Topic:

Regulatory

Latest Headlines

Latest Headlines

Newron faces further FDA delay for Parkinson's drug as regulator demands addiction evidence

Newron Pharmaceuticals' U.S. headache continues as its once-failed drug that was delayed by the FDA last year has now been stiff-armed by the FDA, which handed out a complete response letter to the developer.

Aveo hit with $4M SEC fraud penalty, feds set out to bar former execs for deception

The Securities and Exchange Commission has come down hard on Aveo Pharmaceuticals, handing down a $4 million penalty while seeking to ban three of its former execs from leading any company ever again after allegedly misleading investors on the safety of a key cancer drug.

Big Pharma finds second chance for failed drugs in China

Biopharma companies that have struggled to make a splash in the U.S. or European markets with their new treatments are increasingly turning to China for a reprieve.

AZ approval for Tagrisso in Japan a big change to NSCLC treatment options in Asia

The Japan approval of AstraZeneca's Tagrisso (osimertinib), a first-in-class drug used to treat non-small cell lung cancer (NSCLC), represents a potential major change in treatment options in the country and brings on a comparison with the state-of-play with therapies available in China.

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.