Otsuka faces FDA setback for kidney disease drug; Helix BioPharma established Polish outpost;

@FierceBiotech: Report: Big CROs soared 10% last year. More from FierceCRO | Follow @FierceBiotech

@RyanMFierce: Icon Bioscience snags $15M in B round for eye therapies. News | Follow @RyanMFierce

@EmilyMFierce: ICYMI: UM Pharmacy School researchers develop new opioid pain drug that decreases tolerance, side effects. Article | Follow @EmilyMFierce

> Neurotrope (formerly BlueFlash Communications), an Alzheimer's-focused biotech, has completed a reverse merger in which Neurotrope BioScience, a Delaware corporation, became a wholly owned subsidiary of the company. Item

> Andrea Sloan, a 7-year survivor of Stage 3c ovarian cancer, is seeking a compassionate use exemption from BioMarin ($BMRN) to have the company's BMN 673 inhibitor, which is currently in clinical trials, administered to her. Sloan says the drug is the best option for her BRCA1 mutation of ovarian cancer. More

> Helix BioPharma has established a subsidiary in Poland, Helix Polska, to boost ongoing clinical oncology research in the country. News

> Otsuka Pharmaceuticals said it has received a Complete Response Letter from the FDA regarding the new drug application (NDA) for tolvaptan for the treatment of adult patients with rapidly progressing autosomal dominant polycystic kidney disease (ADPKD). In its letter to Otsuka, the FDA requested Otsuka provide additional data to further evaluate the efficacy and safety of tolvaptan in patients with ADPKD. Release

Medical Device News

@FierceMedDev: Meda grabs MA maker of asthma inhaler for $135M. Story | Follow @FierceMedDev

@MarkHFierce: Covidien won yet another patent battle with a rival. Patent spats aren't cheap. News | Follow @MarkHFierce

@MichaelGFierce: European public health group gets behind tighter device controls. Item | Follow @MichaelGFierce

> Texas neurostim startup pulls in $3.4M for multiple trials. Article

> Medtronic looks to innovate with new Singapore shop. More

> Covidien claims victory in surgical tool patent dustup. Story

Pharma News

@FiercePharma: Bayer's new cancer drug Stivarga (with Onyx) wins approval in Europe, for metastatic colorectal. Release | Follow @FiercePharma

@EricPFierce: J&J takes another step to warn consumers that if you take too much acetaminophen, it will kill you. Story | Follow @EricPFierce

@CarlyHFierce: Cubist recalls four lots of antibiotic Cubicin because of glass particles. More from FiercePharmaManufacturing | Follow @CarlyHFierce

> Novartis' MS drug Gilenya tied to rare brain infection. More

> AbbVie, Shire, Pfizer offended by turning Vicodin, Adderall, Xanax into fashion statement. News

And Finally... Researchers are designing 3-D printers that would print food in space. More

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