Indian commerce officials say the European Union is showing a willingness to restart trade talks and separate those discussions from a ban on 700 drugs tested in India that imperils exports worth billions of dollars, according to a report by India's Economic Times.
Johnson & Johnson scored an early FDA approval for its "breakthrough" blockbuster contender daratumumab, earning a swift OK as a new treatment for multiple myeloma four months ahead of the PDUFA date. The drug will be marketed as Darzalex.
The FDA signed off on Baxalta's twice-weekly upgrade on the top-selling Advate, adding another hemophilia A treatment to the company's portfolio as it faces buyout pressure from Shire.
Hong Kong-based Hutchison China MediTech, or Chi-Med, has moved another notch up the U.S. listing regulatory process, filing an F-1 form with the U.S. SEC and providing a detailed financial snapshot, the company said in a press release.
A senior Indian official says plans are underway to ramp up the biotechnology sector and add 1,500 startups in the next two to three years, according to a report in the Economic Times.
China FDA has opened a window until Dec. 13 for comments on its plans to whittle down a massive backlog on drug and medical device approval applications.
Japan's Ministry of Health, Labor and Welfare said a business improvement order was issued to the Japan unit of Swiss-based Novartis on Nov. 13 for failing to report unspecified drug side effects on time, the third such sanction for the company in 18 months.
The FDA has started testing the precisionFDA platform it developed with DNAnexus. The closed beta test phase is the precursor to a more widespread rollout of the system, which the CEO of DNAnexus has described as being "the most advanced bioinformatics platform in the world."
Merck & Co. is running low on options after a federal appeals court Thursday again declined to back four patents that would have held at bay for 5 more years generics of the antibiotic Cubicin, the drug that was key to its $9.5 billion buyout of Cubist. Next up may be an appeal to the U.S. Supreme Court.
Gilead Sciences enjoys top dog status in the hep C market with Sovaldi and combo drug Harvoni, and the drugmaker wants to keep it that way. The company recently scored FDA approval for new indications for Harvoni in patients with HIV and certain subtypes of hep C, giving Gilead more ammo as it protects its market share from archival AbbVie.