And then there were eight. That is, eight members of the U.S. CDC’s Advisory Committee for Immunization Practices (ACIP).Two days after dismissing the 17 members of the committee, Health and Human Services Secretary Robert Kennedy named eight new members to the panel. Eight is the minimum required for a quorum, which will be necessary for the June 25-27 ACIP meeting.
Three years after litigation started over technology used in an mRNA vaccine for COVID-19, Biontech SE is acquiring its adversary, Curevac NV, through an all-stock transaction valued at about $1.25 billion. The amount is lower than the $3 billion in backpay Curevac could win through the lawsuit if a low mid-single-digit royalty were awarded, Evercore ISI analysts Jon Miller and Umer Raffat said. But the legal uncertainty has weighed heavily on the company, which shed 30% of its workforce last July and sold off rights to two of its infectious disease vaccines.
When it comes to the U.S. biopharma market, pricing seems to be the driving focus of most congressional conversations – and government contracts. Rep. Cliff Bentz, R-Ore., hit pause on that conversation at a June 11 House subcommittee hearing on the drug supply chain, when he asked if the U.S. is sacrificing security for price.
Despite the June 9 gutting of the U.S. CDC’s Advisory Committee for Immunization Practices, the Department of Health and Human Services said the committee’s June 25-27 meeting will continue as scheduled. But a new panel has yet to be named, and typically ACIP members have a lot of behind-the-scenes work to do before a meeting.
With the U.S. FDA’s approval of Enflonsia (clesrovimab) to prevent respiratory syncytial virus (RSV) infection lower respiratory tract disease in newborns and infants, Merck & Co. Inc. steps into a space of competition and regulatory shifts. The preventive, long-acting monoclonal antibody (MAb)
will take its place in the market alongside the blockbuster Beyfortus (nirsevimab) from Sanofi SA and Astrazeneca plc. The MAb for pediatric use brought in about $1.77 billion in 2024.
Absent extraordinary circumstances, the Patent Trial and Appeal Board “should never cancel claims it has not determined to be unpatentable as a sanction” for misconduct during a board proceeding, according to the acting director of the U.S. Patent and Trademark Office (USPTO).
The U.K. Medicines and Healthcare products Regulatory Agency (MHRA) has issued its first official guidance on how to develop bacteriophages as licensed medicinal products. This covers personalized phage therapies designed for specific patients – at present the only form in which they are available – but also is relevant to the development of off-the-shelf products for treating common infections.
Microneedle technology could help simplify vaccine delivery to better support global immunization efforts, and Australia is leading the way in this innovative technology.
Moderna Inc. once again emerged the winner in a court skirmish over claims that its COVID-19 vaccine infringed two Alnylam Pharmaceuticals Inc. patents. The U.S. Court of Appeals for the Federal Circuit issued a precedential opinion May 4, agreeing with a federal district court in Delaware that Moderna didn’t infringe the patents. For both courts, the decision was based on a single issue of claim construction.
The funding boost Moderna Inc. had expected via a roughly $590 million Biomedical Advanced Research and Development Authority award now looks to be off the table. The company disclosed May 28 that the U.S. Department of Health and Human Services (HHS) said it will terminate the award for late-stage development and right to purchase pre-pandemic influenza vaccines.
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