Roche says faricimab meets goals in trial against rivals' Eylea

 Swiss drugmaker Roche said on Monday its experimental eye medicine faricimab matched Bayer and Regeneron’s Eylea against diabetic macular degeneration in acuity gains in two studies, including one in which patients had less-frequent shots.

“More than half of participants in the faricimab personalised dosing arms had extended time between treatments to 16 weeks at year one – the first time this level of durability has been achieved in a phase III diabetic macular edema study,” Roche said in a statement.

https://www.reuters.com/article/roche-faricimab/roche-says-faricimab-meets-goals-in-trial-against-rivals-eylea-idUSKBN28V0JM

Germany says joint European response to new coronavirus strain needed

 The European Union needs to respond jointly and in a coordinated fashion to a new coronavirus strain that was first reported in Britain to limit its spread to other states, Germany’s foreign minister said on Monday.

“We will coordinate very closely among European Union member states on the next steps, in particular on how these measures will be designed beyond Dec. 31,” Heiko Maas told a video news conference. It was very important that any regulation be applied in all EU countries that it should be impossible to circumvent, he added.

https://www.reuters.com/article/us-health-coronavirus-britain-germany/germany-says-joint-european-response-to-new-coronavirus-strain-needed-idUSKBN28V167

Amazon shuts NJ facility til Dec. 26 on virus spike among workers

 Amazon.com Inc said on Sunday it had closed one of its warehouses in New Jersey out of caution till Dec. 26, after seeing an increase in asymptomatic positive cases amongst workers.

“Through our in-house COVID-19 testing program, we detected an increase in the number of asymptomatic positive cases at our PNE5 facility in northern New Jersey and have proactively closed the site until December 26th out of an abundance of caution,” an Amazon spokeswoman said in a statement to Reuters.

Amazon, the world’s largest online retailer, said it isn’t anticipating any impacts to operations or deliveries due to this shutdown.

It did not specify the number of workers who contracted the disease at its PNE5 facility, which is a sorting center.

The company, however said, that its employees will be paid for the shifts that they miss because of the shutdown of the facility.

In October, Amazon said more than 19,000 of its U.S. frontline workers contracted the coronavirus this year, or 1.44% of the total, a disclosure sought by labor advocates who have criticized the COVID-19 response of the company.

Some staff, elected officials and unions in recent months have said Amazon put its employees’ health at risk by keeping warehouses open during the pandemic.

The company had said it would expand virus testing to 50,000 U.S. employees per day by November through internally built capacity.

https://www.reuters.com/article/us-health-coronavirus-amazon-com-warehou/amazon-shuts-new-jersey-facility-till-dec-26-on-virus-spike-among-workers-idUSKBN28V06J

Who's next in line to receive a coronavirus vaccine?

 

• As trucks began delivering Moderna's (NASDAQ:MRNA) shot to health departments, hospitals and other vaccination sites on Sunday, a Centers for Disease Control and Prevention panel voted on the next groups to receive inoculations.
• Vaccination is already underway in the U.S. - via the Pfizer (NYSE:PFE) jab - for the so-called phase 1a group, which includes at least 24M healthcare workers and long-term care facility residents.
• The 1b group, estimated to cover about 49M people, or nearly 15% of Americans, would encompass "frontline essential workers" (i.e. teachers, police and firefighters, grocery workers) and people 75 years of age.
• Phase 1c will broaden eligibility to another 129M people, including persons between the ages of 65 and 74, people between the ages of 16 and 64 who have high-risk underlying conditions and remaining "essential workers."
• If accepted by the CDC director, the committee's recommendations will set federal guidance, though state officials are charged with the final say on distribution.
• https://seekingalpha.com/news/3646051-next-in-line-to-receive-coronavirus-vaccine

No stimulus cheer as new COVID strain intensifies selloff

 

• Lawmakers from both parties announced Sunday night that they finally reached an agreement on a $900B coronavirus spending package to bolster the U.S. economy.
• It would be one of the largest economic relief bills in the nation's history, second only to the $2.2T CARES Act passed back in March.
• The legislation includes $600 in direct payments to individuals and $300 per week of enhanced unemployment benefits, as well as funding for small business, vaccine distribution, food assistance, education and child care. It also covers rental relief and extends the nationwide eviction moratorium through January 31, 2021.
• The House it expected to vote on the bill today, followed by the Senate, and while that was supposed to be a catalyst for the market's next move higher, U.S. stock futures are going in the other direction. Dow -2%; S&P 500 -2.2%; Nasdaq -1.5%.
• What happened? Traders are nervously watching a new COVID-19 mutation in the U.K., which has resulted in a tough lockdown in London and southeast England, and led a number of countries to block travel from Britain.
• The variant is thought to be up to 70% more transmissible than the original strain of the disease and it has so far been identified in the Netherlands, Denmark and Australia.
• The Euro Stoxx 50 is off 3.6% on the news, with shares of travel and leisure stocks leading losses. Oil also went into reverse on demand worries, tumbling 5.8% to $46/bbl.
• https://seekingalpha.com/news/3646065-no-stimulus-cheer-new-covid-strain-intensifies-selloff

ViiV, Janssen's cabotegravir + rilpivirine wins marketing approval in Europe for HIV

 

• ViiV Healthcare announces the authorization of Vocabria (cabotegravir injection and tablets) in combination with Johnson & Johnson (NYSE:JNJ) unit, Janssen Pharmaceuticals' Rekambys (rilpivirine injection) and Edurant (rilpivirine tablets), in the European Union (EU), for the treatment of HIV-1 infection in adults who are virologically suppressed.
• Cabotegravir and rilpivirine injections could reduce the number of days of treatment per year from 365 down to 12 for the once-monthly, or 6 for the once every 2-months dosing regimen.
• This announcement marks the second marketing authorization of the long-acting regimen of cabotegravir and rilpivirine, with once-monthly dosing licensed by Health Canada under the brand name Cabenuva for the treatment of HIV-1 infection.
• ViiV Healthcare is the HIV-focused joint venture between GlaxoSmithKline (NYSE:GSK), Pfizer (NYSE:PFE) and Shionogi (OTCPK:SGIOY).
• In July, ViiV Healthcare resubmitted the NDA for once-monthly dosing of cabotegravir and rilpivirine to the FDA, and further regulatory applications have been submitted and are being reviewed by other regulatory bodies worldwide.
• https://seekingalpha.com/news/3646055-viiv-janssens-cabotegravir-rilpivirine-wins-marketing-approval-in-europe-for-hiv-treatment

Vaccine cuts for several U.S. states due to FDA confusion

 

• Officials with Operation Warp Speed had to slash the number of COVID-19 vaccine doses for several states in America due to confusion over the FDA's certificate of analysis requirement for vaccine rounds, CNBC reports.
• The federal government’s error disrupted vaccination distribution plans in at least 14 states. Washington state, New Jersey, Virginia, Idaho, Michigan, Connecticut, California, Nevada, Minnesota, Wisconsin, Vermont, Massachusetts, Iowa and Oregon will experience a smaller number doses than expected.
• The agency mistakenly assumed Pfizer’s (NYSE:PFE) vaccine was ready to ship when there was actually a two day lag period in which the FDA requires a certificate of analysis on each set of vaccines, said Dr. Moncef Slaoui, chief advisor of Operation Warp Speed.
• “That lag period has resulted in differences in the plan and what was actually done,” Slaoui said Sunday in an interview to CNN.
• A certificate of analysis is required for each round of vaccine at least 48 hours prior to distribution, but doesn’t require the certificate to be reviewed prior to shipment.
• “The mistake I made is not understanding with exactness — again my responsibility — on all the steps that have to occur to make sure the vaccine is releasable,” Operation Warp Speed Chief Operating Officer Gen. Gustave Perna said at a press briefing.
• U.S. shipped 2.9M doses of COVID-19 vaccines last week, with 2M doses allocated for this coming week's shipment. Officials also plan to send out 5.9M doses of Moderna’s (NASDAQ:MRNA) vaccine this week.
• https://seekingalpha.com/news/3646046-vaccine-cuts-for-several-u-s-states-due-to-fda-confusion