COVID-19 vaccines

Certara’s Vaccine Simulator™ Accurately Predicted Optimal Timing Between Doses for COVID-19

Retrieved on: 
Friday, July 23, 2021

PRINCETON, N.J., July 23, 2021 (GLOBE NEWSWIRE) -- Certara, a global leader in biosimulation, today announced that its Vaccine Simulator accurately predicted that eight weeks was the optimal timing between the first and second dose of COVID-19 vaccines.

Key Points: 
  • PRINCETON, N.J., July 23, 2021 (GLOBE NEWSWIRE) -- Certara, a global leader in biosimulation, today announced that its Vaccine Simulator accurately predicted that eight weeks was the optimal timing between the first and second dose of COVID-19 vaccines.
  • The Pitch study conducted at Oxford University in the United Kingdom confirmed Certaras Vaccine Simulator prediction, which was released six months ago .
  • Current dosing for the Pfizer-BioNTech and Moderna vaccines are spaced three and four weeks apart, respectively.
  • We have recently calibrated and validated our Vaccine Simulator with very large clinical data sets and added additional vaccine types, said Piet van der Graaf, PharmD, PhD, senior vice president of QSP at Certara.

EMA Committee for Medicinal Products for Human Use (CHMP) Adopts Positive Opinion Recommending Authorization for the Use of the Moderna COVID-19 Vaccine in Adolescents (12-17 Years of Age) in the European Union

Retrieved on: 
Friday, July 23, 2021

Spikevax is the trade name authorized by the European Medicines Agency (EMA) for the Moderna COVID-19 vaccine.

Key Points: 
  • Spikevax is the trade name authorized by the European Medicines Agency (EMA) for the Moderna COVID-19 vaccine.
  • Following the CHMPs positive opinion, the European Commission will consider authorizing the use of the Moderna COVID-19 Vaccine in adolescents ages 12 years of age and older.
  • The study met its primary endpoint, successfully bridging immune responses to those observed in the COVE efficacy study in adults.
  • The Moderna COVID-19 Vaccine is an mRNA vaccine against COVID-19 encoding for a prefusion stabilized form of the Spike (S) protein.

Pfizer And BioNTech to Supply U.S. Government with an Additional 200 Million Doses of COVID-19 Vaccine to Help Meet Continued Need for Vaccine Supply in the U.S.

Retrieved on: 
Friday, July 23, 2021

This brings the total number of doses to be supplied by the companies to the U.S. government under its existing supply agreement to 500 million.

Key Points: 
  • This brings the total number of doses to be supplied by the companies to the U.S. government under its existing supply agreement to 500 million.
  • These additional doses will help the U.S. government ensure broad vaccine access into next year.
  • The companies expect to deliver 110 million of the additional doses by December 31, 2021, with the remaining 90 million doses to be delivered no later than April 30, 2022.
  • The Pfizer-BioNTech COVID-19 Vaccine, which is based on BioNTech proprietary mRNA technology, was developed by both BioNTech and Pfizer.

Pfizer and BioNTech to Provide U.S. Government with an Additional 200 Million Doses of COVID-19 Vaccine to Help Meet Continued Need for Vaccine Supply in the U.S.

Retrieved on: 
Friday, July 23, 2021

Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced that the U.S. government has purchased an additional 200 million doses of the Pfizer-BioNTech COVID-19 Vaccine.

Key Points: 
  • Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced that the U.S. government has purchased an additional 200 million doses of the Pfizer-BioNTech COVID-19 Vaccine.
  • This brings the total number of doses to be supplied by the companies to the U.S. government under its existing supply agreement to 500 million.
  • These additional doses will help the U.S. government ensure broad vaccine access into next year.
  • The Pfizer-BioNTech COVID-19 Vaccine, which is based on BioNTech proprietary mRNA technology, was developed by both BioNTech and Pfizer.

BYDUREON BCise (exenatide extended-release) Approved in the US for the Treatment of Type 2 Diabetes in Pediatric Patients Ages 10 Years and Older

Retrieved on: 
Friday, July 23, 2021

This is the first completed trial of a once-weekly GLP-1 RA in a pediatric population with T2D.

Key Points: 
  • This is the first completed trial of a once-weekly GLP-1 RA in a pediatric population with T2D.
  • Safety and effectiveness of exenatide extended-release have not been established in pediatric patients less than 10 years of age.
  • If this occurs, patients should discontinue BYDUREON BCise and promptly seek medical advice
    Drug-induced, immune-mediated thrombocytopenia and associated bleeding has been reported with exenatide.
  • Based in Cambridge, UK, AstraZeneca operates in over 100 countries, and its innovative medicines are used by millions of patients worldwide.

Acticor Biotech Announces the Completion of Enrollment in its GARDEN Clinical Trial, a COVID-19-induced Acute Respiratory Distress Syndrome Efficacy Study

Retrieved on: 
Thursday, July 22, 2021

We are proud to have completed patient recruitment for phase 2 of the GARDEN trial using glenzocimab in SARS-Cov-2-related ARDS.

Key Points: 
  • We are proud to have completed patient recruitment for phase 2 of the GARDEN trial using glenzocimab in SARS-Cov-2-related ARDS.
  • Two countries, France and Brazil, have actively participated in including a total of 62 evaluable patients for the GARDEN trial.
  • Acticor Biotech has recently announced the completion of patient enrolment in ACTIMIS (NCT03803007), a multinational, multicenter, randomized, double-blind, placebo-controlled, single-parallel, escalating dose phase 1b/2a safety and efficacy study of glenzocimab.
  • Acticor Biotech is a clinical stage biotechnology company, a spin-off of INSERM, dedicated to developing an innovative treatment for acute thrombotic diseases, including ischemic stroke.

Vaxzevria® Brand Naming Strategy and Logo Revealed

Retrieved on: 
Thursday, July 22, 2021

MIAMI, July 22, 2021 /PRNewswire/ -- Brand Institute , the global leader in pharmaceutical and healthcare-related name development, is proud to share the official logo and creative naming strategy for AstraZeneca's COVID-19 vaccine: Vaxzevria (vax zev' ree ah).

Key Points: 
  • MIAMI, July 22, 2021 /PRNewswire/ -- Brand Institute , the global leader in pharmaceutical and healthcare-related name development, is proud to share the official logo and creative naming strategy for AstraZeneca's COVID-19 vaccine: Vaxzevria (vax zev' ree ah).
  • The name, which was developed by Brand Institute, was first announced by the European Medicines Agency (EMA) on March 25, 2021.
  • "When AstraZeneca approached Brand Institute about partnering on the name for their COVID-19 vaccine, their goals were clear," said Brand Institute's Chairman and CEO, James L. Dettore.
  • The logo for Vaxzevria further underscores the intended messaging of the brand name, with its bold font and brilliant icon, paying homage to AstraZeneca's corporate logo and evoking the interconnected nature of the human race.

Moderna Announces New Supply Agreement with Taiwan for 20 Million Doses of Moderna’s COVID-19 Vaccine and Variant Booster Vaccine Candidate in 2022 and 15 Million Doses in 2023

Retrieved on: 
Thursday, July 22, 2021

Moderna, Inc. (Nasdaq: MRNA), a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, today announced a new supply agreement with Taiwan for 20 million doses of Modernas COVID-19 vaccine and its updated variant booster vaccine candidate, if authorized, to begin delivery in 2022 and an additional 15 million doses in 2023.

Key Points: 
  • Moderna, Inc. (Nasdaq: MRNA), a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, today announced a new supply agreement with Taiwan for 20 million doses of Modernas COVID-19 vaccine and its updated variant booster vaccine candidate, if authorized, to begin delivery in 2022 and an additional 15 million doses in 2023.
  • This new supply agreement is in addition to the prior agreement for 5 million doses in 2021.
  • We thank Taiwan for their support in securing this new agreement to supply in 2022 and 2023 our mRNA COVID-19 vaccine and our updated variant booster candidate, if approved, said Stphane Bancel, Modernas Chief Executive Officer.
  • We remain committed to making our vaccine available around the world.

Sorrento Announces Dosing of COVID-19 Patients in Phase 2 Clinical Trial for COVIDROPS, a Highly Potent Neutralizing Antibody Against SARS-CoV-2 Including Delta and Alpha Variants of Concern, in an At-Home Outpatient Setting in United Kingdom

Retrieved on: 
Wednesday, July 21, 2021

COVID-19 patients with newly diagnosed SARS-CoV-2 infections were treated in this large Phase 2 efficacy trial in the United Kingdom.

Key Points: 
  • COVID-19 patients with newly diagnosed SARS-CoV-2 infections were treated in this large Phase 2 efficacy trial in the United Kingdom.
  • SAN DIEGO, July 21, 2021 (GLOBE NEWSWIRE) -- Sorrento Therapeutics, Inc. (Nasdaq: SRNE, "Sorrento") today announced that COVID-19 patients have been dosed in its Phase 2 efficacy trial.
  • The neutralizing antibody drug substance is the same antibody as in COVI-AMG, which is a high potency/low dose IV push injection.
  • RTX has completed a Phase IB trial for intractable pain associated with cancer and a Phase 1B trial in osteoarthritis patients.

Pfizer and BioNTech Announce Collaboration With Biovac to Manufacture and Distribute COVID-19 Vaccine Doses Within Africa

Retrieved on: 
Wednesday, July 21, 2021

Pfizer and BioNTech expect that Biovacs Cape Town facility will be incorporated into the vaccine supply chain by the end of 2021.

Key Points: 
  • Pfizer and BioNTech expect that Biovacs Cape Town facility will be incorporated into the vaccine supply chain by the end of 2021.
  • Our latest collaboration with Biovac is a shining example of the tireless work being done, in this instance to benefit Africa.
  • We are thrilled to collaborate with Pfizer and BioNTech to produce and distribute the Pfizer-BioNTech COVID-19 Vaccine within Africa.
  • We believe this collaboration will create opportunity to more broadly distribute vaccine doses to people in harder-to-reach communities, especially those on the African continent.