FDA Policy/General

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MilliporeSigma has entered into an agreement to acquire Natrix Separations, an Ontario, Canada-based provider of hydrogel membrane products for single-use chromatography, for an indisclosed amount. The acquisition is intended to complement MilliporeSigma’s efforts to drive next-generation bioprocessing, ultimately enabling faster, more efficient technology for customers.

CSL Limited is buying Tucson, AZ-based Calimmune for $91 million upfront and up to $325 million in performance-based milestones. As part of the deal, CSL will pick up Calimmune’s preclinical product CAL-H, an hematopoietic stem cell gene therapy to treat sickle cell disease and beta-thalassemia. It will also acquire two proprietary platform technologies, Select+ and Cytegrity. Select+ drives selection of genetically modified stem cells once they are infused back into patients, which decreases toxicity and improves efficacy. Cytegrity is a scalable manufacturing technology for the manufacture of lentiviral vectors, which are used to deliver the engineered genes.

Sanofi has completed the acquisition of Protein Sciences, a vaccines biotechnology company based in Meriden, CT. Through the acquisition, Sanofi Pasteur adds a promising product to its influenza vaccine portfolio: Flublok (influenza vaccine), the only recombinant protein-based influenza vaccine approved by FDA. The acquisition also fits with Sanofi Pasteur’s strategic initiative to explore non-egg-based influenza vaccine manufacturing technologies. "

Cantel Medical has completed its acquisition of BHT Hygienetechnik Holding GmbH, the German market leader in automated endoscope reprocessing and related equipment and services as well as flexible endoscope repair.

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