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A federal appeals court has granted a temporary injunction barring Sandoz from marketing its biosimilar of Amgen’s blockbuster chemotherapy drug Neupogen. Read More
An FDA advisory committee Tuesday voted 12 to 1 to recommend approval of the Vertex Pharmaceuticals Orkambi combination therapy for patients 12 years and older with two copies of the most common cystic fibrosis mutation. Read More
Reauthorization of the Prescription Drug User Fee Act is officially underway with the FDA’s announcement of a July 15 public meeting to assess the current PDUFA V. Read More
The National Pharmaceutical Pricing Authority says 59 of the top 100 companies have failed to register with the system, despite several deadline extensions. Read More
Sponsors seeking approval of new drugs based on published literature or postmarketing data must prove that their drug is comparable to its reference product. Read More
British drug giant GlaxoSmithKline hopes to cure HIV/AIDS with a first-of-its-kind partnership with researchers from the University of North Carolina at Chapel Hill. Read More
Vertex Pharmaceuticals’ Kalydeco/lumacaftor combination therapy may be in danger as regulators question whether it will provide significant improvements in lung function for most cystic fibrosis patients. Read More
Sponsors of regenerative drugs can now get a conditional approval in Japan based on limited data, under a new regulatory pathway meant to speed patient access to novel therapies. Read More
An Indian pharmacists group is urging the government to immediately begin requiring detailed instructions on storage temperatures on all drug labels, to prevent improper handling in the supply chain and by end users. Read More