FDA Policy/General

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Avara Pharmaceutical Services has signed an agreement with Pfizer to acquire its Liscate, Italy sterile manufacturing facility. Avara Pharmaceutical Services is a contract manufacturing and technical services company providing both active pharmaceutical ingredient formulation and manufacturing, along with secondary formulation, manufacturing and packaging of small molecule drugs, including highly potent compounds.

New York-based private investment firm SK Capital has agreed to acquire Perrigo API, the active pharmaceutical ingredients business of Perrigo Co. in Israel for $110m in an all-cash deal. Under the terms of the transaction, the parties will enter into a long-term supply agreement for Perrigo API to supply its inventory of existing commercial and pipeline APIs to Perrigo.

A&E Medical has reached a deal with RTI Surgical to acquire its cardiothoracic closure business. RTI Surgical provides surgeons with biologic, metal, and synthetic implants that are used in sports medicine, general surgery, spine, orthopedic, trauma and cardiothoracic procedures.

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