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.
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.
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 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.
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.
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.
Forum Pharmaceuticals has gotten out from under an FDA clinical hold on a Phase III schizophrenia study for its lead drug, but the company's efforts to develop the treatment for Alzheimer's disease remain halted.
The U.S. Supreme Court dealt a blow to Daiichi Sankyo and Mylan Pharmaceuticals when the court declined to hear their appeal in their attempt to head off drugmaker Apotex from introducing a generic version of the hypertension drug Benicar.
Japan's Daiichi Sankyo and its associated company Plexxikon said the U.S. Food and Drug Administration (FDA) has approved cobimetinib for the treatment of people with BRAF V600E or V600K mutation-positive unresectable or metastatic melanoma in combination with Zelboraf (vemurafenib), the company said in a statement.