FDA staffers cite issues in River Plate app; Calando inks licensing deal with Cerulean;

> River Plate Biotechnologies' application to market a new therapy for dry eye has three major statistical issues, according to staff at the FDA. In a review, the FDA staffers noted that one key study did not show a "robust treatment effect." Report

> Calando Pharmaceuticals, a subsidiary of Arrowhead Research, has struck a licensing deal with Cerulean Pharma for Calando's drug delivery platform, Cyclosert, and the associated clinical stage anti-cancer drug, IT-101. Release

> FDA staffers say they have seen no serious safety issues related to Ista Pharmaceuticals' proposed eye drops for allergy-related itching. Story

> Shareholders have approved GPC Biotech's merger agreement with diagennix GmbH, to be renamed Agennix AG and converted into a stock corporation. Release

> SynCardia Systems has raised $10.3 million in its Series D round of funding. Highway 12 Ventures led this round of financing. Release

> Following the special protocol assessment process, OncoGenex has received the FDA's blessing to amend the design of a late-stage trial for OGX-011. Researchers will study patients receiving first-line chemotherapy rather than second-line chemo, as had been planned originally. Story

>  Shares of Lorus Therapeutics soared 40 percent on the news that it had reached a deal to buy back close to $10 million in secured convertible debentures. Report

> Oscient Pharmaceuticals has pulled its European application for Factive, an antibiotic designed for certain types of pneumonia and bronchitis. Story

> RegeneRx will collaborate with the U.S. Army on eye drops that can be used to counter exposure to caustic chemicals. Story

Pharma News

> Good news: The U.K.'s National Institute for Clinical Excellence is using a new cost-effectiveness analysis designed to make more end-of-life drugs available. The bad: Erbitux still didn't make the grade for treatment of head and neck cancer. Report

> FTC's top dog was speaking yesterday at a Center for American Progress-sponsored event, claiming that American consumers could save $35 billion over 10 years if the deals were banned. Report

> A tougher, more transparent FDA? Apparently, the agency is trying. Today, FDA is holding its first public meeting on transparency, focusing on ways the agency "can make understandable and useful information available to the public." Report

> Are misconceptions about generic meds curtailing their use? A new study by pharmacy benefits manager Prescription Solutions (part of UnitedHealth Group) found that one-third of Americans either a.) don't know, or b.) don't believe that copycat meds contain the same active ingredients as branded drugs. Report

> Japan's Takeda Pharmaceutical is calling on some pharma heavyweights for help and guidance. The company has set up a global advisory board--helpfully nicknamed the "TGAB" by the company's PR folk--that combines several of its current execs with four external advisors. Report

And Finally... Researchers have found that a large percentage of women who suffer from migraines in middle age go on to develop brain lesions that could affect their motor functions and senses. Story

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