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While companies have seen plenty of success treating blood cancers with T-cell therapies, solid tumors have largely remained the holy grail for T cells. But Adaptimmune Therapeutics plc has early data from its Specific Peptide Enhanced Affinity Receptor T-cell platform suggesting it may be on the right path for a platform with a wide breadth.
The prospects for Ultragenyx Pharmaceutical Inc.'s adeno-associated virus (AAV) gene therapy, DTX-301, in patients with ornithine transcarbamylase (OTC) deficiency weren't looking too great after treatment of the first two cohorts in a phase I/II study.
As the industry looks forward to 2020 at the 38th Annual J.P. Morgan Healthcare Conference next week, BioWorld is looking backward to those we lost in the past year.
Machine learning and artificial intelligence (AI) are already being actively used in drug discovery to evaluate potential binding of small-molecule drugs to proteins, but there's potential for the technologies to be used on the development side as well, especially in hard-to-treat diseases such as Alzheimer's disease.
SAN DIEGO – Smaller companies looking to move their Alzheimer’s disease drugs into late-stage testing as quickly as possible are eschewing cognitive endpoints that can take years to readout for biomarkers and functional assays of brain activity.
SAN DIEGO – Following up on its October announcement that it would file for FDA approval of beta-amyloid-targeting aducanumab, Biogen Inc. presented the final dataset for the phase III Emerge and Engage studies at the 12th Clinical Trials on Alzheimer’s Disease Meeting.
SAN DIEGO – Three months ago, Acadia Pharmaceuticals Inc. said Nuplazid (pimavanserin), its serotonin inverse agonist and antagonist that preferentially targets the 5-HT2A receptor, met the primary endpoint during an interim look at the phase III Harmony study in patients with dementia-related psychosis (DRP).
The FDA has typically used real-world evidence (RWE) as a way of monitoring safety issues post-approval, especially through the Sentinel Initiative, which started in response to the FDA Amendments Act of 2007.
Roche Holding AG and PTC Therapeutics Inc. together with their partner, the SMA Foundation, reported success in part two of the pivotal Sunfish study testing their survival motor neuron-2 splicing modifier risdiplam in patients with type 2 or 3 spinal muscular atrophy (SMA).
SANTA CLARA, Calif. – Peter Thiel is not a fan of incremental science. The high-profile venture capital investor, who invests across technology and the life...
SAN FRANCISCO – Insulet Corp. aims to get an FDA approval this year and launch its first interoperable device, the cord-free, wearable insulin device Omnipod...
China announced Jan. 17 which further pharmaceutical companies it will buy from under its centralized procurement program that seeks the lowest prices. The price...
In response to the emergence of a new coronavirus seen recently in China, and now America, Novavax Inc. has initiated development of a vaccine candidate, the...
It is equally fair to say that lung cancer treatment has come a long way, and that it has a long way to go. Speaking at a joint conference by the International...
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