FDA authorizes Pfizer's Covid treatment pill, the first oral antiviral drug cleared during the pandemic The Food and Drug Administration granted emergency authorization Wednesday to Pfizer's Covid treatment pill, a major milestone that promises to revolutionize the fight against the virus. The medication, which is recommended for people at a high risk of developing severe Covid-19, could be available to patients as early as this weekend. Pfizer CEO Albert Bourla told CNBC earlier this month the company has already shipped some of the pills to the U.S. so they can be prescribed as soon as the FDA authorization comes through. The Centers for Disease Control and Prevention is expected to quickly follow suit with its seal of approval, authorizing its distribution. The FDA cleared the pill for patients 12 and up with mild to moderate Covid who are most likely to end up hospitalized or not survive. The agency said it should be prescribed as soon as possible after diagnosis and within five days of symptom onset. "Today's authorization introduces the first treatment for COVID-19 that is in the form of a pill that is taken orally — a major step forward in the fight against this global pandemic," Dr. Patrizia Cavazzoni, director of the FDA's Center for Drug Evaluation and Research, said in a statement. "This authorization provides a new tool to combat COVID-19 at a crucial time in the pandemic as new variants emerge and promises to make antiviral treatment more accessible to patients who are at high risk for progression to severe COVID-19." The company reiterated Wednesday that it's ready to start delivery in the U.S. immediately. Pfizer's pill is the first oral antiviral drug authorized by the FDA that is specifically designed to fight Covid. The authorization comes at a crucial turning point in the pandemic, as hospital systems across the U.S. have been battered by a wave of delta infections, and are now bracing for another wave of patients infected with the highly contagious omicron variant. While the FDA said vaccines are the first line of defense against Covid, the drug provides a new tool in its fight against the virus. While the vaccines have proven effective in preventing severe illness from the virus, health-care providers need medications to treat the tens of millions of people in the U.S. who still have not gotten vaccinated. The pill, if delivered in time, could help alleviate the strain on health-care systems during an expected wave of omicron infections. Dr. Paul Offit, director of the Vaccine Education Center at the Children's Hospital of Philadelphia and an FDA advisor, said that the development is good news, but immunizing unvaccinated people remains the ultimate goal. "Would you be more likely to take this drug than you would to get a vaccine? I think the answer to that question is yes," Offit said in a phone interview. "So therefore it is of value for those 40 million, 50 million people in this country who simply refuse to be vaccinated. I mean, this may keep them out of the hospital." The U.S. has purchased 10 million courses of Pfizer's treatment, Paxlovid, in a $5 billion deal. President Joe Biden said in November that his administration is working to ensure that the treatments are free and accessible. Biden said last month that delivery would start by the new year and continue through 2022. Merck has contracted with the U.S. government to supply at least 3 million courses of its pill, molnupiravir, which is still awaiting clearance, for $2.2 billion. The FDA declined to comment on Merck's drug. Pfizer's treatment is administered in two 150 milligram tablets along with a 100 milligram tablet of an HIV drug, ritonavir, twice daily. The HIV drug helps slow the patient's metabolism, which allows Paxlovid to remain active in the body at a higher concentration for a longer period. Merck's 800 milligram pill is taken every 12 hours for five days after symptom onset. The drug was developed with Ridgeback Biotherapeutics.
Stoney, Take note. If you ever volunteer for one of these tests, be nice to the folks or you might end up getting "the dummy pill". The FDA based its decision on company results from a 2,250-patient trial that showed the pill cut hospitalizations and deaths by 89% when given to people with mild-to-moderate COVID-19 within three days of symptoms. Less than 1% of patients taking the drug were hospitalized and none died at the end of the 30-day study period, compared with 6.5% of patients hospitalized in the group getting a dummy pill, which included nine deaths.
Stoney!!!!! Could ELYS be next? $3.43 Flutter Buys Italian Online Gaming Operator for GBP1.62B Published: Dec. 23, 2021 at 2:19 a.m. ET By Michael Susin Flutter Entertainment PLC said Thursday that it has acquired the Italian online gaming operator Sisal from CVC Capital Partners Fund VI for 1.62 billion pounds ($2.16 billion). The Dublin-based gambling group said it expects the deal to be financially enhancing to adjusted earnings in the first year after the acquisition. The transaction is likely to be completed during the second quarter of 2022, it said. The company said Sisal expects to deliver earnings before interest, taxes, depreciation and amortization of GBP211 million for the 12 months to December 2021. +++++++++++++++++++++++++++++++++++++++ Paddy Power owner Flutter Entertainment has bought Milan-based online gaming group Sisal (PA) (PA Wire) Paddy Power and Betfair owner Flutter Entertainment has bought Milan-based online gaming group Sisal for £1.62 billion as it looks to take pole position in the Italian market. Flutter’s acquisition of Sisal from buyout firm CVC Capital Partners will add to its existing presence in Italy through PokerStars and Betfair, giving it a combined online market share of 20%. It said it has been pursuing a deal to lead the Italian market “for some time”, further tapping into the country’s £16 billion gaming sector, which is the second largest regulated gambling market in Europe after the UK. Sisal is the top online gaming group in Italy, with 300,000 average monthly online players and more than 9.5 million retail customers.
Stoney!!!!!! My granny stock Abbott just painted $140 for an all-time high. $122----->$140 From October: Stoney & VZ at the gym. Stoney wearing gray. vvvvvvvvvvvvvvvvvvvvvvvvv
BLDR is a rock star. We bought it later than that though. Wasn't it $69? I have it in my wife's acct- She wants me to buy this Louis Vuittan stk.. I am on a fence here-- I made a big bet on retail already-- I used to be in retail- I thought I knew the sector pretty well. But I forgot about this stupid child credit BS on taxes.. Apparently all of America is going to be spending $300 extra in expenses next month...
VERY ABBREVIATED DAY I GOT TO HIT THE ROAD--- --Planet Labs CEO buys $124.4K in common stock 08:24 PL In a regulatory filing, Planet Labs disclosed that its CEO William Marshall bought 19.2K shares of common stock in a total transaction size of $124K on December 22nd. Shares of Planet Labs are up 3.9% in pre-market trading at $6.60 per share.
WATCH- HOLX- Hologic launches Pnather Trax for high volume molecular testing 08:13 HOLX I noticed yesterday a big searched stk was ARQT I kept thinking it was that battery recycling stk it's not... This you could probably gummy today I imagine.- Arcutis Biotherapeutics secures $225M in non-dilutive debt financing 08:10 ARQT Arcutis Biotherapeutics announced that it has obtained a $225M term loan facility from funds managed by SLR Capital Partners. This additional capital further strengthens Arcutis' balance sheet in advance of a potential 2022 Food and Drug Administration approval and launch of topical roflumilast cream in plaque psoriasis, and in advance of three 2022 pivotal clinical data readouts in atopic dermatitis, seborrheic dermatitis, and scalp psoriasis. This non-dilutive financing commitment extends the Company's cash runway into 2024. Under the terms of this loan facility, $75M was drawn at closing, and an additional $125 million becomes available upon FDA approval of roflumilast cream for the treatment of plaque psoriasis. An additional $25M is also available if certain revenue milestones are achieved. The loan facility maturity date is January 2027, with the interest-only period extending for the entire five years. The loan facility is secured by the Company's assets.
WHAT! Ayr Wellness opens 43rd Florida location in Eustis 08:04 AYRWF Eustis? Is this a typo.... or where I'm retiring? (I'm sure they mean 3rd)
Portfolio Position-> Opko Health announces results from Phase 2 trial of RAYALDEE 08:02 OPK This stock will be the Death of me. Kornit Digital named Top Pick for 2022 at Needham » 07:24 KRNT I can't even tell you...