News
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 Swiss pharma’s fourth-quarter sales fell short of analysts’ estimates on Wednesday, as the company said it dropped a late-stage blood cancer hopeful after failing a Phase III study.
The Centers for Medicare and Medicaid Services will enter talks with manufacturers to come up with a pricing and rebate scheme that will tie the gene therapies’ cost with their effectiveness.
Defender Pharmaceuticals on Tuesday did not reveal the reasons for the regulator’s rejection of its nasal gel version of scopolamine. The company is seeking a meeting with the FDA to “understand the issues.”
Here are the top companies on BioSpace with internship opportunities for graduate students.
Ascidian Therapeutics, a member of BioSpace’s NextGen Class of 2024, on Monday announced it received IND clearance from the FDA and was granted Fast Track designation for ACDN-01.
The FDA has granted Priority Review for AstraZeneca and Daiichi Sankyo’s supplemental BLA for the treatment of adult patients with unresectable or metastatic HER2-positive solid tumors.
After Tamar Bresge was diagnosed with retinitis pigmentosa at age 15, her entrepreneurial father made it his mission to help find a cure.
Excluding its COVID-19-products Comirnaty and Paxlovid, Pfizer’s revenue in the fourth quarter of 2023 grew 8%. The company projects full-year revenue in 2024 to remain about flat.
A minority of companies in the industry use personality tests in hiring. Here’s why—and how to approach the assessments.
Gilead Sciences and Arcus Biosciences have amended their collaboration agreement in an effort to accelerate an anti-TIGIT program, the companies announced Monday.