The company said in a press release that the vaccine’s efficacy against RSV-associated lower respiratory tract disease with three or more symptoms was 77.8% through season two, compared with efficacy of 88.9% after the first RSV season, which led to the shot’s U.S. approval.
AbbVie on Wednesday entered into a strategic partnership with OSE Immunotherapeutics to advance the French biotech’s early-stage monoclonal antibody OSE-230 as a treatment for chronic and severe inflammation.
The FDA has refused to review Theratechnologies’ supplemental Biologics License Application, seeking approval for an intramuscular formulation for the maintenance dose of its HIV therapy Trogarzo (ibalizumab-uiyk), the biotech announced on Tuesday.
The FDA is planning to increase its inspection of drug manufacturing facilities in India this year amid growing quality and supply concerns, Reuters reported Tuesday citing an agency executive.
U.S. drugmaker Eli Lilly expects to launch Mounjaro, its blockbuster diabetes drug and wildly popular obesity treatment, in India as early as next year after it clears an ongoing regulatory review, CEO David Ricks told Reuters on Wednesday.
The Japanese drugmaker plans to scale up the production of its dengue vaccine Qdenga through a partnership with Indian vaccine maker Biological E.
Viking Therapeutics announced Tuesday that its GLP-1/GIP receptor dual agonist helped patients lose up to nearly 15% of their weight over about three months in a Phase II study.
The U.S. drug regulator is set to increase the number of inspections at Indian drug manufacturing units in 2024 amid growing concerns over the quality of drugs, according to reports.
Despite a patent extension, Merck’s muscle relaxant reversal injection is now facing potential generic competition from Hikma Pharmaceuticals, which is seeking the FDA’s approval for a copycat version.
The U.S. Department of Justice has slapped BioMarin Pharmaceutical with a subpoena in connection with its sponsored testing programs for the rare disease therapies Vivizim and Naglazyme.