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Regulatory

Latest Headlines

Latest Headlines

EU backs Roche's Avastin for hard-to-treat ovarian cancer

The EU Committee for Medicinal Products for Human Use (CHMP) handed down a positive ruling on Roche's blockbuster Avastin, recommending that the European Commission approve the drug for use in women with ovarian cancer that's resistant to platinum-based chemotherapy. 

EU smiles on a key cog in Bristol-Myers' hep C combo

European regulators are recommending approval for Bristol-Myers Squibb's daclatasvir, an hepatitis C-fighting antiviral that plays a key role in the company's planned combo treatment.

UPDATED: Ranbaxy's generic of Novartis blockbuster Diovan approved for launch

The long-delayed and highly anticipated launch of generic Diovan is on the way, which is a bummer for Novartis and a huge boost for Indian drugmaker Ranbaxy Laboratories. It is also validation for the decision by Sun Pharmaceutical's owner, billionaire Dilip Shanghvi, who struck a $3.2 billion deal to buy Ranbaxy despite its years of FDA entanglements over quality issues.

Republicans back generic industry's fight against FDA labeling rule

Two Republican lawmakers are supporting the generic industry's fight against the FDA's proposed rule on product labeling.

Cancer practice in Kentucky guilty of using unapproved foreign-made drugs

The FDA says a cancer group in Kentucky has pleaded guilty to federal charges of buying and using unapproved chemo drugs. Hematology and Oncology Center (HOC) of Somerset, KY, and former office manager Natarajan Murugesan, pleaded guilty to violations of the Federal Food, Drug, and Cosmetic Act.

Boehringer bags a 'breakthrough' tag for its Pradaxa antidote

German giant Boehringer Ingelheim is racing to the market with an antidote to its blockbuster blood-thinner Pradaxa, securing the FDA's coveted breakthrough therapy designation for its in-development treatment.

New Indian government looks to help small players finance upgrades

FDA actions against Indian drug manufacturers have not gone unnoticed by the country's newly elected Prime Minister Narendra Modi, and he has a plan to do something about it.

UPDATED: FDA experts spurn AstraZeneca's pitch for ovarian cancer drug olaparib

AstraZeneca's top investigators took their best case for an accelerated approval of the failed cancer drug olaparib to the FDA's panel of outside experts on Wednesday, and they lost.

After 4-year Benicar review, FDA slaps aside heart-risk worries

After four years of sifting data, the FDA says it found "no clear evidence" that Daiichi Sankyo's blockbuster blood pressure drug increased the risk of heart attack. But the agency will require new safety-related data on Benicar's official label.

India production expert urges excellence from drugmakers

Indian pharma officials and regulators have responded defensively to FDA warning letters and bans, saying the country is being picked on. Still, others are suggesting it is time for the industry to step up its manufacturing game with management taking the lead to overcome organizational inertia.