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Novartis, Verastem & Cepheid Making Biotech Headlines On Friday

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Novartis AG (ADR) (NYSE: NVS) obtained approval for an accelerated review of an experimental heart-failure treatment Friday, while Pfizer Inc. (NYSE: PFE)'s new formulation of oxycondone aimed at foiling abuse won acceptance for an evaluation.

Other regulatory news from drug companies Friday included Cepheid (NASDAQ: CPHD) gaining orphan drug status for a drug aimed at asbestos-related cancer, and Verastem Inc (NASDAQ: VSTM) winning approval for expanded claims for its tuberculosis test.

None of the companies' shares appeared to be moving on the news.

Norvartis said it might get a decision on approval in August from the Food and Drug Administration on its investigational medicine for the treatment of heart failure, called LCZ696.

Related Link: Zogenix Received FDA Approval, Now What?

On Friday, the drug was granted priority review designation that could cut approval time to eight months, from 12, Novartis said. Pfizer said its new formulation of oxycodone aimed at deterring abuse got accepted for a review by the FDA. The formulation includes the opioid receptor antagonist naltrexone.

Verastem's treatment for mesothelioma, VS-5584, obtained orphan drug designation from the FDA. The designation for drugs that treat rare diseases provides seven years of U.S. market exclusivity and other benefits.

Verastem is currently conducting a Phase 1 dose trial of the drug.

Cepheid, lastly, got FDA approval for an expanded product claim on its Xpert tuberculosis test product. The new claim enables clinicians to use either one or two negative test results, in conjunction with additional data, to remove tuberculosis patients from respiratory isolation.

Posted-In: News FDA


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