Drug Development
Head-to-head trials are often reserved for approved therapies as drugmakers try to one-up each other to gain further market share. In this case, Novo Nordisk ran the test at the candidate stage, and the bet did not pay off.
FEATURED STORIES
Evidence of durability of psilocybin-based COMP360 is a key point for the FDA, according to Compass Pathways Chief Medical Officer Guy Goodwin. By providing 26 weeks’ worth of such data instead of the requested 12, the company is delivering “in spades,” he said.
Competing with giants like Takeda and Moderna, the plucky biotech believes it has unlocked a future with an easy, yearly oral vaccine.
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.
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THE LATEST
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Merck’s Phase III trial studying Keytruda (pembrolizumab) for unresected locally advanced head and neck squamous cell carcinoma (HNSCC) failed to meet the primary endpoint.
VBL’s ofra-vec candidate was primarily evaluated on its ability to improve PFS and OS in study participants—and delivered disappointing results for both measures.
Avista Therapeutics inked a partnership deal with Swiss pharma giant Roche to develop AAV gene therapy vectors for eye diseases.
Avadel and Jazz Pharma, a leader in treating sleep disorders, are locked in a patent dispute. If it receives final FDA approval, Avadel’s Lumryz could challenge Jazz’s market dominance.
Sanofi has terminated a development agreement with Regulus in Alport syndrome, while Merck reaches the point of futility in a Phase III colorectal cancer trial.
As the BA.4/BA.5 Omicron subvariants spread, researchers continue to develop COVID-19 therapies and approaches for preventing or treating the disease. For that and more, continue reading.
Innovent Biologics’ Phase II trial of mazdutide, a potential treatment for type 2 diabetes, showed the drug met its primary endpoint by successfully reducing HbA1c levels.
The FDA has approved Incyte’s Opzelura as the first and only at-home therapy for repigmentation in nonsegmental vitiligo.