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Celcuity’s gedatolisib doubled progression-free survival versus standard of care in certain patients with advanced breast cancer. Still, the biotech’s stock dropped more than 25% Tuesday.
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Deal dynamics between Chinese biotechs and global pharma companies are changing fast, with the biotechs seeking higher upfront payments and the Big Pharmas seeking more expansive platform deals.
Pfizer showcased multiple late-breakers at the American Society of Clinical Oncology’s annual conference but its biggest data are expected later this year.
For Peter Pitts, a former associate commissioner at the FDA, the appointment to the board of BrainStorm Cell Therapeutics is an opportunity to fulfill a promise he made long ago to a patient with ALS.
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FDA veteran Peter Marks will now shape the future of Eli Lilly’s vaccines work after the buys of Curevo, LimmaTech Biologics and Vaccine Company for up to $3.8 billion total.
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If Biogen has shown that tau can impact cognition, Denali’s technology—validated with an FDA approval in Hunter syndrome—could ensure the medicine gets where it needs to be for the greatest therapeutic impact, analysts said.
Aardvark Therapeutics had previously voluntarily suspended studies of ARD-101—and a related asset called ARD-201—after detecting anomalous echocardiographic readings in healthy volunteers that could indicate reduced heart efficiency.
CREATE Medicines is working on a clinical-stage pipeline for cancer, while its autoimmune programs are still in preclinical testing.
Renewed pharma interest in GPCR biology and radioligand therapies is drawing attention to functional peptide screening platforms.
Shares of REGENXBIO declined 37% on a mixed data readout and other updates from the company’s first quarter earnings call Thursday.
While Biogen’s tau-targeting therapy didn’t demonstrate improvement on a dementia severity scale, the company touted biomarker and cognitive improvements from the Phase 2 study, leaving analysts eager for more data.
In a letter to President Donald Trump, a group of biotech executives recommended former cancer regulator Richard Pazdur to lead the agency after the departure of Marty Makary.
Degron Therapeutics will have stiff competition in immunology, as Novartis inked a $5.7 billion agreement with Monte Rosa Therapeutics last year to develop molecular glues for undisclosed immune-mediated conditions.
Beqalzi is the first BCL2 inhibitor approved for relapsed or refractory mantle cell lymphoma.
While Takeda is eliminating 4,500 roles across its global operations, the company has some 2,200 jobs currently open for hiring, for which internal candidates will be prioritized.