Sarepta headed back to FDA with eteplirsen update; ONCOlog files for bankruptcy;

@FierceBiotech: Industry Voices: Genomics, Biotechnology's Oldest Next Big Thing by Elizabeth Silverman. Story | Follow @FierceBiotech

@JohnCFierce: Cowen's Simos Simeonidis sees a stockholder revolt brewing at $VVUS. Numbers are incredibly ugly and execs have no idea what they are doing. | Follow @JohnCFierce

@RyanMFierce: Receptos made it through the gauntlet to complete $73M IPO, priced at low end of $14-$16 proposed range. Item | Follow @RyanMFierce

> In its quarterly report Sarepta Therapeutics ($SRPT) says that it is wrapping up its response to the FDA, which asked to see more information on the muscular dystrophy drug eteplirsen before offering some guidance on the feasibility of an accelerated approval based on a positive but small mid-stage study. Release

> Eleven Biotherapeutics has presented early-stage data for EBI-005, an IL-1 inhibitor designed for topical ocular administration, at the Association for Research in Vision and Ophthalmology meeting in Seattle. Release

> Acucela and its partner Otsuka say that Phase IIa on emixustat hydrochloride in patients with geographic atrophy associated with dry age-related macular degeneration warrants further clinical work. Release

> Sweden's ONCOlog has filed for bankruptcy. Story

Medical Device News

@FierceMedDev: Report: ICU weighing billion-dollar sale. Article | Follow @FierceMedDev

@MarkHFierce:  Medtronic may have made waves with its renal denervation device, but buyers aren't widespread yet. More | Follow @MarkHFierce

 @DamianFierce:  Vermillion is raising $31.5M in equity to market its ovarian cancer diagnostic. Story | Follow @DamianFierce

> Device tax, sluggish demand moves Theragenics Q1 into the red. More

> Nanostim reports early human success with leadless pacer. Story

> Genomic Health rolls out new prostate cancer Dx. DxExtra

Pharma News

@FiercePharma: Behold the patent cliff: U.S. drug market shrinks for first time. Report | Follow @FiercePharma

@EricPFierce: Rapidly growing Sagent takes control of FDA approved China plant that is ready to produce products. More | Follow @EricPFierce

> Dendreon's Provenge sales disappoint once again with 17% decline. News

> GlaxoSmithKline, Merck offer GAVI 95% discount on HPV vaccines. Article

> Merck rep seeks $100M in sex-discrimination suit. Item

Vaccines News

> CDC continues to build defenses in H7N9 lull. More

> GSK, Merck agree on HPV vax discount with GAVI. Article

> Heroin vaccine keeps rats clean. Item

> Sanofi sees Shantha Biotech's Shan5 back in 2014. Report

> Takeda takes on Sanofi with $250M dengue buyout. More

Pharma Manufacturing News

> Pediatric drug shortages draw Congressional attention. News

> Hamburg faces Senate as new compounding regulations progress. Story

> Proposed law would delay unit drug tracking for 15 years. More

> Ranbaxy sees tough quarter as it recovers from manufacturing mess. Article

And Finally… The death toll in China for a new strain of bird flu has now risen to 32. Story

Suggested Articles

When it’s time to go public, most biotech companies for the Nasdaq. Not so for SQZ Biotech, which raised $71 million in its NYSE debut.

The saga of COVID antibody R&D continues as the REGN-COV2 antibody cocktail used by President Donald Trump has been hit by safety concerns.

A Dartmouth-led team proposed a method for targeting and inhibiting the most aggressive cells in breast tumors to improve responses to chemotherapy.