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An EU-level court has established a precedent that would allow drugmakers to protect orphan drugs from generic competition by developing and patenting a similar drug for the same orphan indications while the original therapy still enjoys market exclusivity. Read More
Biologics makers should file their lot distribution reports using the same electronic messaging standard as is used for drug registration and labeling content of BLAs, FDA final guidance says. Read More
Nothing is stopping Sandoz from launching the first U.S. biosimilar, now that a federal judge has denied Amgen’s bid for an injunction blocking the alternate version of its blockbuster chemotherapy product Neupogen. Read More
The FDA and Department of Justice are pursuing prosecutions of several international drugmakers for serious manufacturing quality violations, underscoring the agency’s increasing tendency to treat quality violations as fraud. Read More
Hundreds of children as young as two years old will now be able to get Vertex Pharmaceuticals’ game-changing cystic fibrosis treatment, following FDA approval Thursday. Read More
Janssen’s blockbuster Xarelto is the target of another liability lawsuit, this time by 12 plaintiffs in California federal court who claim the blood thinner caused gastrointestinal bleeding. Read More
NHS England has reinstated two of the three indications for Novartis’ cancer drug Afinitor to its cancer fund, which is use to reimburse cancer therapies not considered cost effective by the National Institute for Health and Care Excellence. Read More
A team of high-level FDA officials are in India meeting with officials from the Central Drugs Standard Control Organization to discuss the quality of drugs coming from the country, and the Indian regulators’ progress in stepping up oversight of drug safety and quality issues. Read More
The FDA approved Asklepion Pharmaceuticals’ Cholbam, the first treatment for children and adults with single-enzyme bile acid disorders and peroxisomal disorders, under its pediatric rare disease priority review voucher program. Under the terms Congress set for the program, the FDA must now phase it out within 12 months unless it is reauthorized. Read More