FDA Policy/General

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KalVista Pharmaceuticals, a clinical stage pharmaceutical company focused on the discovery, development, and commercialization of small molecule protease inhibitors, has entered into a collaboration agreement with Merck. The agreement will seek to advance KalVista’s investigational intravitreal injection candidate currently in development for treating diabetic macular edema.

China Biologic has agreed to buy an 80% stake in PW Medtech Group’s regenerative medical biomaterial subsidiary TianXinFu for $513 million.

Pharmaceutical firm Lupin has acquired US-based Symbiomix Therapeutics for $150 million. Symbiomix is a privately held company focusing on therapies for gynaecologic infections.

Boston Scientific has closed on its $300-million purchase of a privately-held California medical device company Apama Medical. The deal includes an up-front cash amount of $175 million and the remaining will come in payments of up to $125 million once Apama reaches regulatory and clinical milestones in developing a catheter to treat atrial fibrillation (Apama Radiofrequency Balloon Catheter System).

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