Spotlight On... Shionogi's OIC drug clears another Phase III hurdle; Califf up for Senate vote; and more...

Japanese drugmaker Shionogi said its in-development treatment for opioid-induced constipation met its main goal in a late-stage trial, a positive development for the company as it moves toward a fast-crowding market. The drug, naldemedine, met its primary endpoint by increasing the frequency of bowel movements for 47.9% of patients in at least 9 of the study's 12 weeks, Shionogi said. That marked a statistically significant improvement over placebo, which made a 34.6% difference, the company said. The latest results, presented at the American Academy of Pain Medicine this week, mark the third Phase III success for naldemedine, Shionogi said, and the company plans to file its drug for FDA approval in the first half of this year. Meanwhile, AstraZeneca ($AZN) recently launched the opioid-induced constipation (OIC) treatment Movantik, which competes with Sucampo Pharmaceuticals ($SCMP) Amitiza and Valeant Pharmaceuticals' ($VRX) Relistor in the space. Release

@FierceBiotech: ICYMI Friday: Novartis' blood cancer drug bags a 'breakthrough' tag on the way to FDA filing. Article | Follow @FierceBiotech

@JohnCFierce: Chimerix scraps two PhIII trials as it regroups in wake of a setback. News | Follow @JohnCFierce

> Astellas, which finally closed its $379 million deal for Ocata Therapeutics, plans to appoint the company's chief scientific officer as head of its regenerative medicine department. Robert Lanza will also remain the top scientist at Ocata as it develops stem cell therapies as an Astellas subsidiary, the Boston Globe reports. News

> Robert Califf, President Barack Obama's nominee for FDA commissioner, faces a procedural vote in the Senate on Monday. If he secures the support of at least 60 senators, he'll face a final confirmation hearing later this week. Story

> Amgen ($AMGN) signed a deal to invest up to $75 million in Unilife ($UNIS) to collaborate on wearable drug delivery devices. More

Medical Device News

@FierceMedDev: ICYMI Friday: FDA warns two diagnostics players for marketing unapproved tests. Article | Follow @FierceMedDev

@StacyALawrence: Philips unveils wearable, wireless vitals patch that goes from hospital to home. News | Follow @StacyALawrence

@VarunSaxena2: ICYMI from FierceDrugDelivery: Early-stage drug delivery implant targeting pancreatic cancer tumors showing promise. Story | Follow @VarunSaxena2

@EmilyWFierce: AstraZeneca bags EU approval for gout drug Zurampic as it eyes $500M in sales. More from FiercePharma | Follow @EmilyWFierce

> Boston Sci nabs first CE mark for drug-polymer combo stent for above-the-knee PAD. Story

Pharma News

@FiercePharma: Global group says Zika highlights need for research collaborations across specialties. More from FierceAnimalHealth | Follow @FiercePharma

@EricPFierce: ICYMI from FiercePharmaManufacturing: New York gives $200M for Athenix to build Buffalo plant. Company pledges 900 jobs over 10 years. Report | Follow @EricPFierce

@CarlyHFierce: ICYMI Friday: Perrigo pushes forward with Ireland expansion as sales, earnings lag. Article | Follow @CarlyHFierce

> Merck CEO Frazier: Pharma needs to justify price hikes. Report

Animal Health News

> Aratana shoots for first European approval with canine arthritis drug. Report

> Global group says Zika highlights need for research collaborations across specialties. More

> U.K. charity sets out to sequence genomes from 50 dog breeds this year. Story

> Study: Fat cats will still love you if you put them on a diet. Item

> Pawprint looks to make its mark with EMR-based mobile app for pet owners. Article

Biotech IT News

> IBM strikes $2.6B deal for Truven to feed Watson's appetite for health data. News

> Ransomware becomes big business as hackers demand $3M to relinquish control of hospital files. Report

> Silicon Valley's biotech scene looks to bounce back from Theranos' 'black eye.' Story

> FDA tallies up 35 security incidents a month as hackers pursue stock-moving details. More

> Gamers crush algorithms in RNA structure design challenge. Article

Pharma Marketing News

> With LixiLan decision date set, Sanofi nears another head-to-head contest with Novo. Report

> Mylan gets one step closer to finally challenging Glaxo's Advair. Item

> Bayer's Aleve and GSK's Flonase top list of OTC TV ad spenders for 2015. Story

> Devicemakers give pharma a run for their money with new DTC ads. More

> Eylea may be giving Regeneron trouble in the U.S., but it's pumping up for Bayer in EU. Article

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