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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.
FDA
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?
Job Trends
Follow along as BioSpace tracks job cuts and restructuring initiatives.
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Read our takes on the biggest stories happening in the industry.
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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IRA
Reiterating his ruling in a prior Inflation Reduction Act case, New Jersey District Court Judge Zahid Quraishi ruled that Novo Nordisk’s participation in the Medicare Drug Price Negotiation Program is of its own free will.
Sarepta has been hit with another patent infringement lawsuit, this time from Sanofi and its subsidiary Genzyme alleging that the biotech used protected technology related to AAV vectors.
Generative AI could enhance and accelerate the way people work on clinical trials. In this Q&A, a management consultant shares his insights on benefits, risks and more.
In this episode, Lori and guests discuss the pursuit of adequate representation and how clinical trials are being shaped by the legal environment they operate within.
While many describe California as having a tough life sciences market, there’s some optimism that employment opportunities will improve soon, according to California Life Sciences President and CEO Mike Guerra.
Looking for a quality control job? Check out these nine companies hiring life sciences professionals like you.
Companies will look at job candidates’ LinkedIn profiles, so make sure yours is strong, from the summary of your expertise and qualifications to testimonials from colleagues.
A report from J.P. Morgan shows an increase in biopharma activity so far this year and where some improvement can be made.
Eisai presented a plethora of data on the drug at the Alzheimer’s Association International Conference, including a study showing the consequences of pausing treatment.
Systemic administrative and policy challenges, including updated CDC guidelines regarding the use of RSV shots in seniors, have forced GSK to lower its 2024 outlook for its vaccines business.