Any decision on whether to expand a five-year World Trade Organization (WTO) waiver of intellectual property rights for COVID-19 vaccines to diagnostics and therapies likely will be delayed longer than proponents had hoped. WTO members originally were scheduled to vote on expanding the waiver in December, but the deadline was extended indefinitely when key members, including the U.S., pushed for a delay.
A lot of biosimilar sponsors and wannabes will be watching as the Humira biosimilar competition unfolds in the U.S. While the competition started Jan. 31 with the launch of Amgen Inc.’s Amjevita, the true test of the strength of the competition will come in five months when other adalimumab biosimilars, including Boehringer Ingelheim GmbH’s interchangeable, hit the market.
Neither the courts nor the Department of Health and Human Services (HHS) get to fill in the gaps in the law that created the 340B prescription drug discount program, the U.S. Court of Appeals for the Third Circuit said, as it struck down HHS’ interpretation that requires drug companies to provide the drug discounts to an unlimited number of contract pharmacies.
A Jan. 27 settlement the U.S. SEC reached with a former vice president at a biotech company serves as a reminder that insider trading rules applies to suppliers as well as the companies involved in an M&A.
Taking aim at big pharma’s current penchant for acquisition over in-house innovation, Sen. Elizabeth Warren (D-Mass.) is asking the Federal Trade Commission (FTC) to consider the impact a biopharma merger, whether it’s proposed or a done deal, may have on future innovation.
Harmonization and simplification won the day as the U.S. FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) looked toward the future of COVID-19 vaccines in the U.S. Jan. 26. The committee voted unanimously, 21-0, to recommend using the same strain composition for all COVID-19 vaccines available in the U.S., whether they’re used for primary doses or boosters. Such standardization also would align the composition of Novavax Inc.’s protein-based vaccine with that of the mRNA vaccines produced by Moderna Inc. and Pfizer Inc.-Biontech SE.
As the SARS-CoV-2 virus that’s responsible for COVID-19 continues to evolve across the world, a global response, similar to what’s used with influenza, would be ideal in evaluating and recommending vaccine strain composition changes from year to year. But “the current diversity of vaccine manufacturers and complexities in global supply of COVID-19 vaccines would make a globally coordinated, simultaneous vaccine composition evaluation and recommendation quite challenging,” the U.S. FDA said in its briefing document for the Jan. 26
meeting of the Vaccine and Related Biological Products Advisory Committee.
Long before the U.S. Congress approved a path for importing prescription drugs from Canada to take advantage of their cheaper price, Poornanand Palaparty, an oncologist in Ohio, purchased cancer drugs from a Canadian distributor from 2004 to 2009. Now, nearly a decade after Palaparty pleaded guilty in 2013 to introducing misbranded drugs into the U.S., the FDA is debarring the doctor based on that federal misdemeanor.
As the FDA has in the past when a court issued an opinion it didn’t agree with, the U.S. agency is trying to limit the fallout from an appellate court ruling in Catalyst Pharmaceuticals Inc. vs. Becerra, which involved the breadth of orphan drug exclusivity, to that case alone.
Just as the U.S. mpox public health emergency declaration is about to end, the FDA is releasing a draft guidance on developing drugs and biologics to treat infections caused by the virus.
