Latest Headlines

Latest Headlines

Roche, Boehringer and Gilead line up for EU drug approvals

The European Medicines Agency is moving toward approving a trio of novel medicines from Roche, Boehringer Ingelheim and Gilead Sciences, handing down positive recommendations for each.

Novartis scores EU rec for blockbuster-to-be Entresto

Novartis has predicted that its launch of newly FDA-approved heart failure med Entresto would be its "most exciting" ever. And now, it's one step closer to bringing that excitement to Europe.

Sientra off by more than 50% after it discloses CE mark suspension for its contract manufacturer

Breast implant company Sientra saw its valuation cut in half on news that its contract manufacturer Silimed has had its CE mark suspended by the U.K. Department of Health. The move came after German regulators conducted an inspection of a Brazilian manufacturing plant--and regulators found that "the surfaces of some implants were contaminated with particles."

FDA panel grills Bayer over Essure safety

Bayer has faced a rocky road with its contraceptive implant Essure, with the FDA launching an investigation earlier this year following claims of harmful--and in some cases, lethal--side effects and false trial data for the product. Now the company is facing more pushback after an FDA panel came down on the company for not collecting key safety data for its device.

India's Lupin in price rise spotlight for diabetes drug in the U.S.

India's Business Standard, citing brokerage reports, said the domestic drug company Lupin has raised the price for diabetes drug Fortamet in the U.S. by 200%, though that still puts it below rival Valeant Pharmaceuticals.

India in second probe of GVK BioSciences, though scope in question

India has appointed a 6-member panel to look into GVK BioSciences in the wake of a testing scandal that has hit drug exports to the European Union for more than 700 products and raised deeper questions on quality control for pharmaceuticals from the country.

India to the rescue on U.S. drug prices in wake of Shkreli?

A story in India's Economic Times makes an apples-to-oranges suggestion that India has agreed to supply generic cancer drugs to the U.S. "at a time there is outrage in America about the predatory practices by the U.S. pharma industry, one of whose leaders is getting hammered for increasing the price of life-saving drugs by as much as 5,000% overnight."

What do multinational drug firms want from Xi-Obama summit?

China Daily  ran a series of interviews with multinational business executives about bilateral commercial expectations ahead as U.S. President Barack Obama hosts China's President Xi Jinping at the White House for an official state visit.

BMJ points up 'wide variations' in quality of data for new FDA indications

One of pharma's key strategies for growing a drug's sales is expanding into bigger groups of patients. Thing is, the BMJ contends, those follow-up studies are often less stringent than they should be.

GlaxoSmithKline's asthma injection heads for EU approval

GlaxoSmithKline got a positive opinion from European regulators on its new treatment for severe asthma, setting the stage for a likely approval later this year.