The EMA has changed its mind about an earlier decision that the risks of Leqembi (lecanemab) outweigh the benefits and is now recommending the Alzheimer’s disease drug is approved for a subgroup of patients. That follows an appeal by Eisai Co. Ltd. and a re-examination of the data, after details relating to 274 patients with two copies of the ApoE4 gene were removed from the file.
Despite government efforts to prop up biopharma and med-tech research toward creating women’s health products, companies must eventually reach out to the private markets to bring their inventions to the next stage of development. Anna Zornosa-Heymann, a women’s health investor, serves as a part-time contractor with the U.S. NIH’s SEED (Small business Education & Entrepreneurial Development) office, where she helps companies move from government to external funding. Government funds are “excellent to pay for research … but those funds don’t allow you to build a first-class team and to develop a sales apparatus,” she told BioWorld.
While women make up half the world’s population and own two out of every five businesses, there are substantial knowledge gaps about conditions affecting their health – mostly due to decades of research excluding women from clinical trials and investment decisions.
At the BioFuture 2024 conference held in New York in November, Seema Kumar, the CEO of Cure, described women’s health as something that has been directed at the “bikini area.” That “bikini” bias extended to both diseases and their causes – women’s health covered the breasts and reproductive system, and its causes were hormonal. Both concepts are far too narrow.
It’s difficult to fathom that the health of half the world’s population is underserved. But it’s a hard truth. There are many conditions that disproportionately impact women. Other conditions and diseases affect women in different ways than men. Decades of research excluding women from clinical trials and investment decisions in male-dominated board rooms have ignored these facts. Though an increasing number of women are now managing investments and driving the research, it’s all still woefully behind. In BioWorld’s new report, Healing the health divide, we’ve highlighted the disparities.
Six main cell types form glioblastomas, the most aggressive brain cancer due to its high rate of recurrence. Of these six, quiescent cancer stem cells are responsible for resistance to therapy and the reappearance of the tumor, according to a study that identified the six groups and highlighted the importance of these stem cells for the design of more effective therapies.
More than two years since emerging from stealth, Vesalius Therapeutics Inc. signed its first major pharma deal with GSK plc. Worth up to $650 million and possibly more if an option is exercised, the multitarget alliance aims to discover and develop novel treatments for Parkinson’s disease and another neurodegenerative indication.
Abbvie Inc.’s much-hyped emraclidine, the centerpiece of its $8.7 billion buyout of Cerevel Therapeutics Inc., failed to hit its endpoints in two phase II trials in schizophrenia, sending company shares (NYSE:ABBV) down more than 12.6%, to close at 174.43, catching industry watchers by surprise and removing a potentially near-term competitor for Bristol Myers Squibb Co.’s recently approved antipsychotic, Cobenfy (xanomeline-trospium).
Radiopharmaceutical biotech and contract development and organization firm Duchembio Co. Ltd. filed a securities report to South Korea’s Financial Services Commission Nov. 11, kickstarting the IPO process to list on the Korea Exchange.
As an array of developers push their Friedreich’s ataxia (FA) drugs along, PTC Therapeutics Inc.’s recent update on its program piqued thirst for the 15-lipoxygenase inhibitor vatiquinone. Warren, N.J.-based PTC said the prespecified endpoint for two different FA long-term extension studies was met, with highly statistically significant evidence of durable treatment benefit on disease progression.