Topic:

Regulatory

Latest Headlines

Latest Headlines

UPDATED: FDA AdComm experts acknowledge problems, but give a thumbs-up on Acadia's Parkinson's antipsychotic

An FDA advisory panel of outside experts weighed the data on the risks and potential benefits of using Acadia's Nuplazid (pimavanserin) as a new antipsychotic for Parkinson's patients, and most concluded that it should be OK'd for commercial use at this point.

FDA cites Lupin Indian facilities for what drugmaker calls 'minor' issues

India's Lupin said in a Bombay Stock Exchange filing on Tuesday that it had received four observations for two plants at its Mandideep site following a two-week inspection by the FDA in February.

In surprise decision, FDA blocks crucial cognitive claim for Takeda's Brintellix

The FDA doesn't have to follow the advice of its expert review panels, but it usually does. That's a standard line in stories about advisory committee votes. Unfortunately for Lundbeck and Takeda, their new Brintellix app is one of the unlucky ones.

UPDATED: Astellas cancer med Xtandi draws fire as U.S. lawmakers demand a pricing hearing

U.S. Department of Health and Human Services (HHS) Secretary Sylvia Burwell recently said that the agency wouldn't take "extraordinary action" against rising drug prices unless the situation called for it. Now lawmakers are holding up Astellas' prostate cancer drug Xtandi as an example and are asking HHS and the National Institutes of Health to act, months after a nonprofit and cancer patient group made a similar request.

Biocon wins key Japan approval for Lantus biosimilar

Japan has approved a new biosimilar of Sanofi's blockbuster Lantus (insulin glargine) as its creator Biocon chalks up a much-needed win after a tough 2015.

India releases guidelines on biosimilar approval, manufacturing

India's Central Drugs Standard Control Organization and the Department of Biotechnology have published guidelines on biosimilars that detail the regulatory path to marketing authorization.

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.