On the same day that FDA Commissioner Martin Makary spoke in a fireside chat during the 2025 Biotechnology Innovation Organization’s International Convention, the agency unveiled a pilot commissioner’s national priority voucher program that will enable companies to receive a shortened FDA review time of one to two months.
Researchers from Purdue University and the U.S. Centers for Disease Control and Prevention have recently developed a novel influenza vaccine candidate that uses a bovine adenoviral (BAd) vector to deliver nucleoprotein (NP) antigens from both influenza A and B viruses, along with an autophagy-inducing peptide (C5) to enhance cellular immune responses, particularly T-cell responses.
The 17 members abruptly terminated June 9 from the U.S. CDC’s Advisory Committee for Immunization Practices are not going gently into the night. Instead, they’re raging against what could be the dying of the light.
On the same day that FDA Commissioner Martin Makary spoke in a fireside chat during the 2025 Biotechnology Innovation Organization’s International Convention, the agency unveiled a pilot commissioner’s national priority voucher program that will enable companies to receive a shortened FDA review time of one to two months.
The 17 members abruptly terminated June 9 from the U.S. CDC’s Advisory Committee for Immunization Practices (ACIP) are not going gently into the night. Instead, they’re raging against what could be the dying of the light. The 17 raised their collective voices in a June 16 JAMA opinion piece to decry what’s at stake with Health and Human Services Secretary Robert Kennedy’s efforts, in his words, to “reestablish public confidence in vaccine science” by cleansing ACIP of what he claimed were conflicts due to members’ financial ties to industry.
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.
South Korea’s pharmaceutical exports rose nearly 18% year-on-year to reach $2.56 billion in the first quarter (Q1) this year, according to the Korea Health Industry Development Institute. Medical device exports, however, dropped about 5% in Q1 2025 to $1.39 billion, attributed to a drop in trade of implant products to both China and the U.S.
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.
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