Nephron hit with Class I recall; Rosetta doubles down on sales;

@FierceMedDev: Stryker confronts mounting metal hip recall lawsuits. Story | Follow @FierceMedDev

@DamianFierce: St. Jude is targeting FDA approval for its renal denervation device with a new study. Report | Follow @DamianFierce

@MarkHFierce: Get your FMD Fierce 15 nominations in today. | Follow @MarkHFierce

@MichaelGFierce: ICYMI yesterday: Medtronic triggers summer PMA process for drug-eluting balloon. Story | Follow @MichaelGFierce

> The FDA has assigned its most-serious Class I tag to Nephron Pharmaceuticals' recall of the EZ Breathe Atomizer. Note

> Edwards Lifesciences ($EW) received an FDA warning letter last month, and the agency disclosed its findings. Letter

> Rosetta Genomics ($ROSG) is more than doubling its U.S. sales reach for its recently rebranded Rosetta Cancer Origin Test. News

> Israeli startup OrCam has developed a device that can help the visually impaired read. Article

> AxoGen won Canadian regulatory approval for two new nerve regeneration devices. Item

> A breast implant after mastectomy doesn't threaten a woman's chance of survival, new research from the Northern California Cancer Center suggests. Item

> Soaring breast cancer rates in emerging markets is boosting demand for screening equipment, the research and consulting firm GlobalData concludes in a new analysis. Item

Biotech News

@FierceBiotech: Trending: Top 10 experimental cancer drugs - 2013. Special report | Follow @FierceBiotech

@JohnCFierce: Web traffic at Fierce Life Sciences hit 778,789 in May, 1.6 million PVs. Subscriber openers around 82,000 a day now on reports. All records. | Follow @JohnCFierce

@RyanMFierce: J&J backs $biotech startup Protagonist in $14M financing. News | Follow @RyanMFierce

> FDA clamps clinical hold on Pluristem PhII stem cell trial. News

> R&D: Are true drug breakthroughs a thing of the past? More

> AstraZeneca tosses another PhIII failure onto the scrap heap. Report

> Akebia snags $41M financing in anemia-drug race with GlaxoSmithKline, others. Article

> Cardio3 tests Europe's appetite for biotech IPOs. Item

Pharma News

@FiercePharma: FDA close to resolving all cancer drug shortages; most stem from production halts to fix manufacturing issues. More | Follow @FiercePharma

@EricPFierce: ICYMI: Dr. Reddy's, Fujifilm pull plug on Japanese joint venture. Article | Follow @EricPFierce

@CarlyHFierce: European Commission to crack down on 'pay for delay,' reportedly fine 9 companies including Lundbeck, Merck KGaA, Ranbaxy. Article | Follow @CarlyHFierce

> J&J recalls millions of contraceptives as problems pile up. More

> Limited track-and-trace moves forward in U.S. Story

> Bristol-Myers' Abilify coupons prevail in health-plan lawsuit. Article

Biotech Research News

@EmilyMFierce: Alterations in one gene may drive allergic, autoimmune diseases. Story | Follow @EmilyMFierce

> $750,000 in grants available to scientific researchers under new program. Report

> NIH lays out effects of sequestration on biomedical research. News

> New agent stops replication of hep C virus in preclinical studies. Article

> Pfizer taps UCSF for small-molecule drug discovery. Story

Pharma Manufacturing News

> CorePharma gets closeout letter for NJ plant. Report

> WSJ: Novartis looks to unload CMO LTS Lohmann. Article

> FDA close to resolving all cancer drug shortages. Story

> Explosion, fire at Teva plant kills one, injures 30. More

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