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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AstraZeneca announced a series of wins in Japan with regulatory approvals for Tagrisso, Ultomiris and Lynparza, to treat non-small cell lung cancer, myasthenia gravis and breast cancer, respectively.
NIH researchers found that symptomatic herpes viruses were associated with neurological symptoms, but there was no evidence that herpes viruses are linked to Alzheimer’s disease.
Novartis announced Wednesday it is temporarily halting dosing in its ongoing Phase IIb VIBRANT-HD trial of branaplam in Huntington’s disease.
In an interview with Reuters, AstraZeneca CEO Pascal Soriot said Tuesday that he isn’t sure if the company will continue developing vaccines. He also hinted at potential M&A action.
BrainVectis will begin assessing a gene therapy for Huntington’s disease in France after receiving clearance from health authorities there to conduct a Phase I/II study.
A day after Pfizer and partner BioNTech submitted an EUA request to the FDA for their booster shot targeting Omicron variants BA.4 and BA.5, the regulator appears close to approving it.
Shares of Foghorn are tumbling after the FDA placed a full clinical hold on a Phase I dose escalation study that had already been subject to a partial hold following a patient death.
A combination of Novo Nordisk’s CagriSema injection for overweight people with type II diabetes resulted in a 15.6% body weight reduction compared to taking the drugs individually.
Tessa Therapeutics has tapped former Takeda executive Thomas Willemsen as the man to take its CAR-T portfolio forward.
In a letter to shareholders, RegeneRx provided a pipeline update for investors Monday, outlining plans to potentially move forward with a new asset in light of development delays.