FDA Policy/General

Since Our Last Issue ...

Xynomic Pharmaceuticals has acquired from Pharmacyclics the exclusive worldwide rights to develop, manufacture and commercialize Abexinostat, a potentially best-in-class innovative Pan-Histone Deacetylase Inhibitor designed to target hematological and solid tumors. To date a total of 14 Phase 1 and 2 clinical trials of Abexinostat in U.S., EU and Asia have been completed, demonstrating that Abexinostat is clinically active in multiple tumor settings. Xynomic says it aims to initiate Phase 3 registrational trials worldwide in the third quarter.

Merck took a pre-tax $2.9 billion hit on its hepatitis C drug candidate uprifosbuvir due to flagging sales in the market based on the success of drugs already available, presumably Gilead’s Harvoni and Sovaldi therapies. Merck acquired the drug in 2014 with its $3.9 billion acquisition of Idenix Pharmaceuticals, and it now values the drug at $240 million.

Henry Schein, Inc. has entered into an agreement to acquire Southern Anesthesia & Surgical, a U.S. distributor of anesthesia and surgical supplies to oral surgeons, dental anesthesiologists, and periodontists. Southern Anasthesia, which offers controlled and non-controlled pharmaceuticals, as well as surgical supplies, to about 11,500 customers, had 2016 sales of $72 million.

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

Read more

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