Topic:

Regulatory

Latest Headlines

Latest Headlines

NIH cites European precedent in call for disclosure of clinical trial data

If the U.S. National Institutes of Health gets its way, any researcher it funds will have to publish a summary of their clinical trial results and adverse events, regardless of whether the trial succeeded or failed.

FDA approves Purdue's abuse-resistant Hysingla, a hydrocodone pill aimed at knocking off Zohydro

The FDA has faced a firestorm of criticism since approving Zogenix's superstrength painkiller Zohydro last year, drawing outcry from lawmakers and industry groups concerned with the drug's all-hydrocodone formula. Now, discontent could swell even further as the agency signs off on Purdue Pharma's opioid treatment Hysingla for chronic pain.

Purdue wins a pain pill approval with Zohydro in its crosshairs

The FDA approved Purdue Pharma's latest pain drug, a hydrocodone formulation designed to prevent abuse, potentially spelling trouble for Zogenix and its controversial Zohydro.

Court shoots down Ranbaxy's bid to block rival Nexium and Valcyte generics

Ranbaxy Laboratories suffered a stinging setback in its battle to keep copies of AstraZeneca's blood pressure med Nexium and Roche's antiviral Valcyte off the market, as a U.S. court denied its request for a temporary restraining order against companies producing generic versions of the drugs.

Ranbaxy can't stop the FDA from yanking drug approvals over plant problems

A U.S. federal judge has turned down Ranbaxy Laboratories' request for a temporary restraining order against the FDA after the agency revoked the Indian drugmaker's approvals to make generics of AstraZeneca's blockbuster Nexium and Roche's antiviral Valcyte because of its manufacturing shortcomings.

Doc coughs up $2M for using unapproved Avastin on his cancer patients

A U.S. oncologist who thought he was getting a great deal on drugs that were almost the same thing as Avastin has found they will cost him an extra $2 million and a federal misdemeanor conviction.

Pfizer's MenB reach--and lead on Novartis--limited without ACIP nod

As Pfizer's Trumenba rolls out in the U.S., it may get a head start on Novartis' Bexsero, which is still awaiting FDA approval. But the drug giant still doesn't yet have what it needs to build a considerable lead: a recommendation from the CDC's Advisory Committee on Immunization Practices.

Success or failure, feds want trial results posted online

Federal regulators are proposing a rule that would require makers of drugs and medical devices to publicize the results of thousands of clinical trials, regardless of whether they succeed, part of a global move toward transparency in R&D.

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.