Genetics, Immune Response, Licensing and Protein

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

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

XTalks

MAY 1, 2023

This makes Qalsody the first approved treatment to target a genetic cause of ALS. Tofersen was discovered by Ionis Pharmaceuticals, and Biogen licensed tofersen from Ionis under a collaborative development and license agreement. The recommended dosage of Qalsody is 100 mg (15 mL) per administration. What is SOD1 -ALS?

FDA Approval

FDA Approval Gene Genetics Protein

CMV Vaccine Trials: Moderna’s CMV mRNA Vaccine Enters Phase III

XTalks

FEBRUARY 19, 2024

The study compared the immune responses evoked by Moderna’s mRNA vaccine to those generated by a previous vaccine candidate, namely, the MF59-adjuvanted glycoprotein B (gB) proten subunit vaccine (gB/MF59) developed by Sanofi. After more than 50 years of research, we are closer than ever to having a licensed CMV vaccine,” Permar said.

Vaccination

Vaccination Vaccine Trials Clinical 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

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

South Korea authorises Novavax Covid-19 vaccine as booster dose

Pharmaceutical Technology

JANUARY 19, 2023

Nuvaxovid is a protein-based vaccine created from the genetic sequence of the initial SARS-CoV-2 virus strain. The findings showed that the Nuvaxovid booster dose increased immune responses compared to higher levels associated with the protection in Phase III clinical trials.

Vaccination

Vaccination Vaccine Immune Response Protein

Surrogate Endpoints: How to Choose the Best One for Your Rare Disease Trial

XTalks

SEPTEMBER 17, 2020

Dietary changes, including restriction of salt and animal protein, are also recommended. Symptoms and Etiology: Characterized by progressive muscle weakness and atrophy, Duchenne muscular dystrophy (DMD) is an X-linked genetic condition that primarily affects males. What Is a Surrogate Endpoint? Lipodystrophy.

Trials

Trials Gene Hormones 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

Experimental vaccine protects against deadly Sudan virus

Drug Discovery World

FEBRUARY 3, 2023

A research group from the National Institutes of Health has successfully developed a vaccine against Sudan virus (SUDV) based on the licensed Ebola virus (EBOV) vaccine. SUDV, identified in 1976, is one of the four viruses known to cause human Ebolavirus disease. Next, the researchers tested the safety and efficacy of VSV-SUDV in macaques.

Vaccination

Vaccination Vaccine Genetic Engineering Protein

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

The challenges and trends of cell & gene therapies

Drug Discovery World

SEPTEMBER 6, 2022

Many millions of people have recently been vaccinated against Covid 19 with a genetically modified viral vector (a recombinant adenovirus expressing a Covid 19 protein). This genetic vaccination is an extension of the gene therapy modality,” says Francis. . Workforce .

Gene Therapy

Gene Therapy Gene Manufacturing Medicine

Roche’s quantitative COVID-19 antibody test; Janssen buys a gene therapy asset; Zimmer Acquires A&E Medical; Glaucoma research study: Merck chooses TriNKET cancer immunotherapy program; Ovid fails Angelman phase 3 study

Delveinsight

DECEMBER 3, 2020

Roche has got an authorization from the FDA for a more accurate COVID-19 blood test capable of measuring the levels of specific antibodies, which target the cell-unlocking spike protein of coronavirus. Ovid showed a phase 2 data on OV101 in Angelman, a genetic nervous system disorder, in 2018.

Gene Therapy

Gene Therapy Gene Antibody Research

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.

Vaccination

Vaccination Vaccine Containment Clinical Trials

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

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. is advancing messenger RNA (mRNA) science to create a new class of transformative medicines for patients.

Vaccination

Vaccination Vaccine Containment Clinical 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

AZD7442 PROVENT Phase III prophylaxis trial met primary endpoint in.

The Pharma Data

AUGUST 22, 2021

More than 75% of participants had co-morbidities, which include conditions that have been reported to cause a reduced immune response to vaccination. Under the terms of the licensing agreement with Vanderbilt, AstraZeneca will pay single-digit royalties on future net sales. About AstraZeneca. Wang P, et al. Cell Host Microbe.

Trials

Trials Antibody Vaccination Vaccine

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 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.

Vaccination

Vaccination Vaccine Gene Therapy Trials

Clinical Research Informer

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

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

Trending Sources

CMV Vaccine Trials: Moderna’s CMV mRNA Vaccine Enters Phase III

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

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

South Korea authorises Novavax Covid-19 vaccine as booster dose

Surrogate Endpoints: How to Choose the Best One for Your Rare Disease Trial

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

Experimental vaccine protects against deadly Sudan virus

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

The challenges and trends of cell & gene therapies

Roche’s quantitative COVID-19 antibody test; Janssen buys a gene therapy asset; Zimmer Acquires A&E Medical; Glaucoma research study: Merck chooses TriNKET cancer immunotherapy program; Ovid fails Angelman phase 3 study

Biopharma Leaders Unite To Stand With Science

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

Biopharma Leaders Unite To Stand With Science

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

AZD7442 PROVENT Phase III prophylaxis trial met primary endpoint in.

Clinical Catch-Up: December 14-18 | BioSpace

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

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