Topic:

Regulatory

Latest Headlines

Latest Headlines

Natco plant closed during floods written up by FDA

Yet another Indian drugmaker has had plants written up by the FDA for not hitting manufacturing standards. This time it is Natco, which said it got Form 483s for its pharmaceutical formulations facility at Kothur, near Hyderabad, as well as an API plant at Manali, near Chennai, which it had to close in December because of flooding in the area.

FDA rejects orphan exclusivity for Eagle Pharma's bendamustine

Shares of Eagle Pharmaceuticals slid about 8% this morning after the Woodcliff Lake, NJ-based biotech announced that the FDA had spurned its request for 7 years of orphan drug exclusivity in the U.S., for BENDEKA (bendamustine hydrochloride injection, or bendamustine HCI).

Valeant's wounds bleed onto Ackman's Pershing Square with latest Senate probe

Valeant's price hiking battle wounds are bleeding onto its second largest investor. Months after U.S. lawmakers began targeting the Canadian pharma over dramatic price increases, legislators are asking longtime Valeant ally Bill Ackman and his hedge fund for information about the company.

Lundbeck upgrades ArisGlobal regulatory and safety IT system

Danish drug developer Lundbeck has upgraded to the latest version of ArisGlobal's regulatory and safety platform. The decision, which follows a review of the alternatives, will see Lundbeck move to a fully outsourced hosted system, a model it thinks will lower its upgrade and maintenance costs while freeing it to focus on its core business.

Prosecutors heap more woe on OBI Pharma as 'insider trader' investigation deepens

The bad news just keeps coming for Taiwan's biotech firm OBI Pharma as the country's prosecutor has released new information alleging that the daughter of the head of Taiwan's lead science research agency did in fact sell some of her company stock just three months before it announced the failed trial of its lead cancer drug.

UPDATED: FDA's internal review of Acadia's Parkinson's drug raises safety, benefit concerns

Acadia's regulatory and research crew will face some tough questions come Tuesday's FDA advisory committee review of its Parkinson's antipsychotic drug pimavanserin, but a scan of the agency's internal review document issued today suggests that the door is still open to a possible approval.

A second Indian vaccine maker under WHO scrutiny raises concern

India's second vaccine maker to get bad marks and stern words in a World Health Organization (WHO) notice this month has come at a bad time not only for offender Ahmedabad-based Cadila Healthcare, but also for a prequalification system essential to global programs.

China FDA sets out GCP guide for medical devices to take effect in June

China FDA has unveiled guidelines on medical device clinical trial supervision and management that will take effect in June, marking the latest effort in the field to ensure quality and safety standards for multinational and domestic products.

UPDATED: China FDA vows to fix vaccine supply 'gaps' in remarks at Boao Forum

China FDA repeated that it will root out any "gaps" in the regulation of vaccines exposed in a case of illegal sales of products in Shandong province, using a public forum to vow a tough response.

With Cinqair nod, Teva squares off with GSK in severe asthma

Watch out, GlaxoSmithKline--you've got more competition. Teva won FDA approval Wednesday for its own biologic drug for severe asthma with eosinophilic inflammation, Cinqair. It'll join GSK's Nucala on the market, which rolled out after nabbing the agency's favor in early November.