FDA Policy/General

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Eli Lilly has signed an agreement to acquire CoLucid Pharmaceuticals $960 million. The acquisition would boost the company’s existing portfolio in pain management for migraine and also add a potential near-term launch to its late-stage pipeline. “Lasmiditan is a novel, first-in-class molecule that could represent the first significant innovation for the acute treatment of migraine in more than 20 years,” Lilly said.

Bio-Rad Laboratories has agreed to acquire RainDance Technologies in order to expand into next-generation sequencing applications. RainDance's systems include RainDrop Digital PCR, ThunderStorm and ThunderBolts next-generation sequencing enrichment. The RainDance system partitions samples into one million droplets, which is purportedly 500 times greater than the number generated by the Bio-Rad systems.

Omicia, a clinical genomic data analysis and reporting software firm, has acquired Seattle-based Spiral Genetics. Spiral’s advanced tools should add multiple variant detection capabilities for next generation sequencing (NGS) to Omicia’s industry-leading software platform, the companies say.

Merck has agreed to pay $625 million to Bristol-Myers Squibb and Ono Pharmaceutical to settle patent litigation over its cancer drug Keytruda. As part of the settlement and license agreement, all claims in relevant legal proceedings will be dismissed, and the companies have granted certain patent rights to each other. Merck has also agreed to pay royalties on global Keytruda sales of 6.5% between 2017 and the end of 2023 and 2.5% between 2024 and 2026.

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