Topic:

Regulatory

Latest Headlines

Latest Headlines

DOD-backed BrainScope wins FDA clearance for traumatic brain injury diagnostic

The FDA has cleared BrainScope's Ahead 100 device that uses a wearable device to provide an electroencephalograph that is analyzed to assess the structural condition of a patient's brain after head injury. The first-line diagnostic device for traumatic brain injury is typically a computed tomography scan.

NICE asks Novartis to pony up more information on Xolair for hives

The U.K.'s cost-effectiveness gatekeepers have flip-flopped on Novartis' Xolair before, withdrawing support for the drug in 2012 before expanding its approval for asthma the following year. Now, the National Institute for Health and Clinical is asking the drugmaker to pony up more information about the product before recommending it to treat chronic spontaneous urticarial (CSU), or psoriasis.

UPDATED: Go-go execs at Gilead nab an FDA priority review voucher for $125M

The market price of a priority review voucher at the FDA just doubled. Canada's Knight Therapeutics has auctioned off its voucher--which can be turned in to the FDA in exchange for a regulatory shortcut on a drug decision--for $125 million to Gilead, one of the most aggressive developers in the industry.

EU nod sets up Gilead's Harvoni for record-breaking sales

Open up the floodgates: Gilead's hep C wonder-cocktail, Harvoni, has won approval in Europe.

Ranbaxy sues FDA to protect its exclusive for generic Nexium

Ranbaxy Laboratories has filed a federal lawsuit trying to reverse the FDA's decision to cancel its approvals to make generics of AstraZeneca's blockbuster Nexium and Roche's Valcyte.

Ranbaxy fights FDA for killing its approval to make generic Nexium

This month, the FDA yanked the approvals it granted Ranbaxy to make generics of two blockbuster drugs, saying it was a mistake to grant the approval given that the plants where they were to be made were out of compliance. Ranbaxy has now filed a federal lawsuit against the FDA for canceling the approvals.

FDA to more than double staff in China as visa issues appear resolved

The FDA is extending its tentacles deeper into China, which exported medical devices worth $3.5 billion to the U.S. in 2012, according to the U.S. Department of Commerce.

FDA orders CytRx to halt patient enrollment after death of a cancer patient

CytRx has run into an unexpected roadblock with its cancer drug conjugate aldoxorubicin, slamming the brakes on new patient recruitment in all their clinical trials after the FDA dropped a partial clinical hold on the program. According to the biotech the hold was forced by the death of a patient who was given the drug through a compassionate use program.

Getting more FDA inspectors in China on Hamburg's agenda for trip to China

For nearly two years, efforts by the FDA to expand its oversight of Chinese pharmaceuticals manufactured for the U.S. market have been thwarted, an issue FDA Commissioner Margaret Hamburg hopes to resolve during a visit there this week to meet with Chinese and other global regulators.

FDA Commissioner to talk drug safety with top Chinese officials

While in China for the International Summit of Heads of Medicines Regulatory Agencies, FDA Commissioner Margaret Hamburg will meet with top Chinese regulatory officials about working cooperatively on drug and food safety.