Drug Development
Following the hard-won success of early anti-amyloid drugs, a new generation of Alzheimer’s modalities—from tau-targeting gene silencers to blood-brain barrier delivery platforms—is entering the pipeline to anchor future combination therapies.
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Facing the loss of exclusivity on key products, Pfizer has pulled forward its lead obesity asset into Phase III and targeted a 2028 launch. CEO Albert Bourla explained the pharma’s strategy at J.P. Morgan on Monday.
The prevalence of serious inflammatory safety issues such as cytokine release syndrome and immune effector cell–associated neurotoxicity syndrome limits the reach of these transformative cancer therapies.
After years stuck in the “doldrums,” the biopharma sector is in a “very good place” heading into the new year, analysts told BioSpace, with both rare and chronic diseases headlining investor and R&D interest as JPM26 kicks off.
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Emalex Biosciences closed a Series D funding round Thursday counting $250 million in earnings, much of which will bankroll a Phase III trial of ecopipam for Tourette syndrome.
Exelixis has inked a licensing agreement with Catalent to gain access to three of Catalent’s target programs with antibody and ADC candidates, the companies announced Thursday.
Flush with cash from the growing success of its chemotherapy drug, Exelixis dropped $100M on two collaboration deals this week to invest in promising early clinical assets.
A Data Safety Monitoring Board overseeing the Phase Ib/II trial assessing UniQure’s gene therapy for Huntington’s disease recommended that enrollment in the higher-dose cohort could resume.
The future of Editas Medicine’s EDIT-101 will be determined later in November after a data readout is available. The data could inform the company whether there is a potential commercial path forward.
Verge Genomics dosed its first patient in a Phase I trial studying VRG50635, while Stealth Bio’s SBT-272 was granted Orphan Drug designation by the FDA.
Unity announced advances in diabetic macular edema via Phase II study results, potentially allowing its recipients to return to tasks of daily living, like driving.
In a Phase III trial, Pfizer’s RSVpreF, a bivalent RSV vaccine, protected infants against severe medically attended lower respiratory tract illness when administered during the second or third trimester.
On Nov. 16, the FDA’s Cardiovascular and Renal Drug Advisory Committee will meet to discuss the relative merits of Ardelyx’s tenapanor in chronic kidney disease.
Monday, Actinium Pharmaceuticals released promising results Monday from a Phase III trial studying its lead radiotherapy candidate, Iomab-B, for patients with relapsed or refractory AML.