Regulatory

Earlier this year, we took a look at the most common causes of drug-related recalls in 2022 and the first quarter of 2023. Now, we are expanding our lens to examine drug-related FDA recalls from 2011 to 2023. Understanding the recall landscape In recent decades, prominent incidents like the Tylenol poisonings in 1982 have underscored…

A federal judge ruled against two defendants accused of selling counterfeit HIV medications, denying their motions to lift existing asset freezes obtained by pharmaceutical company Gilead Sciences in the ongoing lawsuit. Judge Ann M. Donnelly of the United States District Court for the Eastern District of New York converted the temporary asset freezes into preliminary…

Harm Reduction Therapeutics announced that it received FDA approval for its over-the-counter RiVive naloxone nasal spray. Pittsburgh-based HRT designed the 3 mg naloxone HCl nasal spray for the emergency treatment of opioid overdose. Approval helps make free or low-cost OTC nasal spray widely available in the U.S. The FDA first approved Narcan 4 mg OTC…

A U.S. bankruptcy judge in New Jersey has dismissed a Johnson & Johnson-created company’s bankruptcy filing to resolve talc-related lawsuits. Judge Michael Kaplan’s ruling on July 28 was similar to a U.S. Court of Appeals for the Third Circuit ruling months ago, which failed to find immediate financial distress over the lawsuits. As recounted in…

Johnson & Johnson continues to face legal challenges over allegations that its talcum powder causes cancer. Recently, a judge dismissed the company’s latest attempt to settle thousands of lawsuits through bankruptcy, marking the second time J&J’s bankruptcy strategy has been rebuffed. We take a look at the timeline of the talc litigation below. Johnson &…

In a recent move, Astellas Pharma challenges IRA, a step that sees them join other pharmaceutical heavyweights in a lawsuit against the federal government. The bone of contention is the Inflation Reduction Act (IRA), a law primarily designed to drive down prescription drug prices, a proposition that no Republican supported. Astellas, along with the other…

Respiratory syncytial virus (RSV) is a common cause of severe lower respiratory tract infections like pneumonia and bronchiolitis in infants and young children. Traditionally there have been no approved treatments for RSV infections, with care being largely supportive. But the landscape is quickly changing. The FDA recently approved Beyfortus (nirsevimab), the first immunoprophylactic to prevent…

Novartis has agreed to sell ophthalmology assets to Bausch + Lomb for an upfront payment of $1.75 billion, with potential milestone payments of up to $750 million. The total value of the deal could reach $2.5 billion. Novartis expects the deal to improve their focus more on higher-margin drugs. Under the terms of the deal,…

Big Pharma firms Merck and Bristol Myers Squibb are challenging President Biden’s Inflation Reduction Act, alleging the law’s plan to lower drug prices infringes on their rights. The U.S. Chamber of Commerce — whose members include drugmakers AbbVie and Eli Lilly — is also aiming to block Medicare from rolling out the program. In 2022,…

In a strong move against the federal government, Merck & Co., based in Kenilworth, New Jersey, has launched a lawsuit against the Inflation Reduction Act (IRA). The firm has retained the services of prominent law firm Jones Day, at times known for its assertive litigation style. In recent years, the firm has also been involved…