Containment, Immune Response, Regulation and Vaccine

Malaria Vaccine a Breakthrough Success with 77 Percent Efficacy

XTalks

APRIL 26, 2021

After years of disappointing malaria vaccine trials, a malaria shot developed by researchers at the Jenner Institute at the University of Oxford has demonstrated an unprecedentedly high efficacy of 77 percent, and may be the magic bullet the world has been waiting for against the deadly disease.

Vaccination

Vaccination Vaccine Immune Response Trials

Covid-19 Omicron boosters will reinvigorate injectables manufacturing

Pharmaceutical Technology

JULY 29, 2022

Pfizer (New York, New York) and Moderna’s (Cambridge, Massachusetts) Omicron-specific Covid-19 vaccines are in late-stage development, have demonstrated good efficacy against the variant and will likely be available to the public later this year to provide an additional booster and increase demand for injectable manufacturing.

Manufacturing

Manufacturing Vaccination Vaccine Packaging

AZ resumes trial of COVID-19 vaccine

The Pharma Data

SEPTEMBER 14, 2020

. AstraZeneca has confirmed that clinical trials assessing its Oxford University partnered coronavirus vaccine AZD1222 have resumed in the UK, following a green light by the Medicines Health Regulatory Authority (MHRA). Source link. Source link.

Vaccination

Vaccination Vaccine Trials 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

.–( 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.

Vaccination

Vaccination Vaccine Immune Response Containment

FDA Takes Additional Action in Fight Against COVID-19 By Issuing Emergency Use Authorization for Second COVID-19 Vaccine

The Pharma Data

DECEMBER 18, 2020

Food and Drug Administration issued an emergency use authorization (EUA) for the second vaccine for the prevention of coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). The emergency use authorization allows the Moderna COVID-19 Vaccine to be distributed in the U.S. Hahn , M.D.

Vaccination

Vaccination Vaccine Production Manufacturing

Pfizer and BioNTech Initiate Rolling Submission of Biologics License Application for U.S. FDA Approval of Their COVID 19 Vaccine

The Pharma Data

MAY 7, 2021

The Pfizer-BioNTech COVID-19 Vaccine is currently available in the U.S. Since then, the companies have delivered more than 170 million doses of the vaccine across the U.S. We are proud of the tremendous progress we’ve made since December in delivering vaccines to millions of Americans, in collaboration with the U.S.

Licensing

Licensing Licensing Vaccination Vaccine

FDA fast-tracks Leap’s gastric cancer immunotherapy

pharmaphorum

SEPTEMBER 25, 2020

Leap Therapeutics will get a swift FDA review for its lead drug DKN-01 for a form of gastric and gastroesophageal junction (G/GEJ) cancer after being awarded fast-track status by the regulator. In animal models, neutralising DKK1 has been shown to activate an innate immune response against malignant cells.

Immune Response

Immune Response Trials Drugs Containment

Pfizer and BioNTech to Potentially Supply the EU with 200 Million Doses of mRNA-based Vaccine Candidate Against SARS-CoV-2

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.

Vaccination

Vaccination Vaccine Clinical Trials Clinical Trials

Merck Discontinues Development of SARS-CoV-2/COVID-19 Vaccine Candidates; Continues Development of Two Investigational Therapeutic Candidates

The Pharma Data

JANUARY 24, 2021

(NYSE: MRK), known as MSD outside the United States and Canada, today announced that the company is discontinuing development of its SARS-CoV-2/COVID-19 vaccine candidates, V590 and V591, and plans to focus its SARS-CoV-2/COVID-19 research strategy and production capabilities on advancing two therapeutic candidates, MK-4482 and MK-7110.

Development

Development Vaccination Vaccine Production

Biopharma Leaders Unite To Stand With Science

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.

Vaccination

Vaccination Vaccine Containment Clinical Trials

Biopharma Leaders Unite To Stand With Science

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.

Vaccination

Vaccination Vaccine Containment Clinical Trials

New Covid-19 vaccines ready to slow spread of EG.5

Drug Discovery World

AUGUST 17, 2023

It is believed that new Covid-19 vaccines developed by Pfizer/BioNTech, Moderna and Novavax will be effective against the fast-spreading EG.5 The new vaccine versions all target Omicron subvariant XBB.1.5, 5, though the latter does contain one particular mutation that is known to evade immunity. which is similar to EG.5,

Vaccination

Vaccination Vaccine Immune Response Manufacturing

Researchers reveal regenerative potential of the thymus

Drug Discovery World

AUGUST 31, 2023

Until now, scientists believed it didn’t contain ‘true’ epithelial stem cells, but only progenitors arising in foetal development. They can develop into epithelial as well as muscle and neuroendocrine cells, highlighting the importance of the thymus in hormonal regulation.

Research

Research Immune Response Scientist Hormones

The path to improved safety of gene-based products

Drug Discovery World

MAY 11, 2023

Gene-based therapeutics and vaccines hold immense potential for more efficient and personalised treatment and prevention of complex diseases. In these cases, injection of the viral vector vaccines induced the production of antibodies recognising platelet factor 4 (PF4) found on patients’ platelets 1.

Production

Production Gene Protein Vaccination

Johnson & Johnson Posts Interim Results from Phase 1/2a Clinical Trial of its Janssen COVID-19 Vaccine Candidate

The Pharma Data

SEPTEMBER 25, 2020

Johnson & Johnson Posts Interim Results from Phase 1/2a Clinical Trial of its Janssen COVID-19 Vaccine Candidate. Johnson & Johnson Posts Interim Results from Phase 1/2a Clinical Trial of its Janssen COVID-19 Vaccine Candidate. Immune responses were similar across the age groups studied, including older adults.

Clinical Trials

Clinical Trials Clinical Trials Vaccination Vaccine

Novartis to present broad range of portfolio data at ECTRIMS, reinforcing long-standing commitment to people living with multiple sclerosis

The Pharma Data

OCTOBER 9, 2021

years of exposure 3 Design of a new open-label study assessing immune response to SARS-CoV-2 mRNA vaccines in MS-patients treated with Kesimpta 4 , and new findings from open-label study assessing immune response to SARS-CoV-2 mRNA vaccines in secondary progressive MS (SPMS) patients treated with Mayzent will be presented 5.

Immune Response

Immune Response Vaccination Vaccine Medicine

Johnson & Johnson Initiates Second Global Phase 3 Clinical Trial of its Janssen COVID-19 Vaccine Candidate

The Pharma Data

NOVEMBER 14, 2020

November 15, 2020 — The Phase 3 ENSEMBLE study of the single-dose regimen of JNJ-78436735, the investigational vaccine candidate for the prevention of COVID-19 being developed by the Janssen Pharmaceutical Companies of Johnson & Johnson, continues to enroll and vaccinate study participants. PHASE 3 ENSEMBLE 2 STUDY.

Clinical Trials

Clinical Trials Clinical Trials Vaccination Vaccine

Necessity Is the Mother of Innovation: Key Trends and Predictions from Biotech Showcase Digital After an Unprecedented Year That Drove Momentous Changes in Healthcare

Pharma Marketing Network

JANUARY 20, 2021

Regarding OWS’s support for vaccine development, Dr Slaoui noted that 5 of the 6 vaccines selected (from a total of 94 programs) are currently in phase 3 development or approved. The response to this crisis has “transformed the vaccine industry.”.

Vaccination

Vaccination Vaccine In-Vivo Genetics

Johnson & Johnson Announces that Janssen’s COVID-19 Investigational Vaccine Candidate Prevents Severe Clinical Disease in Pre-clinical Studies

The Pharma Data

SEPTEMBER 3, 2020

Johnson & Johnson Announces that Janssen’s COVID-19 Investigational Vaccine Candidate Prevents Severe Clinical Disease in Pre-clinical Studies. Johnson & Johnson Announces that Janssen’s COVID-19 Investigational Vaccine Candidate Prevents Severe Clinical Disease in Pre-clinical Studies.

Vaccination

Vaccination Vaccine Immune Response Antibody

Johnson & Johnson Joins World Health Organization in Efforts to Prevent Spread of Ebola in West Africa

The Pharma Data

MAY 13, 2021

May 13, 2021 – Johnson & Johnson (NYSE: JNJ) (the Company) today announced the World Health Organization (WHO) and the government of Sierra Leone have begun administering the Company’s Ebola vaccine regimen as part of a WHO early access clinical program aimed at preventing further spread of Ebola in West Africa. NEW BRUNSWICK, N.J.,

Vaccination

Vaccination Vaccine Medicine Clinical Trials

Johnson & Johnson Announces Single-Shot Janssen COVID-19 Vaccine Candidate Met Primary Endpoints in Interim Analysis of its Phase 3 ENSEMBLE Trial

The Pharma Data

JANUARY 29, 2021

January 29, 2021 – Johnson & Johnson (NYSE: JNJ) (the Company) today announced topline efficacy and safety data from the Phase 3 ENSEMBLE clinical trial, demonstrating that the investigational single-dose COVID-19 vaccine in development at its Janssen Pharmaceutical Companies met all primary and key secondary endpoints.

Vaccination

Vaccination Vaccine Trials Immune Response

COVID-19 Pandemic Coverage

XTalks

SEPTEMBER 14, 2020

“Vaccine Nationalism” Could Prove the Undoing of COVID-19 Containment. Tension is mounting as nations big and small jockey around industry to ensure they are first in line to access a vaccine, should one prove to be successful against COVID-19. Moderna’s COVID-19 Vaccine. The price of that prize is incalculable.

Vaccination

Vaccination Vaccine Antibody Life Science

Clinical Research Informer

Malaria Vaccine a Breakthrough Success with 77 Percent Efficacy

Covid-19 Omicron boosters will reinvigorate injectables manufacturing

Trending Sources

AZ resumes trial of COVID-19 vaccine

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

FDA Takes Additional Action in Fight Against COVID-19 By Issuing Emergency Use Authorization for Second COVID-19 Vaccine

Pfizer and BioNTech Initiate Rolling Submission of Biologics License Application for U.S. FDA Approval of Their COVID 19 Vaccine

FDA fast-tracks Leap’s gastric cancer immunotherapy

Pfizer and BioNTech to Potentially Supply the EU with 200 Million Doses of mRNA-based Vaccine Candidate Against SARS-CoV-2

Merck Discontinues Development of SARS-CoV-2/COVID-19 Vaccine Candidates; Continues Development of Two Investigational Therapeutic Candidates

Biopharma Leaders Unite To Stand With Science

Biopharma Leaders Unite To Stand With Science

New Covid-19 vaccines ready to slow spread of EG.5

Researchers reveal regenerative potential of the thymus

The path to improved safety of gene-based products

Johnson & Johnson Posts Interim Results from Phase 1/2a Clinical Trial of its Janssen COVID-19 Vaccine Candidate

Novartis to present broad range of portfolio data at ECTRIMS, reinforcing long-standing commitment to people living with multiple sclerosis

Johnson & Johnson Initiates Second Global Phase 3 Clinical Trial of its Janssen COVID-19 Vaccine Candidate

Necessity Is the Mother of Innovation: Key Trends and Predictions from Biotech Showcase Digital After an Unprecedented Year That Drove Momentous Changes in Healthcare

Johnson & Johnson Announces that Janssen’s COVID-19 Investigational Vaccine Candidate Prevents Severe Clinical Disease in Pre-clinical Studies

Johnson & Johnson Joins World Health Organization in Efforts to Prevent Spread of Ebola in West Africa

Johnson & Johnson Announces Single-Shot Janssen COVID-19 Vaccine Candidate Met Primary Endpoints in Interim Analysis of its Phase 3 ENSEMBLE Trial

COVID-19 Pandemic Coverage

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