FDA Policy/General

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Absolute Antibody Ltd. and Kerafast Inc. say they have agreed to a merger to improve the selection of research tools available to the scientific community. Absolute Antibody specializes in the sequencing, engineering and recombinant production of antibodies. It says its catalog offers more than 3,400 recombinant antibodies in new engineered versions. Kerafast says it has been growing a catalog of more than 3,500 unique reagents – including antibodies, cell lines, proteins and more. The company has established partnerships with 159 institutions to facilitate access to materials developed by their investigators, a model which helps remove traditional barriers to transferring biomaterials among scientists.

Avadel Pharma says it has entered into an asset purchase agreement with Cerecor Inc. whereby Cerecor will acquire Avadel’s pediatric portfolio. The transaction also covers their intention to enter into a license and development agreement where Avadel will develop up to four product formulations for Cerecor using Avadel’s LiquiTime and Micropump technologies. Under the asset purchase agreement, Avadel says Cerecor will acquire four commercial pediatric products — Karbinal ER, Cefaclor for Oral Suspension, Flexichamber and AcipHex Sprinkle.

Confluent Medical Technologies says it has completed the acquisition of Corpus Medical, Inc. Confluent Medical is a contract manufacturer with capabilities to provide finished Class 3 medical devices, particularly balloon catheters, delivery systems, introducer sheaths, Nitinol products, and balloon expandable stent systems. Corpus says it specializes in the design and development of technically complex catheter technologies, with a particular focus in the fields of electrophysiology, structural heart, neurovascular, cardiovascular, and peripheral vascular.

Elastagen Pty Ltd., a clinical stage company developing medical device products based on recombinant tropoelastin, says it has entered into a definitive agreement under which Allergan will acquire it for $95 million plus contingent, commercial payments. Elastagen says its technology is based on recombinant human tropoelastin, the precursor of elastin which is a key component of youthful skin. Its tropoelastin is identical to that present in human tissue, and has many potential clinical applications, including treatment for acne scars, stretch marks, aesthetic skin repair and surgical wound repair, according to the company.

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