Securing a second major partnership with Sanofi SA – this time worth a potential $2.56 billion – Earendil Labs will provide its AI-driven discovery platform to find new therapeutics for autoimmune and inflammatory diseases.
Zenas Biopharma Inc.’s positive data from the phase III Indigo trial with obexelimab in immunoglobulin G4-related disease (IgG4-RD) set investigators to speculating about the bifunctional antibody’s odds in the marketplace, as the Waltham, Mass.-based firm plans a BLA submission the U.S. FDA in the second quarter of this year.
In October, the Nobel Committee awarded the 2025 Nobel Prize in Physiology or Medicine to Shimon Sakaguchi, Mary Brunkow and Fred Ramsdell for their discoveries in the field of autoimmunity. As has become typical for the scientific Nobel Prizes, the award-winning research is by now several decades old. But the discoveries were the basis for ongoing research into how to prevent autoimmunity that notched significant wins in 2025, in both basic research and in the clinic.
The U.S. FDA’s green lighting of Omeros Corp.’s Yartemlea (narsoplimab) makes it the first approved treatment for hematopoietic stem cell transplant-associated thrombotic microangiopathy (TA-TMA), a life-threatening complication of hematopoietic stem cell (HSC) transplantation. The BLA for narsoplimab, a fully human monoclonal antibody that inhibits the enzyme mannan-binding lectin-associated serine protease-2, had a Dec. 26 PDUFA date.
Speed and innovation from Asia Pacific’s (APAC) biotechnology sector had big pharma scouring the region for the next oncology heir to Keytruda (pembrolizumab), Merck & Co. Inc.’s reigning blockbuster cancer drug.
Driven by a deeply antiscientific political agenda, the current U.S. government is not just sabotaging some of the most groundbreaking technology that has been developed in the past decades. It is also destroying the country’s past successes, such as measles elimination and the reduction of hepatitis B infections in infants to near zero.
BioWorld’s 2022 end-of-year highlights included a toast to the future – of universal vaccines. Even before SARS-CoV-2 vaccines were developed in record time and saved countless lives during the COVID-19 pandemic, vaccines were a rare bright spot in the fight against infectious diseases. Bacteria are becoming multidrug resistant far faster than new classes of antibiotics are being developed, viral spillover events and vector ranges are increasing, and climate change is helping bacteria and fungi alike breach human thermal protections against infections.
Advances in antiretroviral therapy (ART) now allow people living with HIV to lead normal lives with undetectable and nontransmissible levels of the virus in their blood. Yet that reality is limited to those with access to treatment. More than 40 million people worldwide live with HIV, with over a million new infections and hundreds of thousands of deaths each year, underscoring that major challenges remain.
DBV Technologies SA’s pivotal phase III trial with the Viaskin Peanut allergy patch came through for the company, and officials plan a BLA filing with the U.S. FDA in the first half of next year. Shares of the Montrouge, France-based firm (NASDAQ:DBVT) closed Dec. 17 at $22.55, up $4.57, or 25%, on positive top-line results from the study called Vitesse with Viaskin for children, ages 4 to 7.
The cardiomyositis that is a rare adverse effect of mRNA-based COVID vaccines is due to immune cell activity as a result of increased levels of the chemokines CXCL10 and interferon-γ (IFN-γ). Blocking CXCL10 and IFN-γ could prevent muscle cell damage in cell culture, and cardiomyositis in animal models. The findings, reported in the Dec. 10, 2025, issue of Science Translational Medicine, suggest a way of mitigating the risk of cardiomyositis.
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