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Takeda Pharmaceutical’s dengue vaccine candidate, TAK-003, offered strong continued protection against dengue fever, especially infection requiring hospitalization, for up to three years with no significant safety risks, according to a late-stage study. Read More
The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has voiced support for approving Sanofi’s and Regeneron’s monoclonal antibody Libtayo (cemiplimab) for advanced nonsmall-cell lung cancer (NSCLC) and advanced basal cell carcinoma. Read More
FDA and industry are going back to the drawing board on proposals for safety labeling updates, according to the latest GDUFA III meetings, which also included discussions on supplement reviews and continued talks on proposals for data and technology modernization, among other topics. Read More
For the first time, the FDA has approved a treatment for adult nonsmall-cell lung cancer (NSCLC) patients with a specific type of genetic mutation, giving Johnson & Johnson (J&J)’s Rybrevant the green light Friday. Read More
The FDA has approved Bristol Myers Squibb’s blockbuster oncology drug Opdivo (nivolumab) for the treatment of patients with completely resected esophageal or gastroesophageal junction cancer who have residual pathologic disease and have received neoadjuvant chemoradiotherapy — making it the first immunotherapy to receive the agency’s blessing for this indication. Read More
The EMA’s Committee for Medicinal Products for Human Use (CHMP) recommended eight new drugs for approval during its monthly meeting, including Bluebird Bio’s gene therapy for treating early cerebral adrenoleukodystrophy (CALD), a first for the treatment. Read More
In a declaration released Friday following the G20 Global Health Summit in Rome, world leaders called for voluntary patent licensing and technology transfers for COVID-19 vaccines and therapeutics. Read More
Despite a recent warning from HHS that drugmakers could face fines if they continue to hold back 340B drug discounts from clinics and hospitals serving low-income patients, Eli Lilly and AstraZeneca (AZ) appear determined to resist, filing motions in federal court against the department’s June 1 deadline. Read More