The Pharma Data

JUNE 24, 2021

The primary objective in the trial is to describe safety when both vaccines are co-administered, with follow up six months after vaccination. Secondary objectives are to describe immune responses produced by each of the vaccines. Pfizer-BioNTech COVID-19 Vaccine booster plus placebo. 20vPnC plus placebo.

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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

AUGUST 16, 2021

Food and Drug Administration (FDA) to support the evaluation of a third, or booster, dose of the companies’ COVID-19 vaccine (BNT162b2) for future licensure. Vaccination is our most effective means of preventing COVID-19 infection – especially severe disease and hospitalization – and its profound impact on protecting lives is indisputable.

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The Pharma Data

OCTOBER 6, 2021

First study to investigate the safety and immunogenicity of both vaccines when co-administered compared to each vaccine administered separately in adults aged 65 years and older Timely new data for the start of the influenza vaccination campaigns across the Northern Hemisphere. About the study.

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The Pharma Data

AUGUST 15, 2021

Food and Drug Administration (FDA) has approved TICOVAC (tick-borne encephalitis (TBE) vaccine) for active immunization to prevent TBE in individuals 1 year of age and older. 1 TICOVAC is the only FDA-approved vaccine to help protect U.S. We are proud to deliver the first vaccine to help protect people in the U.S.

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The Pharma Data

AUGUST 28, 2020

The government plans to train up an army of health professionals to be ready to give the coronavirus vaccine, if and when one is shown to work. This could include pharmacists, who already deliver flu vaccines, midwives and physiotherapists. But a vaccine is not expected to be ready before Christmas. Source link.

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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.

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The Pharma Data

AUGUST 6, 2020

We pointed out last week that China was a notable missing element in AstraZeneca’s COVID-19 vaccine strategy, despite being the drugmaker’s second-largest market. The pair will also explore the possibility of producing the vaccine for other markets. The vaccine was moved into phase 2/3 in May. That has changed.

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The Pharma Data

JANUARY 22, 2021

As research developments into RNA vaccines help scientists accelerate drug candidates to arm the immune system against coronavirus, Pharma IQ ’s Keeping tabs on Covid-19 update returns with news from some of the biotechnology innovators leading the fight against the global pandemic.

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Drug Discovery World

JUNE 12, 2024

In clinical trials, Moderna’s combination vaccine elicited higher immune responses against influenza (flu) virus and SARS-CoV-2 than licensed flu and Covid-19 vaccines in adults 50 years and older. The Phase III trial investigated mRNA-1083, an investigational combination vaccine against influenza and Covid-19.

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The Pharma Data

OCTOBER 19, 2020

.–( BUSINESS WIRE )– Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced findings from two additional Phase 3 studies evaluating the safety, tolerability and immunogenicity of V114, the company’s investigational 15-valent pneumococcal conjugate vaccine. among adults 65 years of age or older.

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The Pharma Data

JULY 23, 2021

government has purchased an additional 200 million doses of the Pfizer-BioNTech COVID-19 Vaccine. government with 500 million doses of the companies’ COVID-19 vaccine for donation to the world’s poorest nations. government in the fight against this pandemic, we are proud of the impact of vaccination efforts across the country.

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Drug Discovery World

FEBRUARY 28, 2024

With the safety of MOv18 IgE having been established in cancer patients, biotechnology company Epsilogen has licensed the drug and will continue its clinical development following this successful clinical trial.

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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. COMIRNATY was the first COVID-19 vaccine to receive authorization in the EU and is the first to have its CMA extended to adolescents. g doses of the COVID-19 vaccine.

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The Pharma Data

DECEMBER 11, 2020

FDA authorizes COVID-19 mRNA vaccine for emergency use; companies are prepared to deliver first doses in the U.S. In collaboration with Operation Warp Speed, Pfizer and BioNTech, as well as other vaccine companies are expected to deliver hundreds of millions of vaccine doses to Americans by the end of 2021.

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The Pharma Data

MAY 6, 2021

Under the MoU, the companies and the IOC will coordinate with National Olympic Committees (NOCs) around the world to understand and work to help address the local need for vaccine doses for national delegations’ participation in the Games. We are proud to play a role in providing vaccines to athletes and national Olympic delegations.”.

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The Pharma Data

JULY 21, 2021

(NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced the signing of a letter of intent with The Biovac Institute (Pty) Ltd, known as “Biovac,” a Cape Town-based, South African biopharmaceutical company, to manufacture the Pfizer-BioNTech COVID-19 Vaccine for distribution within the African Union. This press release features multimedia.

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The Pharma Data

NOVEMBER 18, 2020

These results will be presented by the lead investigators of OBI Pharma’s novel anti-Globo H therapeutic cancer vaccine, OBI-833. ” 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. .”

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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.

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The Pharma Data

DECEMBER 23, 2020

” Dr. Stanley Plotkin , Professor Emeritus at The Wistar Institute, said, “INOVIO’s DNA vaccine appeared to be quite safe with few significant reactions but yet induced both antibody and T cell responses to SARS-CoV-2.” . PLYMOUTH MEETING, Pa. , mg and 2.0

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The Pharma Data

AUGUST 20, 2020

times the GMT of a panel of 38 sera of SARS-CoV-2 convalescent patients, and in older adults (65-85 years of age) the vaccine candidate elicited a neutralizing GMT 1.6 study of the BNT162 mRNA-based vaccine program against SARS-CoV-2, which has advanced into Phase 2/3 evaluation. and Germany. Jansen, Ph.D.,

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The Pharma Data

SEPTEMBER 9, 2020

The vaccine supply for the EU would be produced by BioNTech’s manufacturing sites in Germany and Pfizer’s manufacturing site in Belgium. The proposed supply agreement with the European Commission would represent the largest initial order of vaccine doses for Pfizer and BioNTech to date. billion doses by the end of 2021.

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The Pharma Data

OCTOBER 26, 2020

Testing Therapies, Antivirals and Vaccines. Novavax will present data from an ongoing Phase I/II clinical trial, including new Phase II reactogenicity data from its COVID-19 vaccine candidate. CoV2373 on Friday during the CDC’s Advisory Committee on Immunization Practices’ (ACIP) meeting. Please read more here. .

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The Pharma Data

DECEMBER 10, 2020

. Data from 43,448 participants, half of whom received BNT162b2 and half of whom received placebo, showed that the vaccine candidate was well tolerated and demonstrated 95% efficacy in preventing COVID-19 in those without prior infection 7 days or more after the second dose. Jansen, Ph.D.,

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The Pharma Data

NOVEMBER 29, 2020

Early interim data show Cytomegalovirus (CMV)-negative kidney transplant recipients vaccinated with three doses of HB-101 had reduced incidence of CMV viremia, reduced antiviral use and no CMV disease. Observed CMV-neutralizing antibody responses and tolerability profile are consistent with previous interim results.

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Drug Discovery World

MAY 6, 2024

The transfer of technologies from the lab to the market, is no longer purely via IP out licensing, but rather via start-up M&A deals – start-ups being the de-risking vehicle for large corporates. Biotechs such as ourselves and Owkin are leveraging artificial intelligence.”

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The Pharma Data

MARCH 25, 2022

People not adequately protected by a COVID-19 vaccine may particularly benefit from pre-exposure prophylaxis with Evusheld. This includes about three million people in the EU who are immunocompromised or being treated with immunosuppressive medicines.(1). 2-4 Evusheld was generally well-tolerated in the trial.(2-4).

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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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The Pharma Data

MARCH 29, 2022

Evusheld has the potential to provide long-lasting protection against COVID-19 for a broad population of individuals, including those who aren’t adequately protected by a COVID-19 vaccine, as well as those at increased risk of exposure.”. 1 It is also authorised for use and being supplied in several other countries around the world.

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Drug Discovery World

APRIL 20, 2023

Symptoms affect the brain, heart, lungs, GI tract and pancreas, are seen equally in vaccinated populations, and sometimes newly emerge after the acute infection has resolved. Given the numbers involved, these persistent symptoms likely represent great future challenges for healthcare systems. Alzheimer’s disease), or by initiating a new one.

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Drug Discovery World

SEPTEMBER 6, 2022

Thompson says that the development of Covid-19 vaccines, which used mRNA technology, resulted in wider acceptance for cell and gene therapies. . “On On the flipside, much of biomanufacturing facilities are now focused on vaccine production which results in less capacity for other critical therapeutic areas,” Thompson adds. .

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Agency IQ

MARCH 7, 2024

Vaccines advisory panel endorses move to trivalent formulation for U.S. flu vaccines Yesterday, FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) weighed in on strains for seasonal influenza vaccines for the Northern hemisphere 2024-2025 season.

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The Pharma Data

JULY 11, 2021

Phase 3 study met primary and secondary endpoints demonstrating MenQuadfi ® induced superior immune responses to serogroup C compared to a standard-of-care vaccine in healthy toddlers MenQuadfi is the first and only quadrivalent ACWY vaccine to demonstrate superior immune response against serogroup C in toddlers.

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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 Anticancer Fund

JUNE 23, 2023

In this small (n=10) proof of concept trial colorectal cancer patients undergoing surgical resection were injected intratumourally with flu vaccine. The primary outcome was safety, which was confirmed.

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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

MAY 15, 2023

The vaccine candidate demonstrated non-inferiority in primary endpoints for five Neisseria meningitidis serogroups (A, B, C, W, and Y) compared to two doses of Bexsero (meningococcal group B vaccine) and one dose of Menveo (meningococcal group A, C, W-135, and Y conjugate vaccine) in 10–25-year-olds.

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