Operation Warp Speed chief adviser resigns: Biden transition official

 Moncef Slaoui, the chief adviser for Operation Warp Speed, has resigned but will be available to the incoming Joe Biden administration as a consultant for about four weeks, a Biden transition official told Reuters late on Tuesday.

Slaoui's role leading the COVID-19 vaccine development for the government effort is expected to be diminished after Jan. 20, according https://cnb.cx/3bAxEce to CNBC, which first reported the development.

The Biden team has not asked Slaoui to stay past his current contract, which includes a 30 days' notice before termination, CNBC said.

The U.S. Department of Health and Human Services, which oversees Operation Warp Speed, did not immediately respond to requests for comment late Tuesday.

Operation Warp Speed is the U.S. government's program to distribute COVID-19 vaccines.

The operation started last year as a national effort by the Department of Health and Human Services, and the Department of Defense, aiming to provide substantial quantities of safe and effective vaccines for Americans by January 2021.

However, only about 2.6 million Americans had received a COVID-19 vaccine going into the last day of December, putting the United States far short of the government's target to vaccinate 20 million people last month. "We know that it should be better and we are working hard to make it better," Slaoui said at a media briefing late in December.

Slaoui, a former GlaxoSmithKline executive who had also served on the board of Moderna Inc, was named last spring to spearhead the government's effort at developing a COVID-19 vaccine on an accelerated schedule.

According to Politico, Slaoui had said he planned to step down by early this year, but last week he said he "decided to extend that in order to ensure that the operation continues to perform the way it has performed through the transition of administration."

https://www.marketscreener.com/quote/stock/MODERNA-INC-47437573/news/Moderna-Operation-Warp-Speed-chief-adviser-resigns-Biden-s-transition-official-says-32182642/

China's Sinovac to double annual COVID-19 vaccine capacity to 1 billion doses

 

A unit of Sinovac Biotech could double annual production capacity of its CoronaVac COVID-19 vaccine to 1 billion doses by February, the group's chairman said on Wednesday.

More than 7 million doses of CoronaVac vaccine, one of the three China has included in its emergency vaccination programme, have so far been supplied to regions including the city of Beijing and Guangdong province, Sinovac Biotech Chairman Yin Weidong told a news conference.

While the first phase of Sinovac Life Sciences' existing production line can make 500 million CoronaVac doses in one year, another with annual capacity of 500 million doses could become operational by February, Yin said.

Researchers in Brazil on Tuesday released new efficacy data for the vaccine, for which there have been varying rates of success from trial sites in three countries.

Trials in different countries are designed differently, but the CoronaVac doses being tested came from the same batch, Yin said.

"These Phase III clinical trial results are sufficient to prove that CoronaVac vaccine's safety and effectiveness are good around the world," Yin said.

China has given over 10 million COVID-19 doses so far, Wang Bin, an official of National Health Commission, told reporters.

As clinical trial data and vaccine supply increases, the country will gradually include those older than 60 to its vaccination scheme, which is currently focused on people aged between 18-59 in priority groups of higher infection risk, Wang said, without giving a clear timeline.

https://www.marketscreener.com/quote/stock/SINOVAC-BIOTECH-LTD-5714593/news/Sinovac-Biotech-China-s-Sinovac-to-double-annual-COVID-19-vaccine-capacity-to-1-billion-doses-32184219/

Walmart: Asda to Provide Coronavirus Vaccinations at UK Birmingham Store

 Walmart Inc.'s U.K. business Asda Group Ltd. said Wednesday that it will start providing in-store Covid-19 vaccinations at one of its stores in Birmingham, England, from Jan. 25, with the potential for expansion to further locations.

The British supermarket, whose sale to private equity firm TDR Capital LLP and the billionaire Issa brothers is scheduled for completion in the first half of this year, said the National Health Service England selected one of Asda's pharmacies in Birmingham to operate a vaccination center.

"The site is the first Asda pharmacy to be approved to support the Pfizer/BioNTech vaccine program and Asda is continuing to work with Public Health England and NHS England to assess other sites within its estate that could support this program," Asda said.

https://www.marketscreener.com/quote/stock/WALMART-INC-4841/news/Walmart-Asda-to-Provide-Coronavirus-Vaccinations-at-Birmingham-Store-32184594/

Bayer: New Prostate Cancer Drug Beats Sales Expectations

 Bayer AG said Wednesday that its new prostate cancer drug, Nubeqa, has outperformed sales expectations.

The German chemicals company did not disclose exact sales figures in an interview with the Wall Street Journal, but its head of pharmaceuticals Stefan Oelrich said the drug has exceeded all expectations and sold well in the U.S. and Europe.

"We have a product which is unmatched in its effects and side effects profiles, and that is something we hear back from doctors too," Mr. Oelrich said.

Bayer expects annual sales of the new drug to be worth over one billion euros ($1.22 billion).

https://www.marketscreener.com/quote/stock/BAYER-AG-436063/news/Bayer-New-Prostate-Cancer-Drug-Beats-Sales-Expectations-32184573/

JPM: 'Very soon,' says J&J CEO as world waits for its COVID-19 vaccine data

 Johnson & Johnson's one-dose COVID-19 vaccine regimen could jump-start an immunization push that's faltering in spite of the millions of doses Pfizer, BioNTech, AstraZeneca and Moderna are rolling out around the world.

And the J&J shot is on the verge of its next big step forward.

The pharma giant is in the “final stages” of data analysis for its phase 3 trial, CEO Alex Gorsky said Monday at the annual J.P. Morgan healthcare conference. The company hopes “to have that information very soon,” he added.  

J&J initially set out to test its adenovirus-based vaccine candidate in a 60,000-patient phase 3 trial, but it halted enrollment at around 45,000 patients last month. Now, it’s nearly ready to deliver its first efficacy numbers—and find out how they stack up against the other vaccines in the mix.

The Pfizer-BioNTech and Moderna vaccines posted efficacy numbers better than 90%. AstraZeneca's vaccine was 70% effective on average, but a half-dose regimen was 90% effective, the company reported in November.

Gorsky’s JPM remarks come after Operation Warp Speed official Moncef Slaoui recently predicted J&J efficacy data in January and a potential FDA emergency authorization in February. Importantly, J&J’s vaccine works with just one dose, which Slaoui said could be a “game-changer,” as quoted by the New York Post. The drugmaker is also testing its shot as a two-dose regimen. 

While J&J’s candidate didn’t beat the mRNA shots from Pfizer and Moderna to the market, the company’s program could still play a crucial role in expanding vaccine access in the U.S. and beyond. As of Monday, about 7 million vaccine doses were administered in the U.S., and the nationwide rollout has gotten off to a slower-than-expected start.

But it's not just about developing a vaccine, Gorsky said Monday. The company is also focused on production and is “on track” to deliver hundreds of millions of doses in the first half of 2021. In all of 2021, the drugmaker intends to produce nearly 1 billion doses. 

Aside from J&J, other vaccine developers—including late-stage players Novavax and AstraZeneca—will be aiming to score U.S. authorizations in 2021. Novavax plans to report interim phase 3 data in the first quarter and is already stockpiling doses in the event the program wins regulatory green lights, CEO Stan Erck said at the virtual JPM conference Monday. 

Since the start of last year, Novavax has established a worldwide manufacturing network that will be able to produce 2 billion vaccine doses per year, Erck added. 

https://www.fiercepharma.com/pharma/jpm-j-j-hopes-to-share-phase-3-coronavirus-vaccine-data-very-soon-ceo-says

U.S. to buy 1.25 million additional doses of Regeneron COVID-19 antibody cocktail

 The U.S. government will buy 1.25 million additional doses of Regeneron Pharmaceuticals' COVID-19 antibody cocktail for about $2.63 billion, bringing the total supply of the treatment to more than 1.5 million doses.

The cocktail, a combination of two antibodies casirivimab and imdevimab, was authorized in November for emergency use by the U.S. Food and Drug Administration.

The Department of Health and Human Services said the doses will be delivered in the first half of 2021 to treat non-hospitalized, high-risk COVID-19 patients.

"With COVID-19 cases continuing to rise, treating people with mild or moderate infections can help prevent hospitalizations," HHS Assistant Secretary for Preparedness and Response Robert Kadlec said in a statement.

The Regeneron treatment, which was given to U.S. President Donald Trump during his COVID-19 infection, is part of a class of drugs known as monoclonal antibodies, which are manufactured copies of antibodies created by the human body to fight infections.

Eli Lilly's antibody treatment has also been authorized for emergency use by the regulator.

Demand for these therapies, which are given as a one-time intravenous infusion, has been disappointing. The government program is distributing and allocating the drugs.

Healthcare systems say they have been slow to ramp up use of the antibodies due to extra levels of complexity during the pandemic - including requirements for quick diagnosis times and the need to isolate infectious patients.

To date, the HHS Office of the Assistant Secretary for Preparedness and Response (ASPR) has allocated more than 127,700 treatment courses of the therapy, the agency said on Tuesday.

Regeneron's therapy will likely be effective against new variants of the coronavirus identified so far in a handful of countries, the company said earlier this week.

https://news.yahoo.com/u-government-buy-1-25-230400121.html

Bausch Health says annual revenue will exceed guidance

 Bausch Health Corp. BSC, -10.00% shares gained more than 5% in after-hours trading Tuesday after the company announced that its annual revenue will come in higher than its guidance. Bausch Health, formerly known as Valeant Pharmaceuticals before a scandal that led to large-scale changes at the company, said that fourth-quarter revenue would top $2.2 billion and lead annual sales to come in higher than the top end of its guidance range, $8 billion. "We also expect a strong finish to the year with regard to Adjusted Ebitda,' Chief Executive Joseph Papa said in a statement, without providing any figures on profit. The disclosure arrived before Bausch executives speak Wednesday morning at the JP Morgan Healthcare Conference on recent accomplishments; full results are expected to be released next month. Bausch stock closed with a 0.1% decline at $23.47, and topped $25 in after-hours trades following the release of the information.

https://www.marketwatch.com/story/bausch-health-says-annual-revenue-will-exceed-guidance-stock-gains-2021-01-12