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The current state of political affairs in the U.S. does not bode well for the direction of that turn. The country is at real risk of losing its long-held lead in biotech innovation.
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The FDA’s refusal to review Moderna’s mRNA-based flu vaccine is part of a larger communications crisis unfolding at the agency over the past nine months that has also ensnarled Sarepta, Capricor, uniQure and many more.
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.
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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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A recent legal decision could signal the ultimate demise of the FTC’s final rule banning most noncompete clauses. A biotech talent expert discusses how that affects biopharma job searches.
The Federal Trade Commission plans to file lawsuits against the three largest pharmacy benefit managers over allegedly steering patients away from less expensive drugs, according to The Wall Street Journal.
For the second quarter of 2024, there were 25% fewer jobs posted live on BioSpace compared to the same quarter of 2023. The year-over-year job response rate rose from 14.6% to 15.3%.
The FDA’s Complete Response Letter turned down Novo Nordisk’s Biologics License Application for its once-weekly basal insulin icodec injection for diabetes mellitus, with “requests” related to the manufacturing process and the type 1 diabetes indication.
Biotech venture capital firm Flagship Pioneering is looking to fund companies focused on artificial intelligence, human health and sustainability, bringing the total raised since 2021 to $6.4 billion.
Amgen has quietly discontinued the development of its Phase I bispecific T-cell engager AMG 794, which the company had been studying for several malignant solid tumors.
Eli Lilly becomes the latest to make a major investment in immunology and inflammation, while antibody-drug conjugate biopharma Myricx Bio nets a large Series A round and new research highlights the potential and possible risks of GLP-1s.
Artificial intelligence is making it faster to get drug candidates to the clinic, but to gain a competitive advantage, companies must have a strong foundation of data.
Interius BioTherapeutics has received approval from Australia’s Human Research Ethics Committee to begin the first-in-human trial of an investigational in vivo CAR-T therapy designed to treat B-cell malignancies.
The regulator Tuesday added atopic dermatitis to the label of Arcutis Biotherapeutics’ topical PDE4 inhibitor Zoryve for the treatment of patients six years of age and older.