A clinical trial for gender-questioning children using puberty blockers will require participants to be at least 11 years old. The Pathways Trial, previously paused due to safety concerns, has strengthened safeguards, including a minimum age and parental consent. Legal challenges and ethical debates continue.
UniQure plans to seek FDA accelerated approval for its Huntington's disease gene therapy, using three-year data from a Phase 1/2 study. This follows a recent FDA meeting that reversed previous criticisms of the evidence, with shares soaring 70%.
China has approved NEO, the world's first commercial brain-computer chip, for mass production. The coin-sized device, designed for patients with spinal cord injuries and paralysis, uses a less invasive approach than Elon Musk's Neuralink, which is still under US regulatory review.
Ben Whitehead, the only known person in Australia with stage four peripheral T-cell lymphoma, has entered remission after undergoing clinical trials. He plans to write a book about his experience and use of humor.
A clinical trial in the US shows promising results as a genetically modified virus has stopped pancreatic cancer in three patients. The virus replicates inside tumors, causing them to burst and release more virus to infect neighboring cancer cells. Further trials are needed to determine optimal dosage and effectiveness.
Korean biotech firms CGBio, Handok, LegoChem Biosciences, Lotte Biologics, and Daewon Pharm announced progress in drug development, clinical trials, and international conferences. Highlights include CGBio's spine treatment strategy, Handok's hyperinsulinism drug trial results, LegoChem's partner's cancer drug receiving FDA rare disease designation, Lotte Biologics' participation in Bio USA, and Daewon Pharm's obesity drug pre-clinical results.
Abivax shares dropped 43.6% after its ulcerative colitis drug, obefazimod, showed a cancer signal in trial data. While efficacy was met, the presence of cancer cases, particularly on the higher dose, has raised concerns and led to a downgrade by analysts, impacting potential takeover talks.
Abivax shares dropped 40% after reporting efficacy data for its ulcerative colitis drug, obefazimod, alongside cancer cases. Analysts cite the 'cancer signal' as a significant overhang, complicating potential takeover talks.
Abivax shares dropped 37% after reporting data on its ulcerative colitis drug, obefazimod. While the drug showed efficacy, the presence of cancer cases, particularly on the higher dose, raised concerns and led analysts to downgrade the stock, complicating potential takeover talks.
Abivax shares dropped 32% after reporting new data for its ulcerative colitis drug, obefazimod. While the drug showed efficacy, the emergence of cancer cases in patients, particularly on the higher dose, has raised concerns and led to a stock downgrade, complicating potential takeover talks.
Serum Institute of India will manufacture clinical trial doses of an experimental Ebola vaccine from Oxford University, backed by up to $8.6 million in funding from CEPI. The vaccine uses the same ChAdOx1 platform as the Oxford-AstraZeneca Covid-19 vaccine, aiming for rapid development and affordable access for affected nations in Africa.
A clinical trial found that gentle yoga significantly reduces mood disturbance, anxiety, fatigue, and insomnia in cancer survivors. The Yoga for Cancer Survivors (YOCAS) program offered a non-pharmaceutical solution for common post-treatment side effects.
A new treatment called amivantamab, developed by Johnson & Johnson, has shown unprecedented results in patients with head and neck cancer who did not respond to chemotherapy and immunotherapy. In a study involving 102 patients across 11 countries, tumors completely disappeared in 15 patients, and shrank in 43 others.
A study published in the Journal of the American College of Cardiology reveals that Africans, despite representing 19% of the global population and being highly exposed to diseases, are largely excluded from clinical trials. Out of over 2,000 publications analyzed between 2019 and 2024, only 3.9% were conducted exclusively in Africa.
Spain boasts around 450 AI startups. Multiverse Computing, a leader, aims for unicorn status with a €500M round. Cala AI, founded by a former Apple exec, focuses on external data for AI. Openchip seeks to lead Europe's microchip industry, and Biorce uses AI to streamline clinical trials.
Cancer immunotherapies, including checkpoint inhibitors and vaccines, work by reactivating or engineering immune cells to attack tumors. Researchers are studying factors influencing patient response and exploring similar approaches for allergies, depression, and autoimmune diseases like multiple sclerosis and inflammatory bowel disease.
Korean biotech companies will present clinical trial results for new cancer drugs at the American Society of Clinical Oncology (ASCO) conference in Chicago. Companies like Onconic Therapeutics, GI Innovation, HLB, Lunit, and DXVX will share findings on various cancer types, including pancreatic, bladder, kidney, and liver cancer.
Chinese company Nuwacell claims its stem cell therapy for Parkinson's disease shows significantly higher efficiency (80-90% conversion) than international competitors (below 25%), citing faster clinical trial timelines.
A new clinical trial suggests a single dose of psilocybin may effectively treat cocaine addiction, with participants showing higher abstinence rates than those receiving a placebo. The study, notable for its majority Black participant group, highlights psilocybin's potential as a catalyst in therapeutic processes for addiction.
Alzheimer’s Research UK says patients at risk of being left behind as lack of formal or accurate diagnoses closes door to trialsPeople with Alzheimer’s disease are missing out on experimental treatments because they are not diagnosed early or accurately enough to be enrolled in clinical trials, a UK charity has said.Trials of Alzheimer’s drugs reached a record high this year, according to data published on Tuesday, but Alzheimer’s Research UK said too few UK patients were taking part because their diagnoses were delayed or were not specific enough. Continue reading...
Researchers at the University of Hong Kong (HKU) say they have developed a world-first nasal spray that delivers neurotherapeutic powder directly to the brain as first aid for ischemic stroke patients, with clinical trials expected by 2030. The treatment is intended for initial use by paramedics, before being rolled out to high-risk groups in care facilities and eventually the general public through pharmacies. It was developed by the Li Ka Shing Faculty of Medicine at HKU and the university’s...
AstraZeneca's experimental breast cancer drug camizestrant faced a setback as a U.S. FDA advisory panel voted 6-3 against approval, citing concerns over the SERENA-6 trial design. The Phase 3 trial showed a 56% reduction in disease progression or death, but panel members weren't convinced early switching improved long-term survival. Shares fell 2% in morning trading, though analysts noted the drug's efficacy wasn't dismissed and the issue shouldn't impact AstraZeneca's $80 billion 2030 sales goal.
South Korea approved 53 clinical trials in Q1 2026, with only 19% led by Korean developers while over 80% were overseas-led. Phase 3 trials accounted for 53%, and antibody-based drugs represented over 80% of approvals. Oncology trials dominated at 49% of total.
President Donald Trump signed an executive order on Saturday aimed at accelerating psychedelics research, directing agencies to expand clinical trials and Right to Try access for psilocybin, MDMA and ibogaine. The order leaves drug scheduling unchanged and comes amid stalled cannabis rescheduling efforts, raising questions about whether psychedelics will face similar federal delays. Psychedelic stocks rallied significantly following the announcement, with AtaiBeckley jumping roughly 25%.
