Latest Headlines

Latest Headlines

Indian officials say EU willing to split trade talks from drug spat

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. 

J&J nabs an early OK for 'breakthrough' multiple myeloma blockbuster contender Darzalex

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.

Baxalta wins FDA OK for a long-acting Advate, padding its hemophilia biz

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.

HK-based Chi-Med takes another regulatory step to Nasdaq listing

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.

India looks to push development of biotech startups

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 seeks comments on device, drug approval backlog plans

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.

UPDATED: Novartis Japan issued business improvement order by MHLW

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.

FDA starts beta-testing 'the most advanced bioinformatics platform in the world'

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 may appeal to Supreme Court after again losing fight to protect Cubicin patents

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 scores additional indications for Harvoni in hep C, HIV patients

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.