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Moderna will not commit to previous 2028 breakeven guidance as the ripple effects of the FDA’s refusal-to-file decision spread through its pipeline.
FEATURED STORIES
The rare disease drugmaker is facing potential competitors for achondroplasia drug Voxzogo. Is a big M&A deal with two approved assets enough to maintain investor interest?
The FDA issued a rare Refusal-to-File letter to Moderna over its mRNA-based influenza vaccine application, in an unusual move that sent the biotech’s shares tumbling.
A rapturous response to data published last year for Pelage’s hair loss candidate overwhelmed the biotech. Now, the company is ready to show the world the science behind the breakthrough.
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Read our takes on the biggest stories happening in the industry.
Novo Nordisk and Eli Lilly have been battling head-to-head in an exploding obesity market. They should never have been compared apples to apples.
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Novartis on Thursday announced that it is making $150 million in upfront payments to protein degradation biotech Arvinas, while separately revealing that its tender offer for MorphoSys has begun.
GLP-1 treatments are all the rage in this space, but they aren’t the only approach in development. The pipeline assets highlighted here offer a differentiated approach, potentially increasing efficacy or reducing side effects.
On the heels of withdrawing Relyvrio from the U.S. and Canadian markets, Amylyx is now charting a path in Wolfram syndrome with promising interim Phase II data for its lead asset AMX0035.
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.