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The clinical hold doesn’t cover its drug’s Investigational New Drug application for autoimmune hepatitis, for which the Phase IIa PORTOLA trial is ongoing.
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Mixed headlines have plagued the cell and gene therapy space of late. We believe that a renewed case of optimism is not only warranted but essential if these therapies are to reach their full potential.
Since July, several biotechs have been forced to pivot as previous agreements with the FDA around evidence required for approval were reversed, a phenomenon that, according to experts, could portend a more restrictive regulator.
The drugmaker’s dominance of the obesity market is fueling predictions that years of growth lie ahead.
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Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi today announced that The Lancet has published positive results from a Phase 3 Dupixent® (dupilumab) trial in children aged 6 months to 5 years with uncontrolled moderate-to-severe atopic dermatitis.
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Read our takes on the biggest stories happening in the industry.
Unpredictable communication and a lack of transparency are eroding the industry’s and the public’s trust. The FDA, experts agree, needs to take control of the narrative.
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While women’s clinical trial participation has increased, clinical trials still largely are not designed for women. In this episode, we discuss the many areas where trials can be improved, such as human and historical diagnosis and screening biases, accessibility, data capturing, and more
Metabolic dysfunction-associated steatohepatitis experts welcomed Madrigal’s Rezdiffra as an “important first,” but there are more mid- to late-stage therapies showing promising results.
Less than half of cancer drugs approved via the FDA’s accelerated approval pathway between 2013 and 2017 showed clinical benefit in confirmatory trials in terms of overall survival or quality of life, according to the paper.
Merck and Kelun-Biotech’s antibody-drug conjugate achieved a 22% objective response rate and 80.5% disease control rate in heavily pretreated patients with gastric or gastroesophageal junction cancer.
Late-stage study results released Tuesday show YS Biopharma’s rabies vaccine candidate can induce twice the seroconversion rate at seven days versus a standard, globally marketed comparator.
A new Scandinavian study published Wednesday found no conclusive evidence to support the link between GLP-1 receptor agonists and an increased risk of thyroid cancer.
Many promising small molecules have lost significant investment appeal as a result of lopsided incentives favoring biologics in 2022’s Inflation Reduction Act.
Looking for a biopharma job in San Diego? Check out these top five companies hiring life sciences professionals like you.
A pair of biotechs burst onto the scene Tuesday, exiting stealth with $100 million in financing each and tapping executives who made their names at bluebird bio and Karuna Therapeutics.
After BrainStorm Cell Therapeutics withdrew its BLA in October 2023 for NurOwn, the company announced Tuesday that the FDA has agreed to the design of a Phase IIIb trial for its amyotrophic lateral sclerosis candidate under a Special Protocol Assessment.