FDA urged to back mifepristone
53 biotechnology leaders and investors submitted a letter to FDA Commissioner Martin Makary supporting Citizen Petition FDA-2025-P-0377-0001, which upholds mifepristone’s continued availability. They endorse the petition filed by major medical associations, emphasizing the drug’s long-established safety, supported by decades of peer-reviewed data and FDA assessments. They criticize a recent report by the Ethics and Public Policy Center as methodologically flawed, lacking peer review, and misrepresenting data. The signatories stress that such unscientific challenges to FDA-approved medicines threaten the stability of the drug development process and could deter future innovation. They urge the FDA to continue basing decisions solely on rigorous scientific evidence and not on politically motivated or low-quality studies.
Novartis’ infant-friendly malaria drug approved in Switzerland
Novartis’ Coartem (artemether-lumefantrine) Baby has been approved by Swissmedic as the first malaria medicine for newborns and infants. The new treatment was developed in collaboration with Medicines for Malaria Venture, as well as eight African countries. Novartis plans to introduce the treatment to areas where malaria is endemic. CEO Vas Narasimhan said, “For more than three decades, we have stayed the course in the fight against malaria, working relentlessly to deliver scientific breakthroughs where they are needed most. Together with our partners, we are proud to have gone further to develop the first clinically proven malaria treatment for newborns and young babies, ensuring even the smallest and most vulnerable can finally receive the care they deserve.”
EMA recommends increased plasma manufacturing capacity
The European Medicines Agency (EMA) has issued recommendations to address vulnerabilities in the supply chain of anti-D immunoglobulins. These medicines are currently the only available treatment for the prevention of RhD immunization during pregnancy. RhD immunization occurs when a pregnant person with RhD-negative blood type is exposed to RhD-positive blood from their fetus, potentially leading to serious health issues for the fetus and newborn.
Plasma, collected from donors and containing the anti-D immunoglobulin, is currently the only source for manufacturing these medicines. With the number of donors declining and anti-D immunoglobulins limited, it is recommended that EU Member States develop plans to secure the supply of anti-D immunoglobulins, reduce unnecessary use through non-invasive prenatal screening, support the development of alternatives, and increase awareness of plasma collection.
Expansion keeps Almac cool
Almac Clinical Services has completed a multi-million-pound investment at its Craigavon, Northern Ireland, headquarters to significantly enhance cold chain capabilities. The expansion includes a new ultra-low temperature facility, tripling -15°C to -25°C packaging capacity and doubling -60°C to -80°C storage. The upgraded infrastructure supports the rising demand for Advanced Therapy Medicinal Products, including cell and gene therapies. Additional enhancements include new secondary production rooms, label printing suites, and packaging design facilities. The move aligns with Almac’s global expansion program and reinforces its commitment to supporting clinical trial sponsors with robust, compliant, and efficient cold chain logistics.
Research
Weill Cornell develops cancer-targeting molecule
Researchers at Weill Cornell Medicine have developed a new precision medicine strategy for treating ovarian cancer, detailed in a study published in Cell Reports Medicine. Rather than targeting specific genetic mutations, the approach focuses on the activation of growth signaling pathways common in ovarian tumors. The team identified that the MAPK pathway is frequently hyperactive in these cancers. They discovered that the experimental drug rigosertib, which inhibits the MAPK pathway, effectively slows tumor growth. However, rigosertib alone can inadvertently activate the PI3K/mTOR pathway, leading to treatment resistance. To counter this, researchers combined rigosertib with a PI3K/mTOR inhibitor, resulting in a more potent suppression of tumor growth in preclinical models. This dual-targeting method outperformed standard chemotherapy and may offer a new therapeutic avenue for ovarian cancer patients, especially those lacking curative second-line treatment options.
Nanomedicine could take on bladder cancer
Researchers at Sun Yat-Sen University in China have developed a novel nanomedicine, Fe-EGCG@RSL3, offering a potential treatment for bladder cancer. This self-assembling nanoparticle combines iron ions, green tea-derived EGCG, and the ferroptosis-inducing agent RSL3. Upon administration, it targets tumor cells, releasing its components in the acidic tumor environment to trigger ferroptosis – a form of cell death distinct from apoptosis. Beyond directly killing cancer cells, Fe-EGCG@RSL3 modulates the tumor's immune microenvironment, enhancing beneficial immune cell activity while suppressing immunosuppressive cells. The dual action not only combats treatment-resistant tumors but also boosts the efficacy of existing immunotherapies. Importantly, the treatment demonstrated minimal toxicity in healthy tissues and can be administered intravenously or directly into the bladder, eliminating the need for external activation methods.
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