We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
Drugmakers are asking the European Commission to clarify new requirements for equipment used in the manufacturing process, including when it’s okay to test such equipment at the factory instead of on site. Read More
The NIH Clinical Center suspended operations of its Pharmaceutical Development Section, effective Thursday, due to serious manufacturing problems and lack of compliance with standard operating procedures discovered during an FDA investigation. Read More
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