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,…
Federal judge throws out Purdue Pharma’s opioid settlement that protected Sackler family
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…
FDA authorizes abortion drug distribution by mail
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 settles U.S. securities class action suit
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…
Public Citizen sues FDA over Propecia side effects
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…
Automating audio records processing to manage surges in patient data
The volume of audio files that potentially contain valuable data on adverse events (AEs) has exploded, outpacing the pace pharmacovigilance (PV) operations originally anticipated in the COVID era. Healthcare company call centers, which in some instances saw up to 75% of adverse drug reaction (ADR) notifications reported through this channel, are challenged to handle this drastic…
FDA hands out warning letter over nasal antiseptic marketed as COVID-19 treatment
FDA concluded that NIH-funded BlueWillow Biologics (Ann Arbor, Mich.) had marketed an alcohol-free, over-the-counter (OTC) nasal antiseptic to “mitigate, prevent, treat, diagnose, or cure COVID-19 and other conditions in people.” The agency concluded that the NanoBio Protect product is an unapproved new drug and that the product is misbranded. FDA explained in the warning letter…
Biden and Pelosi pursuing plans to cap drug prices
President Biden has instructed FDA to develop a plan to import prescription drugs from Canada while asking federal officials to create a “comprehensive plan” to cut drug prices within 45 days. Biden has also recommended that FTC block “pay for delay” agreements from pharma companies paying generic drug makers to hold off on introducing competitive…
U.K. preps COVID-19 booster program
The U.K. is laying the groundwork for a COVID-19 vaccine booster program starting in the fall, making it one of the first nations to do so. The interim initiative would prioritize providing boosters to those 70 and older, other high-risk patients and frontline health workers starting in September. Officials at the Joint Committee on Vaccination…
Nestlé to invest up to $525M on microbiome drug
Nestlé Health Science (SWX:NESN) plans on taking a leading role in commercializing Seres Therapeutics’ (NSDQ:MCRB) experimental oral microbiome drug SER-109 for recurrent Clostridioides difficile infection (CDI). The infection from the bacteria can lead to diarrhea and, in severe cases, severe colon damage and life-threatening inflammation. More than 20,000 Americans die each year from CDI, according…