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One of the two drugs in the antiviral cocktail could cause serious interactions with widely used prescriptions, including statins, blood thinners and some antidepressants...the first antiviral pills for Covid-19 promise desperately needed protection for people at risk of severe disease. However, many people prescribed Pfizer’s or Merck’s new medications will require careful monitoring by doctors and pharmacists, and the antivirals may not be safe for everyone, experts caution...could cause severe or life-threatening interactions with widely used medications, including statins, blood thinners and some antidepressants. And the FDA does not recommend Paxlovid for people with severe kidney or liver disease...READ MORE

A booster shot of Moderna's authorized coronavirus vaccine significantly increases antibody levels against the omicron variant, according to the results of laboratory tests the company disclosed... The update comes days after another analysis indicated the initial two-shot regimen is less effective at neutralizing omicron than other variants like delta...As a result of the booster's apparent cross-protection against multiple variants, Moderna said it will focus its efforts away from a more complex "multivalent" shot and toward further study of its existing booster dose formulation. The biotech said it will still develop an omicron-specific booster, however, and aims to begin clinical testing of that in early 2022...READMORE

Drugs like AbbVie's Lupron, used to treat children with a condition that triggers premature puberty, have also gained use by transgender kids and their parents to forestall the development of sexual features...Hormone blockers, used to treat children with a condition that triggers premature puberty, have also gained use by transgender kids and their parents to forestall the development of sexual features. But Texas Attorney General Ken Paxton is taking issue with that trend...Texas...is investigating makers of the drugs, Endo and AbbVie, for allegedly promoting them outside of their FDA approved use without disclosing their risks...In Texas, Paxton is employing the Texas Deceptive Trade Practices Act to launch the investigation. The probe centers on AbbVie's Lupron Depot plus Endo's Supprelin LA and Vantas...The drugs are "being used to treat gender dysphoria even though they are not approved for such use," Paxton's office said in a statement...READ MORE 

Two doses of the Pfizer/BioNTech vaccine ‘may not be sufficient’ to protect against infection with the Omicron variant; but three doses of the vaccine neutralize the variant, according to a preliminary laboratory study released by the companies...it is the first data to indicate whether existing COVID-19 vaccines are likely to protect against the Omicron variant or not...Meanwhile, Pfizer and BioNTech say a variant-specific vaccine could be ready by March should it prove to be needed to increase the level and duration of protection against Omicron...READMORE

Paxlovid and molnupiravir are the first oral treatments for COVID-19, potentially valuable new tools as the fast-spreading omicron variant fuels a sharp surge in cases across the U.S...The Food and Drug Administration...authorized the first pill for COVID-19, clearing for emergency use an antiviral treatment from Pfizer at a precarious moment in the two-year-old pandemic. One day later...the agency cleared a second pill developed by Merck & Co...READ MORE

COVID-19 vaccines from Pfizer and Moderna should be "preferred" over Johnson & Johnson's shot, a U.S. government advisory panel said...after reviewing data on potentially dangerous blood vessel blockages from clotting associated with J&J's vaccine. The recommendation follows a strengthened warning the Food and Drug Administration added to the shot...The recommendation from the Centers for Disease Control and Prevention's advisory panel...is likely to further constrain use of J&J's vaccine...READ MORE

A federal judge overturned a roughly $4.5 billion settlement that legally shielded members of the Sackler family who stand accused of helping fuel the U.S. opioid epidemic, a decision that threatened to upend the bankruptcy reorganization of their company, OxyContin maker Purdue Pharma LP...U.S. District Judge...said...the New York bankruptcy court that approved the settlement did not have authority to grant the Sacklers the legal protection from future opioid litigation that formed the linchpin of Purdue’s reorganization...READ MORE

The revised regulations mean providers can prescribe and mail abortion medication to patients without an in-person appointment in more than half the country...The U.S. Food and Drug Administration...modified its restrictions on mifepristone, one of the medications used in abortion. The new regulations enable abortion via telemedicine in more than half of the country...The permanent modification of the requirement means that abortion providers in many states will be able to send medication to patients via mail-order pharmacy, bridging some access gaps in places with few in-person clinics or burdensome multi-appointment waiting period rules...some researchers and advocates have noted that the FDA left in place some certification components for providers and pharmacies, as well as patient agreements...READMORE

Nevada health officials have confirmed the state’s second confirmed case of the coronavirus caused by the highly transmissible omicron variant, this time in a rural county...The second case was found in Churchill County in northern Nevada and involved an unvaccinated woman in her mid-40s, according to the Nevada State Public Health Laboratory...READ MORE

As the omicron variant sweeps through South Africa, Dr. Unben Pillay is seeing dozens of sick patients a day. Yet he hasn’t had to send anyone to the hospital...That’s one of the reasons why he...suspect that the omicron version really is causing milder COVID-19 than delta, even if it seems to be spreading faster...“They are able to manage the disease at home,” Pillay said of his patients. “Most have recovered within the 10 to 14-day isolation period.” said Pillay...In the two weeks since omicron first was reported in Southern Africa, other doctors have shared similar stories. All caution that it will take many more weeks to collect enough data to be sure, their observations and the early evidence offer some clues...READMORE