NCE delay for Amarin takes a bite out of its share price; Actelion scales back layoff plans; Takeda completes Russian drug plant;

Conversations on Twitter :

 @FierceBiotech: Enzyme deletion slashes Alzheimer's plaque production. Story | Follow @FierceBiotech

 @JohnCFierce: Impressive. Sweden investing $320M in biotech, mostly Stockholm-Uppsala region. Release | Follow @JohnCFierce

 @RyanMFierce: AstraZeneca and Broad team up on discovery of infectious disease drugs. Add to long list of pharma/academia tie-ups. More | Follow @RyanMFierce

> Shares of Amarin ($AMRN) took a hit overnight after the company filed papers noting that the FDA had yet to decide whether its industrial-strength fish oil product Vascepa warranted approval as a new chemical entity, a classification that carries 5 years of marketing exclusivity with it. The lengthy delay on the NCE ruling caused considerable hooting on Twitter as analysts like Adam Feuerstein at TheStreet concluded that Amarin is likely to wind up without the NCE stamp, leaving the company with only three years of exclusivity and a quick onslaught of generic competition. Amarin shares are down 5% this morning. Story

> After negotiating with labor groups Switzerland's Actelion has reduced the number of jobs it plans to cut from a maximum of 70 down to 40. Actelion has been streamlining operations following its R&D success with a next-gen therapeutic. Story

> Racing to snag a leading position in the growing Russian drug market, Japan's Takeda has just completed a $96 million manufacturing facility in an effort to build local production capability. Story

> Sunesis Pharmaceuticals says it plans to implement a one-time, 225-patient sample size increase to its Phase III study of vosaroxin in acute myeloid leukemia, bringing target enrollment to 675 patients. Release

Pharma News

 @FiercePharma: Citi says lax cash management costs Big Pharma big bucks. Item | Follow @FiercePharma

> India opens up its drugmakers to foreign investment. More

> Novartis swings for fences in battle over Gleevec patent in India. Article

> Pharma pins new social media hopes on Pinterest. Story

Medical Device News

 @FierceMedDev: Exagen raised $5.3M for Dx development. News | Follow @FierceMedDev

 @MarkHFierce: As the House looks to IRS implementation of the device tax, AdvaMed continues to fight it. Release | Follow @MarkHFierce

 @DamianFierce: GE touts positive Phase III for its next-gen Alzheimer's imaging agent. Next step: FDA application. More | Follow @DamianFierce

> FDA rejects Navidea's app for cancer diagnostic aid. Story

> Welch Allyn plans to slash 275 jobs, blames device tax. Report

Biotech Research News

> Personalized lung cancer treatments are already out there, researchers conclude. Story

> Respiratory virus tried as targeted cancer treatment. More

> StemCells wins $20M grant to fuel preclinical Alzheimer's treatment advance. Report

> Swedish scientists to test gene therapy for excessively high bone density. Item

Pharma Manufacturing News

> FDA's Woodcock changing up drug quality oversight. Item

> CSL secures U.S. contract to supply flu vaccine antigens. More

> Ipsen keeps up Increlex supply amid Lonza plant failures. Article

> Environmental fights drive China's Harbin to uproot drug factory. Report

> New Shire plant to feed expansion in regenerative medicine. Story

And Finally… Those electronic devices we use at night can reduce levels of melatonin and interfere with sleep schedules, according to a new study. Story

 

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