FDA Policy/General

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Janssen R&D Ireland has entered into a collaboration with ViiV Healthcare to develop and commercialize a new single tablet regimen containing Janssen’s non-nucleoside reverse transcriptase inhibitor Edurant (rilpivirine) and ViiV’s integrase inhibitor Tivicay (dolutegravir) as the sole active ingredients for the maintenance treatment of patients with HIV.

Eli Lilly says a Phase 3 trial of Cyramza (ramucirumab), which was approved by FDA in April for advanced stomach cancer, failed to meet its primary endpoint of statistically significant overall survival in a study assessing its effectiveness on liver cancer. According to the company, the REACH trial enrolled 565 patients in 27 countries and compared Cyramza plus best supportive care to placebo. The trial also compared Cyramza plus best supportive care as a second-line treatment in patients with hepatocellular carcinoma after first-line treatment with sorafenib.

Portola Pharmaceuticals reported that Phase 2 data from a study in 27 healthy volunteers of andexanet alfa, an FDA-designated breakthrough therapy and a first-in-class Factor Xa inhibitor antidote showed that it can reverse a low molecular weight heparin, thereby expanding its potential use to enoxaparin-treated patients. The company says andexanet alfa is being developed as a direct reversal agent for patients receiving a Factor Xa inhibitor who suffer a major bleeding episode or who may require emergency surgery.

American Medical Systems, an Endo International subsidiary has enrolled the first patient in Embrace, a post market surveillance study for the Elevate Anterior and Apical Prolapse Repair System. FDA has required post market surveillance studies on all transvaginal mesh products currently on the market.

Vivus has filed a lawsuit in the New Jersey federal court against Actavis in response to an ANDA, filed by Actavis seeking to market generic versions of the currently approved doses of Qsymia (phentermine and topiramate extended-release) capsules prior to the expiration of the U.S. patents.

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome