Business Strategy

With accelerated approval in advanced urothelial cancer, the sponsors now have data that could support full approval plus a move into first-line therapy.

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

BenevolentAI has added Merck KGaA to its list of partners but the UK firm is looking for a new CEO after Joanna Shields decided to leave as a major restructuring continues.

After a multi-year lull, NASH R&D has picked up this past year with key data readouts, several programs advancing toward Phase III and Madrigal's resmetirom under FDA review with a March 2024 action. This graphic provides a look at the overall status of NASH drug R&D.

The liver disease is one of the hottest areas of drug development. Here are some upcoming catalysts to look out for.

Following a positive opinion from the CHMP, the Spanish company is hoping to launch its challenger to Dupixent in the EU before the end of the year.

The US FDA rejected TAK-721 for eosinophilic esophagitis (EoE) in 2021, requiring another study, and Takeda ended development in 2022, but in a newly accepted NDA it is seeking a short-term treatment indication.

The company blamed lack of funding for incomplete enrollment of the Phase II study in acute suicidal ideation and behavior in major depressive disorder, saying it would have reached statistical significance had it fully enrolled.

The Swiss drug maker’s decision to give back rights to tislelizumab means BeiGene goes without the potentially $1.55bn in milestone payments the companies had agreed to in early 2021.

As Medicare drug price negotiations creep closer to reality, industry leaders are turning attention to the challenges of implementation and commercial concerns.

With a Phase II study stopped for efficacy in bleeding reduction, Anthos hopes to bring abelacimab, a dual Factor XI/XIa inhibitor to market to prevent strokes in a-fib patients and to treat cancer patients with thrombosis.

Emerging Company Profile: BioAge has Phase Ib proof-of-concept data in age-related muscle loss and is gearing up for its first Phase II study, but will need fresh cash or a partner for a potential weight loss-related muscle loss study.