Digital therapeutics have made great strides in recent years, with Pear Therapeutics Inc. playing a key role. Now, the company has reported the dosing of the first patient in part two of a study assessing Pear-006 to address depressive symptoms in multiple sclerosis (MS).
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.
Fueled by new positive data, Axsome Therapeutics Inc. plans to seek approval during the second half of 2020 for its dextromethorphan/bupropion modulated delivery tablet, AXS-05, an oral NMDA receptor antagonist to treat major depressive disorder.
Neurotrauma Sciences LLC and Emory University’s Institute for Drug Development entered a license agreement for patents and technology invented at the school, enlarging a deal the two cut about a year ago.
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.
Despite some encouraging top-line data from Sage Therapeutics Inc.’s phase III Mountain study of SAGE-217 on depressive symptoms in adults with major depressive disorder (MDD), the company, the market and analysts were taken aback at the trial’s failure to hit its primary endpoint.
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).
In its second large deal of the calendar year, Neurocrine Biosciences Inc. acquired the rights to Xenon Pharmaceutical Inc.’s selective sodium channel inhibitor for treating epileptic encephalopathy. Xenon receives $30 million up front, $20 million in equity and up to $1.7 billion in potential development, regulatory and commercial milestone payments.
Supernus Pharmaceuticals Inc. CEO Jack Khattar said the phase III failure in the study called P301 with SPN-810 (molindone hydrochloride) was "very puzzling" to the Rockville, Md.-based firm, which will be "digging very deep into the data" with hopes of figuring out what went wrong. Shares (NASDAQ:SUPN) closed Wednesday at $19.93, down $9.20, or 31.6%.
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