Mystery solved: Roivant is Pfizer's TYK2 partner—and is cutting other programs to fund late-phase trials 'Welcome to scrutiny': BIO chair mounts defense against more rigorous accelerated approval process Astellas pays Sutro $90M to hit cancer with one-two punch from new ADC modality Kezar's phase 2 lupus data spur hope for former pipeline-in-a-drug contender—and a share rally Data key to boosting trial diversity—and its time for CROs to act, says Phesi Researchers look to the stars for new Alzheimer's target Volume turns up on Decibel as hearing loss therapy protects patients in early-stage trial Conflicting state laws and 'unpredictable' enforcement await providers in post-Roe America DermBiont's topical gel hits goal in benign skin growth phase 2, clearing path for further development Cue Health to lay off 170 workers due to 'economic challenges,' COVID test funding cuts CMS rolls out new payment model on improving cancer treatments Trial failure for Jazz’s cannabis-derived drug blunts goal to expand its use to US Featured Story | 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. read more |
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Top Stories 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. read more 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. read more By James Waldron Kezar’s hopes for zetomipzomib to become a catch-all drug for inflammatory disease having been stunted earlier in the year, new phase 2 data suggest the therapy is still in play to treat lupus nephritis. read more By Gareth Macdonald Regulators' efforts to boost trial diversity are not enough, according to Phesi, which says data from unrepresentative studies should not be considered good quality. The artificial intelligence technology firm made the comments this week to coincide with a new analysis of clinical studies conducted over the past 15 years. read more By Gabrielle Masson To help crack Alzheimer's disease, researchers are looking to a North Star—or, more accurately, a star-shaped cell in the brain that could play a role in progression of the neurodegenerative disease. read more By Annalee Armstrong A small data set but big improvement in the hearing loss brought on by chemotherapy was enough to send Decibel Therapeutics' shares soaring in premarket trading Tuesday. read more 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. read more By Nick Paul Taylor DermBiont’s bet on SeylanMED has delivered a win in phase 2. Twenty months after acquiring the topical drug candidate SM-020, DermBiont has linked the prospect to improved outcomes in people with benign tumors, causing the phase 2 clinical trial to meet its primary and secondary endpoints. read more By Andrea Park After rocketing to medtech stardom amid the COVID-19 pandemic, Cue Health seems to be drifting back down to Earth. read more 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. read more 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). read more Resources Sponsored By: Blue Matter Consulting For an emerging biopharma company, Europe can be very attractive. But it can also be complex and confusing. This e-book covers the 12 most common pitfalls for companies entering European markets for the first time, offering guidance to help growing companies avoid them and succeed. Sponsored By: Catalent What is the most suitable dosage form technology for the Oral Delivery of Lipid-Based Formulations? Sponsored by: Blue Matter, strategic consultants in the life sciences Medical Affairs plays a critical role in generating insights to inform strategic decisions, but that role is changing. This paper explores why, and how MA teams can stay ahead of the curve. 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