Generex shares surge after FDA grants early access to insulin therapy; GATC plans to add 100 workers;

> Shares of Generex Biotechnology surged 30 percent this morning after the FDA granted patients with serious cases of diabetes early access to its oral insulin therapy Oral-lyn. Story

> MAP Pharmaceuticals used an appearance at the International Headache Society to boast about the effectiveness of its inhaled migraine therapy in various patient groups. Researchers had unveiled late-stage clinical data for Levadex earlier this year, but said that subsequent analysis indicated that the therapy demonstrated an ability to work against a broad spectrum of migraine. Story

> GATC Biotech plans to invest five million euros in its headquarters until 2012 to create offices and laboratories for an additional 100 employees. Release

> Mpex Pharmaceuticals says it has harvested positive data from its Phase IIb trial with Aeroquin, an aerosol formulation of levofloxacin, in cystic fibrosis. Release

> QuatRx Pharmaceuticals announced positive efficacy results from the second of two patient cohorts in the second pivotal Phase III study for Ophena (ospemifene tablets), its therapy for postmenopausal vulvovaginal atrophy. Release

> Neuralstem has won a patent covering the production and transplantation of stem cells. Story

Pharma News

> It's a good news-bad news day for Bayer and Onyx Pharmaceuticals' Nexavar drug. While Onyx CEO Anthony Coles touted soon-to-be released data on Nexavar use against breast cancer, the U.K.'s National Institute for Health and Clinical Excellence opted out on the drug for liver cancer. Article

> In a letter to The Guardian published today, Chris Strutt, GlaxoSmithKline's Senior VP of government affairs, public policy and patient advocacy, says the drugmaker has already been in discussions with Unitaid regarding an HIV patent pool and is open to further meetings. Article

> Two out of three ain't bad. Yesterday, Merck's HPV shot Gardasil saw a potential competitor step closer to the market. But it also won an FDA advisory panel recommendation for approval to prevent genital warts in young men. And it got the nod from European regulators for use in women up to the age of 45. Article

> Cool it, jurors. That's what the U.S. judge hearing the first Fosamax jaw-deterioration case said yesterday after disagreements among jury members got, well, a little overheated. Article

Vaccine News

> With two new swine flu vaccines approved for use and five million doses scheduled for delivery this month, China is set to become the first country to begin a mass vaccination campaign against the H1N1 pandemic. But officials with the World Health Organization say that there are some concerns about potential side effects. Article

> The FDA is giving Dynavax Technologies a green light to resume testing of a late-stage hepatitis B vaccine that had been derailed 18 months ago after a patient in one study developed a rare inflammatory autoimmune disease. Article

> Vical is touting new animal data demonstrating that its experimental H1N1 vaccine produced a strong immune response against three distinct strains of swine flu. And it's rushing ahead in an attempt to gain additional funds for early-stage human trials, which could start weeks after the money is available. Article

And Finally... By adapting a single protein on the surface of the bacterium Caulobacter crescentus, researchers at the University of British Columbia have turned it into a protein production factory, making useful proteins that can act as vaccines and drugs. Release

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