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The collaboration focuses on ‘molecular gates,’ a class of molecules that the startup company Gate Bioscience says can stop pathogenic proteins from leaving the cell.
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Cell and gene therapy leaders say the agency’s decision to remove the Risk Evaluation and Mitigation Strategies that had been attached to approved CAR T cancer therapies reflects “thoughtful consideration of real-world evidence” and “regulatory trust.”
Big Pharmas like Eli Lilly, Sanofi and Novartis headed back to the dealmakers table multiple times, with 32 total deals counted across the industry for the first half.
Changing how biopharmas package their products, how regulators review new drugs and how mutated genes are fixed could make ultrarare disease treatments possible.
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Candidates looking to enter biotech should focus on cultivating key skills, thoughtfully crafting their resumes and putting their best, most authentic foot forward in interviews. An internship, co-op or fellowship won’t hurt, either.
FROM OUR EDITORS
Read our takes on the biggest stories happening in the industry.
Roche’s fenebrutinib this week scored a mid-stage win in relapsing multiple sclerosis, while Sanofi’s tolebrutinib met the primary endpoint in a Phase III trial for progressive MS but flopped in two late-stage relapsing MS studies.
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Despite the failure, BMS remains “encouraged” by Reblozyl’s clinical activity in myelofibrosis-associated anemia and will approach regulators to discuss potential submissions for this indication, for which few treatment options exist.
The panelists flagged safety concerns with Blenrep and GSK’s failure to optimize its dosing regimen for the antibody-drug conjugate in multiple myeloma.
The patient, who was being treated with an investigational gene therapy for limb-girdle muscular dystrophy, died of acute liver failure, the same complication responsible for the deaths of two boys taking Sarepta’s Duchenne muscular dystrophy treatment Elevidys.
In advance of CMS’ negotiated price for the blood thinner taking effect next year, partners Bristol Myers Squibb and Pfizer pitched the direct-to-consumer program as a way to allow uninsured, underinsured and self-pay patients to pay less out of pocket.
Sarepta Therapeutics appears to have right-sized itself after laying off over a third of its staff, announcing a significant pipeline shift and adding a black box warning to its Duchenne muscular dystrophy gene therapy Elevidys.
The life sciences job market continues to shift. BioSpace’s Q2 2025 U.S. Life Sciences Job Market Report is now available, offering exclusive insights into the latest hiring trends, layoffs, and workforce dynamics across the life sciences industry.
In this episode presented by IQVIA, BioSpace’s head of insights Lori Ellis discusses the evolving role of local qualified persons for pharmacovigilance with Ana Pedro Jesuíno, global head local QPPV network at IQVIA.
In its Q2 earnings call Thursday, Novartis said it is moving quickly to reshore its drug manufacturing operations, but CEO Vas Narasimhan told reporters that for most medicines, it typically takes three to four years to completely relocate production.
In the first six months of 2025, 385 employees resigned from the Center for Drug Evaluation and Research, compared with under 130 staff during the same period last year.
FDA reviewers flag “discordant results” in a briefing document published ahead of Friday’s advisory committee meeting for the partners’ application for the antipsychotic in post-traumatic stress disorder.