UK may allow Christmas as COVID cases start to flatten

 There are signs that coronavirus cases in Britain are starting to flatten as a result of current lockdowns, health minister Matt Hancock said, paving the way for a Christmas period with less stringent restrictions.

“There are encouraging signs that the number of cases is starting to flatten, and that the lockdown that we brought in, earlier this month, is working,” Hancock told Sky News, adding that a UK-wide approach to rules for Christmas was being worked on.

“It of course won’t be like a normal Christmas, there will have to be rules in place, but we hope that they’ll allow for a bit more of that normal Christmas that people really look forward to.”

https://www.reuters.com/article/us-health-coronavirus-britain-hancock/britain-may-allow-christmas-as-covid-cases-start-to-flatten-idUSKBN2800Q1

Pfizer to seek emergency vax OK today, doses may ship in 24 hours: Azar

 Pharmaceutical companies Pfizer and partner BioNTech will seek emergency government approval for their coronavirus vaccine on Friday, Health and Human Services Secretary Alex Azar said, paving the way for millions of doses to be distributed within 24 hours.

“We will ship millions of doses of vaccine within 24 hours of FDA approval. So my message is hope and help are on the way,” Aazar said Thursday as he announced the pending emergency use application during a White House coronavirus task force briefing.

Pfizer’s German partner BioNTech had said this week that it would seek the emergency approval for the vaccine, which showed 94.5 percent efficacy in clinical trials.

Vice President Mike Pence said at the briefing that “literally, we could well be a matter of just a few weeks away from a vaccine being available across this country for the most vulnerable among us.”

Officials did not take questions during the briefing, at which health authorities including immunologist Dr. Anthony Fauci urged the public to avoid spreading the virus amid a cold-weather surge in new cases.

The Pfizer vaccine requires ultra-cold storage, but task force leaders said at the briefing that distribution was ready to go.

Azar said “there is light at the end of the tunnel, this isn’t forever.” He said a second drugmaker, Moderna, is likely to also seek for permission for its vaccine, which was 95 percent effective, and does not require special ultra-cold storage.

“For the last two weeks, we’ve seen just unprecedented historic news about vaccines. Two vaccines, each with 95 percent efficacy, rivaling the 98 percent accuracy of our measles vaccine, produced in some of the largest vaccine clinical trials ever conducted in history — over 40,000 patients in each of these clinical trials demonstrating good safety profiles,” Azar said.

“BioNTech has announced that tomorrow they intend to file for emergency use authorization at the FDA. We would expect to see Moderna filing soon also. We also have this comprehensive distribution plan that… builds on a public-private partnership… with a goal to make the distribution of this vaccine as convenient to you as the flu vaccine is.”

Earlier this week, Azar said that the US could distribute 40 million doses of the Pfizer and Moderna vaccines by the end of the year.

Army General Gustave Perna, the chief operating officer of the task force’s Operation Warp Speed, shared flow charts for the “relatively simple” rapid distribution of vaccines that are approved.

Perna said that Pfizer is “capable of distributing on their own. They will utilize FedEx and UPS in order to execute distribution.”

“Simultaneously we will ship ancillary kits, needles, syringes, alcohol wipes and the dilutant required for the vaccine to meet the vaccine at the end-state facilities,” Perna said. “For the Moderna vaccine, what we’re going to do is meet up the vaccine with the ancillary kits at a distribution warehouse, we’re going to put them together, and then we’re going to distribute to FedEx and UPD down to our distribution sites.”

Perna said the vaccine doses will be shipped to “any place that a state wants to administer a vaccine” and that 100 million kits have been prepared for the vaccines, meaning supplies shortages won’t slow the process.

“We can go to one place in a state or we can go to 10,000 places in a state,” Perna said.

https://nypost.com/2020/11/19/pfizer-to-seek-vaccine-ok-friday-doses-could-ship-in-24-hours-azar/

Global stocks wobble after Mnuchin pulls plug on Fed stimulus

 

World financial markets stalled on Friday as news U.S. Treasury was ending emergency loans programmes dealt a blow to economic recovery hopes just as California announced curfews to try and fight surging coronavirus infections.

S&P500 futures slipped 0.5% while Dow futures fell 0.6%, cancelling out a firmer lead from a strong Wall Street session overnight.

The dollar <=USD> was slightly weaker and the 10-year Treasury yield slipped to the lowest in 10 days at 0.818%.

Eurostoxx futures started almost flat while London's FTSE futures was up 0.25%

In Asia, Japan's Nikkei <.N225> stumbled 0.5% while Australian shares were flat. Chinese shares were little changed while South Korea's KOSPI index <.KS11> was a shade firmer.

That left MSCI's broadest index of Asia-Pacific shares excluding Japan <.MIAPJ0000PUS> up 0.3%. It is up 1.5% so far this week.

In a letter to U.S. Federal Reserve Chair Jerome Powell, U.S. Treasury Secretary Steven Mnuchin said the $455 billion allocated to Treasury under the CARES Act should be instead available for Congress to reallocate.

"This divide between the Treasury and the Fed risks undermining the unwavering faith that investors have placed on continuous policy support to help the economy weather the pandemic," Singapore-based DBS wrote in a note.

Although the programmes were not used extensively, Fed officials felt their presence reassured financial markets and investors that credit would remain available to help businesses, local agencies and even nonprofits through the pandemic downturn.

Mnuchin's decision added to market anxiety about broader economic growth as data shows the early fast recovery from a historic plunge in the U.S. economy is fading, with more than 10 million who had jobs in January still out of work.

"The Fed has been one of the only sources of stability in Washington and removing its latitude to offer support in a shaky recovery is simply nonsensical," said Isaac Boltansky, director of policy research at Washington-based Compass Point Research & Trading.

"This is a distressing development that injects uncertainty and instability into markets completely unnecessarily. How many times will Washington trip on its shoelaces in response to this crisis?"

Investor sentiment was also hit by data that showed COVID-19 hospitalisations across the United States jumped by nearly 50% in the last two weeks, threatening the recovery of the world's largest economy as cities and states began to impose lockdowns.

California on Thursday imposed a curfew on social gatherings and other non-essential activities in one of the most intrusive of the restrictions being ordered across the country to curb an alarming surge in infections.

All three major U.S. stock indexes, however, got a healthy boost overnight after Senate Democratic Minority Leader Chuck Schumer said Republican Majority Leader Mitch McConnell had agreed to revive talks to craft a new fiscal relief package.

A senior Democratic aide told Reuters there had been a mid-afternoon meeting on Thursday among congressional aides that discussed coronavirus relief and efforts to pass a $1.4 trillion bill to keep government agencies operating beyond Dec. 11 when current funding expires.

The Dow rose 0.15%, the S&P 500 gained 0.39% and the Nasdaq added 0.87%.

In currencies, the dollar index <=USD> was last at 92.232, edging closer to Thursday's low of 92.236.

The euro was up at $1.1881 while the yen weakened to 103.8 per dollar. The Australian dollar gained to be up 0.2% at $0.7294 <AUD=D4>.

In commodities, oil prices steadied after losses the previous day, when concerns about coronavirus lockdowns affecting fuel demand weighed on the market.

West Texas Intermediate was flat $41.74 a barrel. Brent crude was up 10 cents at $44.30.

Gold was flat with spot prices at 1,867.3 an ounce.

https://www.marketscreener.com/news/latest/Global-stocks-wobble-after-Mnuchin-pulls-plug-on-Fed-stimulus--31816330/

Amarin up on 'positive' late-stage data in VASCEPA trial in China

 

• Amarin (NASDAQ:AMRN) jumps 23% after-hours after sharing positive top-line results from Protocol Number EDPC003R01, a Phase 3 clinical trial of Vascepa (icosapent ethyl) conducted in China by partner, Edding.
• The study, which investigated Vascepa as a treatment for patients with very high triglycerides (≥500 mg/dL), met its primary efficacy endpoint.
• The median baseline TG levels in the study were 812 mg/dL and 837 mg/dL for the patients assigned to placebo (n=123) and 4 grams per day of Vascepa (n=122), respectively.
• The Vascepa patient group showed a statistically significant median TG decrease of 19.9% (p<0.001) compared to placebo at the end of the 12 weeks.
• The study’s primary endpoint, the percent change in TG levels from baseline to week 12, was met for the 4 gram per day Vascepa dose group.
• Vascepa was well-tolerated with a safety profile similar to placebo. No treatment-related serious adverse events were seen.
• The findings are being prepared to support Edding’s dossier for seeking regulatory approval for Vascepa in China.
• https://seekingalpha.com/news/3638219-amarin-stock-rise-23-on-positive-late-stage-data-in-vascepa-trial-in-china

AstraZeneca’s additional Imfinzi fixed-dose OK'd in U.S.

 

• AstraZeneca’s (NASDAQ:AZN) Imfinzi (durvalumab) has been approved in the U.S. for an additional dosing option, a 1,500mg fixed dose every four weeks, for Stage III non-small cell lung cancer (NSCLC) after chemoradiation therapy and previously treated bladder cancer.
• This new option is consistent with the approved Imfinzi dosing in small cell lung cancer and will be available to patients weighing more than 30kg as an alternative to the approved weight-based dosing of 10mg/kg every two weeks.
• This new four-week dosing option gives doctors the choice to cut the number of visits in half and offers a more convenient regimen for patients.
• https://seekingalpha.com/news/3638225-astrazeneca-s-additional-imfinzi-fixed-dose-okd-in-u-s

EU may approve BioNtech, Moderna vaccines in December, could pay $10B for doses

 

• According to the head of European Commission (EC), Pfizer (NYSE:PFE), BioNTech (NASDAQ:BNTX) and Moderna (NASDAQ:MRNA) could receive conditional European Union (EU) marketing authorization for their COVID-19 vaccines in the second half of next month - Bloomberg.
• The EMA is in daily contact with the FDA about the evaluation of the vaccines in order to “synchronize” assessment, said EC President Ursula von der Leyen.
• The speedy regulatory assessment comes as many European countries battle new waves with the onset of colder weather, forcing governments to impose new lockdowns. European leaders are increasingly counting on vaccines to provide relief.
• The EU could pay more than $10B to buy hundreds of millions of vaccine doses jointly developed by PFE and BNTX as well as that of CureVac, Reuters said Friday, EU official name not disclosed.
• Bloc has agreed to pay €15.50 ($18.34) per dose for Pfizer-BioNTech shot, less than what the U.S. is paying.
• The EU has confirmed a purchase of up to 300M doses of Pfizer and BioNTech’s vaccine and has also inked supply agreements with AstraZeneca (NASDAQ:AZN), Sanofi (NASDAQ:SNY)/GlaxoSmithKline (NYSE:GSK), Johnson & Johnson (NYSE:JNJ), and CureVac (NASDAQ:CVAC). In total, it’s pre-ordered some 1.2B doses.
• Von der Leyen said the Brussels-based commission will “hopefully soon” reach a vaccine-supply agreement with Moderna and is also in talks with Novavax (NASDAQ:NVAX).
• https://seekingalpha.com/news/3638224-eu-may-approve-biontech-moderna-vaccines-in-december-pay-10b-for-doses

Mesoblast in deal with Novartis to develop COVID-19/ARDS stem cell therapy

 

• Mesoblast (NASDAQ:MESO) surges 17% after entering into an exclusive worldwide license and collaboration agreement with Novartis (NYSE:NVS) for the development, manufacture and commercialization of Mesoblast’s remestemcel-L, with an initial focus to develop treatment for acute respiratory distress syndrome (ARDS), associated with COVID-19.
• Novartis will make a $50M upfront payment including $25M in equity.
• From the initiation of a Phase 3 trial in all-cause ARDS, Novartis will fully fund global clinical development for ARDS and other respiratory indications.
• Mesoblast may receive pre-commercialization milestone payments of $505M for ARDS indications, up to $750M in post-commercialization milestones and tiered double-digit royalties on product sales.
• Mesoblast will retain full rights and economics for remestemcel-L for graft versus host disease, and Novartis has an option to become the commercial distributor outside of Japan.
• For most non-respiratory indications, the parties may co-fund development and commercialization on a 50:50 profit-share basis.
• Mesoblast will be responsible for manufacturing and Novartis will purchase commercial product under agreed pricing terms.
• NVS will reimburse Mesoblast up to $50M on the achievement of certain milestones.
• Novartis intends to initiate a Phase 3 study in non-COVID-19-related ARDS after closing of the license agreement and successful completion of the study.
• On Nov. 11, Mesoblast gets recommendation to continue Covid-19 ARDS trial without any modifications.
• https://seekingalpha.com/news/3638221-mesoblast-inks-deal-novartis-to-develop-covidminus-19-ards-stem-cell-therapy-sharesplus-17