FDA Policy/General

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Regen BioPharma has entered into a non-exclusive license agreement with Pan Am Cancer Treatment Center in Tijuana, Mexico to test HemaXellerate in a first-in-human proof of concept study. According to the company, HemaXellerate is comprised of cells extracted from the patient’s own fat tissue and processed to induce a biological response in the patient that heals damaged bone marrow and restores the ability to generate healthy blood cells. The company says that up to 10 patients with chemotherapy-induced aplastic anemia will be treated with HemaXellerate, and it will measure outcomes at one, three and six months intervals.

Takeda Pharmaceuticals U.S.A. and Lundbeck say that Brintellix (vortioxetine) indicated to treat major depressive disorder in adults will be marketed in the U.S. under the new name Trintellix (vortioxetine) beginning in June. The company received reports of the drug being confused in the marketplace between with the anti-blood clotting therapy Brilinta (ticagrelor).

Encore Vision reports that in its Phase 1-2 study of EV06 ophthalmic solution 1.5% in treating the gradual stiffening of the crystalline lens, a major underlying cause of presbyopia, the primary efficacy and safety endpoints have been met. The company says that 75 subjects between the ages of 45 and 55 with distance corrected near visual acuity worse (DCNVA) than 20/40 and best corrected distance visual acuity of 20/20 or better in each eye were randomized 2:1 to receive one drop of EV06 or placebo twice daily over 90 days. The study saw a significant improvement of DCNVA from baseline in the EV06 group compared to placebo.

Johns Hopkins University School of Medicine has awarded Pharos Biologicals (formed by university professor J. Thomas August) the exclusive worldwide licenses for a patented Lysosome-Associated Membrane Protein DNA vaccine technology and for certain nanotechnologies to deliver the vaccines for use in the development and delivery of vaccines for influenza and flaviviruses. The company plans to focus on the Zika vaccine development, and later on dengue and influenza virus vaccines.

Endo International says the U.S. District Court for the Southern District of New York has issued an order upholding its 8/2015 ruling and confirming the court’s prior injunction against the manufacture or sale of Actavis’ generic version of non-crush-resistant Opana ER as well as an approved, but not yet marketed generic from Roxane Laboratories.

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