Showing similar results as the first phase III trial completed in 2022, Nicox SA’s nitric oxide-donating bimatoprost eye drop, NCX-470, met the primary endpoint in the phase III Denali trial for open-angle glaucoma or ocular hypertension, clearing the way for regulatory filings in both the U.S. and China.
With the trial sites now open for its CRISPR-edited T-cell receptor immunotherapy trial, Anocca AB has raised SEK440 million (US$46 million) to fund the phase I part of the multicenter study to completion. The company’s engineered T-cell receptor T-cell therapy (TCR-T) is first being tested against KRAS mutations in pancreatic cancer.
Adding another name to an impressive roster of partners assembled over the past few years, Skyhawk Therapeutics Inc. inked a neurology-focused deal with Merck KGaA aimed at discovering small-molecule RNA-targeted drugs that could be worth more than $2 billion.
Eli Lilly and Co. has fallen into line with U.S. President Donald Trump’s May 12 executive order on most-favored nation pricing, announcing it will put up drug prices in Europe in order to make them lower in the U.S. In a statement on Aug. 14, the company said it supports the Trump administration’s objective of more fairly sharing costs of “breakthrough medical research” across developed countries.
German researchers have cracked the decades-long mystery of why males are more susceptible to acute kidney injury than females, demonstrating that estrogen has a protective effect in females.
The increasing recognition of its importance in national security, economic growth and health has seen biotech emerging as the latest frontier in geopolitical competition, with implications for companies ranging from startups to multinationals – and for global investment in the sector.
The U.K. Medicines and Healthcare products Agency (MHRA) is calling for more research into the vaginal microbiome as a way to redress the historic under-representation of women in clinical studies, which it said has contributed to “critical shortcomings” in understanding of female-specific conditions.
Novartis AG’s monoclonal antibody, ianalumab, has notched back-to-back wins, one in treating Sjögren’s disease and the other for primary immune thrombocytopenia (ITP). In Sjögren’s, which has no U.S. FDA-approved treatment, the phase III Neptunus-1 and Neptunus-2 studies are the first phase III trials to prompt statically significant reductions in adults with the autoimmune disease. In ITP, a disease that has yet to see a cure, top-line data of a phase III study of ianalumab combined with eltrombopag stretched to the time to treatment failure compared to placebo, the primary endpoint showing the maintenance of safe platelet levels.
The largest genome-wide association study to date of myalgic encephalomyelitis/chronic fatigue syndrome has identified eight genetic loci that are significantly associated with the chronic debilitating condition.
The U.K. quoted biotech investment firm Syncona plc is facing into the volatile market conditions and the impact U.S. trade policy, regulatory uncertainty and pharma pricing are having on access to capital, with a plan to end its evergreen structure and transition to a closed fund.
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