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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

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

...CVS Health recently announced that it will close about 900 of its retail pharmacies. This downsizing complements the company’s shift toward its healthcare delivery future...This long-overdue move highlights the retail industry’s fundamental economic headwinds. The pharmacy shakeout is accelerating, as smaller competitors exit and larger companies reduce store count...Retail pharmacies are experiencing a period of intense competition that continues to pressure prescription profits. After years of stability, the number of U.S. pharmacy locations across all formats is trending downward...READ MORE

Here are 10 key forces behind deteriorating retail pharmacy industry margins:

1) Slow retail prescription growth and intense competition for consumers.

2) Low generic drug prices.

3) Slower growth in brand-name drug list prices.

4) Limited exposure to the dispensing of specialty drugs.

5) Reduced margins from participating in payers’ narrow retail pharmacy networks.

6) Lower reimbursement and store traffic from 90-day maintenance prescriptions.

7) Rapid growth in direct and indirect (DIR) remuneration rebates.

8) Retail pharmacy’s cost structure.

9) Growing competition from technology-enabled online pharmacies.

10) Potential Policy Changes.

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 Biden administration is doling out $30 million in unprecedented grants aimed at harm reduction strategies to combat opioid abuse, including funding for needle exchanges and fentanyl test strips..The Substance Abuse and Mental Health Services Administration announced...it is accepting applications for the harm reduction grant program, including from primary care and other types of providers. The announcement comes more than a month after recent data showed more than 100,000 people died of a drug overdose over a 12-month period...READ MORE

The Biden administration is asking the Supreme Court to preserve its vaccination mandate for healthcare workers after legal challenges in several states...The Department of Justice released a legal filing...that seeks to overturn a ruling from a federal court late last month that blocked the mandate in 10 states...a divided panel in the Eighth Circuit Court of Appeals denied the government’s motion to hold off enforcing the ruling until an appeal can be heard...This week, a federal appeals court reinstated in 26 states the administration's vaccination mandate for health workers at hospitals that receive federal funding. As it stands, the vaccine requirement for Medicare and Medicaid providers is blocked by courts in about half of U.S. states but not in the other half, creating the potential for patchwork enforcement across the country...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

A former Immunomedics executive was charged with tipping his partner and several relatives of confidential information that the biotech's then-experimental breast cancer drug had succeeded in a clinical trial, according to a suit filed by the Securities and Exchange Commission in New Jersey district court...Usama Malik, Immunomedics' chief financial officer from 2017 until late 2020, learned the drug, now sold as Trodelvy, benefited patients in the late-stage study. Within hours of being told of the trial's success, the SEC charges said, Malik relayed the news to his former girlfriend Lauren Wood and three relatives, who subsequently bought shares in Immunomedics before the results were disclosed publicly...READMORE