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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
Takeda Pharmaceutical subsidiary Baxalta and Bayer have hashed out a settlement that will dismiss a 2019 jury verdict that ordered Baxalta to pay $173 million for infringing on Bayer’s patents for the hemophilia A drug Adynovate, with Bayer agreeing not to pursue the money it is owed. Read More
Eli Lilly said its experimental drug, tirzepatide, reduced blood glucose levels and body weight in type 2 diabetics with increased risk of heart disease more effectively than Sanofi’s blockbuster diabetes drug Lantus (insulin glargine) in a head-to-head phase 3 study. Read More
The FDA and European Medicines Agency (EMA) have eased the ultra-cold storage requirements for the Pfizer/BioNTech COVID-19 vaccine, permitting doses to be held longer at normal refrigeration temperatures. Read More
The pharmaceutical industry should brace itself for a spike in drug recalls as companies begin returning to normal operations in the U.S. and the FDA looks to catch up on inspection-related activities, a research firm advised in a new report. Read More