Topic:

Regulatory

Latest Headlines

Latest Headlines

Purdue earns a nod--and a quick slap--for abuse-resistant painkiller

The FDA has approved a new pain drug from Purdue Pharma that's intended to throw up a line of defense against the abuse of an extended-release reformulation of OxyContin. But all the approval seems to have accomplished is triggering some added eye-rolling from some of the experts fighting abuse.

FDA warns hospitals that Texas compounder's products are unsafe

Most companies voluntarily recall products, and sometimes even stop production, when they or the FDA find quality issues. In the case of a Texas compounder, the FDA has formally requested that it halt sterile drug work and pull back all of its sterile products.

FDA opens the door for a Novartis biosimilar of Amgen's Neupogen

The FDA accepted Novartis' application to sell a knockoff of Amgen's biological treatment Neupogen, making the company a pioneer among those looking to capitalize on a soon-to-come U.S. market for biosimilars that is expected to explode.

GSK submits world's first malaria vaccine for EMA approval

It's taken 30 years, but GlaxoSmithKline's experimental malaria vaccine is finally ready for regulatory review. Looking to bring the world's first shot for the mosquito-borne disease to market, the pharma giant said Thursday that it has submitted its candidate for approval.

UPDATED: Gilead picks up blockbuster FDA blood cancer approvals for idelalisib

Gilead said today that the FDA has approved its PI3k inhibitor idelalisib for three types of B-cell blood cancers following its early Phase III success last fall on impressive leukemia data. EvaluatePharma analysts estimate this drug could earn $1.2 billion a year by 2020, making it one of the top therapies in late-stage development.

Edwards Lifesciences CEO asks Congress for better device regulation

Edwards Lifesciences CEO Mike Mussallem advocated for a more efficient regulatory and reimbursement system for medical devices before the congressional House Committee on Energy and Commerce yesterday July 22, pointing out that the U.S. was the 42nd country to approve the Irvine, CA-based company's Sapien artificial heart valve for frail, high-risk patients.

Patent Office grants Alnylam new claims on its RNAi delivery method

Alnylam announced July 22 that its intellectual property estate has been strengthened due to the U.S. Patent Office's issuance of a Notice of Allowance for claims in one of its patent applications that covers "chemically modified RNA therapeutics conjugated with an N-acetylgalactosamine (GalNAc) ligand independent of length, sequence, or disease target," according to a statement. 

Celgene has to fight a former rep's off-label marketing suit, judge says

Thanks to a recent court ruling, a former Celgene sales rep's off-label marketing lawsuit will go forward.

Judge refuses to toss off-label Revlimid marketing lawsuit against Celgene

Thanks to a recent court ruling, a former Celgene sales rep's off-label marketing lawsuit will go forward. The rep, Beverly Brown, claims the company pushed its multiple myeloma drugs Thalomid and Revlimid for uses not approved by the FDA--and a judge says she's produced enough evidence to justify a trial.

Eagle Pharma nabs FDA OK for hyperthermia drug

Eagle Pharmaceuticals ($EGRX) has nabbed an FDA approval for its new-and-improved formulation of dantrolene sodium, which will be sold as Ryanodex, for potentially lethal cases of malignant hyperthermia.