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Ralph Abraham, a vocal vaccine skeptic who served at the agency for just three months, has stepped down due to “unforeseen family obligations,” according to the CDC.
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The first gene therapies approved to treat sickle cell disease in December 2023 are struggling on the market. But there are glimpses of forward momentum as Vertex and Genetix Bio provide updates.
After last year’s ‘stampede’ for FGF21 assets, the focus for the metabolic dysfunction-associated steatohepatitis space has shifted toward differentiated approaches, such as THR-β agonists and combination treatments, that seek to mirror the commercial success of Madrigal’s Rezdiffra.
Maintaining America’s momentum demands that policymakers resist policies that undermine research and development incentives.
FROM OUR EDITORS
Read our takes on the biggest stories happening in the industry.
Following the FDA’s refusal to review Moderna’s investigational mRNA flu vaccine last week, Commissioner Marty Makary faced questions from the U.S. president about the agency’s handling of vaccines. It’s a clear signal that the tension long brewing at the drug regulator has now gone all the way to the top.
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Vertex Pharmaceuticals on Wednesday announced it is acquiring clinical-stage immunotherapy company Alpine Immune Sciences for $4.9 billion in cash, the largest acquisition so far this year.
The U.S. Department of Justice has filed a complaint against Regeneron alleging that the pharma knowingly omitted credit card price concessions for Eylea to inflate Medicare reimbursement rates.
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.
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