FDA Policy/General

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Perrigo Company has completed the previously announced acquisition of a portfolio of generic dosage forms and strengths of Retin-A (tretinoin) from Matawan Pharmaceuticals. Perrigo was the authorized generic distributor of these products from 2005-2013.

Janssen Pharmaceuticals has suspended dosing in two Phase 2 clinical trials of their FAAH inhibitor, JNJ-42165279, in patients with social anxiety disorder or major depressive disorder with anxious distress response to 1/15 reports of severe adverse reactions (severe neurological injuries) in a Phase 1 clinical trial of Portugal-based Bial-Portela’s experimental drug in the same general class.

Resverlogix Corp. says the journal Atherosclerosis has accepted for publication a manuscript entitled: “RVX-208, a BET-Inhibitor for Treating Atherosclerotic Cardiovascular Disease, raises ApoA-I/HDL and represses pathways that contribute to cardiovascular disease.” The company says the manuscript details some of the beneficial actions of apabetalone (RVX-208), a bromodomain extra-terminal protein inhibitor for treating high-risk cardiovascular disease (CVD) patients.The data presented say that not only can apabetalone (RVX-208) raise the levels of ApoA-I and HDL, but also that the epigenetic actions of this BET inhibitor can modulate several factors known to be major contributors to CVD risk.

Barcelona-based pharmaceutical firm Almirall has acquired Irving, TX-based ThermiGen, a private esthetic medical device company known for its minimal thermal energy product line. ThermiGen offers products that allow plastic surgeons, dermatologists, cosmetic surgeons, and OB-GYNs to use thermal energy during micro-invasive procedures to “boost patient safety and clinical effectiveness,” the company says.

Two recently published studies in Nature Medicine and Nature Biotechnology report that researchers from the Massachusetts Institute of Technology, Boston Children’s Hospital, and several other institutions have shown encapsulated human islet cells transplanted into mice can effectively halt Type 1 diabetes for up to six months without causing an immune response.

Non-profit research institute Broad Institute Genomic Services has partnered with Takeda Pharmaceutical to perform genomic analysis on patient samples from a Phase 3 clinical trial of Ninlaro (ixazomib), an oral proteasome inhibitor that was recently approved by FDA for treatment in combination with lenalidomide and dexamethasone, for patients with multiple myeloma who have received at least one prior therapy. The institute says data from the analysis is expected to aid the understanding of multiple myeloma biology and potentially identify mechanisms of sensitivity or resistance to proteasome inhibitor treatment.

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