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FDA
The FDA on Tuesday approved Day One Biopharmaceuticals’ type II RAF inhibitor Ojemda, which is designed to penetrate the blood-brain barrier, for the treatment of relapsed or refractory pediatric low-grade glioma.
Looking for remote regulatory jobs in the life sciences industry? Check out the BioSpace list of the top five jobs that don’t require relocation.
Despite the benefits of hiring foreign-born STEM employees, some companies avoid it largely due to unfamiliarity with the visa process, according to two recruitment experts.
This is the first round in a series of cuts that will cost 75 people their jobs this year, according to a WARN notice. Employees in other states are affected as well.
While Sanofi restructures and parts with employees from U.S. and Belgian sites, a new company in the GLP-1 space emerges from stealth.
While Bristol Myers Squibb did not explicitly mention China as the company expands and diversifies its manufacturing capacity, Cellares said the BIOSECURE Act would be a boon to its own growth.
As the Phase III amyotrophic lateral sclerosis pipeline thins out, the ALS community is placing its hopes on earlier-stage trials sponsored by Denali Therapeutics, PTC Therapeutics and more.
The Swiss drugmaker raised its full-year guidance Tuesday projecting net sales to grow in the high-single to low double-digit range while reporting better-than-expected first-quarter results.
CEO Hervé Hoppenot said Tuesday on an investor call that Escient Pharmaceuticals’ two lead assets “address large populations with a clear medical need” with a potential multibillion-dollar market opportunity.
Data from the Phase III LUNA 3 study on Tuesday showed that Sanofi’s BTK inhibitor rilzabrutinib significantly improved durable platelet response in patients with chronic immune thrombocytopenia.
The U.S. Supreme Court on Monday indicated that it will not hear Vanda Pharmaceuticals’ petition in its patent case against Teva Pharmaceuticals regarding the former’s sleep-wake disorder drug Hetlioz.
The regulator on Monday slapped Abeona Therapeutics with a Complete Response Letter for its investigational cell therapy pz-cel due to chemistry, manufacturing and controls issues.
FDA
Bouncing back from a previous rejection, ImmunityBio on Monday secured the FDA’s green light for its IL-15 superagonist Anktiva for non-muscle invasive bladder cancer.
Policy changes by health insurance companies will likely determine which Humira biosimilars rise to the top.
Bristol Myers Squibb will be using Cellares’ Cell Shuttles, an automated production system capable of producing multiple cell therapies simultaneously, to potentially improve turnaround time to support the pharma’s CAR T cell therapies.
Boehringer Ingelheim is paying $35 million in upfront and near-term fees to work with Ochre Bio to identify and validate regenerative targets for metabolic dysfunction-associated steatohepatitis and other chronic liver diseases.
Ipsen is looking to deepen its expertise in movement disorders in a research collaboration with Skyhawk Therapeutics to develop small molecule drugs for RNA targets in neurological diseases.
Bolstered by its portfolio of “revolutionary” therapies, AbbVie remains the top pharma company in the immunology space, according to a new survey of doctors by ZoomRx.
Following an investigation regarding antitrust practices against Pharmacosmos’ Monofer, CSL Vifor has proposed a sweeping multi-channel communication campaign designed to reverse allegedly misleading messages about its rival.
As AbbVie and NeuroDerm race toward potential U.S. approvals later this year, the companies presented strong data at last week’s American Academy of Neurology 2024 annual meeting for their respective continuous subcutaneous levodopa infusions.