Detailed results from an updated analysis of the Phase III CASPIAN trial showed AstraZeneca’s Imfinzi (durvalumab) in combination with a choice of chemotherapies, etoposide plus either carboplatin or cisplatin, demonstrated a sustained, clinically meaningful overall survival (OS) benefit for adults with extensive-stage small cell lung cancer (ES-SCLC) treated in the 1st-line setting.
SAB Biotherapeutics (SAB), a clinical-stage biopharmaceutical company with a proprietary technology to produce fully human polyclonal antibodies without the need for human plasma donors, today announced in vitro data demonstrating that SAB-185, its COVID-19 therapeutic candidate, has highly-potent neutralizing antibodies to SARS-CoV-2 that are four times higher than the most potent human convalescent plasma serum sample evaluated.
Roche has announced the commencement of phase III clinical study of Actemra/RoActemra plus remdesivir in hospitalised patients with severe Covid-19 pneumonia.
PhaseBio Pharmaceuticals has secured approval from the US Food and Drug Administration (FDA) to begin a VANGARD pivotal clinical to assess PB1046 as a treatment for hospitalised Covid-19 patients.
Algernon Pharmaceuticals has completed the submission of an investigational new drug (IND) application to the US Food and Drug Administration (FDA) to assess the Ifenprodil in the phase 2b/3 clinical study to treat Covid-19 patients.
Antisense Therapeutics is pleased to advise that the Phase II clinical trial of ANP’s immunomodulatory therapy, ATL1102 for Duchenne Muscular Dystrophy (DMD) has met its primary endpoint confirming the safety and tolerability of ATL1102 for advancement into a potentially pivotal Phase IIb clinical trial.
Appili Therapeutics has secured regulatory clearance from Health Canada to move ahead with a phase 2 study for studying FUJIFILM Toyama Chemical’s favipiravir as a preventative measure against the outbreak of novel coronavirus (Covid-19).
Gilead Sciences and Galapagos announced positive topline results from SELECTION, a randomized, double-blind, placebo-controlled, Phase 2b/3 trial evaluating the efficacy and safety of the investigational, oral, once-daily, selective JAK1 inhibitor filgotinib in 1,348 biologic-naïve or biologic-experienced adult patients with moderately to severely active ulcerative colitis (UC).
Octapharma USA has secured approval from the US Food and Drug Administration (FDA) for its investigational new drug (IND) application to begin a phase three clinical trial to assess the efficacy and safety of Octagam 10% [Immune Globulin Intravenous (Human)] therapy in Covid-19 patients with severe disease progression.
The Janssen Pharmaceutical Companies of Johnson & Johnson today announced results from the Phase 1 CHRYSALIS study evaluating amivantamab (JNJ-6372) in the treatment of patients with advanced non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) Exon 20 insertion mutations.
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