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Sanofi will take venglustat to regulators for Gaucher disease but an application for Fabry disease is less clear after the failure of a Phase III trial.
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With Lykos’ regulatory failure now squarely in the rearview mirror, Compass Pathways and Definium are leading what one analyst suspects will be “a very big year for psychedelics.”
The Senate failed to pass a massive spending bill on Thursday—which includes the rare pediatric PRV program but also funding for the Immigration and Customs Enforcement’s large-scale crackdown in Minnesota and other states.
With the biopharma industry performing better of late, analysts, executives and other industry watchers are “cautiously optimistic”—a term heard all over the streets of San Francisco at the J.P. Morgan Healthcare Conference earlier this month.
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Phacilitate’s annual event dawns as cell and gene therapies reach a new tipping point: the science has hit new heights just as regulatory and government policies spark momentum and frustration.
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The abstracts, made available Tuesday ahead of the European Society for Medical Oncology Congress 2023, show strong efficacy data from some promising non-small cell lung cancer treatments.
The complement inhibitor won the FDA’s approval for the treatment of generalized myasthenia gravis, a rare autoimmune disease. The therapy will be sold under the brand name Zilbrysq.
The company’s resubmission succeeded in getting the greenlight for tenapanor, now to be marketed as Xphozah, to lower serum phosphorus levels in chronic kidney disease patients.
After the FDA released draft guidance on increasing diversity in clinical trials, companies have been left to figure out the details. Here’s what experts say is working.
The Pharma Proteomics Project isn’t the first precompetitive collaboration between pharma companies, but it’s one of the largest. Members recently published associations they’ve uncovered in UK Biobank data.
In its first financial report since the Kenvue consumer health spinoff, Johnson & Johnson beat analyst expectations fueled by strong pharmaceutical sales including Darzalex, Erleada and Stelara.
Life sciences talent acquisition teams are examining internal processes and thinking critically about their employer value proposition as they prepare for innovation and market swings.
Months after a denial of its rare eye cancer injection, Aldeyra Therapeutics is bracing for another potential rejection by the regulator, this time for its investigational dry eye disease treatment.
In a follow-up readout, data from the head-to-head SEQUENCE study showed that AbbVie’s Skyrizi induced better rates of steroid-free remission in Crohn’s disease than Johnson & Johnson’s Stelara.
The blockbuster PD-1 inhibitor’s label expanded further on Monday when the FDA greenlit Keytruda as a perioperative treatment for certain patients with earlier stages of non-small cell lung cancer.