Drugs

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Mallinckrodt has agreed to acquire U.S.-based Ocera Therapeutics, a clinical-stage biopharmaceutical company in a deal valued at about $117 million. The transaction gives Mallinckrodt Ocera’s developmental product OCR-002, an ammonia scavenger currently being studied to treat hepatic encephalopathy, a neuropsychiatric syndrome that is associated with hyperammonemia, a complication of acute or chronic liver disease.

Almac Group, a contract development and manufacturing organizatio), announced that it will acquire BioClin Laboratories, a contract analytical research and development company based in Athlone, Ireland that specializes in GMP pharmaceutical and biopharmaceutical analysis, microbiology testing, and formulation development.

Owens & Minor has agreed to buy Halyard Health’s surgical and infection prevention business for about $710 million. Owens & Minor supplies surgical gowns, sterilization wraps, and medical gloves under the Aeroblue, Aerochrome, One-Step, Quick Check and Smart-Fold brands. Halyard makes medical devices that are mostly used for pain management, such a respiratory pumps.

The Netherlands-based medical device-focused CRO Factory has acquired Milestone Research Organization, which has expertise in orthopedics, neurological and IVD clinical trials. The addition of San Diego-based Milestone builds on Factory’s existing U.S. presence in Austin, TX and Princeton, NJ.

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