J&J files NDA for hep C drug; Medivation, Astellas outline interim analysis plan for Xtandi;

 @FierceBiotech: Sanofi to build $75m plant in Vietnam. Market there growing fast, and so is payer coverage. Article | Follow @FierceBiotech

@JohnCFierce: While India's SC strikes at pharma, the U.K. tees up a sweet tax deal for patented pharma products--the "patent box." More | Follow @JohnCFierce

@RyanMFierce: Amgen claimed Big Data software prize in $415M deCODE buyout. Report | Follow @RyanMFierce

> Late last week Johnson & Johnson's ($JNJ) Janssen Research & Development  announced it had submitted a New Drug Application to the FDA for simeprevir (TMC435), an investigational NS3/4A protease inhibitor for hep C. The drug was in-licensed from Medivir. Release

> Medivation ($MDVN) and Astellas Pharma have established an updated interim analysis plan for their Phase III clinical trial evaluating Xtandi (enzalutamide) capsules in men with metastatic castration-resistant prostate cancer who have not yet received chemotherapy. Release

> Isis Pharmaceuticals ($ISIS) has published new data in the journal Circulation Research "demonstrating that antisense targeting of apolipoprotein C-III (apoC-III) resulted in significant reductions in apoC-III and triglycerides." Release

Medical Device News

 @FierceMedDev: Dx approach offers chance to spot pancreatic cancer earlier. Story | Follow @FierceMedDev

 @MarkHFierce: Sony and Olympus have delayed their joint medical device venture again. Talk about unrealized potential. More | Follow @MarkHFierce

 @DamianFierce: A Chinese court is asking the SFDA to crack down on local clinical trial regulations. Article | Follow @DamianFierce

> ResMed battles Taiwanese outfit in apnea device patent fight. Item

> Olympus, Sony postpone joint medical device venture indefinitely. Article

> Covidien defeats J&J/Ethicon in surgical tool patent battle. News

Pharma News

@FiercePharma: Reports of serious reactions to Affymax's Omontys surfaced last August, WSJ says, 6 months b/f recall. More | Follow @FiercePharma

@EricPFierce: Pfizer's Xeljanzi forecast to hit $1.86 billion by 2016 but Amarin's Vascepa disappoints. Story | Follow @EricPFierce

> J&J faces big spending, big rivals for new diabetes drug Invokana. Report

> Sanofi plots new production in China, Vietnam to fuel Asian growth. More

> Biogen prices Tecfidera below oral MS rival Gilenya. Article

CRO News

> Biotrial takes tech, talent from failing Forenap. Story

> ReSearch launches joint venture with Japanese CRO. News

> bioRASI buys Ukraine CRO for E. Europe heft. Article

> Frontage gets FDA chiding over Chinese lab. Item

> Chinese court wants tougher clinical trial regs. Report

Biotech IT News

> George Church-affiliated startup blueprints genetic data marketplace. News

> FoldIt creator wins Bill Gates nod for science crowdfunding site. Item

> Sequoia-backed genomics startup, others face who-pays hurdle. Story

> NSF touts role of supercomputer in autism, neuroscience discoveries. Article

> Big Data sheds light on pharma's 'Small Data' problems. Industry Voices

> 5 keys to going mobile in pharma. Editor's Corner

And Finally… Following up on earlier studies showing that African-American men are less likely to be screened and get early treatment for prostate cancer, a new study shows that they also wait longer to get treated once they have been diagnosed, adding to their chances for a poor outcome. Release


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