Latest Headlines

Latest Headlines

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.

Forbes: For multinationals, CFDA reform paramount

Forbes  magazine recently polled 50 drug multinational company executives asking them what was most important in their dealings with China and 86% of those interviewed said reforms to the China Food and Drug Administration (CFDA) "were going to be essential for their company's future" there.

India's drug regulator handcuffed by low funding, lack of trained personnel

The reputation of India's massive $15 billion drug industry is being threatened at the federal and state level by a lack of properly trained personnel and a shortage of funding that may lead the country to change how it finances inspections and quality control, according to a report in the Business Standard.

NeuroDerm stock yo-yos after FDA meeting yields mixed results

NeuroDerm has received written confirmation from the FDA that it can file for approval of its Parkinson's disease treatment on the strength of data from one clinical trial, freeing it of the need to run a second, 360-person study. But with the FDA also demanding additional GMP documents from NeuroDerm's device supplier, investors were unsure whether the update was good or bad news.

Japanese ministry knocks Novartis unit, again, on side effects nondisclosure

Japan's Ministry of Health, Labor and Welfare is planning to slap the Japanese unit of Novartis with a "business improvement order" for failing to properly disclose serious side effects of some of its drugs, the Japan Times is reporting.

Ready to rumble, Novartis? Roche targets melanoma-fighting combo market with new FDA nod

When Novartis bought GlaxoSmithKline's oncology business, the newest products were a pair of targeted melanoma drugs, Taflinlar and Mekinist. The two meds had racked up trial data showing they beat Roche's own targeted drug Zelboraf when used in tandem.