Idorsia announced positive top-line results of the second pivotal Phase 3 study investigating 10 and 25 mg doses of its dual orexin receptor antagonist, daridorexant, in 924 adult and elderly patients (39.3% ≥ 65 years) with insomnia.
EUSA Pharma said that the U.S. Food & Drug Administration (FDA) has approved a randomized, double-blind, placebo-controlled Phase 3 clinical trial protocol to evaluate the safety and efficacy of intravenous siltuximab plus standard of care in hospitalized patients with COVID-19 associated Acute Respiratory Distress Syndrome (ARDS).
Daiichi Sankyo Company announced the first patient with triple negative breast cancer (TNBC) has been dosed in the ongoing phase 1 study assessing DS-1062, a TROP2 directed DXd antibody drug conjugate (ADC).
Pfizer and BioNTech announced preliminary data from the most advanced of four investigational vaccine candidates from their BNT162 mRNA-based vaccine programme , Project Lightspeed, against SARS-CoV-2, the virus causing the current global pandemic.
Exelixis, Inc. (NASDAQ: EXEL) today announced the initiation of CONTACT-02, a global phase 3 pivotal trial of cabozantinib (CABOMETYX) in combination with atezolizumab (TECENTRIQ) in patients with metastatic castration-resistant prostate cancer (CRPC) who have been previously treated with one novel hormonal therapy.
NuvOx Pharma, a Tucson-based biotechnology company developing NanO2 emulsion for oxygen delivery, has received a “No Objection Letter” from Health Canada to proceed with a Phase IIa clinical trial of NanO2 in COVID-19 subjects with acute hypoxic respiratory failure (AHRF).
Noxopharm has launched a clinical programme, called NOXCOVID, for its Covid-19 drug candidate Veyonda by starting a phase 1 trial in Europe.
Full results from the positive Phase III ETHOS trial showed AstraZeneca’s triple-combination therapy PT010 (budesonide/glycopyrronium/formoterol fumarate) demonstrated a statistically significant reduction in the rate of moderate or severe exacerbations compared with two dual-combination therapies in patients with moderate to very severe chronic obstructive pulmonary disease (COPD).
Novaremed, a clinical-stage Swiss biopharmaceutical company, announced that the U.S. Food and Drug Administration (FDA) has cleared an Investigational New Drug (IND) application to initiate its US-based Phase 2 clinical study of the novel drug candidate, NRD135S.E1, for the treatment of Painful Diabetic Peripheral Neuropathy (PDPN).
Merck said that V114, its investigational 15-valent pneumococcal conjugate vaccine candidate, has met safety and immunogenicity goals in two initial phase 3 trials in adults.
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