FDA Policy/General

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Sanofi has agreed to buy Belgium-based Ablynx for $4.8 billion. Ablynx focuses on Nanobodies, a novel class of next-generation biologics. The company has a pipeline of more than 45 proprietary and partnered drug candidates for treating hematology, inflammation, immuno-oncology and respiratory diseases.

Casi Pharma has acquired a portfolio of 25 FDA-approved ANDAs from Sandoz. Casi anticipates launching several acquired products in China. Casi is headquartered in Rockville, MD and has a wholly owned subsidiary and R&D operations in Beijing, China.

DanDrit Biotech has signed an agreement to acquire Enochian Biopharma and its proprietary technology in the field of HIV/AIDS. DanDrit believes the technology will help advance its research and development efforts and add to its pipeline. DanDrit plans to change its name to Enochian ImmunoScience and relocate from New York to Los Angeles.

Boston Scientific has decided to make a $90 million equity investment in medical device firm Millipede that also included an option to acquire the startup outright. According to the agreement, Boston Scientific must exercise its option before the startup completes its ongoing clinical trial for its heart valve repair device, which is designed to treat severe mitral regurgitation.

Medical device maker Harvard Bioscience is set to acquire Minnesota-based biomedical firm Data Sciences International for $70 million. Data Sciences focuses on physiology monitoring for customers in the pharmaceutical, biotech, research and government sector.

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