Regulatory

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…

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 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…

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…

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 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…

Senate finance Committee members Elizabeth Warren (D-MA) and Bill Cassidy (R-LA) are pushing to have a hearing to discuss the Medicare coverage of Aduhelm (aducanumab), Biogen’s controversial Alzheimer’s treatment, which recently won FDA approval. In a letter addressed to Senate Finance chair Ron Wyden (D-OR) and ranking member Mike Crapo (R-ID), Warren and Cassidy express…

The West Virginia Senator Joe Manchin III (D-W. Va) sent a letter to President Joe Biden expressing his dismay regarding the FDA’s approval of Aduhelm (aducanumab), the controversial Alzheimer’s treatment from Biogen (NSDQ:BIIB). The nonprofit watchdog group Public Citizen sent a broadly similar letter to HHS Secretary Xavier Becerra to “express its outrage” over the approval and to demand…

Another large amount of doses of Johnson & Johnson’s COVID-19 vaccine produced at an embattled manufacturing plant reportedly have to be thrown out. The New York Times reported that the FDA told J&J that about 60 million doses of the single-dose vaccine produced at Emergent BioSolutions’ Baltimore plant can’t be used because of possible contamination.…