Medivation wins fast review for enzalutamide at FDA; Pluristem plots orphan drug app;

NEW! Conversation on  Twitter :

 @FierceBiotech: A handful of genetic mutations drive acute leukemia transformation. Article | Follow @FierceBiotech

 @JohnCFierce: Washout. Via NYT: Bapi investigator says "absolutely no evidence at all of a clinical benefit". Report | Follow @JohnCFierce

 @RyanMFierce: Hard to find who in bio isn't using Big Data. Special Report: 10 Reasons Why Biotech Needs Big Data. Report | Follow @RyanMFierce

> Medivation ($MDVN) and Astellas won a priority review for their closely watched prostate cancer drug enzalutamide, an advance that triggers a $10 million milestone for the biotech company. Shaving months off the review of the treatment is a big plus for the partners, who are planning to elbow into a market that includes Zytiga and Provenge, both relatively new entries. Bayer has been pushing its own candidate, alpharadin. Release

> Pluristem ($PSTI) says it plans to seek an orphan drug approval of its stem cell therapy for aplastic bone marrow. "Orphan drug status in the U.S. would help accelerate our path to full FDA approval and we intend to apply for a similar designation in Europe and global territories," said Zami Aberman, chairman and CEO of Pluristem. Story

> Psyadon Pharmaceuticals announced that its mid-stage study of ecopipam in patients with Tourette Syndrome was stopped early when an interim analysis revealed a statistically significant reduction in the severity of the patients' tic symptoms. Release

> BioCryst ($BCRX) today reported "favorable" 52-week safety results and sustained efficacy from the extension phase of its randomized Phase IIb trial of ulodesine (BCX4208) added to allopurinol in patients with gout who had failed to reach the serum uric acid therapeutic goal of <6 mg/dL on allopurinol alone, as well as positive Phase II safety results in patients with mild to moderate renal impairment. Release

Pharma News

 @FiercePharma: Acorda's MS drug Ampyra gets FDA warning on seizure risks. More | Follow @FiercePharma

> Tang Capital can't shuttle Savient into receivership, judge says. Article

> Italian drug cuts threaten thousands of jobs, industry says. Story

> FDA staff backs Roche's Lucentis for new use. News

Medical Device News

@FierceMedDev: Siemens snagged FDA clearance for a new MRI scanner the company says is more cost-effective than its competitors. Release | Follow @FierceMedDev

 @MarkHFierce: A new study connects increased heart attack risk with total hip and knee replacement surgery. More | Follow @MarkHFierce

 @DamianFierce: The FDA has slapped CareFusion with another Class I recall over leaky ventilators. Story | Follow @DamianFierce

> As health costs rise, 'generic' devicemakers see opportunity. More

> Histogenics reels in $49M Series A for tissue engineering implants. News

> As health costs rise, 'generic' devicemakers see opportunity. Story

Biotech Research News

> Novel class of Alzheimer's drugs looks promising in animals. Story

> A handful of genetic mutations drive acute leukemia transformation. Article

> One molecule may stand in the way of liver cancer. Report

> Genetic mutations linked to childhood brain cancer subtypes. More

Pharma Manufacturing News

> Owens & Minor buys unit from wholesaler Celesio. More

> Strides Arcolab to expand manufacturing in Africa with French investment. Report

> Drugmakers played unintended role in counterfeits hitting U.S. Article

> New Florida drugmaker springs from debacle of another. Story

> NZ doc faces 30 years after fake Cialis conviction. News

And Finally… A researcher at the University of North Carolina School of Medicine says that the notorious "bath salts" grabbing headlines act on the brain much the same way as cocaine. Release

 

Suggested Articles

Loretta Itri, M.D. has been helping Immunomedics out with its troubled antibody-drug conjugate. Now, she’s signing on as its chief medical officer.

Light Chain Bioscience, a unit of Swiss biotech Novimmune, has been handed a nice royalty milestone check from partner Takeda.

The fund received money from Chinese organizations inside and outside the biopharma industry, enabling CICC Capital to ease past its financing goal.