By Max Bayer
As regulators and elected officials consider reforming the accelerated approval process, BIO chairman Paul Hastings is mounting a vigorous defense against proposals he says could threaten innovation.
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By Dave Muoio
Single- and multistate provider organizations alike may find it difficult to keep their women's health services within the bounds of the law, attorneys say.
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By Andrea Park
After rocketing to medtech stardom amid the COVID-19 pandemic, Cue Health seems to be drifting back down to Earth.
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By Nick Paul Taylor
Pfizer has revealed the new home of its TYK2 inhibitors. Months after disclosing a pact with a mystery startup, the Big Pharma has taken the wrapping off a deal with Priovant Therapeutics, a new Roivant unit that will seek to bring brepocitinib to market in dermatomyositis and lupus.
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By Robert King
The Supreme Court declined to take up a lawsuit challenging whether PBMs have a fiduciary duty under ERISA to keep drug prices low.
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By Kevin Dunleavy
On Tuesday morning, Sanofi revealed two approvals from the European Commission—both for enzyme replacement treatments for rare diseases—that speak to CEO Paul Hudson’s mission to "play to win."
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By Conor Hale
After working with biotechs and Big Pharmas to accelerate their research programs, high-tech molecule modeler Schrödinger is taking its first steps as a clinical company.
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By Nick Paul Taylor
Astellas has struck its second immuno-oncology deal of the month. The latest pact will see the Japanese drugmaker pay Sutro Biopharma $90 million, plus potentially upward of $1 billion in biobucks, for rights to three immunostimulatory antibody-drug conjugates, a modality designed to combine the best features of ADCs and personalized vaccine biology.
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By Kevin Dunleavy
Jazz Pharmaceuticals has revealed a setback, saying that its nabiximols oromucosal spray has flunked a phase 3 trial, coming up short in helping multiple sclerosis patients with lower-limb spasticity. Over a 21-day span, the spray—known as Sativex and on the market in Europe for 12 years—failed to improve muscle tone as measured by the Modified Ashworth Scale (MAS).
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By Conor Hale
Bayer is diving into the radiology AI market, which the drugmaker estimates will grow by more than 25% per year between now and 2025.
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By Robert King
CMS announced a new payment model aimed at improving care coordination and services for cancer treatments, including a new focus on improving health equity.
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By Gareth Macdonald
Clinical trials are generating more data than ever and researchers need systems capable of recording, storing and managing the additional information, says tech firm Medidata.
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