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Insmed Incorporated

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Latest From Insmed Incorporated

Deal Watch: Merck KGAA Teams With AI Biotechs On Drug Discovery Efforts

Plus deals involving Debiopharm/SunRock, RefleXion/3B Pharmaceuticals, Pharmanovia/Sanofi and more.

Deal Watch Business Strategies

Insmed Makes A Case For Accelerated Approval Of First-Line Arikayce Use

Insmed’s ARISE trial validated a patient-reported outcome measure it plans to use as the new primary endpoint in the ongoing pivotal ENCORE study, but it will ask the US FDA about accelerated approval based on ARISE. 

Clinical Trials Growth

US FDA’s Breakthrough Designation Pace Slows, But Topics Broaden

The 19 breakthrough therapy designations awarded so far this year run the gamut from areas that traditionally have not fared well with BTDs, like cardiovascular and respiratory disease, alongside the traditional cancer and orphan disease tentpoles.

US FDA Performance Tracker Review Pathway

Minute Insight: FTC Pressure Kills Cooper’s Planned Deal For Cook’s Reproductive Assets

Cooper announced a plan to buy Cook’s reproductive health business in February. The deal would have been worth $675m up front and $200m in four annual installments. The US FTC determined the deal would have impaired competition in the reproductive health market.

Minute Insights M & A
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