Outlook Therapeutics Inc. is forging onward with plans to resubmit the BLA for ONS-5010, an ophthalmic version of Avastin (bevacizumab, Roche AG), after a missed endpoint in phase III with the VEGF binder for wet age-related macular degeneration (AMD). Read More
The conditional marketing approval for Ocaliva (obeticholic acid) has been revoked with immediate effect, following a standoff between the EMA and Advanz Pharma Ltd., the company that markets the primary biliary cholangitis (PBC) therapy in Europe. On Sept. 5, London-based Advanz won a short reprieve after challenging the EMA’s June 28 ruling that the marketing authorization for Ocaliva should be revoked, when the General Court of the EU granted a temporary suspension of EMA’s decision. However, on Nov. 27, Advanz announced the court had said it would not be extending the suspension. Read More
Arovella Therapeutics Ltd. is heading toward the clinic with its lead product, ALA-101, which consists of a chimeric antigen receptor (CAR) targeting CD19 and invariant natural killer T (iNKT) cells. Read More
The U.K.’s leading bioethics body is calling for a new law to regulate the generation of stem cell-derived human embryo models and ensure that research does not cross ethical red lines. Currently, there is no statute governing the oversight of these models. In particular, bioethicists say there should be a statutory ban on the transfer of embryo models into the reproductive tract of humans and animals, with legal penalties for contraventions. Read More
Researchers at the University of Copenhagen have identified a signaling pathway that simultaneously increased energy expenditure and decreased food intake. In both human and primate studies, agonists of the tachykinin NK2 receptor (NK2R) led to both decreased food intake and increased energy expenditure. And in behavioral tests, they were not aversive, suggesting they do not cause the nausea that is a major side effect of GLP-1 agonists. Read More
Our immune cells are not just “defenders” against deadly viruses and pathogens but also a great balancer for tissue homeostasis. For neurological disorders, understanding the neuro-immune axis could be key to treating previously untreatable conditions such as autism spectrum disorder, according to Jun R. Huh, professor of immunology at Harvard Medical School. Read More
In October 2024, BioWorld logged 219 clinical trial updates, marking a decrease from 252 in September but a rise from 92 in August. The month featured 14 positive phase III trial outcomes and one unsuccessful trial. Read More
The U.S. District Court for the Northern District of California ordered Lorik Papyan, who pleaded guilty three years ago to one count of unlicensed wholesale distribution of prescription drugs, to pay Gilead Sciences Inc. nearly $32 million in restitution to cover lost profits due to a counterfeit HIV drug scheme he was involved in. Read More
BioWorld's offices will be closed in observance of Thanksgiving in the U.S. No issues will be published Thursday, Nov. 28, or Friday, Nov. 29. Read More
It’s difficult to fathom that the health of half the world’s population is underserved. But it’s a hard truth. Women’s health has traditionally focused on what Seema Kumar, the CEO of Cure, coined as the “bikini zone.” However, reproduction and breast health are a drop in the bucket when it comes to women’s health. In this multipart, in-depth series, BioWorld provides insight into the oft-overlooked space of women’s health, exposing the disparities in research and funding while looking toward future opportunities for bridging the gender gap in health care. Read More
Karen Carey, BioWorld’s managing editor and chief analyst, and Anette Breindl, managing editor of Bioworld Science, join this episode of the BioWorld Insider podcast to talk about the business and the science of women’s health. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Pharmather, Soleno, Theratechnologies. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Axsome, Cognition, Genentech, Maat, S. Biomedics, Urogen. Read More
