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Disc Medicine’s leadership tried to express optimism that its rare disease therapy bitopertin can be approved based on a Phase 3 trial set to begin shortly. However, analysts are worried that the protocol was developed with former FDA leaders.
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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.
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.
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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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Neuroscience-focused Rapport Therapeutics and radiopharma developer Telix Pharma announced their respective plans Friday for initial public offerings on the Nasdaq for undisclosed dollar amounts.
To support its growing antibody-drug conjugate portfolio, AstraZeneca on Monday said it is investing $1.5 billion in a Singapore production site that will include all steps of the ADC manufacturing process.
The European Patent Office last week upheld one of Moderna’s key patents, handing the biotech an important victory in its protracted COVID-19 vaccine battle with Pfizer and BioNTech.
Pfizer’s Wyeth unit notched a legal victory over AstraZeneca on Friday as a federal jury found the British-Swedish company violated two key patents in developing and marketing its lung cancer drug Tagrisso.
While Eli Lilly and Novo Nordisk currently dominate the GLP-1 receptor agonist space, there are more than 50 candidates in clinical development for obesity and type 2 diabetes, according to analytics firm GlobalData.
Life science companies can protect intellectual property in multiple ways, including leveraging IP rights.
Bayer on Thursday provided additional data on late-stage studies of its rival drug to Astellas’ Veozah, which met all primary endpoints.
A European Medicines Agency panel on Friday cited a possible but unconfirmed risk of cancer and recommended that hydroxyprogesterone caproate drugs be suspended from the European Union market.
Bolstered by promising response data from its Phase II study, Amgen announced Thursday it got the FDA’s green light for its first-in-class bi-specific T-cell engager Imdelltra for extensive-stage small lung cancer.
Disappointed with Phase I/II results for two Ionis-partnered programs, one for amyotrophic lateral sclerosis and another for Angelman syndrome, Biogen has opted to not proceed with their development.