News

FEATURED STORIES
A recent FDA reversal sparked new hope for patients with Huntington’s disease. Flying under the radar, Skyhawk Therapeutics revealed 12-month functional data from a midstage trial of its own candidate showing improvements on a key disease measurement scale.
Recent approvals for Corcept Therapeutics and Merck have injected momentum into the space, where GSK, Allarity Therapeutics, OSE Immunotherapies and others are advancing their own candidates.
The FDA plans to hold an advisory committee meeting to discuss Capricor Therapeutics’ application for deramiocel, which the agency rejected last July. The news surprised CEO Linda Marbán, who told BioSpace the FDA has not communicated any issues of concern with the company’s resubmitted application.
FROM OUR EDITORS
Read our takes on the biggest stories happening in the industry.
If cell and gene therapy makers are going to achieve their mission to improve patients’ lives, the industry must come together to share information across stakeholders, from regulators to manufacturers to payers.
THE LATEST
Merck initiated a tender offer Monday to buy all outstanding shares of Imago Biosciences. This follows the November announcement of the buyout.
Affimed will not seek accelerated approval for AFM13 as a monotherapy in advanced-stage relapsed/refractory peripheral T cell lymphoma.
Amgen confirmed Monday it will acquire rare disease giant Horizon Therapeutics for $26.4 billion.
Wall Street is no longer enamored with NASH drug developers.
Combinations including Ibrutinib stood out in hard-to-treat hematological cancers at the 64th American Society of Hematology (ASH) annual meeting.
As 2022 comes to its conclusion, the FDA has a handful of Prescription Drug User Fee Amendments still to wrap up. Here’s a look at that and more.
UCB shared positive top-line results Friday from two Phase III studies of bimekizumab for adults with moderate to severe hidradenitis suppurativa.
Autolus Therapeutics is calling the Phase II FELIX trial, assessing its next-generation CAR-T therapy obe-cel for leukemia, a win after an interim analysis revealed an overall remission rate of 70%.
A combination of Exelixis’ cabozantinib and Roche’s Tecentriq missed the primary endpoint of overall survival in a Phase III study.
ImmunoGen entered into a clinical collaboration deal with Gilead Sciences Friday to evaluate the safety and efficacy of two drugs that, when used in concert, have the potential to treat AML.