Drug Development
The disagreement between Moderna and the FDA has reached a resolution just eight days after the biotech received a Refusal-to-File letter in response to its application for mRNA-1010. Moderna will now seek approval of the vaccine based on age.
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The FDA’s refusal to review Moderna’s mRNA-based flu vaccine is “part of a disturbing pattern” of moving regulatory goalposts, according to Clay Alspach, executive director of the Alliance for mRNA Medicines. Meanwhile, streamlined communications with regulators in other countries pave the way for rapid uptake of novel modalities.
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.
Pfizer, Eli Lilly, Novartis, Bristol Myers Squibb and AstraZeneca are all ramping up the use of AI, but drug discovery is not the primary success story—yet.
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Akero Therapeutics announced its mid-stage drug candidate, efruxifermin improved liver fibrosis and prevented disease worsening in patients with NASH.
Novartis has had a busy few days, announcing plans to shutter a Sandoz plant, a $300 million infrastructure investment, and Cosentyx, Kisqali and Tislelizumab readouts.
AstraZeneca presented data showing Imfinzi and Tagrisso boosted survival chances for patients in different forms of lung cancer at ESMO on Monday.
It was a busy weekend at ESMO 2022 with Merck, Astellas, Seagen, Regeneron, AstraZeneca and GRAIL all presenting data from their various cancer programs.
Regeneron’s oncology strategy is centered around improving checkpoint inhibitor treatments with combination therapies, according to a pipeline overview presented Monday morning.
The week has seen a series of significant updates from BioVie, Regeneron, Relay Therapeutics, Oxford University, Vistagen and Palatin.
Now that most people in North America and Europe are vaccinated and the COVID-19 pandemic is diminishing, Moderna is looking for its second act.
An AstraZeneca/Merck combination showed mostly positive ovarian cancer data, Adaptimmune posted a strong ORR in solid tumors and BioNTech revealed data from a CAR-T cell therapy.
The ESMO conference is serving as a post-mortem on the trials that sunk the multi-billion-dollar partnership between Bristol-Myers Squibb and Nektar Therapeutics.
Biogen announced that its mid-stage monoclonal antibody litifilimab is showing promise in reducing joint pain related to systemic lupus erythematosus (SLE) lupus.