Infectious disease stocks stumbled in the early months of 2025, with the BioWorld Infectious Disease Index (BIDI) plunging 17.83% by the end of April, well behind the broader markets. By comparison, the Nasdaq Biotechnology Index slipped just 1.16%, and the Dow Jones Industrial Average declined 4.41%. In 2024, the BIDI ended the year down 6.28%, after hitting a low of -25.12% in late April.
The appointment May 6 of Vinay Prasad as the head of the U.S. FDA’s Center for Biologics Evaluation and Research (CBER) “bodes poorly” for Sarepta Therapeutics Inc.’s development-stage pipeline, said Wainwright analyst Mitchell Kapoor – and Wall Street reflected as much, as the stock (NASDAQ:SRPT) ended that day down 26.6% vs. an XBI drop of 6.6% – this ahead of the after-hours earnings disclosure that pushed the Cambridge, Mass.-based firm down even farther by more than another 20%, with the XBI unchanged.
Amid an overall positive earnings report of $3.2 billion in 2024 revenues, Moderna Inc. disclosed that the U.S. FDA placed its norovirus vaccine on a phase III clinical hold due to a single adverse event of Guillain-Barré syndrome (GBS).
Robert F. Kennedy Jr. moved a step closer Feb. 4 to becoming the next secretary of the U.S. Department of Health and Human Services (HHS). The Senate Finance Committee voted 14-13 along party lines to send Kennedy’s nomination to the Senate floor for confirmation. While “no” votes were expected from the 13 Democrats serving on the committee, a big question mark had hung over which way Sen. Bill Cassidy, R-La., would vote, given the comments he made at two committee hearings on the nomination. In the end, Cassidy voted along with his 13 Republican colleagues, offering no comment on his vote at the meeting.
While Moderna Inc. plans to cut its expenses by $1 billion in 2025, the company has received a little breathing room by a hefty U.S. Department of Health and Human Services (HHS) grant. The Biomedical Advanced Research and Development Authority awarded Moderna roughly $590 million to support late-stage development of its mRNA-based avian-variant vaccines and to increase the number of clinical trials for another five additional subtypes of pre-pandemic influenza.
The 2025 edition of Clarivate’s Drugs to Watch features 11 candidates or approved therapeutics that may well revolutionize treatments or become blockbusters. The 12th annual report has a strong track record. Twelve of the 13 drugs from the 2024 Drugs to Watch report have been approved and launched.
The 2025 edition of Clarivate’s Drugs to Watch features 11 candidates or approved therapeutics that may well revolutionize treatments or become blockbusters. The 12th annual report has a strong track record. Twelve of the 13 drugs from the 2024 Drugs to Watch report have been approved and launched.
The BioWorld Drug Developers Index (BDDI) continued its downward spiral through the fall, going from a modest 1.11% decline at the end of August to a 6.2% dip in September and an 11.3% loss by October’s close.
Researchers from Moderna Inc. and affiliated organizations presented preclinical data for the novel mRNA-lipid nanoparticle (LNP) vaccine, mRNA-1769, against mpox virus.
What comes down must go up seems to be the rule of thumb these days, even for U.S. FDA fees. The cost of using a priority review voucher (PRV) to shave four months off an FDA standard 10-month drug review has dropped drastically over the past several years. But come Oct. 1, biopharma companies will have to pay nearly 89% more than on the previous day to use a PRV.
