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Eagle Pharmaceuticals is objecting to the FDA’s decision to grant orphan drug Bendeka only three years of exclusivity instead of the full seven years and says it may take action. Read More
The European Commission has granted orphan drug designation to fosbretabulin for the treatment of gastro-entero-pancreatic neuroendocrine tumors. Read More
The FDA slapped pharmaceutical manufacturer and repackager Safecor Health with a 13-item Form 483 citing lapses in quality control, batch specification and written procedures. Read More
A federal jury ruled that Gilead Sciences must dole out $200 million in damages to Merck and Ionis Pharmaceuticals for patent infringement over the active ingredient sofosbuvir in Gilead’s blockbuster hepatitis C drugs. Read More
There is a strong correlation between a surge in warning letters over data integrity issues and increased FDA inspections of manufacturers in India and China — one that could cause production headaches for U.S. drugmakers partnering with these facilities. Read More
A three-judge panel for the U.S. Court of Appeals for the Federal Circuit has upheld two Depomed patents, enabling it to resume its lawsuit against Purdue Pharma. Read More
EC Grants Orphan Drug Designation to BioMarin’s Gene Therapy for Hemophilia A
Portola’s Long-lasting Blood Thinner Betrixaban Misses Primary Endpoint
Forum Pharmaceuticals’ CIS Candidate Misses Primary Endpoints in Phase 3 Trials Read More
In its second move this week to tackle the growing opioid epidemic, the FDA is outlining what tests sponsors of abuse-deterrent generic opioids should submit. Read More