EU committee backs Novartis drug; Affitech regains VEGF program;

> Novartis has reported that the EU's Committee on Human Medicinal Products has issued a positive opinion recommending the approval of Ilaris for cryopyrin-associated periodic syndrome, or CAPS, a fatal auto-inflammatory disease. Release

> Affitech has taken back a preclinical antivascular endothelial growth factor antibody development program from Peregrine as it pursues plans to shift into more development work. Financial details were not disclosed. Report

> Bioheart has won FDA approval to start a Phase I trial of its congestive heart failure therapy. The small trial of MyoCell SDF-1 should launch later this year. "To our knowledge, this will be the first clinical trial ever to test a combination gene and stem cell therapy for cardiovascular disease," Bioheart Chairman and CEO Howard Leonhardt said in a news release. Story

> The UK charity Action Duchenne is providing $1.2 million to AVI Biopharma to support new research on Duchenne muscular dystrophy. Story

Pharma News

> Sanofi-Aventis is one busy company. It has agreed to buy Swiss generics maker Helvepharm. It has forged a deal to take over Merial, the animal-health company it co-owns with Merck. And it's boosting its growth forecast for the year after the second quarter came in stronger than expected. Sanofi report

> What's up at Mylan? After trading yes-you-did, no-we-didn't statements with the FDA over possible manufacturing violations at a key plant, the company announced that it's reshuffling its management. Report

> The first Neurontin trial is shaping up to be an off-label marketing trial. Report

> Remember Robert Wessman? The Icelandic businessman, who stepped down as CEO of Actavis about a year ago, is plotting a new assault on the generics business, using the U.S.-based Alvogen Group as a platform. After building Actavis into a big-time maker of generic meds, and leaving after selling out to an Icelandic magnate, Wessman now plans to build Alvogen into a top 10 copycat company within five years. Report

> Apotex may just be the little Canadian drugmaker that could. Despite all the evidence, the company still thinks it can knock down the patent on Plavix, the top-earning blood thinner marketed by Bristol-Myers Squibb and Sanofi-Aventis. Report

Manufacturing News

> Product authentication, e-pedigree compliance, returns and recalls, and product usage data form the basis of a partnership between brand protection company Authentix and One Network, a supply chain solutions provider. Report

> Sanofi-Aventis recently lost a trailer full of drug products to thieves. The shipment contained blood thinner Lovenox (enoxaparin), the antihistamines Xyzal (levocetirizine) and Nasacort AQ nasal spray (triamcinolone), and acne treatment BenzaClin Gel (clindamycin), according to Securing Pharma. Report

> A deal said to move the totally disposable bioprocessing factory "one step closer to reality" has been struck by single-use bioprocessing equipment and services supplier Sartorius Stedim Biotech and SAFC Biosciences, a provider of cell culture materials and development services for upstream and downstream processing. Report

And Finally... A lack of sunlight is associated with reduced cognitive function among depressed people, researchers found. Report

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