The FDA has granted Fast Track designation for Moderna’s mRNA vaccine candidate (mRNA-1273) against the novel coronavirus (SARS-CoV-2). In explanation, Moderna’s Chief Medical Officer Tal Zaks said, “Fast Track designation underscores the urgent need for a vaccine against the novel coronavirus. As we await the full set of clinical data from the NIAID-led Phase 1 […]

Moderna and Lonza have announced a 10-year strategic collaboration agreement to enable larger scale manufacture of Moderna’s mRNA vaccine (mRNA-1273) against the novel coronavirus (SARS-CoV-2) and additional Moderna products in the future. Under the terms of the agreement, the companies plan to establish manufacturing suites at Lonza’s facilities in the U.S. and Switzerland for the […]

Alexion has announced it will acquire Portola, a commercial-stage biopharma focused on life-threatening blood-related disorders. Portola’s commercialized medicine, Andexxa  (marketed as Ondexxya in Europe) is the first and only approved Factor Xa inhibitor reversal agent, and has demonstrated transformative clinical value by rapidly reversing the anticoagulant effects of Factor Xa inhibitors rivaroxaban and apixaban in […]

Pfizer and BioNTech have dosed the first participants in the U.S. and Germany in the Phase 1/2 clinical trial for the BNT162 COVID-19 vaccine program. The Phase 1/2 study is designed to determine the safety, immunogenicity and optimal dose level of four mRNA vaccine candidates evaluated in a single, continuous study. Pfizer and BioNTech’s development […]

TScan Therapeutics has announced it will partner with Novartis to discover and develop novel T cell receptor (TCR) engineered T cell therapies. TCR therapies reprogram a patient’s own T cells to recognize shared cancer targets. The collaboration includes an upfront technology access fee and research funding totaling $30 million, and potential milestone payments contingent on […]

Moderna has been promised up to $483 million from the U.S. Department of Health and Human Services (HHS) Biomedical Advanced Research and Development Authority (BARDA) to accelerate development of its mRNA vaccine candidate (mRNA-1273) against the novel coronavirus (SARS-CoV-2). mRNA-1273 is an mRNA vaccine encoding for a prefusion stabilized form of the Spike (S) protein. […]

Pfizer and Germany’s BioNTech have disclosed additional details of their collaboration, previously announced on March 17, to jointly develop a mRNA COVID-19 vaccine. The effort has the potential to supply millions of vaccine doses by the end of 2020, subject to the technical success of the development program and approval by regulatory authorities, and then […]

The NIH and the Foundation for the NIH (FNIH) are bringing more than a dozen leading biopharmaceutical companies together with governmental agencies to coordinate the research response to the COVID-19 pandemic. The planned Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV) partnership will develop a framework for prioritizing vaccine and drug candidates, streamlining clinical trials, coordinating […]

Sanofi and California-based Luminostics have signed an agreement to evaluate a collaboration on a unique self-test for COVID-19. Luminostics would contribute its proprietary technology for consumer-diagnostics for COVID-19 testing while Sanofi would bring its clinical research testing experience and capabilities. The goal of the collaboration is to provide a consumer-based test that can detect the […]

Arrakis Therapeutics has entered into a strategic collaboration and license agreement with Roche for the discovery of RNA-targeted small molecule (rSM) drugs against a broad set of targets across all of Roche’s research and development areas. Under the terms of the agreement, Arrakis will lead discovery and research activities for each target to a defined […]