News and Trends 23 Nov 2022 UCB publishes Lennox-Gastaut syndrome study data UCB has announced the publication of long-term open-label extension (OLE) study results of FINTEPLA (fenfluramine) CIV in the journal Epilepsia. Long-term efficacy and safety findings showed that FINTEPLA, when added to a patient’s current anti-epileptic treatment regimen for seizures associated with Lennox-Gastaut syndrome (LGS), was effective in reducing the frequency of multiple seizure types and […] November 23, 2022 - 4 minutesmins - By Jim Cornall Share WhatsApp Twitter Linkedin Email
News and Trends 23 Nov 2022 Trial to start for new heart attack drug A potential new drug to improve the long-term outcomes for heart attack patients will be trialed in the U.K. With the signing of a partnership between the University of Birmingham and Acticor Biotech, a new clinical trial called LIBERATE will take place in two acute care hospitals in the U.K.: the Queen Elizabeth Hospital, Birmingham […] November 23, 2022 - 3 minutesmins - By Jim Cornall Share WhatsApp Twitter Linkedin Email
News and Trends 23 Nov 2022 First patients dosed with Infex Therapeutics’ RESP-X for chronic respiratory disease A new anti-virulence therapy, RESP-X, treating Pseudomonas aeruginosa (Pa) infections in non-cystic fibrosis bronchiectasis (NCFB) patients has been given to the first subjects in a trial run by Infex Therapeutics. Infex Therapeutics is an anti-infectives company and announced the first subjects were dosed in the phase 1 study in healthy volunteers evaluating the company’s lead […] November 23, 2022 - 3 minutesmins - By Liza Laws Share WhatsApp Twitter Linkedin Email
News and Trends 22 Nov 2022 Arecor to start second type 2 diabetes clinical trial Arecor Therapeutics plc says the BASG (Bundesamt für Sicherheit im Gesundheitswesen) has cleared the company’s clinical trial application (CTA) for AT278, an ultra-rapid acting, ultra-concentrated (500 U/mL) insulin candidate, in type 2 diabetic patients. The CTA approval means Arecor can start its second phase I clinical trial for AT278. AT278 has previously demonstrated a faster […] November 22, 2022 - 3 minutesmins - By Jim Cornall Share WhatsApp Twitter Linkedin Email
News and Trends 21 Nov 2022 Legend Biotech small cell lung cancer drug gets FDA ok for clinical development Legend Biotech Corporation has announced that the U.S. Food and Drug Administration (FDA) has cleared Legend Biotech’s investigational new drug (IND) application to proceed with the clinical development of LB2102, an investigational, autologous chimeric antigen receptor T-cell (CAR-T) therapy for the treatment of adult patients with extensive stage small cell lung cancer (SCLC). LB2102 is […] November 21, 2022 - 2 minutesmins - By Jim Cornall Share WhatsApp Twitter Linkedin Email
News and Trends 21 Nov 2022 Immorna cleared for mRNA-based Covid-19 vaccine study U.S. biotech company Immorna says the U.S. Food and Drug Administration (FDA) has cleared its investigational new drug (IND) application to conduct a phase 1/2 multi-center study of JCXH-221, a lipid nanoparticle (LNP) complexed broadly protective mRNA vaccine against SARS-CoV-2 infection and diseases. The goal of the multi-center study is to assess the safety and immunogenicity […] November 21, 2022 - 3 minutesmins - By Jim Cornall Share WhatsApp Twitter Linkedin Email
News and Trends 18 Nov 2022 Novavax’ COVID-19 vaccine gets expanded authorization for booster in adults Novavax, Inc., a U.S-based biotechnology company announced today (November 18) that Health Canada has granted expanded authorization for Covid-19 vaccine Nuvaxovid. The vaccine NVX-CoV2373 for active immunization to prevent the disease caused by severe acute respiratory syndrome (SARS-CoV-2) as a homologous booster in adults aged 18 and older. “Canadians now have access to our […] November 18, 2022 - 2 minutesmins - By Liza Laws Share WhatsApp Twitter Linkedin Email
More News! 18 Nov 2022 Triastek cleared for 3D printed medicine treatment of ulcerative colitis Triastek, Inc. has received clearance for its Investigational New Drug (IND) application from the United States Food and Drug Administration (FDA) to initiate clinical studies of the 3D printed medicine, T21, a potential treatment for ulcerative colitis. “We are excited to receive IND clearance to begin clinical trials of this potentially transformative treatment for patients,” […] November 18, 2022 - 2 minutesmins - By Jim Cornall Share WhatsApp Twitter Linkedin Email
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