News and Trends 18 Nov 2022 Sanofi’s Enjaymo for hemolytic anemia given marketing authorization by EC Sanofi’s treatment, Enjaymo, for hemolytic anemia in adult patients with cold agglutinin disease (CAD), has been granted marketing authorization by the European Commission (EC). Enjaymo is the first and only approved therapeutic option for the rare, serious and chronic autoimmune disease where the body mistakenly attacks healthy red blood cells and causes their rupture, known […] November 18, 2022 - 4 minutesmins - By Liza Laws Share WhatsApp Twitter Linkedin Email
News and Trends 18 Nov 2022 NW Bio reports positive top-line results from phase 3 glioblastoma trial Northwest Biotherapeutics, which is developing DCVax personalized immune therapies for solid tumor cancers, yesterday (November 17) reported that both median and long tail survival were increased in both newly diagnosed and recurrent glioblastoma. The brain tumor cancer patients were treated with DCVax-L and in its phase 3 clinical trial met both the primary and secondary […] November 18, 2022 - 4 minutesmins - By Liza Laws Share WhatsApp Twitter Linkedin Email
News and Trends 17 Nov 2022 Astellas meets primary endpoint in gastric cancer study Astellas Pharma Inc. has announced positive topline results from its phase 3 SPOTLIGHT clinical trial evaluating the efficacy and safety of zolbetuximab in combination with mFOLFOX6 (a combination regimen that includes oxaliplatin, leucovorin and fluorouracil). Zolbetuximab is an investigational first-in-class monoclonal antibody targeting Claudin 18.2 (CLDN18.2), for the first-line treatment of patients with CLDN18.2-positive, HER2-negative, […] November 17, 2022 - 4 minutesmins - By Jim Cornall Share WhatsApp Twitter Linkedin Email
News and Trends 17 Nov 2022 VISEN growth hormone deficiency trial results announced VISEN Pharmaceuticals has published detailed clinical data from its pivotal phase 3 study of lonapegsomatropin, a long-acting prodrug of unmodified somatropin being investigated as a once-weekly injection in children with growth hormone deficiency (GHD) in China. The data showed that lonapegsomatropin demonstrated an annualized height velocity (AHV) of 10.66 cm/year compared to 9.75 cm/year for […] November 17, 2022 - 2 minutesmins - By Jim Cornall Share WhatsApp Twitter Linkedin Email
More News! 16 Nov 2022 Mineralys has positive topline results from trial evaluating treatment of hypertension U.S.-based Mineralys Therapeutics, Inc., announced today (November 16) topline results from its phase 2 Target-HTN trial in individuals with uncontrolled and resistant hypertension. MLS-101, a highly selective investigational aldosterone synthase inhibitor, at doses of 50 mg and 100 mg once daily, met its primary endpoint with statistically significant and clinically meaningful reduction in systolic blood […] November 16, 2022 - 4 minutesmins - By Liza Laws Share WhatsApp Twitter Linkedin Email
News and Trends 16 Nov 2022 Immutep announces efti clinical results for non-small cell lung cancer Immutep Limited has revealed what it says are compelling new clinical data from its TACTI-002 all-comer PD-L1 phase II trial evaluating Immutep’s lead product candidate, eftilagimod alpha in combination with MSD’s (Merck and Co., Inc., Rahway, N.J., USA) anti-PD-1 therapy KEYTRUDA (pembrolizumab) in 114 patients with non-small cell lung cancer (NSCLC). The new data was […] November 16, 2022 - 3 minutesmins - By Jim Cornall Share WhatsApp Twitter Linkedin Email
News and Trends 15 Nov 2022 Aelis Farma’s first trial for cognitive disorder drug for Down Syndrome patients Aelis Farma has announced positive results from its safety trials in healthy volunteers and the authorization to start the first trial in people with Down syndrome, with AEF0217, its drug candidate for the treatment of cognitive disorders. Aelis Farma is a clinical stage biopharmaceutical company specializing in the development of treatments for brain diseases, made […] November 15, 2022 - 4 minutesmins - By Liza Laws Share WhatsApp Twitter Linkedin Email
More News! 15 Nov 2022 Sequana Medical has positive results for heart failure therapy drug Sequana Medical has had some very positive top-line results from a phase 2a study, that the company says reinforces its view that direct sodium removal (DSR) is a potential disease modifying heart failure therapy. The study called SAHARA was testing its first-generation DSR product, DSR 1.0. Data from ten evaluable diuretic-resistant heart failure patients with […] November 15, 2022 - 3 minutesmins - By Liza Laws Share WhatsApp Twitter Linkedin Email
News and Trends 15 Nov 2022 First patient dosed in Nouscom colorectal cancer study Nouscom, a clinical stage immuno-oncology company developing off-the-shelf and personalized immunotherapies, says the first patient has been dosed in a randomized phase 2 clinical trial evaluating NOUS-209 in combination with anti-PD1 checkpoint inhibitor (CPI) pembrolizumab versus pembrolizumab alone. NOUS-209 is an off-the-shelf immunotherapy targeting 209 specific neoantigens for the treatment of mismatch repair/microsatellite instable high […] November 15, 2022 - 3 minutesmins - By Jim Cornall Share WhatsApp Twitter Linkedin Email
News and Trends 15 Nov 2022 Beckley Psytech completes treatment resistant depression and alcohol use disorder study Beckley Psytech, a private, clinical-stage biotechnology company dedicated to addressing neuropsychiatric conditions through the novel application of psychedelic medicines, has completed its phase I clinical study of BPL-003, a synthetic intranasal formulation of 5-methoxy-N, N-dimethyltryptamine (5-MeO-DMT), which is under development for treatment resistant depression and alcohol use disorder. The double-blind, randomized, single ascending dose study […] November 15, 2022 - 2 minutesmins - By Jim Cornall Share WhatsApp Twitter Linkedin Email
News and Trends 14 Nov 2022 Nuance Pharma’s RSV vaccine cleared for trial in China Nuance Pharma says China’s Center for Drug Evaluation (CDE) has approved its investigational new drug (IND) application supporting its pivotal phase III clinical trial of MVA-BN RSV vaccine against respiratory syncytial virus (RSV) in adults in China. MVA-BN RSV is being developed for the prevention of RSV in older adults. The vaccine incorporates five distinct RSV […] November 14, 2022 - 3 minutesmins - By Jim Cornall Share WhatsApp Twitter Linkedin Email
News and Trends 14 Nov 2022 HUTCHMED announces positive gastric cancer study results in China HUTCHMED (China) Limited has announced initial results from FRUTIGA, a phase III study of fruquintinib combined with paclitaxel in 703 Chinese patients with advanced gastric or gastroesophageal junction (GEJ) adenocarcinoma. The trial was positive, having met one of the primary endpoints of statistically significant improvement in progression-free survival (PFS), which is clinically meaningful. The other […] November 14, 2022 - 3 minutesmins - By Jim Cornall Share WhatsApp Twitter Linkedin Email