Development of COVID-19 Vaccine AZD1222 Expands Into US Phase III Clinical Trial Across All Adult Age Groups

Trial enrolling up to 30,000 adults aged 18 years or over to assess safety, efficacy and immunogenicity of AZD1222 for the prevention of COVID-19 AZD1222 supported by safety and immunogenicity across all adult age groups WILMINGTON, Del.–(BUSINESS WIRE)–AZD1222 development expanded into a Phase III clinical trial in the US to assess its safety, efficacy and … [Read more…]

Novavax and Takeda Announce Collaboration for Novavax’ COVID-19 Vaccine Candidate in Japan

Novavax will license COVID-19 vaccine technology to Takeda for local production and commercialization in Japan Matrix-M adjuvant to be supplied from Novavax Government of Japan will provide funding to Takeda for technology transfer, establishment of infrastructure and scale-up of manufacturing Adds to Takeda’s ongoing support of influenza pandemic preparedness in Japan GAITHERSBURG, Md. & OSAKA, … [Read more…]

FDA Approves EUA Amendment Increasing Applied DNA’s COVID-19 Diagnostic Kit Testing Capacity Through Use of Automated RNA Extraction and Expands Supported Platforms

– Diagnostic Kit Authorized for Use on Widely Installed RT-PCR Device and High-Throughput RNA Extraction Robotics; Company Ramps Kit Production in Response – STONY BROOK, N.Y.–(BUSINESS WIRE)–$APDN #COVID19–Applied DNA Sciences Inc. (NASDAQ: APDN) (“Applied DNA” or the “Company”) a leader in Polymerase Chain Reaction (PCR)-based DNA manufacturing that enables in vitro diagnostics, and pre-clinical nucleic … [Read more…]

Pfizer and BioNTech to Supply Japan with 120 Million Doses of their BNT162 mRNA-based Vaccine Candidate

 Supply of 120 million doses to be provided in the first half of 2021, subject to regulatory approval Agreement is part of Pfizer’s and BioNTech’s global commitment to help address the pandemic Pfizer and BioNTech began a Phase 2b/3 safety and efficacy trial and remain on track to seek regulatory review as early as October … [Read more…]

Pfizer and BioNTech Choose Lead mRNA Vaccine Candidate Against COVID-19 and Commence Pivotal Phase 2/3 Global Study

Companies advance nucleoside-modified messenger RNA (modRNA) candidate BNT162b2, which encodes an optimized SARS-CoV-2 full-length spike glycoprotein, at a 30 µg dose level in a 2 dose regimen into Phase 2/3 Study Candidate and dose level selection informed by preclinical and clinical data obtained in Phase 1/2 studies conducted in the U.S. (C4591001) and Germany (BNT162-01)  … [Read more…]

Moderna Announces Expansion of BARDA Agreement to Support Larger Phase 3 Program for Vaccine (mRNA-1273) Against COVID-19

Additional funding to support expanded mRNA-1273 clinical development plan including 30,000 participant Phase 3 COVE study conducted in collaboration with the NIH CAMBRIDGE, Mass.–(BUSINESS WIRE)–Moderna, Inc. (Nasdaq: MRNA), a clinical stage biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines to create a new generation of transformative medicines for patients, today announced a modification to … [Read more…]

Vizient Helps Ensure Better Supply Reliability of Personal Protective Equipment for Member Health Care Providers

IRVING, Texas–(BUSINESS WIRE)–Ensuring supplies and medications are where they are needed, when they are needed has never been simple, even before COVID-19. Vizient, Inc. has been actively working to help improve supply resiliency and today announces the addition of critical PPE items to its successful Novaplus® Enhanced Supply Program. Standard Textile is the first supplier … [Read more…]

Applied DNA and Takis Report Positive Preclinical Results from LineaDNA™ Vaccine Candidates for COVID-19

– Demonstrates Evidence of Production of Antibodies and T Cell Responses in Mice: Shows Strong Antibody Responses, Activation of Sustainable T-Cell Responses, Presence of IgG in Lungs – STONY BROOK, N.Y.–(BUSINESS WIRE)–$APDN #COVID19–Applied DNA Sciences Inc. (NASDAQ: APDN) (“Applied DNA” or the “Company”) a leader in Polymerase Chain Reaction (PCR)-based DNA manufacturing that enables in … [Read more…]

CEPI Expands Partnership with Clover Biopharmaceuticals to Rapidly Advance Development and Manufacture of COVID-19 Vaccine Candidate

CEPI to invest an additional $66m upfront in Clover’s S-Trimer protein vaccine candidate. Funding will support clinical development in parallel with scale-up of manufacturing capacity to potentially produce hundreds of millions of doses per year.   OSLO, Norway–(BUSINESS WIRE)–CEPI, the Coalition for Epidemic Preparedness Innovations, today announced the expansion of its partnership with Sichuan Clover … [Read more…]