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RECOVERY COVID-19 Phase 3 Trial to Evaluate Regeneron’s REGN-COV2 Investigational Antibody Cocktail in the UK

Regeneron Pharmaceuticals, Inc. and the University of Oxford today announced that RECOVERY (Randomised Evaluation of COVid-19 thERapY), one of the world's largest randomized clinical trials of potential COVID-19 treatments, will evaluate Regeneron's investigational anti-viral antibody cocktail, REGN-COV2. The Phase...

Roche receives FDA approval for expanded use of the CINtec PLUS Cytology test to aid clinicians in preventing cervical cancer

Roche announced U.S. FDA approval for the expanded use of CINtec® PLUS Cytology, the first triage test based on biomarker technology for women whose cervical cancer screening results are positive for high-risk types of human papillomavirus (HPV). Additional information...

Vaxart Announces FDA Clearance of IND Application for Oral COVID-19 Vaccine and Provides Update on COVID-19 Program

Vaxart, Inc., a clinical-stage biotechnology company developing oral vaccines that are administered by tablet rather than by injection, announced that the U.S. FDA has completed its review of the Company’s Investigational New Drug (IND) application for its Phase 1...

Moderna and Chiesi Group Establish Collaboration to Discover and Develop mRNA Therapeutics for Pulmonary Arterial Hypertension (PAH)

Moderna, Inc., a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines to create a new generation of transformative medicines for patients and Chiesi Farmaceutici S.p.A., an international research-focused healthcare group (Chiesi Group), announced a collaboration aimed at the...

Pfizer and BioNTech Propose Expansion of Pivotal COVID-19 Vaccine Trial

Pfizer Inc. and BioNTech SE announced that they have submitted an amended protocol to the U.S. Food and Drug Administration to expand the enrollment of their Phase 3 pivotal COVID-19 vaccine trial to up to approximately 44,000 participants which...

Valneva Announces Major COVID-19 Vaccine Partnership with U.K. Government

Valneva SE, a specialty vaccine company focused on prevention against diseases with major unmet needs, announced a vaccine partnership with the UK government for its inactivated COVID-19 vaccine, VLA2001. Under the agreement, if vaccine development is successful, Valneva will provide...

Novavax & Serum Institute of India to manufacture COVID-19 Vaccine

Novavax, Inc., a late-stage biotechnology company developing next-generation vaccines for serious infectious diseases, announced an amendment to its existing agreement with Serum Institute of India Private Limited (SIIPL) under which SIIPL will also manufacture the antigen component of NVX?CoV2373,...

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