Abeona raises $8.5M for rare disease R&D; ZS Pharma moves toward FDA decision;

@FierceBiotech: FierceBiotech Radio on Allergan's change in tune, Sanofi's new bet on Regeneron, and the latest big biotech IPO. Listen/Subscribe | Follow @FierceBiotech

@JohnCFierce: These Afrezza sales numbers say A: Afrezza isn't winning over many people and B: spurring any patient migrations in diabetes will be tough. | Follow @JohnCFierce

> Abeona Therapeutics raised $8.5 million to fund the development of treatments for rare genetic diseases, with billion investor George Soros chipping in. Item

> Immune Pharmaceuticals ($IMNP) is raising as much as $21.5 million in two transactions, borrowing $9.5 million and selling $12 million in stock to support the development of bertilimumab, an antibody designed to treat inflammatory disease. More

> The FDA accepted ZS Pharma's ($ZSPH) application for ZS-9, a treatment for dangerously high potassium, and the agency has promised to hand down a final decision on the drug by May 26. News

Medical Device News

@FierceMedDev: ICYMI yesterday: FDA approves first weight-loss balloon, giving the obese a minimally invasive option. Article | Follow @FierceMedDev

@VarunSaxena2: FDA clears devices to reduce snoring in patients without sleep apnea. Report | Follow @VarunSaxena2

@EmilyWFierce: Indian diagnostics outfit debuts 'lab-on-cartridge' device for developing countries. More | Follow @EmilyWFierce

> In a big week for obesity devices, GI Dynamics terminates U.S. pivotal obesity device trial. More

> NeuWave Medical gets FDA clearance for software upgrade to its ablation system. News

Pharma News

@FiercePharma: VCA ups 2015 guidance as 2Q sales and profits soar past expectations. FierceAnimalHealth article | Follow @FiercePharma

@EricPFierce: As #Hospira expands recall of #ketorolac to 37M vials you've got to wonder what Pfizer thinks. Story | Follow @EricPFierce

@CarlyHFierce: Here's our latest at @FierceBiotech radio. I haven't listened to it yet, but someone told me it was good. Listen | Follow @CarlyHFierce

> Express Scripts: Pricey PCSK9 drugs poised to 'wreak havoc.' More

> Depomed pooh-poohs Horizon's new bid in latest rejection. Story

Vaccines News

> Pfizer's U.S. Prevnar 13 sales jump 87% in Q2. Report

> GSK envisions 'thoughtful, staged rollout' for Mosquirix. More

> Sanofi's dengue vax protects two-thirds of people aged 9 and up: NEJM. Story

> NIH's MERS vaccine looks promising in mice. Item

> Bavarian Nordic starts PhII of Prostvac in early-stage cancer. Article

CRO News

> Charles River's revenue slips on slumping R&D demand. More

> Covance names a new CEO as it adjusts to life with LabCorp. Story

> Patheon unloads some assets on the way to an IPO. Item

> PRA boosts its profit forecast after a strong sales quarter. Report

> Quintiles restores its rosy outlook after a big quarter. Article

Pharma Manufacturing News

> More cuts as Sun Pharma pulls Ranbaxy into the fold. Item

> Cardinal reports rising revenues and says next year looks even better. More

> McKesson reports higher Q1 revenues, but international sales were flat. Report

> FDA issues draft guidance on quality manufacturing metrics. Story

> Regulators in Europe propose bans on plants in China and India. Article

Pharma Asia News

> Is Asia's IP landscape in for big changes under TPP? Item

> India drugs watchdog to look at feasibility of online drug sales. More

> Syngene IPO by India's Biocon reaches top of range with no GVK, Quest blowback. Story

> More change ahead for Novogen as interim CEO Ross orders wide review of programs. Article

> S. Korea's Hanmi sells lung cancer candidate rights to BI in second major deal this year. Report

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