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The discovery of a tumor in a patient who received REGENXBIO’s gene therapy for Hurler syndrome prompted the FDA to place a hold on that program along with the company’s Hunter syndrome program, which is awaiting an FDA decision on or before Feb. 8.
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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.
Bristol Myers Squibb, GSK and Merck are contributing drug ingredients as part of their deals with the White House but are keeping many of the terms of their agreements private.
Some 200 rare disease therapies are at risk of losing eligibility for a pediatric priority review voucher, a recent analysis by the Rare Disease Company Coalition shows. That could mean $4 billion in missed revenue for already cash-strapped biotechs.
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The FDA’s rare pediatric disease priority review voucher program missed reauthorization at the last minute in 2024; advocates have been fighting to get it back ever since.
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The bladder cancer-focused biotech is looking to be one of the first companies out of the gate with an initial public offering in 2024.
Regulatory authorities worldwide are tightening their monitoring mechanisms and launching their own investigations after reports of secondary malignancies potentially linked to chimeric antigen receptor T cell therapies.
Taiwanese contract development and manufacturing organization Bora will purchase Minnesota-based Upsher-Smith Laboratories, expanding operations into the U.S. for the first time.
The FDA’s Complete Response Letter identified problems with the drug candidate’s chemistry, manufacturing and controls, parent company Shin Nippon Biomedical Laboratories announced Thursday.
The Swiss pharma’s Phase III trial of ligelizumab in patients with peanut allergies has been terminated, according to a ClinicalTrials.gov update on Tuesday.
The San Diego-based startup, specializing in allogeneic engineered Treg and CAR-Treg cell therapies, plans to be in Phase I clinical trials in multiple indications in 2024.
The sweeping changes are meant to “reduce hierarchies” and “accelerate decision-making” as Bayer weathers several business crises and continues to suffer from the fallout of its disastrous Monsanto acquisition.
In a changing landscape, top companies are increasingly embracing remote work.
When combined with Tecentriq and chemotherapy, tiroagolumab increased median survival to 15.7 months compared to 11.1 months for patients with esophageal squamous cell carcinoma on chemo alone.
The team comes together to discuss the dominant themes of what was an incredibly busy week of events in San Francisco during JPM 2024.