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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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A federal court in Delaware ruled Friday that the pharma company had no “entitlement” to any price above what the buyer is willing to pay.
FogPharma’s latest financing round will help fund the ongoing clinical development of the company’s potential first-in-class intracellular TCF-blocking β-catenin inhibitor being evaluated in a Phase I/II study.
Palatin Technologies’ melanocortin agonist PL9643 came up short in a late-stage study evaluating its safety and efficacy.
Formerly known as Ryne Bio, Kenai Therapeutics emerged on Thursday with backing from several groups and has a cell therapy candidate going after Parkinson’s disease.
Despite Ironwood Pharmaceuticals’ apraglutide getting positive late-stage study results in treating short bowel syndrome with intestinal failure, the stock plummeted nearly 40% on Thursday.
The annual observance highlights how far the industry has come and serves as a wake-up call for how far it must still go to meet the needs of patients with rare diseases.
Antibody-drug conjugates are a breakthrough in targeted cancer therapy and will continue to attract big pharma investment over the next few years, finds a new report from market intelligence firm Evaluate.
The FDA and CDC warned Thursday of a small increased risk of developing Guillain-Barré syndrome in older adults after immunization with respiratory syncytial virus vaccines from GSK and Pfizer.
Retaining the full rights to Trodelvy, Gilead now has access to $210 million in financing from venture capital firm Abingworth to help push the antibody-drug conjugate into non-small cell lung cancer studies.
Despite the approval of two novel therapies for this uniformly fatal neurodegenerative disease, experts say regulatory standards and expectations are still evolving.