Containment, Immune Response, Licensing and Protein

AvantGen Announces Licensing of Its Anti-SARS-CoV-2 Antibodies to IGM Biosciences for COVID-19 Therapy Development

The Pharma Data

JANUARY 11, 2021

a San Diego-based biotechnology company with an array of technology platforms for antibody discovery and optimization, and novel NK and T cell engager generation, today announced licensing of a panel of its anti-SARS-CoV-2 antibody clones to IGM Biosciences for COVID-19 therapy development.

Antibody

Antibody Licensing Licensing Development

WHO Grants Novavax’s COVID-19 Vaccine Covovax Emergency Use Listing

XTalks

DECEMBER 20, 2021

It has also applied for regulatory licensing in the UK, European Union (EU), Australia, Singapore, India, United Arab Emirates (UAE), New Zealand and Japan. Covovax is a recombinant protein-based vaccine and can be regarded as a more “traditional” vaccine as it isn’t genetic-based like mRNA or viral vector vaccines.

Vaccination

Vaccination Vaccine Manufacturing Protein

Malaria Vaccine a Breakthrough Success with 77 Percent Efficacy

XTalks

APRIL 26, 2021

It is the world’s first and only licensed malaria vaccine and also the first licensed for use against a human parasitic disease of any kind. Moreover, a very strong immune response is needed to fend off the disease. Malaria Vaccine Phase II Trial. Two different doses of the adjuvant (MM) were assessed (25 mcg and 50 mcg).

Vaccination

Vaccination Vaccine Immune Response Trials

EU places firm order for AZ/Oxford Uni’s ChAdOx1 COVID-19 vaccine

pharmaphorum

AUGUST 16, 2020

ChAdOx1 – which is in large-scale phase 2/3 trials – was licensed by AZ in April and renamed AZD1222, and should be ready for first deliveries before the end of the year. It will be provided on a no-profit basis while the pandemic is ongoing.

Vaccination

Vaccination Vaccine Immune Response Trials

Qalsody (Tofersen) Becomes First-of-Its-Kind Treatment for ALS

XTalks

MAY 1, 2023

Tofersen was discovered by Ionis Pharmaceuticals, and Biogen licensed tofersen from Ionis under a collaborative development and license agreement. Qalsody contains tofersen, an antisense oligonucleotide that specifically targets the mRNA made from mutated SODI genes to prevent the formation of toxic SOD1 proteins.

FDA Approval

FDA Approval Gene Genetics Protein

Vaxzevria approved in the EU as third dose booster against COVID-19

The Pharma Data

MAY 27, 2022

The authorisation is based on a review by the Committee for Medicinal Products for Human Use (CHMP) of the substantial body of evidence demonstrating an increased immune response after a third dose booster with Vaxzevria following a primary vaccine schedule of either Vaxzevria or an mRNA COVID-19 vaccine.(1-5). About AstraZeneca.

Vaccination

Vaccination Vaccine Immune Response Medicine

Pfizer and BioNTech Advance COVID-19 Vaccine Strategy With Study Start of Next-Generation Vaccine Candidate Based on Enhanced Spike Protein Design

Pfizer

JULY 26, 2022

Pfizer and BioNTech Advance COVID-19 Vaccine Strategy With Study Start of Next-Generation Vaccine Candidate Based on Enhanced Spike Protein Design. Pfizer and BioNTech Advance COVID-19 Vaccine Strategy With Study Start of Next-Generation Vaccine Candidate Based on Enhanced Spike Protein Design. deliesschef. Tue, 07/26/2022 - 17:41.

Vaccination

Vaccination Vaccine Protein Immune Response

Merck Announces Positive Topline Results from Two Additional Phase 3 Adult Studies Evaluating V114, Merck’s Investigational 15-valent Pneumococcal Conjugate Vaccine

The Pharma Data

OCTOBER 19, 2020

Immune responses following vaccination with PNEUMOVAX 23 (month 13) were comparable in both vaccination groups for the 15 serotypes in V114. Results from both studies are based on opsonophagocytic activity (OPA) responses – a measure of vaccine-induced functional antibodies. among adults 65 years of age or older.

Vaccination

Vaccination Vaccine Immune Response Containment

COADMINISTRATION OF ITS 20-VALENT PNEUMOCOCCAL CONJUGATE VACCINE

The Pharma Data

JUNE 24, 2021

Secondary objectives are to describe immune responses produced by each of the vaccines. The Pfizer-BioNTech COVID-19 Vaccine has not been approved or licensed by the U.S. Immunocompromised persons, including individuals receiving immunosuppressant therapy, may have a diminished immune response to the Pfizer?BioNTech

Vaccination

Vaccination Vaccine Immune Response Licensing

Pfizer and Valneva Issue Update on Phase 3 Clinical Trial Evaluating Lyme Disease Vaccine Candidate VLA15

Pfizer

FEBRUARY 16, 2023

The companies intend to work with regulatory authorities, and as previously announced, 1,2 aim for Pfizer to potentially submit a Biologics License Application (BLA) to the U.S. OspA is a surface protein expressed by the bacteria when present in a tick. Blocking OspA inhibits the bacterium’s ability to leave the tick and infect humans.

Clinical Trials

Clinical Trials Clinical Trials Vaccination Vaccine

INOVIO Announces Publication of Phase 1 Data from its COVID-19 DNA Vaccine Candidate, INO-4800 in The Lancet’s EClinicalMedicine

The Pharma Data

DECEMBER 23, 2020

Cellular (T cell) response were observed to multiple regions of the spike protein including the RBD region. 74% had measurable cellular responses at the 1.0 mg dose group demonstrated cellular responses. The 1.0 mg and 2.0 mg dose group and 84% demonstrating neutralizing antibodies in the 2.0

DNA

DNA Vaccination Vaccine Immune Response

SELLAS Announces Promising Initial Clinical Data for Galinpepimut-S (GPS) in Combination with Checkpoint Inhibitors in Two Solid Tumor Indications

The Pharma Data

DECEMBER 20, 2020

GPS has previously been shown to invoke multi-epitope, broad cross-reactivity along the full-length of the WT1 protein, suggestive of epitope spreading, and immunologically mediated cancer cell destruction, which are hallmarks of an effective cancer vaccine. This press release contains forward-looking statements. Kenilworth, N.J.,

Life Science

Life Science Immune Response Trials Clinical Trials

Biopharma Leaders Unite To Stand With Science

The Pharma Data

SEPTEMBER 8, 2020

mRNA medicines are designed to direct the body’s cells to produce intracellular, membrane or secreted proteins that can have a therapeutic or preventive benefit and have the potential to address a broad spectrum of diseases. Sanofi, Empowering Life. For further information, please visit www.sanofi.com.

Vaccination

Vaccination Vaccine Containment Clinical Trials

Biopharma Leaders Unite To Stand With Science

The Pharma Data

SEPTEMBER 8, 2020

mRNA medicines are designed to direct the body’s cells to produce intracellular, membrane or secreted proteins that can have a therapeutic or preventive benefit and have the potential to address a broad spectrum of diseases. This press release contains “forward-looking statements” of. Empowering Life. www.sanofi.com. the United States.

Vaccination

Vaccination Vaccine Containment Clinical Trials

Regeneron Announces Encouraging Initial Data from COVID-19 Antibody Cocktail Trial in Hospitalized Patients on Low-flow Oxygen

The Pharma Data

DECEMBER 29, 2020

The analysis was prospectively designed to focus on patients who had not yet mounted their own immune response to SARS-CoV-2 (i.e., The EUA is temporary and does not take the place of a formal biologics license application (BLA) submission review and approval process and the use of the antibody cocktail remains investigational.

Antibody

Antibody Trials Production Clinical Trials

Regeneron’s COVID-19 Outpatient Trial Prospectively Demonstrates that REGN-COV2 Antibody Cocktail Significantly Reduced Virus Levels and Need for Further Medical Attention

The Pharma Data

OCTOBER 28, 2020

“We continue to see the strongest effects in patients who are most at risk for poor outcomes due to high viral load, ineffective antibody immune response at baseline, or pre-existing risk factors. Yancopoulos , M.D., President and Chief Scientific Officer of Regeneron. Regeneron has shared these results with the U.S.

Antibody

Antibody Trials Production Clinical Trials

Sanofi and Translate Bio initiate Phase 1 clinical trial of mRNA influenza vaccine

The Pharma Data

JUNE 26, 2021

The trial will evaluate the safety and immunogenicity of a monovalent flu vaccine candidate coding for the hemagglutinin protein of the A/H3N2 strain of the influenza virus. The two formulations differ in the lipid nanoparticle (LNP) that contains the mRNA. We look forward to sharing initial results by year-end. ”. “

Clinical Trials

Clinical Trials Clinical Trials Vaccination Vaccine

New England Journal of Medicine Publishes Positive Initial Regeneron Antibody Cocktail Results in Non-hospitalized Patients with COVID-19

The Pharma Data

DECEMBER 17, 2020

To develop this novel medicine, Regeneron scientists evaluated thousands of fully-human antibodies produced by the company’s VelocImmune ® mice, which have been genetically modified to have a human immune system, as well as antibodies identified from humans who have recovered from COVID-19.

Antibody

Antibody Medicine Production Trials

Advisory Committee on Immunization Practices Recommends Pfizer’s PREVNAR 20® for Adults Previously Vaccinated with PREVNAR 13®

Pfizer

OCTOBER 20, 2022

With more than 26 million adults over the age of 19 who have been previously vaccinated with PREVNAR 13®, today’s ACIP vote recognizes the importance of helping to protect them against the seven additional serotypes contained in PREVNAR 20®,” said Angela Hwang, President, Global Biopharma Business, Pfizer.

Vaccination

Vaccination Vaccine Containment Immune Response

Edesa Biotech Receives Approval to Initiate COVID-19 Study in the U.S.

The Pharma Data

OCTOBER 18, 2020

” EB05 is an experimental monoclonal antibody that Edesa believes could regulate the overactive immune response associated with Acute Respiratory Distress Syndrome (ARDS) – the leading cause of death in COVID-19 patients. The company is based in Markham, Ontario, Canada, with a U.S. Sign up for news alerts.

Immune Response

Immune Response Antibody Regulation Development

U.S. FDA Approves PREVNAR 20™, Pfizer’s Pneumococcal 20-valent Conjugate Vaccine for Adults Ages 18 Years or Older

The Pharma Data

JUNE 18, 2021

PREVNAR 20 includes capsular polysaccharide conjugates for the 13 serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F) already included in Prevnar 13 ® (Pneumococcal 13-valent Conjugate Vaccine [Diphtheria CRM 197 Protein]). pneumoniae serotypes 8, 10A, 11A, 12F, 15B, 22F, and 33F is approved based on immune responses.

Vaccination

Vaccination Vaccine FDA Approval Containment

Lilly Delivers Strong Second-Quarter 2021 Financial Results, Updates 2021 Financial Guidance

The Pharma Data

AUGUST 3, 2021

The company announced donanemab received Breakthrough Therapy designation for treatment of Alzheimer’s disease and its intention to submit a biologics license application (BLA) for donanemab under the accelerated approval pathway later this year based on data from TRAILBLAZER-ALZ. Loxo Oncology at Lilly and Kumquat Biosciences Inc.

Antibody

Antibody Sales Development Production

Regeneron’s Casirivimab and Imdevimab Antibody Cocktail for COVID-19 is First Combination Therapy to Receive FDA Emergency Use Authorization

The Pharma Data

NOVEMBER 20, 2020

The clinical evidence from Regeneron’s outpatient trial suggests that monoclonal antibodies such as casirivimab and imdevimab have the greatest benefit when given early after diagnosis and in patients who have not yet mounted their own immune response or who have high viral load.

Antibody

Antibody Production Clinical Trials Clinical Trials

Pfizer Investor Day Features Significant Number of Pipeline Advances for COVID-19 Programs and Across Numerous Therapeutic Areas

The Pharma Data

SEPTEMBER 15, 2020

20vPnC showed a safety and tolerability profile that was similar to Prevnar 13 ® Pneumococcal 13-valent Conjugate Vaccine [Diphtheria CRM197 Protein]. Based on the acceptable safety profile and the favorable immune response data, including the 4th dose response data, Pfizer received Breakthrough Therapy Designation.

Gene Therapy

Gene Therapy Vaccination Vaccine Trials

Regeneron’s REGEN-COV2 is First Antibody Cocktail for COVID-19 to Receive FDA Emergency Use Authorization

The Pharma Data

NOVEMBER 21, 2020

The clinical evidence from Regeneron’s outpatient trial suggests that monoclonal antibodies such as REGEN-COV2 have the greatest benefit when given early after diagnosis and in patients who have not yet mounted their own immune response or who have high viral load.

Antibody

Antibody Production Clinical Trials Clinical Trials

Clinical Catch-Up: December 14-18 | BioSpace

The Pharma Data

DECEMBER 20, 2020

It is an optimized, non-chemically modified mRNA that codes for the prefusion stabilized full-length spike protein of the SARS-CoV-2 virus. Pfizer and BioNTech announced additional data on neutralizing antibody and T-cell responses from their Phase I/II trial of their COVID-19 vaccine conducted in Germany.

Trials

Trials Gene Therapy Vaccination Vaccine

Pfizer and BioNTech Initiate Phase 1 Study of Single Dose mRNA-Based Combination Vaccine Candidate for Influenza and COVID-19

Pfizer

NOVEMBER 2, 2022

The vaccine candidate is based on BioNTech’s proprietary mRNA platform technology and contains mRNA strands encoding the wild-type spike protein of SARS-CoV-2 and the spike protein of the Omicron BA.4/BA.5 Hemagglutinin is a surface protein of the influenza virus which plays a role in the initiation of infection.

Vaccination

Vaccination Vaccine Clinical Trials Clinical Trials

Sanofi continued its growth trajectory. Strong increase in Q1 2021 business EPS(1) at CER

The Pharma Data

APRIL 27, 2021

A new study to select the most appropriate antigen dosage for Phase 3 evaluation of an adjuvanted recombinant protein COVID-19 vaccine candidate (SP0253) was initiated and already completed enrollment. MRT5500 (SP0254), an mRNA vaccine candidate against SARS-CoV-2, entered Phase 1/2 to assess safety, immune response and reactogenicity.

Sales

Sales Vaccination Vaccine Medicine

Clinical Research Informer

AvantGen Announces Licensing of Its Anti-SARS-CoV-2 Antibodies to IGM Biosciences for COVID-19 Therapy Development

WHO Grants Novavax’s COVID-19 Vaccine Covovax Emergency Use Listing

Trending Sources

Malaria Vaccine a Breakthrough Success with 77 Percent Efficacy

EU places firm order for AZ/Oxford Uni’s ChAdOx1 COVID-19 vaccine

Qalsody (Tofersen) Becomes First-of-Its-Kind Treatment for ALS

Vaxzevria approved in the EU as third dose booster against COVID-19

Pfizer and BioNTech Advance COVID-19 Vaccine Strategy With Study Start of Next-Generation Vaccine Candidate Based on Enhanced Spike Protein Design

Merck Announces Positive Topline Results from Two Additional Phase 3 Adult Studies Evaluating V114, Merck’s Investigational 15-valent Pneumococcal Conjugate Vaccine

COADMINISTRATION OF ITS 20-VALENT PNEUMOCOCCAL CONJUGATE VACCINE

Pfizer and Valneva Issue Update on Phase 3 Clinical Trial Evaluating Lyme Disease Vaccine Candidate VLA15

INOVIO Announces Publication of Phase 1 Data from its COVID-19 DNA Vaccine Candidate, INO-4800 in The Lancet’s EClinicalMedicine

SELLAS Announces Promising Initial Clinical Data for Galinpepimut-S (GPS) in Combination with Checkpoint Inhibitors in Two Solid Tumor Indications

Biopharma Leaders Unite To Stand With Science

Biopharma Leaders Unite To Stand With Science

Regeneron Announces Encouraging Initial Data from COVID-19 Antibody Cocktail Trial in Hospitalized Patients on Low-flow Oxygen

Regeneron’s COVID-19 Outpatient Trial Prospectively Demonstrates that REGN-COV2 Antibody Cocktail Significantly Reduced Virus Levels and Need for Further Medical Attention

Sanofi and Translate Bio initiate Phase 1 clinical trial of mRNA influenza vaccine

New England Journal of Medicine Publishes Positive Initial Regeneron Antibody Cocktail Results in Non-hospitalized Patients with COVID-19

Advisory Committee on Immunization Practices Recommends Pfizer’s PREVNAR 20® for Adults Previously Vaccinated with PREVNAR 13®

Edesa Biotech Receives Approval to Initiate COVID-19 Study in the U.S.

U.S. FDA Approves PREVNAR 20™, Pfizer’s Pneumococcal 20-valent Conjugate Vaccine for Adults Ages 18 Years or Older

Lilly Delivers Strong Second-Quarter 2021 Financial Results, Updates 2021 Financial Guidance

Regeneron’s Casirivimab and Imdevimab Antibody Cocktail for COVID-19 is First Combination Therapy to Receive FDA Emergency Use Authorization

Pfizer Investor Day Features Significant Number of Pipeline Advances for COVID-19 Programs and Across Numerous Therapeutic Areas

Regeneron’s REGEN-COV2 is First Antibody Cocktail for COVID-19 to Receive FDA Emergency Use Authorization

Clinical Catch-Up: December 14-18 | BioSpace

Pfizer and BioNTech Initiate Phase 1 Study of Single Dose mRNA-Based Combination Vaccine Candidate for Influenza and COVID-19

Sanofi continued its growth trajectory. Strong increase in Q1 2021 business EPS(1) at CER

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