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Members of the FDA’s Bone, Reproductive and Urologic Drugs Advisory Committee and Drug Safety and Risk Management Advisory Committee voted 18-6 Thursday to recommend approval of Sprout’s female sexual dysfunction drug, despite lingering safety concerns. Read More
A federal appeals court is considering whether to lift a temporary injunction that bars Sandoz from marketing its Zarxio-sndz biosimilar pending an outcome in patent infringement litigation involving reference product maker Amgen’s blockbuster chemotherapy drug Neupogen. Read More
ISPE’s quality metrics team has settled on 13 metrics that it will ask drugmakers to collect data on during the second phase of a pilot program meant to help the FDA boost quality compliance. Read More
Genzyme said Thursday that it has received FDA breakthrough therapy designation for olipudase alfa, an enzyme replacement therapy for patients with nonneurological manifestations of acid sphingomyelinase deficiency, also known as Niemann-Pick disease type B. Read More
The UK’s healthcare cost regulator is asking BioMarin to provide more information on Vimizim, its treatment for the rare inherited disease Morquio A Syndrome, saying current evidence doesn’t support coverage of the drug. Read More
Active pharmaceutical ingredient maker VUAB Pharma was hit with an FDA warning letter over complaint handling, contamination and data integrity issues. Read More
The European Commission will revise four annexes to its good manufacturing practice guideline and add a new one, as it moves to harmonize GMPs with international standards and speed the path to mutual reliance with foreign regulators, a UK official says. Read More