s action sends a strong signal that the United States stands with all Ukrainians whose work drives reforms forward. We are committed to helping Ukraine achieve a future that so many Ukrainians demanded six years ago on the Maidan. This designation is based on acts during his time in office, but the department is also drawing attention to Kolomoyskyy’s current and ongoing efforts to undermine democratic processes and institutions, which pose a serious threat to Ukraine’s future.

We are committed to promoting accountability and combating impunity for those involved in significant corruption and will – and we will continue to use all tools available to combat corruption globally. These public designations under authorities such as this allow the United States to promote accountability for government officials who engage in corruption or perpetrate human rights violations and abuses and to support efforts to disrupt and to deter future abuses.

When it comes to the basis for today’s actions, as we have said previously, the Secretary of State has credible information that Kolomoyskyy was involved in significant corruption while serving as the governor. This corruption undermined rule of law and the Ukrainian public faith in their government’s democratic institutions and in public processes. This credible information is gathered from a variety of sources; of note, numerous media outlets have widely reported on Kolomoyskyy’s corrupt activities, and it’s been the subject of investigations by Ukrainian Government as well.

All right. Why don’t we go back to the line of Matt Lee, since he was cut off?

QUESTION: Hey, thanks. Sorry. I just wanted to ask you about two things. AUMF – you guys have any thoughts on that?

And then secondly, yesterday, your – can you hear me?

MR PRICE: I can, yes.

QUESTION: Yeah, okay. And then yesterday at the Pentagon, your colleague, John Kirby – and one-time predecessor John Kirby spoke about the attacks in Iraq and who was responsible for them, and said that they were – that they believe they came from Shia-backed militia. And when he was pressed and asked what does Shia-backed mean, he didn’t really have much of a response. Do you guys still believe that Shia militia in Iraq are backed, are supported by Iran, and do you think that Iranian-backed Shia militia are responsible? Thanks.

MR PRICE: Thanks for those questions. On the second, my Pentagon counterpart was referring to the activities and the attacks of Iran-backed militias. I imagine he will – I refer you to him for any additional questions. But the activity we’re talking about is that of Iran-backed militias.

On the question of the AUMF, I know the White House has spoken to this in recent hours even. I believe my colleague at the White House recently took a question on it pointing to the framework for a narrow and specific authorization. And this, of course, is based on this President’s longstanding belief that we need to work constructively with Congress. We believe deeply in Congress’ prerogative in this area, and it’s time to reset the balance between the Executive Branch and the Legislative Branch when it comes to the authorization for the use of military force.

It also gets to this President’s view that for two decades now this country has engaged in forever wars, so-called forever wars, that have broadened in scope. And we believe that it is very much in line with our democratic republic, very much in line with our constitution that we engage in a constructive dialogue and that Congress assert its prerogative in this area. And so that’s precisely why you have heard the White House now speak to their desire to see this narrow and specific framework for the use of force overseas.

Okay. Let’s go to the line of Joseph Aboush.

QUESTION: Hi, can you hear me?

MR PRICE: We can.

QUESTION: Great, thanks. I wanted to ask if you had any comment on Iran’s president saying the Trump-era sanctions cost the Iranian economy $200 billion in damages. And secondly, was the State Department’s denial today that the U.S. was considering sanctions against Lebanon’s central bank chief an endorsement of the bank’s governor himself, because it seems a bit unusual to come out with a denial of a report that didn’t cite any U.S. officials. And are there concerns now that he’s said that he’s going to file lawsuit against a Bloomberg reporter of press freedom? Thank you.

MR PRICE: Well, we had an opportunity yesterday to speak generally to the protests in Lebanon. What we said at the time is that we’re closely monitoring them. We and our other international partners, we’ve repeatedly underscored both public and privately the urgency for Lebanon’s political leaders to finally act upon the commitments they made to form a credible and effective government. We support, of course, the Lebanese people in their continued calls for accountability and the reforms needed to realize economic opportunity, better governance, and an end to endemic corruption.

When it comes to the reports about possible sanctions on Riad Salameh, those are not true.

When it comes to Iran, look, I, of course, don’t want to get into a tit-for-tat on this question. What we have said and the offer that we have put on the table together with our European partners still stands. It’s been a couple weeks now that we indicated our willingness to accept an invitation on the part of the EU to engage in direct diplomacy. On our part, it would be clear-eyed, principled, direct diplomacy with Iran in the context of the P5+1. That’s where we believe these issues need to be addressed and need to be discussed if we are to make progress in a mutual return to compliance with the JCPOA commitments. I think I would leave it at that.

All right, we will take a final question or two here. We’ll go to Ben Samuels. Ben, are you there?

QUESTION: Can you hear me?

MR PRICE: Oh, yes, we have you now.

QUESTION: Hi. Thanks. All good?

MR PRICE: Yes, go ahead.

QUESTION: Okay, great. So the other day, Matt Lee asked where Palestinians should go for redress if not to the ICC, and you directly related it to the need for achieving a two-state solution. But you’ve also said from the podium that a final status agreement is not the in the immediate offing. So where does the administration believe that Palestinians should appropriately air their grievances as you work on rebuilding the foundation for improved relations? And also, does the administration plan on conditioning the resumption of financial assistance in cooperation with Palestinian leadership on their continued support of the ICC probe?

MR PRICE: So, again, what we have said is that we will seek to advance the possibility of achieving a negotiated two-state solution, and we continue to believe that that two-state solution is the best course because it guarantees that Israel would live in peace and security alongside a viable Palestinian state. This approach remains the best way to ensure Israel’s future as a democratic and Jewish state, while also, of course, enabling the Palestinian people to live with dignity and security in a viable state of their own.

We’ll work closely with Israel. We’ll renew our diplomatic ties with the Palestinians. We’ll consult with partners in the region and beyond. We’ll consult with all of those who have a common interest in supporting efforts to advance a lasting peace. What was your second question again?

QUESTION: If the administration plans on conditioning the resumption of financial assistance and cooperation with the Palestinian leadership based on their continued support of the ICC probe.

MR PRICE: Look, what we have said is that we will look for ways to support the Palestinian people. We have committed to that. We’ve also at the same time made our approach to the ICC very clear. You saw that in a statement from – when – I should say our approach to this particular matter, when it comes to the ICC, is very clear. You saw that in a statement from the Secretary earlier this week. You heard it from the podium as well. We’ll go – we’ll end with the line of Rosiland Jordan.

QUESTION: Regarding Afghanistan, we have some reporting out of Kabul that Ambassador Khalilzad was meeting and trying to be persuasive to all of the locally interested parties to support a type of peace conference – and I’m using that term loosely – the last week of March. Do you have a readout on the ambassador’s latest trip to the region? Is there going to be a global conference sponsored by the UN with U.S. participation the last week of March? Thanks.

MR PRICE: Thanks, Rosiland. Well, as you know, Special Representative Khalilzad and his team, they’re in the region. They’re meeting with Afghan and regional leaders to discuss a path forward and a path forward that produces durable results. The outcomes of Afghan – Afghanistan peace negotiations are up to Afghans. We believe those outcomes should reflect the wishes and the aspirations of the Afghan people. We continue to consult closely with our allies, our partners, countries in the region regarding how we can collectively support this peace process, and we’re considering a number of different ideas that might accelerate the process forward. That’s precisely what the special representative and his team have been doing, first on the ground in Kabul and now on the ground in Doha, and what they will continue doing in an effort to achieve progress on this very important and necessary goal.

I think we will end it there. We will see – or we will see many of you in person on Monday. Thanks very much. And I’m sorry for the technological difficulties today.

(The briefing was concluded at 2:17 p.m.)

* This article was originally published here

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Joining forces on drugs and alcohol

BACHS Drug and Alcohol Worker Chelsea Simmonds, Western NSW LHD Nurse Practitioner Linda Doherty, Weigelli / Orana Haven Alcohol and Drug Worker Elizabeth Kerr, Western NSW LHD Clinical Nurse Consultant Ree McMillan, Weigelli / Orana Haven Alcohol and Drug Coordinator Joseph Clarke and BACHS CEO Leanne Orcher at ‘The Centre of Excellence’ in Sturt Street. Photos TWH

Weigelli/Orana Haven, Bourke Aboriginal Corporation Health Service and Far West Local Health District, have joined forces in a new project to address drug and alcohol needs in the Bourke community.

Located in Sturt Street Bourke, the newly appointed Weigelli/Orana Haven Hub building has been titled ‘The Centre of Excellence and Well-Being’.

The Centre, an outreach service that provides case management, support and counselling services, also offers a rehabilitation drop-in centre.

The Centre’s vision is to provide a range of services to assist drug and alcohol addicted community members who wish to get well, to participate and engage in programs that lead to brighter futures.

Read more local news in the printed edition of The Western Herald. To subscribe call (02) 6872 2333 today and receive The Western Herald in your letterbox next week!

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Copyright © 2019 The Western Herald


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We've Got Hollywood Covered

RJ Mitte Says He’s Not in the ‘Breaking Bad’ Movie, but He Has an Idea for Walt Jr

“My idea is that he’s trying to go out, find what happened to Hank and go after Jesse and Walt,” Mitte says

We still don’t know much about the “Breaking Bad” movie that is reportedly a sequel following the events of the original series. But sadly, Walter White’s son, aka Flynn, will not be in it.

That, at least, is according to actor RJ Mitte, who says he’s “not a part of” the film that the Albuquerque Journal reported may be code-named “Greenbriar.” It’s a shame, because Mitte envisioned a future for Flynn in which the character has now joined the DEA and is committed to finding out what happened to his uncle Hank.

“Walt escapes capture, Jesse came back to Walt after the whole shootout, Walt and Jesse disappear for five years, and Walt Jr. is still living with his sister, almost in like DEA housing,” Mitte told TheWrap, while also sharing his involvement as a judge in the Easterseals Disability Film Challenge. “Then Walt Jr. pretty much joins the DEA and is hunting after his father. He kind of takes Hank’s role where Hank left off. My idea is that he’s trying to go out, find what happened to Hank and go after Jesse and Walt.”

The show’s star, Bryan Cranston, has reiterated that Walter White is, in fact, dead, but it’s not clear if Flynn would necessarily know that. Things ended poorly between Flynn and his parents, with Flynn refusing to go by the name Walt Jr. after learning of Walter White’s criminal secrets and then accusing his mother Skyler of being just as bad for her involvement in money laundering. What’s more, Flynn is the only major character on the show who never met Jesse Pinkman.

News broke last year that “Breaking Bad” creator Vince Gilligan was developing a sequel, with Slashfilm reporting that it would center around Aaron Paul’s Jesse.

Mitte, like his character, has cerebral palsy and took the role on “Breaking Bad” when he was just 13. Though he insists he’s not involved and doesn’t know anything beyond what has been reported, he’s on board if asked.

“Of course I would be interested in being a part of it. I miss being part of a job that actually pays well,” Mitte said. “It’s been an iconic part of my life. I started that show when I was 13 years old and I finished it when I was 20 years old, and that was my whole career, that was my whole existence for those 7 years, and I miss that family. I miss those people. It would be great to be a part of that.”


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Ren Qian works 2007-9

Collection of images, texts and various documents of the artist’s work between 2007 and 2009.

Artist / Author Ren Qian
Reference D1929
Date 2009
Type DVD

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Govt may act to curb house boom

House prices are in danger of rising so high next year that the government may be forced to take tough action to prevent a repeat of the property bubble of the Eighties.

John Wriglesworth, a leading housing market expert, says prices are likely to rise by at least 13%, repeating the price inflation already recorded this year. Wriglesworth, a former building society director and housing market analyst at UBS bank, believes the housing market could explode as people scramble to buy homes before prices rise further, so chasing prices up in a spiral.

Unlike other housing commentators, such as lenders Nationwide and Halifax, Wriglesworth was one of the few who predicted earlier this year that the market was on the verge of a boom. As late as the second quarter of this year Nationwide was refusing to acknowledge a market upturn - but on Friday it conceded that prices will have risen by 13.5% this year and are likely to go up by 11% in 2000.

Wriglesworth says a return to the boom and bust housing cycle of the Eighties cannot be ruled out. 'Though housing remains affordable when you look at prices compared with average earnings, it seems that other experts refuse to acknowledge the speculative factor,' he said. 'When house prices are on the march, they breed expectations of further increases and give an added incentive to homeowners to get in quick before the home of their dreams becomes unaffordable. Housing is one of the few markets where price rises fuel a surge in demand. 'It happened in the late Eighties when prices were fuelled by people frantically moving from renting accommodation to join the housing bandwagon. It could happen again.'

Wriglesworth believes that if house prices continue to surge at more than five times the inflation rate, the government will have no choice but to take action to cool the market, either by putting up stamp duty on house purchases or by pushing up interest rates.

Last week, Abbey National and mortgage broker John Charcol joined Nationwide in making house price predictions for 2000. However, both were more cautious than Wriglesworth, respectively predicting increases of 10% and 8%.

Govt may act to curb house boom

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How to Talk About the Weather in German

Old bridge in rain at dusk, Wurzburg and River Main, Bavaria, Germany
Peter Adams/Getty Images

Regardless of the language, everyone likes to talk about the weather. Learning how to talk about the weather in German is a key part of learning the language. This means you'll need to learn more than just the terms for the weather in German. You will also need to adjust how you talk about the weather. As with many other countries, Germany measures weather-related issues like barometric pressure and temperatures differently than in the U.S. There are even a few hidden vocabulary traps you'll need to learn to avoid when talking about how warm or cold you are in German.

When you're in German-speaking Europe, you also need to learn how to listen to a typical weather forecast. For example, you may need einen Regenschirm (an umbrella ) if Regen (rain) is in the Wettervorhersage (weather forecast).

Weather-Related Vocabulary and Phrases in German

The tables list common weather phrases and vocabulary. Review the chart below to learn many common German weather words and weather-related expressions. The table offers the German phrase or question on the left with the English translation on the right. In German, weather phrases can begin with es (it is, or it's) or es ist (which also means "it is" or "it's). You use es with a verb and es ist with an adjective.

Das Wetter Expressions

Fragen Questions
Wie ist das Wetter heute? What's the weather like today?
Ist es warm/ kalt/ kühl? Is it warm/cold/cool?
Wie viel Grad sind es? What's the temperature?
"How many degrees is it?"
Scheint die Sonne? Is the sun shining?
Wo ist mein Regenschirm? Where's my umbrella?
Es regnet. It's raining.
Es blitzt. There's lightning.
Es donnert. It's thundering.
Es schneit. It's snowing.
Es hagelt. It's hailing.
Es ist schön. It's nice.
Es ist bewölkt. It's cloudy.
Es ist heiß. It's hot.
Es ist kalt. It's cold.
Es ist windig. It's windy.
Es ist schwül. It's muggy/humid.
So ein Sauwetter! Such lousy weather!
Mir ist kalt. I feel cold./I'm cold.
Ist es dir zu heiß? Do you feel too hot?/Are you too hot?

A Note About Dative Phrases

Although it is OK to say "I'm hot/cold" in English, this is not the case in German. To express that you feel hot or cold in German, use a dative pronoun —  dir (to you) and mir (to me) in the examples above. In German, you say, "to me, it is hot" rather than "I am hot," which in German would roughly translate as "you are in heat."

Indeed, if you want to speak German, you'll also have to know your dative prepositions. Many dative prepositions are common terms in German, such as nach (after, to), von (by, of) and mit (with). It's hard to speak without them. Simply put, dative prepositions are governed by the dative case. That is, they are followed by a noun or take an object in the dative case.

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Your Citation
Flippo, Hyde. "How to Talk About the Weather in German." ThoughtCo, Aug. 26, 2020, Flippo, Hyde. (2020, August 26). How to Talk About the Weather in German. Retrieved from Flippo, Hyde. "How to Talk About the Weather in German." ThoughtCo. (accessed June 15, 2021).


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Global Management of Social Issues

Understand and manage international societal challenges by combining insights from human resource studies, organization studies, and sociology.

BSc Global Management of Social Issues

3 years English Starts end of August

The Bachelor's program in Global Management of Social Issues integrates knowledge from three academic fields in the social sciences: human resource studies, organization studies, and sociology, from a cross-cultural and international comparative perspective. You will learn to approach complex societal challenges in an international context from an organizational and management perspective (‘Organizing for Wicked Problems'). You will for example learn how to run projects and to compose teams of experts that work on complex social issues also called ‘wicked problems’.

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Discover our compact and green campus where everything is within a walking distance: state-of-the-art study facilities, different restaurants, and an excellent sports center.

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  • Maria

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    "I chose GMSI with the idea of learning how to tackle world problems. During the program I learned to think about issues from different perspectives: organizational, economical, and sociological. And last but not least, I found a second family in my fellow students."

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Are you and Global Management of Social Issues a match? If you...

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TMCnet Feature
July 15, 2020

How Technology can Shape the Future of Automotive Industry

Just like cell-phones can do much more than just making calls, thanks to technology, cars can do much more than just take you from one place to another. As the automotive industry works hand-in-hand with technology, the companies are delivering cars that not just drive but do much beyond that. Cars are considered fewer mechanical devices and more smart devices nowadays with advanced braking capabilities, fuel efficiency, and mapping technology.

The future of this industry is much brighter and so much more advanced that cars will not be seen as a medium just to take you from point A to point B, but much more than that.

Here are a few ground-breaking technologies in talks now, and you can look forward to them in the near future.

1. Self-Driving Technology:

Several cars already have this technology installed, but they are semi self-driving vehicles where driver assistance is needed. These cars include motorway lane sensors, automatic braking sensors, Mapping technology, adaptive cruise control, cameras in the back, and front of the car, and self-parking capabilities. We are still far away from adopting these complete self-driving cars, though companies are doing wide testing to make it a reality.

2. More Fuel-Efficient:

Companies are not just bothered about increasing the car's performance but also reducing the effect it causes to the atmosphere, which is why they are constantly pushing themselves towards developing efficient electric vehicles. Many companies have already launched these in the market, but the shift from fuel to electric is still slow. Hybrid vehicles are quite popular nowadays as people are not ready to shift 100% to electric vehicles but we are sure by 2030, 99% of people will adopt electric vehicles in the U.S.

3. Predictive Vehicle Technology

The combination of Artificial intelligence (AI) and Machine Learning (ML) is being extensively used to predict the performance of the vehicle, and this is known as Predictive Vehicle Technology. The Internet of Things (IoT) also got into the mix to connect the vehicle to your smartphones where you can get feedback from the vehicle about its condition and you can give voice commands.

The Predictive Vehicle technology also uses sensors built in your car, the mileage, and car condition to determine the car performance and inform the users of any car malfunctions.

The Bottom Line- Till What Extent Should We Depend on Technology When it Comes to Trusting Our Lives with It:

This is one debate we humans have had with ourselves and others. The idea of driving a complete self-driving car where you take a back seat is great, but can you trust technology so much? Yes, the chances of human errors may be high, but are automation technology full-proof and safe? We believe that 99.99999% of times it is safe, but there is still that small chance something might go wrong because of a glitch. Introducing technology such as IoT to connect cars to a smartphone is great, but leaving the control of the car (to think of you giving control of your life) on technology completely is something that still sounds risky to most human beings.

The famous case of the accident of the Self-driving Tesla car which was set on auto-pilot mode when the car crashed into a truck towing a trailer, killing the driver is one of the reasons why we believe the complete self-driving car is something from the future. Right now even Tesla insists that the driver should not leave the wheel even if the car is in Auto-pilot mode.

Tesla got caught up in an enormous litigation case due to this incident. In fact, with so much of technology involved in cars nowadays, any case of an accident due to malfunctioning of the vehicle can end up in the court for settlement as per famous car accident lawyer Joe Stephens. Such cases usually work in favor of the victim if they hire the right lawyers early in the case.

Even AI and Big Data are playing essential roles to customize the vehicles and notify the car owner if the vehicle needs any maintenance. The rise of the electric vehicle is helping curb down the pollution as it helps in reducing carbon emission.

We believe that technology has made our lives so much easier which is why we can let it take control of things to an extent but we need to learn to draw a line somewhere and take the control of the important aspects that can affect our life gravely.

» More TMCnet Feature Articles

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Maidstone United 1
6 Tonbridge Angels Academy
Maidstone Utd (1) vs Angels Academy (6) 09/06/21

Angels triumph in Local Derby

Report and Picture : Wink Tomkinson

Tonbridge Angels said a fond farewell to their third year scholars with a rousing victory at the home of our A26 neighbours, Maidstone United. Ned Lewis, who will be taking up a scholarship in the United States, and Jacob Lambert signed off with a brace of goals each whilst Harry Hudson and Sam Babayale, who depart for University, along with Harrison Mayhew can reflect on three outstanding years at the club with a solid defensive showing.

At the other end of the spectrum, the Angels fielded seven first year students and three Under-16’s in this performance of virtual domination.

Such was the control that the visitors had on the game, it was added time in the first half before goalkeeper Matt Larkin, drafted in from the Angels’ Under-16 Kent Youth League side, had any sort of save to make.

It was a very warm lunchtime kick-off at the Gallagher with the Angels, fast out of the blocks and producing chance after chance with Lambert ruling the roost in midfield. Lambert forced the first save of many from the Stones’ keeper within the first minute. Ben Hermitage wasted a very good chance after five minutes and the keeper pulled off a blinding save to thwart Billy Kent and so it continued, Tonbridge versus the Stones’ goalkeeper until the half-hour mark when finally the custodian was beaten.

A lofted through ball from Lewis sent Lambert clear to deftly lob the advancing goalkeeper to put the Angels into a deserved lead. This actually sparked the home side into life but a couple of attacks failed to employ Larkin.

Three quick goals in the last eight minutes put a scoreline on the board far more in keeping with the pattern of the game. After 40 minutes, Lambert supplied the pass for Lewis to score from 10 yards and, four minutes later, a well executed cross from Hermitage gave Kent an easy close range header to make it 3-0. Three minutes into time added, Lewis added his second when latching on to a cross from the right, his first shot was well saved but he was on hand to convert the rebound.

After what one would imagine a stern half-time talk, Maidstone made a better fist of the second period but continued to be dominated by the visitors with Lewis and Kent bringing saves and Ben Twist seeing his shot cannon down from the underside of the crossbar.

The fifth goal arrived on 63 minutes when Hermitage set up substitute Cameron Wootton who, once again, needed the benefit of a second attempt as the goalkeeper saved his initial shot.

Larkin showed his potential and desire to keep a clean sheet making two good saves in quick succession before a brilliant run from Keiarn Corner set up Wootton but his shot was smothered by a fine defensive block.

Sadly, Larkin’s debut was not to be celebrated with a clean sheet when, seven minutes from time, he was beaten when the ball was bundled home after saving the initial attempt.

Jacob Lambert said his final goodbye to Academy football with a characteristic finish in the final minute to round off an impressive display that obviously delighted Tommy Parkinson, who said after the game that it was an outstanding performance and on the departing scholars: “All have been a credit to themselves and their families, they have come on leaps and bounds as players over the three years and more importantly become top people who will all have bright futures.”

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Environmental Science

Choose from one of the following environmental topics that is an issue in your area.

  • Atmospheric Pollution
  • Oceanic Resources
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  • Energy Development and Management
  • Agricultural/Rangeland Management
  • Wildlife Population Management
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  • Invasive Species Control
  • Endangered Species Recovery
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Create a 10-15 slide PowerPoint Presentation. The presentation should provide a detailed description of a sustainability plan for your selected environmental issue. Include the following:

  • Introduce your choice. Explain why this issue is important for humans, wildlife and the environment.
  • Detailed description of the problem. Present specific details about your selection. This might include a specific habitat, ocean, species, forest, agricultural method, or energy source.
  • What are the social, economic, and environmental perspectives regarding your choice?
  • Explain how unsustainable human consumption has caused the problem. Describe the effects the problem is creating for people, wildlife, and the environment.
  • Present a plan or approach that is currently being used to address this problem, or a similar problem. Is the current strategy effective? Why or why not?
  • Your plan to reach sustainability. Consider the sustainability plans presented in the assigned reading, videos and the Gamescape Episodes.
  • Explain how your plan includes social, economic, and environmental perspectives.
  • Identify the stakeholders in your plan (local community residents, businesses, governmental agencies, non-profit organizations, etc.). What is the role of each of these groups in ensuring that the plan is successful?
  • Close by reviewing your plan and explain why you think it will be more successful than current actions.

Include 750 to 1,050 words in your speaker notes.

Include supporting visuals, such as photos, diagrams, and/or graphs.

Include at least four outside sources. Two of the sources must be academic journal articles from the University’s library. If you need assistance with identifying academic journal articles (also known as peer-reviewed articles), review the Finding Peer-Reviewed Articles document.

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Health Information Management

Health Information Management

HIM (Health Information Management) Department Budget
You are in the midst of preparing the departmental budget for the year. The next portion of the budget is the coding staff development budget.Â You currently have five coders in your department.
In a word document prepare the following:
1. A staff development plan for the coding staff for the coming year.
2. A budget for staff development.
A. A. First step of this assignment is to assess the needs of your staff:
• What resources will go for staying current with the new code changes, rules and guidelines?
• What continuing education will keep staff current on the latest procedures and techniques done within your facility that may impact coding?
• What resources will go training based on the feedback from the last peer-to-peer audit and also the last external audit.
• What professional development do your coders need or want in the areas of topics like HIM, electronic health records, general computer skills, or supervisory or interpersonal skills.
Develop a prioritized list of what training is needed for your coding staff. Look at the training opportunities that may be available at low cost or no cost.D. Also consider the amount of time the coders will be away from their production responsibilities while attending these training events. Will your accounts receivable be impacted if all the coders are out at a two-day conference? Will you have to replace their productivity with temporary staff?
Prior-year Expenditures

Budget vs. Actual

Coding Area
Item Budget Amount Amount Spent
Supplies $1,200 $1,000
Travel $2,000 $2,500
Conference Fees $1,000 $1,200
Membership Dues $750 $600
Subscriptions $350 $325
Equipment $5,000 $3,000
1. Analyze which area/areas have variances and their proposals for correcting this in the future.
2. Along with each variance calculation, prepare a brief report justifying why there may be a variance.

Follow this link to get a similar paper written from scratch


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WATCH: Vegan singer Billie Eilish says ‘people who don’t like pooping probably eat like s***’ – Totally Vegan Buzz

WATCH: Vegan singer Billie Eilish says ‘people who don’t like pooping probably eat like s***’

Image: @billieeilish on Instagram

Vegan singer Billie Eilish has spoken out once again about the many benefits of a vegan lifestyle, this time describing how much she loves pooping thanks to her plant-based diet.

The 17-year-old superstar appeared in a Pitchfork video where she said that ‘pooping is one billion percent underrated’.

“Pooping is my favorite part of the day. There was one day I pooped eight times… That was the best day of my life. And they were all solid, good poops too,” she said.

 “It’s really about your diet, because you can have miserable poops. People who don’t like pooping are probably people who eat like s***.”

Eilish also joked that she used to suck on pennies and jewellery because she has an iron deficiency.

Vegan activist

Last month the singer launched into a passionate plea to her fans, asking them to wake up to the realities of the meat industry and go vegan.

Eilish urged her 26 million Instagram followers to react to an investigation which revealed abuse at huge dairy business Fair Oaks Farms.

“I keep my mouth shut most of the time about this because I believe everyone should do eat and say whatever they want… and I don’t feel the need to shove what I believe in, in anyone’s face,” she wrote.

“But man … if you can watch the videos that I just posted and not give a f*ck that it’s you contributing by literally eating the creatures that are being fully tortured just for your pleasure, I feel sorry for you.

“I understand that meat tastes good … and I know you think you’re just one person and it won’t change anything if you stop but that’s ignorant and stupid. If you have half a brain, you should know ‘one person’ adds up. Be smarter.”

What do you think of Billie Eilish’s interview? Share your thoughts in the comments below!

Published by Oli Gross

Oli’s career and personal ethical values both help shape his reporting of the diverse world of veganism. His background is in local newspaper and magazine journalism, and his work has included reporting court cases, celebrity interviews, business analysis, food and drink features and government legislation.

Vegan culture, food, beauty & more

All the quizzes you love to binge!


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E3 schedule outlines presentations from Gearbox, Warner, Take-Two, and more

E3 2021 kicks off on Saturday, June 12, and the official schedule has been revealed.

Along with the E3 2021 presentations, there will be panel discussions, celebrity appearances, various reveals, and more.

Watch on YouTube

If you are interested in all things E3, you can register at the E3 website to gain access to the online portal and app, which the ESA says is a key hub for the duration of the show.

Details around the schedule are available below.

Schedule Overview

Hosted by Alex “Goldenboy” Mendez, Jacki Jing, and Greg Miller, the E3 2021 broadcast will feature publisher showcases, press conferences, industry panels, extended livestreams, celebrity guest appearances and more.

  • Saturday, June 12, broadcast pre-show starts at 10am PT / 1pm ET
    • E3 2021 will kick off with press conferences from Ubisoft and Gearbox Entertainment, as well as a session with GamesBeat.
  • Sunday, June 13, broadcast pre-show starts at 8:45am PT / 11:45am ET
    • The Xbox & Bethesda Games Showcase will take place starting at 10am PT / 1pm ET.
    • Special presentations from Square Enix, the PC Gaming Show, and the Future Games Show will also tale place this day.
    • Warner Bros. and Back4Blood and 24 Entertainment will also be featured.
  • Monday, June 14, broadcast pre-show starts at 8:00am PT / 11:00am ET
    • Alongside press conferences from several indie developers, presentations from Take-Two Interactive, Mythical Games, Freedom Games, Razer, and Capcom will take place throughout the day.
    • Verizon and Intellivision will also be featured, along with a session with VENN.
  • Tuesday, June 15, broadcast pre-show starts at 8:00am PT / 11:00am ET
    • The last day of E3 will include Nintendo’s Nintendo Direct and Nintendo Treehouse: Live programming starting at 9am PT / 12pm ET.
    • Bandai Namco, Yooreka Games and GameSpot will also have focused events.
    • The broadcast will round out with the Official E3 2021 Awards Show.

Registration begins today for fans to access the E3 online portal and app. Beginning on Saturday, June 12, the portal will provide access to:

  • Select Exhibitor Booths – Featuring special events, VOD content, and articles, exhibitor booths will act as hubs within the portal for key announcements and game or product information tied to participating exhibitors (the full list of exhibitors with virtual booths can be found on the E3 website)
  • Lounges – Online gathering spots for all E3 attendees
  • Forums – Special boards for focused online discussion and sharing among attendees
  • Leaderboards – Gamified elements that can be collected and displayed, encouraging fans to interact in as many ways as possible
  • Profile Creation – All attendees can create and customize their own unique profiles

The online E3 2021 portal and app will also feature the E3 live broadcast, with interactive overlays that include viewer polls, featured tweets, and more.

If you want to keep up with anything and everything E3 2021, be sure to bookmark our page on when to expect each show to kick-off, what to expect, and get a look at some of our predictions.

The post E3 schedule outlines presentations from Gearbox, Warner, Take-Two, and more appeared first on VG247.

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The Trade360 Blog

Welcome to our ever-expanding library of articles on all topics trading-related. Click on one of the posts to discover a wealth of information by top industry writers.

Top Pharma Companies Enter the Coronavirus Vaccine Race. Will the US catch up to the UK?

Wow! The more we advance into the trading week, the higher our adrenaline rises. Last week, the UK made a historic stride forward in approving and ordering the first 800,000 doses of the new coronavirus vaccine developed by Pfizer and BioNTech. Spearheading the healthcare revolution, the UK has also secured 5 million doses of their competitor’s jab, Moderna. At the time of writing, the coronavirus vaccine rollout is in full swing, with the first shot being given to someone outside a clinical trial.

coronavirus vaccine vial

Margaret Keenan, aged 90, and the grandmother of four, was the “privileged” receiver of the first shot of health. Is this humanity’s victory against COVID-19? That’s perhaps premature to even think at this stage. One thing is certain though: the race for health is on. Who will win? Time will tell. As to whether whose vaccine will make it to the market first, that is a different story… Perhaps, this article will give you a clue, or make you wonder even more and want to add one of these stocks to your watchlist for 2021.

Following the spate of breaking news, Trade360 stock experts compiled a list of top pharma stocks to keep an eye on. So, check them out and make your pick.

Pfizer or BioNTech?

pfizer logo

Both. When it comes to global healthcare, Pfizer and BioNTech took the bull by the horns (pun intended), and results have already started to show. Proven 94.5% effective in the prevention of coronavirus infections, the Pfizer-BioNTech jab is already being administered to the elderly in the UK and has cleared its path towards the US approval as well. On 8 December, the US Food and Drug Administration Authority released a set of documents backing the safety and efficacy of Pfizer and BioNTech’s coronavirus vaccine for emergency use. Right on time before the FDA meeting on Thursday, 10 December, when the approval decision will likely make the breaking news.

Michael Yee, an analyst at Jefferies, characterised the material submitted by the two companies as “very simple and straightforward, which we think will lead to approval imminently”. So, the FDA may well keep up with the UK’s MHRA (Medicines and Healthcare products Regulatory Agency) after all.

moderna logo with medicine vial

A serious contender of Pfizer and BioNTech, Moderna is coming in hard. On 30 November, the biotechnology company announced the results of its clinical trial for its coronavirus vaccine candidate. Out of a group of 30,000 people, only 11 who received two doses of the vaccine developed COVID-19 symptoms after being infected with the pandemic virus, compared with 185 people in a placebo group who presented symptoms. The data gathered from this clinical trial was sufficient to prove an encouraging 94.1% efficacy of Moderna’s COVID vaccine, way above what many vaccine scientists anticipated. Furthermore, the jab proved 100% effective against developing severe forms of the disease.

Last week, the company submitted an extended data set to the FDA for review, which made the drug regulator mull an approval.  “This is striking. These are amazing data”, said Dr. Paul Offit, FDA vaccine advisory committee member. Chances are Moderna will have the FDA approval and soon.

On another note, both the PfizerBioNTech pair and Moderna applied for conditional marketing authorisation (CMA) with the European Medicines Agency (EMA) last week. The agency has already examined part of the data they submitted via a “rolling review” and might issue a verdict “within weeks”.

The Commission has already secured up to 300 million doses of the Pfizer-BioNTech coronavirus vaccine and 160 million doses of Moderna’s candidate. Still, Moderna said that its initial 20 million doses would be made and used for the US. The American biotechnology company hopes to supply its vaccine globally in 2021.

AstraZeneca is yet another pharma colossus to have developed a vaccine for coronavirus. Backed by Oxford University in its endeavour to rid the world of COVID-19, AstraZeneca became the first vaccine developer to enter its Phase 3 trial during the pandemic and publish its findings in a peer-reviewed paper – the Lancet medical journal. According to the publication, the vaccine is 70.4% effective against SARS-COV-2. Furthermore, no hospitalisations or severe cases were reported three weeks after the first dose was taken by around 11,600 volunteers in the UK and Brazil, the study showed.

Johnson & Johnson

Associated with brands like Johnson’s Baby, Aveeno, Neutrogena, Clean&Clear, Visine, Acuvue, Bengay, Band-Aid, and lots and lots of consumer goods, Johnson & Johnson got into the public eye for developing a single-dose vaccine for coronavirus. Entering its phase 3 trial in October, the company had paused it when one of the up to 60,000 participants experienced a side effect to the vaccine. However, the trial was resumed at the end of the month as ‘no clear cause’ had been identified, according to a press release published on the company’s website. Johnson & Johnson is the first pharmaceutical company to develop a single-dose COVID-19 vaccine to enter the final stage of its clinical trial. The Phase III study is the largest coronavirus vaccine studies so far testing volunteers at more than 200 sites in the US, South Africa, Argentina, Brazil, Chile, Colombia, Mexico, and Peru.

In a recent statement during an event held by the International Federation of Pharmaceutical Manufacturers and Associations, J&J Chief Scientific Officer Dr. Paul Stoffels said he expects results of the late-stage experimental vaccine trial in January 2021.

Requiring only one shot, Johnson & Johnson’s vaccine may eventually turn out to be less costly compared with Pfizer’s jab, for example. After procuring only 50 million doses of Pfizer’s jab to vaccinate less than a half of the population and refusing to buy more, the Trump administration could allegedly beat this deficit with Johnson & Johnson (if its vaccine candidate passes the FDA). Will it be approved? Will J&J save America? That’s for the news break. Meanwhile, just enjoy it in a different shape and form.

novavax logo

Novavax is a more traditional vaccine developer. Unlike its competitors using other techniques and vaccine components – for example, AstraZeneca and Johnson & Johnson use mono-virus vectors, while Moderna and Pfizer have adopted a messenger RNA model – Novavax uses a protein subunit from the spike protein in SARS-COV2, the virus responsible for COVID-19 infections. The spike protein is the main target for the development of immunity. The spike protein is basically injected into the body together with a booster to help the system develop antibodies that latch on to the spike protein and thus generate immune response  by feeding on it.

Particularly because of its “traditional” composition based on virus antigens (e.g.: SARS-COV2 spike protein), Novavax holds great promise for the future, says Stuart Cohen, Chief of the Division of Infectious Diseases, Director of Hospital Epidemiology and Infection Prevention at UC Davis Health, where the Novavax vaccine trial is still ongoing. This is also what makes storage and handling of the Novavax jab much easier compared to others. While Pfizer or AstraZeneca vaccines require storage at temperatures way below 00C, Novavax can be stored at temperatures between 20C to 80C. Novavax received fast-track authorisation from the FDA on 9 November.

GlaxoSmithKline, self-titled “the vaccine company” is the pharma brand behind numerous coronavirus vaccines. According to the company, “more than one vaccine” is needed. Partnering with other pharma titans like Sanofi, Medicago, and Clover Biopharmaceuticals, GlaxoSmithKline is a serious competitor in the vaccine race. Combining adjuvant technology with other cutting-edge techniques, the company said it would request regulatory approval for its Sanofi and Medicago vaccine candidates in the first half of 2021, according to an article published on its website.

In early December 2020, Glaxo confirmed positive results on its Clover-backed jab, which proved safe in 150 adult individuals and elderly volunteers. Advanced-stage trials on Glaxo adjuvant-based vaccines are scheduled for this month. Looking into the near future, the company plans to manufacture 1 billion doses of its adjuvant in 2021. That’s what we like to hear! Thumbs up, Glaxo!

Gilead Sciences

gilead logo, trading chart on the background

Gilead Sciences plays in a slightly different league. Receiving the FDA approval on 22 October, for its anti-COVID drug remdesivir (Veklury), Gilead is the only FDA-approved drug maker that can sell its antiviral drug in the US. Efficient in treating Ebola and SARS-COV-2 infections, remdesivir has so far generated $873 million in sales, mostly in the US.

Eli Lilly or Regeneron?

If it helps your trading choice or your general knowledge of pharma history, both Eli Lilly and Regeneron are linked to the Trump administration (in a therapeutic way- naughty, naughty if you were thinking otherwise). Yes, you almost wouldn’t believe it, but Trump owes his miraculous recovery to Regeneron’s antibody therapy. Known as REGN-COV2, the antibody drug given to the incumbent US President reduced the amount of virus and associated damage in the lungs.

Regeneron obtained FDA approval for emergency use on 21 November,about 3 weeks after the approval granted to Eli Lilly for its similar drug (9 November). All’s well that ends well.

Eli Lilly also won the acclaim of a high-profile official in the person of Chris Christie, former New Jersey Governor and Trump supporter, who had as miraculous a recovery as the president after taking Lilly’s antibody drug. Were they testing the drugs, or what? That’s way out of our league (we’re also curious). Joke aside, the point is that both antibody therapies worked. Lilly’s candidate, LY-COV555, had similar results as REGN-COV2, helping reduce hospitalisation and emergency room visits for COVID-19 patients.

Abbott Laboratories

Famous for developing the coronavirus portable antigen tests, Abbott Laboratories made it to our top pharma stock list for its ingenuity in creating a cost-effective COVID detection solution. The tests deliver results within 15 minutes and are extremely easy to use. Roughly the size of a credit card, the Abbott test doesn’t require any additional equipment to operate and is less invasive than traditional tests.

Sold for only $5 each, antigen tests are faster and significantly more cost-effective than lab tests yet reportedly less accurate. Abbott obtained FDA approval for its antigen test (BinaxNOW) in late August. The Trump administration then purchased 150 million of the touted BinaxNOW tests for $750 million.

Finally, we can really say we’re on the right path. With so many options at hand, which brand will the world choose? Who will win this tight vaccine race? Hmm… This is a tough question. Until we figure it out, stocks from all these pharma companies are sure to drive the financial markets in the near to the not-so-near future. Therefore, it may be worth adding them to your watchlist. To do that, just open an account with Trade360.

RISK WARNING: CFDs are complex instruments and come with a high risk of losing money rapidly due to leverage. 67.55% of retail investor accounts lose money when trading CFDs with Trade360. You should consider whether you understand how CFDs work and whether you can afford to take the high risk of losing your money. Learn more about managing risks.


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Penang Hill Lower Station in Penang, Malaysia - get details, & find more attractions to visit nearby

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Penang Hill Lower Station

11500 Bukit Bendera, Pulau Pinang, Malaysia

Man-made Structures- Other

About Penang Hill Lower Station

The Penang Hill Railway is a one section funicular railway which climbs the Penang Hill from Air Itam, on the outskirts of the city of George Town in the Malaysian state of Penang. The railway first opened in 1923 as a two-section railway, and the system was overhauled in 2010. The total journey time can take between five and twenty minutes. The funicular train coach travels directly from the lower station to the top, but may stop at other intermediate stations upon request.

Attractions near Penang Hill Lower Station

Kek Lok Si Temple1.31km from Penang Hill Lower Station

An important pilgrimage center for Buddhists from Southeast Asia. The main attraction in the complex is the striking seven-story Pagoda which combines a Chinese octagonal base with a middle tier of Thai design, and a Burmese crown.

Penang Hill1.86km from Penang Hill Lower Station

Hill station comprising of a group of hills offering breathtaking views of the city below.

Penang State Mosque2.75km from Penang Hill Lower Station

The Penang State Mosque or Masjid Negeri Pulau Pinang is a state mosque located at Jalan Masjid Negeri in George Town, Penang, Malaysia. The mosque was inspired by Brazilian Oscar Niemeyer's design of the Cathedral of Brasilia in Brasilia, the capital of Brazil. Its architecture is an amalgamation of Western Modernist. The mosque was designed by the Filipino architect, Efren Brindez Paz.

Arulmigu Balathandayuthapani Temple, Penang3.23km from Penang Hill Lower Station

The Balathandayuthapani Temple, officially the Arulmigu Balathandayuthapani Kovil, better known as the Waterfall Hill Temple or "Thaneer Malai" by locals, is a temple complex located in George Town, Penang. The main deity of this temple is Murugan. Visitors need to climb 513 stairs to reach the temple. It is the focal point of the Hindu festival of Thaipusam in Malaysia, after the Batu Caves. The hilltop temple, with its seven-story 21.6m-tall gopuram, has been touted as the largest Lord Murugan

Mahindarama Buddhist Temple (Theravada)3.33km from Penang Hill Lower Station

Mahindarama Buddhist Temple is a Sri Lankan temple situated in Jalan Kampar of George Town of Penang in Malaysia. It is the sole and the oldest Malaysian Sri Lankans temple in the state which is also one of the few temples in Malaysia where the Buddha's relics are stored. The temple became a focal point for the Candle Lighting Day and the annual Wesak festival within the city suburb.

City Park3.39km from Penang Hill Lower Station

The City Park, also colloquially known as the Youth Park, is an urban park in the city of George Town in [Penang], Malaysia. Located near the Penang Botanic Gardens, City Park was opened in 1972 as a recreational area and a green lung for the city's residents. it is one of the main tourist attractions in Malaysia.

Where is Penang Hill Lower Station

Discover more attractions in Penang, where Penang Hill Lower Station is located

Penang29 attractions

Known as the Silicon Valley of the East for its industries, Penang is one of Malaysia's most vital economic powerhouses. Penang has the highest GDP per capita among all Malaysian states and is considered a high-income economy.