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As cell and gene therapy leaders gathered in Maryland to discuss accelerating clinical trials in children, one “cutting edge” session focused on the need to expedite more bespoke gene editing treatments like the one that saved young KJ Muldoon.
Neal and Azbee awards have validated our approach to reporting on the industry at a time of unprecedented shifts at the FDA and other federal agencies.
The FDA is signaling change, but actual success depends on more than simply bringing in a new leader at the Center for Biologics Evaluation and Research; it requires accountability, transparency and consistent action.
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FROM OUR EDITORS
Read our takes on the biggest stories happening in the industry.
Doubling survival in pancreatic cancer, a long-fought rare disease approval, a massive IPO and ambitious biotech entrepreneurs have BioSpace Senior Editor Annalee Armstrong feeling upbeat about the biotech scene.
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President Donald Trump is considering tariff exemptions for certain “non-patented” pharmaceuticals, though the White House has yet to release specific guidelines.
IPO
LB Pharma landed on the Nasdaq Thursday, with 3 million additional shares sold than expected.
A draft executive order obtained by The New York Times purports to clamp down on the pharmaceutical industry’s ability to buy new molecules from biotechs based in China, along with a number of other proposed reforms.
The biopharma job market remains challenging, based on BioSpace data. In August, job postings live on the website dropped 32% year over year. In addition, during the first eight months of 2025, over 26,000 people were laid off or projected to be laid off.
New York City has seen increased life sciences employment during the past decade as public funding and key projects like JLABS @ NYC have given the area a boost. A Partnership Fund for New York City executive discusses the city’s strengths and a notable challenge facing businesses.
Capsida has yet to disclose the exact cause of death. The patient had received the gene therapy CAP-002 for a type of epilepsy.
New draft guidelines suggest the FDA is open to exercising regulatory flexibility for non-opioid drugs being developed for chronic pain.
Analysts at BMO Capital Markets expect the lack of other exon-44-skiping therapies to facilitate a “smooth” approval process for Avidity’s del-zota.
Claiming that the domestic market undervalues pharma innovation, Merck has decided to pull the plug on all of its R&D efforts in the U.K.
The autoimmune and inflammatory disease–focused company canceled plans to go public earlier this year as the IPO window slammed shut.