Search Results for: covid-19
CLINICAL TRIALS – Statistical Challenges in Preserving Integrity of Ongoing Clinical Trials During the COVID-19 Pandemic June 1, 2021
Karen Ooms, Msc, believes the consequences of this pandemic on ongoing clinical trials can be objectively assessed, and with the correct mitigation strategies put in place, study integrity can be preserved, optimizing use of the available resources for both patients and sponsors.
Vectura & Inspira Pharmaceuticals Sign Agreement to Develop Potential Inhaled Treatment for COVID-19 May 6, 2021
Vectura Group plc and Inspira Pharmaceuticals Limited recently announced an agreement to develop an inhaled formulation of Inspira’s lead drug candidate for the potential treatment of….
Contributor Cindy Dubin explores how device developers and parenteral contract development and manufacturing organizations (CDMOs) are addressing current challenges, as well as advancements in customized device design, the continuous effort to incorporate safety and human factors, and how COVID-19 is shaping the future of the market.
CureVac Swiss AG Initiates Rolling Submission Process for mRNA-Based COVID-19 Vaccine Candidate April 21, 2021
The CureVac Swiss AG, the Swiss subsidiary of CureVac N.V. recently announced initiation of a rolling submission for CVnCoV, the company’s mRNA-based COVID-19 vaccine….
Moderna & Catalent Announce Long-Term Strategic Collaboration for Dedicated Vial Filling of Moderna’s COVID-19 Vaccine & Clinical Portfolio April 8, 2021
Moderna, Inc. and Catalent, Inc. recently announced the expansion of their strategic collaboration to dedicate a new high-speed vial filling line for the manufacture of the Moderna COVID-19 Vaccine and potentially other….
Pfizer-BioNTech Announce Positive Topline Results of Pivotal COVID-19 Vaccine Study in Adolescents April 1, 2021
Pfizer Inc. and BioNTech SE recently announced that, in a Phase 3 trial in adolescents 12 to 15 years of age with or without prior evidence of SARS-CoV-2 infection, the Pfizer-BioNTech COVID-19 vaccine BNT162b2….
Researchers at the Hospital General Manuel Gea González in Mexico City have reported results from a study designed to assess the impact of four specific strains of probiotics on the rate of remission from infection with SARS-CoV-2….
Catalent Expands Partnership With Johnson & Johnson to Significantly Increase Capacity for Sterile Manufacturing & Packaging of COVID-19 Vaccine in Italy March 17, 2021
Catalent recently announced an expanded partnership with Janssen Pharmaceutica NV and Janssen Pharmaceuticals, Inc., two of the Janssen Pharmaceutical Companies of Johnson & Johnson, whereby Catalent Biologics will significantly….
Baxter BioPharma Solutions & Moderna Announce Manufacturing Agreement for Covid-19 Vaccine in the US March 10, 2021
Baxter International Inc. and Moderna, Inc. recently announced they have entered into an agreement for Baxter BioPharma Solutions to provide fill/finish sterile manufacturing services and….
Mateon Provides Update on Global Covid-19 Study March 10, 2021Mateon Therapeutics, Inc. recently announced it has completed the enrollment of its sentinel Part 1 and Part 2 COVID-19 patients,...
Ridgeback Biotherapeutics & Merck Announce Preliminary Findings From Phase 2a Trial of Investigational COVID-19 Therapeutic Molnupiravir March 8, 2021
Merck and Ridgeback Biotherapeutics recently announced preliminary results from Ridgeback’s Phase 2a randomized, double-blind, placebo-controlled trial to evaluate the safety, tolerability, and efficacy to eliminate SARS-CoV-2 viral RNA….