Government
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. Senate Finance Committee and the House Oversight Committee started hearings on Tuesday, January 29, focused on dealing with high drug prices.
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.
Real-world evidence (RWE) or real-world data (RWD) relates to the collection of information about a drug’s safety and efficacy outside the structure of a clinical trial. Speaking yesterday, FDA Commissioner Scott Gottlieb laid out the FDA’s new framework for dealing with RWE and RWD.
Numerous biotech companies had filed for initial public offerings (IPOs) during the five-week government shutdown, but were unlikely to actually be able to be listed until the U.S. Securities and Exchange Commission (SEC) had a chance to review their filings.
The approval of the combination marks a first for the U.S. market. The combination of AbbVie and Janssen’s Imbruvica with Roche’s Gazyva is the first chemotherapy-free, anti-CD20 combination to treat CLL and SLL patients who have not yet started therapy, AbbVie said this morning.
Here’s a look at this week’s calendar for decisions coming down from the U.S. Food and Drug Administration (FDA).
On Thursday, regulators with both the FDA and EMA announced that patients prescribed the drug should ask their doctors if it is wise to continue taking it. This comes after Lartruvo failed to hit endpoints in a Phase III study of advanced or metastatic soft tissue sarcoma.
This week, the U.S. Supreme Court rejected Swiss pharmaceutical company Helsinn Healthcare S.A.’s claim that Teva Pharmaceutical violated patent rights when the Israel-based company released a generic version of its anti-nausea medicine, Aloxi.
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