FDA Policy/General

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AmerisourceBergen has agreed to acquire independent drug wholesaler H. D. Smith for $815 million. Founded in 1954, H. D. Smith has 10 drug distribution centers across the U.S. It provides full-line distribution of brand, generic and specialty drugs.

Orig3n, a Boston-based biotech, has acquired Interleukin Genetics’ CLIA laboratory and its assets. Interleukin Genetics’ technology will be integrated into Orig3n’s DNA test business. The automated genotyping lab is fully-licensed for testing in all 50 U.S. states and is capable of processing over one million samples per year.

Private investment firm SK Capital has acquired Perrigo’s active pharmaceutical ingredients (API) business, which will be renamed Wavelength Pharmaceuticals. The company will now have primary operations located in Israel and supporting functions in the U.S. and India. It provides products that are made with its specialized manufacturing capabilities, including cytotoxic, steroid and high potency products.

Medical-device repair company Alpha Source has completed its acquisition of imaging system developer BC Technical. The transaction will expand Alpha Source’s ultrasound and bone density equipment service to include maintenance services and refurbished equipment for CT, MRI and molecular scans. Earlier this year, Alpha Source purchased Medical Optics, which repairs scopes, cameras and surgical tools.

Montreal-based artificial intelligence company Imagia has completed its acquisition of medical imaging firm Cadens Medical Imaging for an undisclosed amount. Cadens develops and markets FDA and CE-Marked medical imaging software products designed for oncology. Imagia said it plans to integrate its technologies with imaging products to accelerate development of biomarker discovery processes.

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