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A key European panel recommended approval for Eli Lilly and Boehringer Ingelheim’s biosimilar of Sanofi’s blockbuster long-acting insulin drug Lantus, creating a potential threat to the French drugmaker’s multi-billion dollar product. Read More
A European Medicines Agency committee has recommended approval of Bristol-Myers Squibb’s direct-acting antiviral Daklinza in combination with other drugs for the treatment of chronic hepatitis C virus (HCV) infection in adults. Read More
Generics maker Ranbaxy has the green light to launch an exclusive version of Novartis’ blockbuster hypertension drug Diovan, a move that comes nearly two years after the drug lost patent protection. Read More
A coalition of muscular dystrophy advocates, researchers, clinicians and drug manufacturers has submitted the first-ever patient-initiated draft guidance on drug development to the FDA, a move prompted by the agency’s efforts to get more patient perspectives into the drug approval process. Read More
International authorities recently seized more than $31 million in potentially counterfeit and dangerous drugs and shuttered over 10,600 websites for peddling unapproved and substandard pharmaceuticals, in the third annual international sweep of its kind. Read More
Sponsors of biosimilars need to demonstrate how their products compare with reference drugs, including pharmacokinetic and pharmacodynamic data to show compatibility in clinical trials, according to U.S. Food and Drug Administration draft guidance on non-brand versions of the complex therapies. Read More
The U.S. Food and Drug Administration has been quicker to approve new active substances over the last decade than both its European and Japanese counterparts, a recent study finds. Read More
British drugmaker GlaxoSmithKline is facing another bribery probe, this time from a UK watchdog that plans to investigate the company’s global business practices. Read More
U.S. and European regulators have made strides toward mutual recognition of quality inspections, so that companies inspected by one regulator won’t face a second inspection by the other, but setbacks remain, a top EU regulatory official told IPRM. Read More