WASHINGTON, DC — The Melanoma Research Alliance (MRA), the largest non-profit funder of melanoma research worldwide, welcomes the U.S. Food and Drug Administration (FDA) decision to approve Iovance Biotherapeutics’ AMTAGVI™ (lifileucel) for the treatment of patients with advanced melanoma in the second line treatment setting. AMTAGVI is the first individualized...
Latest News
STOCKHOLM, Sweden and WALTHAM, Mass, USA – Swedish Orphan Biovitrum AB (publ) (Sobi™) (STO:SOBI) and Apellis Pharmaceuticals, Inc. (Nasdaq: APLS) today announced that The New England Journal of Medicine (NEJM) published results from the phase 3 PEGASUS study, which demonstrated the superiority of pegcetacoplan, an investigational targeted C3 therapy, in improving...
Amsterdam, The Netherlands – A new stool test appears to detect colorectal cancer precursors better than the current test. This could further reduce the number of new colorectal cancer cases as well as the number of people dying from the disease. A study led by the Netherlands Cancer Institute compared...
NEWARK, Calif. — CymaBay Therapeutics Inc. (NASDAQ: CBAY), a biopharmaceutical company focused on innovative therapies for patients with liver and other chronic diseases, today announced that The New England Journal of Medicine (NEJM) has published detailed results from the RESPONSE Phase 3 trial evaluating seladelpar, an investigational agent, and the...
WALTHAM, Mass. — Apellis Pharmaceuticals, Inc. (Nasdaq: APLS) today announced that The New England Journal of Medicine (NEJM) published positive results from the Phase 3 VALIANT study investigating EMPAVELI® (pegcetacoplan) for C3 glomerulopathy (C3G) and primary immune complex membranoproliferative glomerulonephritis (IC-MPGN), which are severe and rare kidney diseases. “The positive data published in...
CAMBRIDGE, Mass. – Results from the pivotal Phase 2 KarMMa study evaluating the efficacy and safety of bluebird bio, Inc. (Nasdaq: BLUE) and Bristol Myers Squibb’s (NYSE: BMY) investigational B-cell maturation antigen (BCMA)-directed chimeric antigen receptor (CAR) T cell immunotherapy, idecabtagene vicleucel (ide-cel; bb2121), in adult patients with relapsed and...
Utrecht, Netherlands – The Organoid group at the Hubrecht Institute has identified a new link between FBXW7 mutations and EGFR signaling activity. The FBXW7 gene is commonly mutated in colorectal cancer and such mutations have been associated with worse treatment outcome. The researchers used colon organoids and the CRISPR/Cas9 gene...
TOKYO, Japan — Astellas Pharma Inc. today announced that Japan’s Ministry of Health, Labour and Welfare (MHLW) has granted priority review for the company’s Supplemental New Drug Application (sNDA) for PADCEV™ (enfortumab vedotin (genetical recombination)) with KEYTRUDA® (pembrolizumab (genetical recombination)) as a combination therapy for the first-line treatment of adult...
CLEVELAND, Ohio — A recent study from researchers at University Hospitals (UH) Connor Whole Health and UH Rainbow Babies & Children’s Hospital describes a quality improvement project where pain screening procedures were embedded within an outpatient pediatric sickle cell disease (SCD) clinic. The study examined (1) the feasibility of routine pain...
BELFAST, Northern Ireland – People with rare diseases in Northern Ireland have been sharing their stories through a series of short films. There are more than 7,000 known rare conditions worldwide. It is estimated that more than 110,000 people, or one in 17, are impacted by rare conditions in Northern...