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Genentech, a Roche company, is flexing its litigation muscle this week. The South San Francisco-based company has filed 18 lawsuits over the past few weeks to block competitors from selling a generic version of a treatment for idiopathic pulmonary fibrosis, a fatal lung-scarring disease.
Pharnext SA announced that the U.S. Food and Drug Administration has granted Fast Track designation for the development of PXT3003 for the treatment of patients with Charcot-Marie-Tooth disease Type 1A.
Almost three months to the day after an FDA advisory committee overwhelmingly rejected Alkermes’ major depressive disorder treatment, ALKS-5461, the company received word that the regulatory agency will not approve the medication.
Over the next two weeks, the U.S. Food and Drug Administration (FDA) has three upcoming decisions. Here’s a look.
Shares of AVEO Oncology plunged 45 percent Thursday trading after the Cambridge, Mass.-based company said it accepted the recommendation of the U.S. Food and Drug Administration to not seek regulatory approval of its kidney cancer drug, Tivozanib at this time.
The plan is aimed at providing new transparency to the prescription drug market and removing the veil of hidden rebates conducted between companies and pharmacy benefits managers.
Shares of GlaxoSmithKline took a slight dip Wednesday afternoon after the U.S. Food and Drug Administration approved Mylan NV’s generic version of Advair Diskus, a staple blockbuster drug in the U.K. pharmaceutical company’s pipeline.
The regulatory agency issued a Complete Response Letter to the Marlborough, Mass.-based Sunovion, the company said this morning. After reviewing the New Drug Application, the FDA said it could not approve the application for the apomorphine sublingual film in its present form.
The U.S. Food and Drug Administration issued a Complete Response Letter to the company in November, one month after an advisory committee rejected the drug. When the FDA issued the CRL, the regulatory agency requested additional clinical data on QT prolongation and indicated that the submitted safety database is not of adequate size for the proposed dosing.
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