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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.
FROM OUR EDITORS
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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As part of an ongoing Senate investigation into pharma companies’ tax rates, Sen. Ron Wyden (D-Ore.) has asked Pfizer CEO Albert Bourla to explain irregularities in its reported revenues, losses and taxes paid.
Johnson & Johnson on Tuesday released Phase II/III results showing its monoclonal antibody Tremfya is better than its blockbuster Stelara in terms of endoscopic outcomes in Crohn’s disease.
Approaches and targets for depression and other mental health illnesses have remained stagnant for decades. With several readouts for novel therapies on the horizon, that could be changing.
Odds are, you won’t love every job. Is that OK? And what should you do if you’re struggling to find happiness at work?
Participants experienced fewer asthma attacks when receiving the antibody every six months, GSK said Tuesday, positioning the company to file for approval of the potential blockbuster.
Formerly known as AbGenomics Holding, AltruBio on Tuesday said it will use the funds to push its ulcerative colitis asset into a Phase IIb trial with an anticipated readout in 2026.
Eli Lilly is paying $60 million upfront to Aktis Oncology to discover and develop novel tumor-targeting radiopharmaceuticals, as radiopharma dealmaking continues to heat up in 2024.
The PR departments of Chinese CDMOs affected by the BIOSECURE Act and their U.S. partners must step up to ensure proposed legislation doesn’t squash innovation.
AstraZeneca on Tuesday laid out an ambitious plan to boost growth in its existing oncology, biopharma and rare disease portfolios, as well as launch 20 new medicines before the end of the decade.
Late-stage results from the NOTUS trial showed Sanofi and Regeneron’s Dupixent lowered moderate to severe chronic obstructive pulmonary disease exacerbations by 34% and led to significantly better lung function.