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The limited supply of this common reagent is set to drive drug prices higher, but there are ways for companies to lessen the impact.
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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.
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?
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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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Following several clinical failures for its candidates Roxadustat and pamrevlumab, FibroGen CEO Enrique Conterno is stepping down for “personal reasons,” the company announced Tuesday.
Embattled SQZ Biotechnologies announced Tuesday that the Swiss biotech will not exercise its option for HPV 16 positive solid tumors under the SQZ-APC-HPV program.
The biotech’s “Fit for Growth” program, which includes the headcount reduction, is expected to generate a net savings of $700 million on operating expenses by 2025.
Late-stage data, which showed significant overall and progression-free survival benefits in unresectable hepatocellular carcinoma patients, supports Elevar’s New Drug Application filed in May 2023.
The license and option deal, for an undisclosed amount, seeks to develop potentially first-in-class antibody-drug conjugate candidates against different oncology targets.
Following two BLA rejections for its Humira biosimilar, Alvotech is expanding its partnership with Teva Pharmaceuticals, which will enable the latter to have greater involvement with quality and control.
Company shares fell over 50% after two late-stage studies failed to demonstrate vision improvements in patients with diabetes macular edema.
The Danish vaccine maker’s respiratory syncytial virus candidate did not meet all primary endpoints in a late-stage study in older adults and the company is discontinuing the program.
James Ellis, an authority on employer branding for small businesses and biotechs, weighs in on the best ways to earn candidates’ trust.
With an upfront payment of $310 million in cash, Roche is partnering with Alnylam to develop the latter’s RNA interference candidate zilebesiran for hypertension patients with high cardiovascular risk.