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Nearly 80% of patients saw tumor shrinkage after being treated with Kura Oncology’s darlifarnib plus Bristol Myers Squibb’s Krazati, findings Mizuho analysts say could open up a $2 billion opportunity for the biotech.
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Partners Summit Therapeutics and Akeso are expected to steal the show at the American Society of Clinical Oncology’s annual conference with data from their potential Keytruda rival, alongside Revolution Medicine’s groundbreaking pancreatic cancer candidate and other assets that could reshape patient care.
The tragic tale of TIGIT is well known. However, RIPK1, myc, STING and alpha-synuclein have also left a trail of failed clinical trials, canceled partnerships and sunk investments in their wake.
Analysts homed in on Duchenne muscular dystrophy and myotonic dystrophy type 1 assets during first quarter earnings as major players like REGENXBIO and Novartis as well as Dyne, Wave, Solid and Sarepta near the regulatory finish line.
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The Department of Health and Human Services is spinning its wheels, unable to establish steady leadership at three major divisions—the CDC and the FDA’s two primary review units.
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Following disappointing Phase IIb results, BioSenic is pausing the development of its tibial fracture cell therapy ALLOB derived from mesenchymal stem cells.
In the first head-to-head trial of CGRP antagonists, Lilly’s Emgality failed to demonstrate that it was significantly better than Pfizer’s Nurtec ODT at easing migraine headaches.
On the heels of a legal challenge to the Inflation Reduction Act by Merck, Bristol Myers Squibb on Friday filed its own lawsuit claiming that the law’s drug price negotiation provision is unconstitutional.
The company reported results Friday from the KEYNOTE-811 trial in which the anti-PD-1 therapy took an important step toward FDA approval for rare esophageal tumors.
The data for Reproxalap, Aldeyra Therapeutics’ drug for treating allergic conjunctivitis and dry-eye disease, could potentially pave the way for an alternative to over-the-counter eye drops.
The stock deal aims to strengthen Coherus Biosciences’ position in the field of cancer therapeutics and expand its product portfolio.
The Bespoke Gene Therapy Consortium intends to bring AAV-based gene therapies to patients whose diseases are often ignored by commercial interests.
With Roche’s FDA approval on Thursday, both companies’ bispecific antibodies will hit the market this summer for relapsed or refractory diffuse large B-cell lymphoma.
In the latest HEALEY trial readout, Clene’s CNM-Au8 significantly reduced plasma neurofilament light chain levels in ALS patients, which could be a strong and reliable signal of its clinical benefit.
In a unanimous 21-0 vote, an FDA advisory committee recommended an updated monovalent formulation of the COVID-19 vaccine targeting the now-dominant XBB.1.5 subvariant.