FDA Policy/General

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OncBioMune Pharmaceuticals has acquired Vitel Laboratorios, which gives OncBioMune two drugs sold in Mexico — Bekunis for constipation and Cirkused for stress. Vitel has a total of seven other products that are either already in the registration stage or planned for launch later in 2017.

Mylan has agreed to the terms of a global settlement with Genentech in relation to patents for Herceptin (trastuzumab), which provides Mylan with global licenses for its trastuzumab biosimilar product. Under the settlement, Mylan has agreed to withdraw its pending inter partes review challenges against two U.S. Genentech patents. Mylan says it anticipates potentially being the first company to launch a biosimilar to Herceptin in the U.S.

Seven Point Equity Partners has acquired Totowa, NJ-based Medin Corp. a maker of sterilization cases and trays for the orthopedic implant and instrument industry. No financial terms were disclosed.

3D Medical Manufacturing is expanding its presence in A Palm Beach County, FL. The producer of implants, cutting tools and similar instruments has committed to create over five years 178 jobs, and invest $12 million in new equipment and an expanded headquarters in Riviera Beach.

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