Drug Development
Keytruda is set to lose exclusivity in 2028, meaning Summit may face competition from cheaper biosimilars. Meanwhile, other branded drugmakers are also seeking to improve on the blockbuster checkpoint inhibitor.
FEATURED STORIES
While at SCOPE 2025, Sam Srivastava, CEO at WCG Clinical discusses the challenges and responsibilities of the life sciences industry in building public trust amidst growing anger towards healthcare.
ITF, IntraBio and Orchard are among the companies that have won FDA nods in the past year for Duchenne muscular dystrophy, Niemann-Pick disease type C, metachromatic leukodystrophy and more.
As it did during the COVID-19 pandemic, mRNA technology offers an efficient way forward in developing products for diseases that lack approved treatments.
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The British pharmaceutical giant is working with the U.K. Dementia Research Institute to exploit a “natural randomization” experiment to determine whether 65- and 66-year-olds who received GSK’s shingles vaccine Shingrix have reduced dementia risk.
Led by alums from Takeda and Boston Pharmaceuticals, Hillstar Bio is working on treatments that remove harmful immune cells to relieve disease.
The Eylea franchise was in need of a win after an appellate court last week denied the pharma’s bid to block Amgen’s biosimilar from the U.S.
In attempt to keep R&D costs low, the vivarium business model has emerged as a crucial solution for drug developers.
Biosimilars are essential healthcare equalizers, but their regulation is overly complicated due to lobbying by makers of branded biologics looking to maintain blockbuster revenue.
It’s early days for xenotransplantation, but eGenesis, Eledon, United Therapeutics and more are working to develop solutions to make this approach a viable option and help ease the organ shortage crisis.
Since 2016, the FDA has approved three disease-modifying treatments for spinal muscular atrophy, with several companies—including Novartis, Scholar Rock and Biogen—progressing novel candidates through clinical trials.
The label expansion could help J&J establish Tremfya as a successor to Stelara, which is now facing a growing biosimilar challenge.
The FDA approval of Alnylam’s Amvuttra sets up a three-way race with Pfizer and BridgeBio, which both market transthyretin stabilizers for transthyretin amyloid cardiomyopathy.
After Sarepta reported the death of a patient who had recently taken the gene therapy Elevidys, patient advocacy group Parent Project Muscular Dystrophy stepped up—as they always do.