Policy & Regulation
Celltrion Completes Enrolment for Global Phase II Clinical Trial with COVID-19 Treatment Candidate CT-P59
25 November 2020 - - Enrolment of 327 patients with mild-to-moderate symptoms of SARS-CoV-2 infection has completed in the global Phase II clinical trial of CT-P59, an anti-COVID-19 monoclonal antibod...
FDA Defers Approval of DaxibotulinumtoxinA for Injection in Glabellar Lines Due to COVID-19 Related Travel Restrictions Impacting Manufacturing Site Inspection
25 November 2020 - - The United States Food and Drug Administration has deferred a decision on the Biologics License Application for DaxibotulinumtoxinA for Injection, an investigational neuromodulato...
European Commission's Approves Advance Purchase Agreement for Initial 80m Doses of Moderna mRNA COVID-19 Vaccine
25 November 2020 - - The European Commission has approved an agreement to secure 80m doses of mRNA-1273, US-based biotechnology company Moderna, Inc's (NASDAQ: MRNA) vaccine candidate against COV...
Bristol Myers Squibb Receives European Commission Approval for Opdivo as Second-Line Treatment for Unresectable Advanced, Recurrent or Metastatic Esophageal Squamous Cell Carcinoma
25 November 2020 - - The European Commission has approved Opdivo (nivolumab) for the treatment of adults with unresectable advanced, recurrent or metastatic esophageal squamous cell carcinom...
Vedanta Biosciences Names Karuna Therapeutics CFO Ignelzi to Its Board of Directors
25 November 2020 - - US-based clinical-stage company Vedanta Biosciences has appointed Troy Ignelzi as an independent member of its board of directors, the company said.

Ignelzi has more ...
US Food and Drug Administration Approves Oxlumo for Primary Hyperoxaluria Type 1 to Lower Urinary Oxalate Levels in Pediatric and Adult Patients
25 November 2020 - - The US Food and Drug Administration approved Oxlumo (lumasiran) injection for subcutaneous use, the first-ever therapy available for the treatment of primary hyperoxaluria type 1 ...