Akebia touts positive PhII anemia study; GTx outlines new trial plans for Capesaris;

@FierceBiotech: DepoVax drug and vaccine combo finds cancers that duck immune attacks. Story | Follow @FierceBiotech

@JohnCFierce: Sanofi blockbuster contender Zaltrap flunks a prostate cancer PhIII; gets priority review for colorectal cancer. Release | Follow @JohnCFierce

@RyanMFierce: Good stuff from Biogen's ($BIIB) Michael Gilman about how fibrosis has turned into a prime target for biotech (he'd know). Piece | Follow @RyanMFierce

> Cincinnati-based Akebia Therapeutics says it gathered positive data in a Phase II dose-ranging study of AKB-6548 in patients with stage 3 and 4 chronic kidney disease. AKB-6548 is an oral HIF-PH inhibitor designed to increase the production of erythropoietin, spurring a rise in hemoglobin in patients with anemia. The study met its primary endpoint of a dose-responsive increase in hemoglobin from baseline over the 42 days of the study. Release

> GTx says it's prepping for talks with the FDA on a new design for clinical trials of Capesaris, a prostate cancer treatment that drew a clinical hold from the FDA after it was linked to an increased risk of blood clots. The developer wants to test a lower dose as a secondary treatment for the disease. Report

> Angiotech says it will gain an initial $20 million payment from Johnson & Johnson ($JNJ) for certain IP related to its wound closure technology. J&J is also committed to paying an additional $42 million in potential contingent considerations. Release

> Sucampo Pharmaceuticals announced positive top-line results from a Phase III study designed to evaluate the long-term safety and efficacy of lubiprostone in opioid-induced bowel dysfunction patients with chronic, non-cancer-related pain. CEO Ryuji Ueno says Sucampo is prepared to file a supplemental NDA. Release

Pharma News

@FiercePharma: Fake Avastin's path to US passes through fake addresses--WSJ. News | Follow @FiercePharma

> Watchdog says FDA should consider restricting Gilenya. More

> CHMP chair makes sudden exit from EMA. News

> U.K. drug costs drop as blockbusters go off patent. Article

Medical Devices News

@FierceMedDev: Article questions Consumer Reports analysis of device registration process. News | Follow @FierceMedDev

> Report: Poor health to fuel CRM device growth. More

> Ex-Synthes employee fights back in generic device tussle. Article

CRO News

> Can computer games aid in pediatric clinical trials? Item

> Charles River and Metabolon partner to advance oncology research for others. News

> Warnex catches break in dealing with financial woes. Story

Manufacturing News

> Abbott gets more incentives for its new Ensure plant. More

> FDA cites 32 contamination complaints at biologics maker. Story

> With new plant, Ranbaxy back in force in North America. Article

Vaccines News

> Preventing a heart attack is just a shot away? Story

> Lung cancer vax improves survival in late-stage disease. Article

> Nasal RSV vax shows promise in the lab. Item

And Finally… A new study from the University of Michigan suggests that African-Americans and Hispanics are less likely to be prescribed antidepressants than whites. Story

 

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