Britain to make Pfizer COVID-19 pill available starting in February

 Great Britain will begin its rollout of Pfizer’s antiviral COVID-19 pill in February, the United Kingdom Department of Health and Social Care announced Friday.

The antiviral will be available to those with “weakened immune systems” beginning on Feb. 10. The U.K. has procured 4.98 million courses of the antivirals and 2.23 courses of molnupiravir specifically.

“It is fantastic news that this new treatment, the latest cutting-edge drug that the NHS is rolling out through new COVID-19 medicine delivery units, will now be available to help those at highest risk of COVID-19,” said NHS National Medical Director Professor Stephen Powis.

The department reported that clinical trials showed an 88 percent decrease in hospitalization or death when a person was treated with the antiviral.

Antiviral medication is already available to the highest risk COVID-19 patients, and almost 10,000 patients have been treated thus far.

“Our pharmaceutical defences are crucial as we learn to live with COVID-19,” said Health and Social Care Secretary Sajid Javid. “And the UK is leading the way, especially when it comes to the use of cutting-edge antivirals.”

The Pfizer pill was conditionally approved Thursday by the European Medicines Agency for use among high-risk patients in the European Union. It was authorized by the U.S. Food and Drug Administration last month.

https://thehill.com/blogs/blog-briefing-room/591839-britain-to-make-pfizer-covid-19-pill-available-starting-in-february

Gottlieb: US should be 'aggressive' in lifting COVID-19 measures as conditions improve

 Former FDA Commissioner Scott Gottlieb said in an interview on Friday that there should be very clear goalposts for how the U.S. removes current mitigation measures and when to lift vaccine mandates.

During an appearance on MSNBC's "Morning Joe," Gottlieb told co-anchor Willie Geist that he thinks COVID-19 infection levels are "going to continue to come down as we get into the spring and the summer" and the U.S. needs to think about removing some of the restrictions currently in place.

He added that people will resume their normal lives "hopefully this spring" and said that "we don't see anything on the horizon that's going to dramatically alter that trajectory." 

However Gottlieb added the caveat that the delta variant "surprised us last year." 

He noted that there was "much more immunity in the population" this year owing to the existing immunity from infections caused by the delta and omicron variants and high vaccination rates against COVID-19.

"I think we need to prescribe very clear goalposts for how we take these mitigation measures off. When do we lift the vaccine mandates? When do we stop using masks in schools?" he said.

He added that the U.S. should be "willing to relax some of these provisions that have created a lot of acrimony," particularly mask requirements and other provisions in schools.

Gottlieb added that "we want our kids to try to get back to some kind of semblance of normalcy."

He said the U.S. should be "as aggressive" in lifting precautionary measures as conditions improve as "we were about putting them in place."

According to Gottlieb, removing the existing measures will help "preserve the authority among public health officials to re-implement some measures in the future," if COVID does return next winter.

Between Jan. 15 and Jan. 19 the the U.S. seven-day average of new cases fell from about 798,000 to about 744,000, according to Centers for Disease Control and Prevention (CDC) data. This downtick, the first since mid-December, has sparked widespread optimism that the omicron wave in the country has peaked.

“Overall nationally the case numbers are coming down, which I consider an optimistic trend,” CDC Director Rochelle Walensky said in a press briefing last Friday.

https://thehill.com/homenews/media/591823-gottlieb-us-should-be-aggressive-in-lifting-covid-measures-as-conditions

Applied DNA to Deploy Linea COVID Assay for New Omicron Subvariant BA.2

 - Announcement Follows First Cases of BA.2 Identified in New York State Where the Majority of COVID-19 Testing Clients Reside -

- Linea 1.0 Assay’s Unique Double S-gene Target Design Likely Allows for the Identification of Samples that Contain a Mutation Profile Indicative of BA.2 -

Applied DNA Sciences, Inc. (NASDAQ: APDN) (the "Company"), a leader in Polymerase Chain Reaction (PCR)-based DNA manufacturing and nucleic acid-based technologies, announced today that its wholly-owned clinical laboratory subsidiary, Applied DNA Clinical Labs, LLC (ADCL), intends to deploy its Linea™ 1.0 COVID-19 Assay (the "Linea 1.0 Assay" or the "Assay"), part of ADCL’s Linea COVID-19 diagnostics and testing portfolio, for the rapid detection of samples containing a mutation profile that is indicative of the BA.2 subvariant (BA.2) of Omicron in COVID-19-positive samples.

ADCL believes the Linea 1.0 Assay has clinical utility as a genomic surveillance solution to enable public health authorities to detect and assess BA.2 spread via the reflex testing of COVID-19 positive samples with the Linea 1.0 Assay. When used as a reflex test, the Company believes the Linea 1.0 Assay allows for the rapid and inexpensive identification of positive COVID-19 samples that are indicative of BA.2 relative to costly and time-consuming next-generation sequencing.

First identified in November 2021, BA.2 is a descendant of the Omicron variant (BA.1) but differs in some of its genetic traits, including certain mutations in the spike protein, which may make it somewhat harder to detect via S-gene target failure ("SGTF") on certain third-party assays. SGTF was used globally to track the spread and prevalence of the Omicron variant (BA.1). In silico analysis of the BA.2 subvariant conducted by ADCL indicates that BA.2 will likely result in a unique detection signature on the Linea 1.0 Assay that is distinct from BA.1 and other currently circulating SARS-CoV-2 variants of concern and/or interest. The Linea 1.0 Assay’s ability to identify samples containing a mutation profile indicative of BA.2 via SGTF is possible due to the Assay’s unique double S-gene target design.

https://finance.yahoo.com/news/applied-dna-deploy-linea-1-161000945.html

Quest cut to Hold from Buy by Deutsche Bank

 Target to $129 from $190

https://finviz.com/quote.ashx?t=DGX&ty=c&ta=1&p=d

ResMed upped to Sector Perform from Underperform by RBC

 Target to $241 from $234

https://finviz.com/quote.ashx?t=RMD

Kaiser poll: 62 percent who tried to find at-home COVID-19 test had difficulty

 A new poll finds that more than 60 percent of U.S. adults who tried to get an at-home COVID-19 test reported difficulty doing so, underscoring problems with testing access.  

The survey from the Kaiser Family Foundation found that 62 percent of U.S. adults who tried to get an at-home coronavirus test in the past month had difficulty, compared to 38 percent who found it easy.  

The results were better for in-person tests, with 65 percent saying it was easy and 35 percent difficult. But experts have pointed to the value of at-home tests for their ease of use and rapid results, avoiding the need to wait days for a reading.  

The poll, which was conducted Jan. 11-23, adds some statistical rigor to anecdotal reports across the country of retailers sold out of at-home tests.  

Overall, 23 percent of adults said they tried to get either an in-person or at-home test in the past month and had difficulty, the poll found, with 24 percent trying and not having difficulty, but a majority, 52 percent, not trying at all.

The Biden administration this month has taken some steps to try to make rapid at-home tests more available. A website launched this month to allow people to order free tests shipped to their home, but there is a limit of four tests per residence. Insurers are also now required to cover the cost of eight at-home tests per month, but the reimbursement process can be cumbersome, posing an obstacle. 

Asked about responsibility for limited test availability, 49 percent put a lot or a fair amount of blame on the Food and Drug Administration, while 44 percent placed a lot or a fair amount of blame on President Biden.  

The poll also signaled some resignation with the state of the pandemic: 77 percent said it is inevitable that most people in the U.S. will eventually get COVID-19.  

The poll surveyed 1,536 U.S. adults, with a margin of error of plus or minus 3 percentage points.  

https://thehill.com/policy/healthcare/591717-poll-62-percent-who-tried-to-find-at-home-test-had-difficulty

Pfizer Gets EC OK for Lorviqua as First-Line Treatment for Lung Cancer

 Pfizer Inc. on Friday said the European Commission has approved the expanded use of Lorviqua as monotherapy for adults with anaplastic lymphoma kinase-positive advanced non-small cell lung cancer previously not treated with an ALK inhibitor.

The New York drugmaker said the approval is based on results from a Phase 3 study in which Lorviqua reduced risk of disease progression or death by 72% in newly diagnosed individuals compared to the company's Xalkori cancer treatment.

The EC in 2019 granted conditional marketing authorization for Lorviqua as a monotherapy for adults with ALK-positive advanced non-small cell lung cancer whose disease has progressed after alectinib or ceritinib as the first ALK tyrosine kinase inhibitor therapy, or crizotinib and at least one other ALK tyrosine kinase inhibitor.

Pfizer markets the drug in the U.S. under the trade name Lorbrena.

https://www.marketscreener.com/quote/stock/PFIZER-INC-23365019/news/Pfizer-Gets-EC-OK-for-Lorviqua-as-First-Line-Treatment-for-ALK-Positive-Advanced-Lung-Cancer-37674825/