skin infections news from FierceBiotech

Switzerland's Basilea took its turn on the public markets' whipping post, shedding 27 percent of share value after announcing that its antibiotic ceftobiprole had failed to quickly win over FDA Read more...

AstraZeneca is pumping $100 million into its research center in Waltham, MA to boost its R&D efforts for infectious diseases and cancer research. Construction on a 132,000-square-foot facility will begin soon and the facility will open in mid-2009. The expansion will allow AstraZeneca to add 100 more researchers to the 400 it already employs at the research complex.

Since the opening of AstraZeneca R&D Boston, scientists there have discovered three potential drugs that are …

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Press Release: Basilea Announces Positive Top-line Results on Second Pivotal Phase III Ceftobiprole Trial

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Forest Laboratories has joined the lineup of drug developers bidding their way to new prospects with its agreement to buy the antibiotic developer Cerexa for $480 million in cash. Forest gains development and marketing rights for three antibiotics, including one--ceftaroline acetate--which is poised to begin a late-stage trial for skin infections. It could be launched in 2010 or 2011. If its sales break the $500 million mark in any 12-month period after the five years it is launched, …

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The FDA has issued Replidyne and partner Forest Labs a non-approvable letter for faropenem medoxomil, an antibiotic for acute bacterial sinusitis, community-acquired pneumonia, chronic bronchitis and adult skin infections. The FDA called for further trials of the drug, despite the fact that researchers went to the NDA with data from 11 Phase III trials involving 5,000 patients. Replidyne says that it has apparently fallen victim to the FDA's recent preference that drug developers prove …

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Theravance shares were on the decline this morning despite some upbeat news from its pivotal trial on the antibiotic telavancin. Studies involving more than 1,800 volunteers demonstrated that the injectable antibiotic for skin infections is just as effective as vancomycin while demonstrating greater bacteria death (telavancin 89.9 percent versus vancomycin 85.4 percent) and cure rates (telavancin 90.6 percent versus vancomycin 86.4 percent). "With the data from this program, telavancin …

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Replidyne has filed for a $100 million IPO. The Louisville, CO biotech company has been backed by George Soros' venture group. Replidyne hit an important milestone when the company filed an NDA for its new antibiotic last December. The FDA accepted it in February. Replidyne is looking for FDA approval for faropenem medoxomil as a therapy for acute bacterial sinusitis, community-acquired pneumonia, chronic bronchitis and adult skin infections. Researchers went to the FDA with data from 11 …

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Theravance and Astellas Pharma have signed a deal to develop and market Theravance's antibiotic telavancin, an drug currently in phase III trials for skin infections and Hospital-Acquired Pneumonia (HAP). Astellas will make an initial payment of $65 million and will also pay Theravance up to $156 million in clinical and regulatory milestones. If the drug is approved, Theravance will receive royalties on global sales of the antibiotic.

- read this press release for more details on the deal

> As expected, Canadian health officials say they have begun to draft new regulations that would stop bulk drug shipments going south. But the move is unlikely to threaten the online pharmacies currently in operation. Article

> The FDA has approved Johnson & Johnson's Topamax as an initial monotherapy for epilepsy. …

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Touting a late-stage trial that highlights the effectiveness of Cubicin in reducing heart valve and blood infections caused by Staph bacteria, Cubist Pharmaceuticals says it will ask the FDA for an accelerated review to expand its use. Cubicin is currently approved to prevent skin infections caused by Staph bacteria.

- read this article from the AP for more