FDA to miss PDUFA date on Zogenix's painkiller; Hyperion out to raise $50M;

 @FierceBiotech: From FierceVaccines.com: Is it too soon to quit on Nabi's nicotine vaccine? More | Follow @FierceBiotech

@JohnCFierce: Optimer shares spiking with CEO turned out and the board looking for a buyer. Release | Follow @JohnCFierce

@RyanMFierce: What Facebook and Google billionaires could do for overlooked biotech brains. Item | Follow @RyanMFierce

> The FDA will likely miss its March 1 deadline to decide on the fate of Zogenix's ($ZGNX) painkiller Zohydro. Report

> Just weeks after winning an approval for Ravicti, Hyperion Therapeutics is out to raise $50 million in a public offering. Story

> Higher R&D costs at Bio-Rad has weighed heavily on its profits. Report

Pharma News

@FiercePharma: Allergan settles Botox case in OK. Article | Follow @FiercePharma

@EricPFierce: AstraZeneca manager accused of getting home makeover at the company's cost. Sunroom, new kitchen, bathroom fixtures. Story | Follow @EricPFierce

> Hospira issues three recalls as it faces crucial FDA inspection. Item

> FDA halts pediatric study of Amgen's Sensipar after death. Story

> India may kill compulsory licensing based on price. More

Medical Device News

 @FierceMedDev: Work advances on early-detection ovarian cancer blood Dx. Story | Follow @FierceMedDev

 @MarkHFierce: J&J faces possible punitive damages in the first verdict regarding faulty vaginal mesh. Thousands of cases to come. Report | Follow @MarkHFierce

 @DamianFierce: The device industry is urging lawmakers to settle on a budget and, of course, repeal the device tax. Article | Follow @DamianFierce

> Quotient draws another $5M for transfusion Dx development. Story

> France's SpineGuard wins Russian nod for wireless spine surgery tool. Item

> Devicemakers: Excise tax, budget battle could cripple industry. Article

Drug Delivery News

@MichaelGFierce: Sanofi's Genzyme hits target with muscular dystrophy RNA drug in mice. Article | Follow @MichaelGFierce

> Ocular Therapeutix submits cataract-surgery sealant for FDA approval. Story

> Synthetic protein tricks immune system for drug delivery, device safety. News

> SHL ups Taiwanese auto injector production by $40M. More

And Finally… The spread of drug-resistant strains of gonorrhea has caused the number of new cases to spike in the U.K. Story

 

Suggested Articles

A TGen-led research team found that increased activity of the gene AEBP1 drives severe liver fibrosis in nonalcoholic steatohepatitis.

Days after announcing its R&D chief was stepping down, Gilead announced it will be buying a few of Novartis’ unwanted early-stage infection assets.

Mallinckrodt is teaming up with Silence Therapeutics to develop an RNAi program aimed at a group of proteins that play a part in promoting inflammation.