Drugs

BMS, LabCentral Agreement on Pharma/Biotech Startups

Bristol-Myers Squibb and LabCentral, a Cambridge, MA shared space and launch pad for life-sciences and biotech startups, have entered into an agreement under which Bristol-Myers Squibb has become a platinum sponsor and can nominate up to two startup companies per year to take up residence in the lab’s Kendall Square facilities. “Our residents who are working to move early-stage science from the lab bench toward clinical trials stand to gain valuable insights from regular interactions with Bristol-Myers Squibb mentors who are veterans of the process,” LabCentral co-founder and president Johannes Fruehauf is quoted in a release as saying. Last year, Bristol-Myers Squibb announced that it will launch a new state-of-the-art research site in Kendall Square, which is expected to open in early 2018.

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