Washington, DC – Advances in antibody-drug conjugates, including novel payloads and new targets, will be featured at the American Association for Cancer Research’s annual conference, taking place this week in San Diego, where companies, including Elevation Oncology and Tubulis, will present new data from their respective programs. The first antibody-drug...
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Washingon, DC – After a years-long drought, progress in the amyotrophic lateral sclerosis (ALS) space began to accelerate with the 2022 approval of Amylyx’s Relyvrio and Biogen and Ionis’ Qalsody in 2023. But now, that progress appears to have stalled. Earlier this month, Amylyx announced it would pull Relyvrio from...
Washington, DC – Over the last few years, we’ve witnessed a significant shift in the regulatory space for rare disease therapeutics, with the FDA and other authorities making conscious efforts to implement much-needed regulatory flexibility to accommodate the practical challenges of trial design for these conditions. For small biotechs and...
Washington, DC – Despite having not yet received full approval, Travere Therapeutics’ first-in-class endothelin and angiotensin II receptor antagonist Filspari—which received the FDA’s accelerated approval in February 2023—is already making strides in treating IgA nephropathy. A rare autoimmune disease, IgA nephropathy occurs when immunoglobulin A accumulates in the kidneys, leading...
Washington, DC – The FDA’s authorization of therapies that fail their efficacy endpoints casts doubt on the regulator’s accelerated approval pathway, according to an article from David Rind, chief medical officer of the drug pricing non-profit Institute for Clinical and Economic Review, published Wednesday in the Journal of the American...
San Diego, Calif. – The American Association for Cancer Research’s annual conference kicks off Friday as more than 20,000 attendees descend on San Diego. Analysts and researchers who spoke with BioSpace said they’re looking forward to early scientific data, and antibody-drug conjugates (ADCs) will be a key focus. Stay tuned to...
Basel, Switzerland – The past two years have seen a pair of new treatments approved for a particularly intractable neurodegenerative disease—amyotrophic lateral sclerosis. But while Amylyx’s Relyvrio and Biogen’s Qalsody have crossed the FDA finish line, others have stumbled in a regulatory space that experts say is still evolving. The...
NEW HAVEN, Conn. — BioXcel Therapeutics, Inc. (Nasdaq: BTAI), a biopharmaceutical company utilizing artificial intelligence to develop transformative medicines in neuroscience and immuno-oncology, today announced the completion of patient enrollment in the safety lead-in portion of the investigator-sponsored Phase 2 trial of BXCL701 in combination with KEYTRUDA® (pembrolizumab) in previously treated metastatic...
NEW HAVEN, Conn. — BioXcel Therapeutics, Inc., a biopharmaceutical company utilizing artificial intelligence to develop transformative medicines in neuroscience and immuno-oncology, today announced that the United States Patent and Trademark Office (USPTO) has allowed U.S. Patent Application No. 17/496,470 with claims pertaining to a method of treating agitation in patients...
New research presented this week at ACR Convergence, the American College of Rheumatology’s annual meeting, shows that Black people living with systemic sclerosis may have more severe disease and worse prognosis than patients in other racial or ethnic groups, and these worrying disparities may be driven by several socioeconomic factors...