Bioxodes SA is gearing up fundraising for a follow-up study to the newly released interim phase IIa results of its lead asset in preventing secondary damage after an intracerebral hemorrhagic stroke. Data from the first 16 patients in the phase IIa study show BIOX-101 hit its primary safety and secondary endpoints in an indication that has no approved treatment.
As pharma deals with the impact of U.S. NIH grant cuts and the imposition of tariffs, a lot of pressure is shifting to smaller and midcap companies, according to two executives who spoke on the newest BioWorld Insider podcast.
Veraxa Biotech AG is merging with special purpose acquisition company (SPAC) Voyager Acquisition Corp. to become a publicly traded company that will develop treatments for solid tumors.
After more than three years of discussion, the World Health Organization’s Intergovernmental Negotiating Body (INB) has agreed on a proposal to prevent, prepare and respond to a pandemic. The plan is born, the INB proposal said, out of inequities around the world that slowed timely and equitable access to health products to respond to the COVID-19 pandemic.
The U.S. FDA issued a complete response letter in October 2023 for Dupixent (dupilumab) in treating chronic hives but has now approved the monoclonal antibody for the indication. The approval makes Dupixent the first targeted biologic the agency has approved in the past 11 years for chronic spontaneous urticaria.
Earendil Labs will collaborate with Sanofi SA in a $1.8 billion license deal. Earendil, which specializes in artificial intelligence-based R&D for biologics, is getting $125 million up front and $50 million as a near-term payment. In return, Sanofi gets the exclusive global rights to the bispecific antibodies HXN-1002 and HXN-1003.
After more than three years of discussion, the World Health Organization’s Intergovernmental Negotiating Body (INB) has agreed on a proposal to prevent, prepare and respond to a pandemic. The plan is born, the INB proposal said, out of inequities around the world that slowed timely and equitable access to health products to respond to the COVID-19 pandemic.
After more than three years of discussion, the World Health Organization’s Intergovernmental Negotiating Body (INB) has agreed on a proposal to prevent, prepare and respond to a pandemic. The plan is born, the INB proposal said, out of inequities around the world that slowed timely and equitable access to health products to respond to the COVID-19 pandemic.
Despite missing a phase II study’s primary endpoint in moderate to severe asthma, Sanofi SA sees a way forward to a phase III program in the crowded disease space. Preliminary results showed the annualized exacerbation rate endpoint wasn’t met at the highest dosage of amlitelimab. Those numbers, at week 48, showed nominal significance at the medium dose.
Positive early stage data for Verve Therapeutics Inc.’s base editing therapy points to a range of development options, including bringing partner Eli Lilly and Co. in a little closer. The new data helped ease the company’s pain from the April 2 enrollment pause of a similarly designed therapy from Verve. Verve’s Heart-2 phase Ib of VERVE-102 in treating 14 patients with heterozygous familial hypercholesterolemia and/or premature coronary artery disease showed one infusion led to dose-dependent decreases in blood PCSK9 protein levels and low density lipoprotein cholesterol.
