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 protein subunit vaccine developed by Novavax and the Coalition for Epidemic Preparedness Innovations (CEPI). The vaccine demonstrated an overall efficacy of 90.4

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The Pharma Data

AUGUST 28, 2020

There are also plans to strengthen the Medicines and Healthcare products Regulatory Agency (MHRA)’s powers to roll out an unlicensed vaccine rapidly if one becomes available before the new year. Oxford coronavirus vaccine triggers immune response. UK signs deals for 90 million virus vaccine doses. Source link.

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The Pharma Data

MARCH 11, 2021

Clinical trial to assess safety, immune response and reactogenicity, after preclinical data showed high neutralizing antibody levels. The joint development team is working on improving the temperature stability of the mRNA vaccine candidate and targeting a -20°C storage temperature for late-stage clinical trials and at launch.

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The Pharma Data

DECEMBER 17, 2020

NASDAQ: REGN ) today announced that the New England Journal of Medicine (NEJM) has published initial clinical data from an ongoing seamless Phase 1/2/3 trial of the antibody cocktail casirivimab and imdevimab in non-hospitalized patients with COVID-19. and Roche will develop, manufacture and distribute it outside of the U.S.

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The Pharma Data

MAY 27, 2022

AstraZeneca’s COVID-19 vaccine, Vaxzevria (ChAdOx1-S [Recombinant]), has been granted approval in the European Union (EU) by the European Medicine Agency (EMA) as a third dose booster in adults. Based in Cambridge, UK, AstraZeneca operates in over 100 countries and its innovative medicines are used by millions of patients worldwide.

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The Pharma Data

MARCH 25, 2022

This includes about three million people in the EU who are immunocompromised or being treated with immunosuppressive medicines.(1). 5-7) New data from Washington University School of Medicine demonstrated Evusheld retained potent neutralising activity against the emerging and highly transmissible BA.2

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pharmaphorum

DECEMBER 15, 2020

When and if the pandemic finally recedes there will still be an ongoing issue with a dearth of new antibiotics and a growing number of bacterial strains resistant to existing antibacterial medicines. GBS is responsible for nearly half of all life-threatening infections in newborns. The post Minervax raises €47.4m

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The Pharma Data

DECEMBER 23, 2020

All 38 subjects who were evaluable for immunogenicity had balanced cellular and humoral immune responses following the second dose of INO-4800. The lead Principal Investigator for the INNOVATE trial is Dr. Pablo Tebas , Professor of Medicine at the Hospital of the University of Pennsylvania. .

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Drug Discovery World

MARCH 24, 2023

dendritic cells, monocytes) triggers a broad immune response that includes significant increases in cytotoxic CD8 plus T cells armed with chemo-induced tumour antigens to target cancer. This synergy was demonstrated by the AIPAC Phase IIb trial’s encouraging efficacy and safety, including a over 2.9-month

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The Pharma Data

DECEMBER 10, 2020

Food and Drug Administration and the European Medicines Agency. Senior Vice President and Head of Vaccine Research & Development, Pfizer. “As We strive to set the standard for quality, safety and value in the discovery, development and manufacture of health care products, including innovative medicines and vaccines.

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The Pharma Data

MARCH 29, 2022

Evusheld significantly reduced the risk of developing symptomatic COVID-19 in PROVENT Phase III trial, with protection lasting at least six months Evusheld retains neutralising activity against the Omicron BA.2 2 subvariant, now the dominant strain in Europe. 1-3 Evusheld was generally well-tolerated in the trial.

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The Pharma Data

AUGUST 16, 2021

These data also will be submitted to the European Medicines Agency (EMA) and other regulatory authorities in the coming weeks. The Pfizer-BioNTech COVID-19 Vaccine, which is based on BioNTech proprietary mRNA technology, was developed by both BioNTech and Pfizer. today announced that they have submitted Phase 1 data to the U.S.

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pharmaphorum

DECEMBER 21, 2020

The agreement sees San Diego-based Janux in line for around $500 million in milestones apiece for two T-cell engager therapies – which bind to a tumour cell and recruit a patient’s T cells to eradicate tumour cells – that will be developed using Janux’ TRACTr platform.

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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.

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The Pharma Data

NOVEMBER 18, 2020

.” Ming-Tain Lai, PhD, Chief Scientific Officer at OBI Pharma stated, “In the trial, OBI-833 demonstrated a favorable safety profile and generated detectable anti-Globo H IgM/IgG responses. Department of Internal Medicine, Tri-Service General Hospital, Taipei, Taiwan. ” Presentation number: 397P / Poster: ID 680. .”

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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

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Pfizer

JULY 19, 2022

Pfizer and BioNTech Complete Submission to European Medicines Agency for Omicron BA.1 Pfizer and BioNTech Complete Submission to European Medicines Agency for Omicron BA.1 The Pfizer-BioNTech COVID-19 Vaccine, which is based on BioNTech’s proprietary mRNA technology, was developed by both BioNTech and Pfizer. has a fever.

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pharmaphorum

JUNE 2, 2021

The 50 mcg dose was put through its paces in a study reported last month which found that it was able to generate an encouraging immune response against some key SARS-CoV-2 variants, including the Brazil and South Africa strain – when administered as a booter to previously vaccinated individuals.

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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. 2-4 About VLA15 VLA15 is the only Lyme disease vaccine candidate currently in clinical development.

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The Pharma Data

DECEMBER 11, 2020

Pfizer and BioNTech expect to file a Biologics License Application for possible full regulatory approval in 2021. company, today’s news brings great pride and tremendous joy that Pfizer has risen to the challenge to develop a vaccine that has the potential to help bring an end to this devastating pandemic.

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Vaccination Vaccine Clinical Trials Clinical Trials 52

The Pharma Data

JUNE 24, 2021

This follows the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) positive opinion to authorize the vaccine in this age group. The Pfizer-BioNTech COVID-19 Vaccine, which is based on BioNTech proprietary mRNA technology, was developed by both BioNTech and Pfizer. BioNTech COVID-19 Vaccine.

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Vaccination Vaccine Clinical Trials Clinical Trials 52

The Pharma Data

AUGUST 16, 2021

Fast Track designation is granted for a medicine that is intended to treat a serious condition and data demonstrate the potential to address an unmet medical need. AD, also known as atopic eczema, is a chronic inflammatory skin disorder caused by skin barrier dysfunction and dysregulation of the immune response. Almirall S.A.’s

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Drug Discovery World

SEPTEMBER 6, 2022

DDW Editor Reece Armstrong looks at the cell and gene therapy landscape, examining the challenges facing developers and the trends we can expect to see throughout the year. . billion in 2020, according to the Alliance for Regenerative Medicine’s (ARM’s) Regenerative Medicine: Disrupting the Status Quo report.

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Gene Therapy Gene Manufacturing Medicine 52

pharmaphorum

JULY 18, 2022

It then elicits an immune response against that spike protein. You have a response with immunoglobulins type G (antibodies) and robust cellular response with both CD4 and CD8 T-cells being activated,” Morgon states. We get a higher immune response with the inhaled compared to the injectable,” Morgon relays.

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The Pharma Data

MAY 6, 2021

The Pfizer-BioNTech COVID-19 Vaccine, which is based on BioNTech proprietary mRNA technology, was developed by both BioNTech and Pfizer. The Pfizer-BioNTech COVID-19 Vaccine has not been approved or licensed by the U.S. The Pfizer-BioNTech COVID-19 Vaccine may not protect all vaccine recipients.

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Vaccination Vaccine Clinical Trials Clinical Trials 52

The Pharma Data

JULY 21, 2021

To facilitate Biovac’s involvement in the process, technical transfer, on-site development and equipment installation activities will begin immediately. We believe that our mRNA technology can be used to develop vaccine candidates addressing other diseases as well. CEO and Co-founder of BioNTech. “We

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Manufacturing Vaccination Vaccine Clinical Trials 52

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., Seronegative patients (n=217) had much higher viral loads than those who had already developed their own antibodies (seropositive) to SARS-CoV-2 at the time of randomization. futility analysis).

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The Pharma Data

DECEMBER 20, 2020

We are encouraged by the data shown in these two studies of GPS in combination with checkpoint inhibitors and look forward to additional data from these studies,” stated Dragan Cicic, MD, Senior Vice President, Clinical Development of SELLAS. “We NEW YORK, Dec. 21, 2020 (GLOBE NEWSWIRE) — SELLAS Life Sciences Group, Inc.

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The Pharma Data

SEPTEMBER 8, 2020

Nine CEOs sign historic pledge to continue to make the safety and well-being of vaccinated individuals the top priority in development of the first COVID-19 vaccines. FDA has established clear guidance for the development of COVID-19 vaccines and clear criteria for their potential authorization or approval in the US.

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Pfizer

JULY 26, 2022

(NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced that the companies have initiated a randomized, active-controlled, observer-blind, Phase 2 study to evaluate the safety, tolerability, and immune response of an enhanced COVID-19 mRNA-based vaccine candidate at a 30 µg dose level. Emergency Use Authorization . has a fever.

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The Pharma Data

SEPTEMBER 8, 2020

— Nine CEOs sign historic pledge to continue to make the safety and well-being of vaccinated individuals the top priority in development of the first COVID-19 vaccines. FDA has established clear guidance for the development of COVID-19 vaccines and clear criteria for their potential authorization or approval in the US.

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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. Senior Vice President and Head of Global Clinical Development at Regeneron. Yancopoulos , M.D., combined dose groups; 6.5%

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The Pharma Data

SEPTEMBER 9, 2020

We would like to thank the European Commission for its commitment and confidence in our development efforts,” said Albert Bourla, Chairman and CEO, Pfizer. “We Our aim is to develop a safe and effective vaccine to contribute to bringing this pandemic to an end in Europe and across the world. CEO and Co-founder of BioNTech.

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The Pharma Data

AUGUST 20, 2020

T cell immune responses elicited by BNT162b2 are being evaluated in the German study and the companies expect to submit the data for peer review and potential publication. Senior Vice President and Head of Vaccine Research & Development, Pfizer. “We This press release features multimedia. View the full release here: [link].

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The Pharma Data

OCTOBER 14, 2020

Potential Development of Human Monoclonal Antibody Therapeutics to SARS-CoV-2. The research is part of an ongoing collaboration between Columbia University and Tonix that focuses on T cell and antibody responses to SARS-CoV-2 (CoV-2), the virus that causes COVID-19. CHATHAM, N.J., Sergei Rudchenko, Ph.D.,

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The Pharma Data

AUGUST 3, 2021

Revenue growth was 12 percent when excluding effects of 2020 COVID-related stocking patterns, revenue from COVID-19 antibodies and recent business development. We accelerated use of our newest medicines around the world with solid sequential growth versus first-quarter 2021,” said David A. Business Development/Other Developments.

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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.

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