Island Pharmaceuticals Ltd. has secured government and ethics approvals to deploy its investigational antiviral galidesivir in patients infected during the escalating Bundibugyo Ebola outbreak in Africa, giving the small Australian biotech a rare opportunity to collect prospective human data in an active filovirus emergency.
Takeda Pharmaceutical Co. Ltd.’s anti-CD38 antibody mezagitamab (TAK-079) is showing benefits beyond platelet restoration, with new data suggesting the candidate may improve quality of life for patients with chronic immune thrombocytopenia (ITP) and sustain those gains after treatment ends.
The House Select Committee on China launched an investigation into clinical trials involving U.S. companies that are conducted at Chinese military hospitals and in Xinjiang, China.
The data mill continues to churn out encouraging results in pancreatic ductal adenocarcinoma (PDAC), with shares of Ramat Gan, Israel-based Can-Fite Biopharma Ltd. benefiting from the latest, phase IIa dispatch that pushed shares (NYSE:CANF) up 58%, or $1.73, to close July 1 at $4.70.
Regenerative medicine company Bellaseno GmbH is accelerating development of its absorbable breast scaffold, with a pivotal Australian trial recruiting faster than expected and a newly announced licensing deal with Johnson & Johnson subsidiary Mentor Worldwide LLC positioning the technology for global commercialization.
To Ivan Oransky, China’s paper-mill problem is best understood as an incentives story. “This is literally organized crime,” the Retraction Watch co-founder told BioWorld. “Follow the money. When there’s an opportunity to make money, they will find it, and if your whole career is based on how often you publish and what journals you publish in and how often you’re cited, it’s not surprising that leads to bad behavior.”
Nature Medicine has retracted a widely publicized Chinese lung cancer study that suggested administering immunotherapy before 3 p.m. could dramatically improve survival in a decision that comes amid heightened scrutiny of research integrity and data transparency in high-impact biomedical journals.
Otsuka Pharmaceutical Co. Ltd. reported another clinical study win with once-daily centanafadine, a non-stimulant compound targeting attention deficit hyperactivity disorder (ADHD). Top-line results of a dedicated phase IIIb study in patients with ADHD and comorbid anxiety found that centanafadine met the primary endpoint, defined as score improvements on the Adult Investigator Symptom Rating Scale, compared with placebo at week 8.
Corxel Pharmaceuticals Ltd.’s oral small-molecule GLP-1 receptor agonist, CX-11, met the primary endpoints in a phase II trial evaluating the candidate in obese and overweight patients in the U.S., according to top-line results.
Samsung Bioepis Co. Ltd. announced positive top-line phase I and phase III data for SB-27, a proposed biosimilar to Merck & Co. Inc.’s blockbuster immunotherapy Keytruda (pembrolizumab). Preliminary analysis of parallel-run global phase I and phase III studies demonstrated SB-27’s clinical and pharmacokinetic (PK) equivalence to the reference product, according to a company announcement.