Regulatory

The Centers for Medicare & Medicaid Services (CMS) released a national policy regarding coverage for Aduhelm (aducanumab). Controversy has surrounded the Alzheimer’s drug Aduhelm from Biogen (NSDQ:BIIB) and Eisai (TYO:4523) since the FDA’s fast track approval last year. Three members of an FDA advisory committee resigned after the approval. About a week later, nonprofit watchdog group Public Citizen called for high-profile resignations of…

Novartis announced that it received FDA approval for its Vijoice (alpelisib) PIK3CA-Related Overgrowth Spectrum (PROS) treatment. Basel, Switzerland-based Novartis said in a news release that Vijoice is the first FDA-approved treatment for PROS, a spectrum of rare conditions characterized by overgrowth in blood vessel anomalies. FDA approval followed real-world evidence from the EPIK-P1 retrospective chart…

Ariste Medical recently won FDA 510(k) clearance for its drug-embedded, polypropylene hernia mesh to fight microbial colonization. The Salt Lake City-based drug-device developer said the patents and proprietary formulations behind the technology could prevent infection, inflammation or clotting associated with implants. Ariste’s synthetic mesh carries two antibiotics — minocycline and rifampin —  to prevent contamination…

Amazon appears to have growing troubles around herbal supplements sold on its site. The online retail giant has informed the herbal supplement company Celebrate Today (Brentwood, New York) that its Red Mammoth pills were tainted with sildenafil and tadalafil, both of which are FDA-regulated drugs for erectile dysfunction and other conditions. Similarly, Amazon announced that…

Moderna (NSDQ:MRNA) announced today that it received full FDA approval of the biologics license application for its COVID-19 vaccine. FDA’s approval for the company’s Spikevax mRNA COVID-19 vaccine covers the prevention of the virus in individuals aged 18 years or older. Moderna submitted for full FDA approval back in June 2021 and becomes the second…

The FDA announced earlier this week that it made some temporary changes to its inspectional activities due to COVID-19. With the omicron variant of the virus causing surges across the world, the FDA implemented the changes in the U.S. on Dec. 29, 2021, to ensure the safety of its employees and the firms it regulates,…

Colleen McMahon of the U.S. District Court for the Southern District of New York overturned a sweeping settlement against Purdue Pharma over its role in the opioid crisis. Purdue’s Oxycontin (oxycodone) is among the most widely used opioids. In September, Judge Robert Drain of the U.S. Bankruptcy Court in White Plains, New York, authorized a…

The FDA has decided to allow dispensing of mifepristone from Danco Laboratories by mail using certified prescribers of pharmacies. The move also allows dispensing of the drug via telemedicine. The agency had previously required that individuals obtain the abortion drug mifepristone (Mifeprex) in person. FDA notes that the mail-order distribution model became popular during the pandemic, leading…

Novo Nordisk (NYSE:NVO) has agreed in principle to settle securities class action litigation in the Federal District Court of New Jersey. The Bagsværd, Denmark–based company would pay $100 million in the settlement. That amount includes plaintiffs’ attorneys’ fees, expenses and settlement costs. The lawsuit alleged that the company made misleading statements regarding the price of its…

The nonprofit watchdog group Public Citizen has filed a lawsuit on behalf of the Post-Finasteride Syndrome Foundation (PFSF), which, in 2017, petitioned the FDA to pull the hair loss drug Propecia (finasteride) from the market. The lawsuit, which was filed in the U.S. District Court for the District of Columbia, asks the court to force FDA to issue…