Drug Development
The companies have an expansive clinical program for the mRNA neoantigen therapy intismeran autogene in combination with immuno-oncology heavyweight Keytruda.
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Three years after the accelerated approval of its anti-amyloid Alzheimer’s therapy, Biogen—neck and neck in the market with Eli Lilly and its Kisunla offering—is focused on a near-term FDA decision for a subcutaneous induction dose of Leqembi, a presymptomatic readout in 2028 and a clutch of next-generation candidates.
BMO analysts say Eli Lilly is well-positioned to maintain its lead in the ballooning weight loss space, predicting “strengthening leadership in obesity and beyond” as portfolios expand and patient access improves.
Facing the loss of exclusivity on key products, Pfizer has pulled forward its lead obesity asset into Phase III and targeted a 2028 launch. CEO Albert Bourla explained the pharma’s strategy at J.P. Morgan on Monday.
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The LPN technology used in the mRNA COVID-19 vaccines has been the target of numerous patent challenges. Here’s a look at recent biopharma patent disputes.
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.
The buyout comes on the heels of promising Phase I/II results from GTX-102, an antisense oligonucleotide candidate being developed to treat Angelman syndrome.