Allergies, Clinical Development, Containment and Licensing

Tiziana announces appointment of Dr Neil Graham MBBS, MD, MPH as Chief Medical Officer

The Pharma Data

JANUARY 12, 2021

Dr Graham is a medicines development expert and Infectious Diseases Epidemiologist with global Biotech and Pharma R&D experience in Phase I-IV therapeutics as well as in-vivo & in-vitro diagnostics, across many modalities. He has in depth Global Development Expertise (e.g. About Tiziana Life Sciences.

Life Science

Life Science Antibody In-Vivo In-Vitro

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

Emergency uses of the vaccine have not been approved or licensed by FDA, but have been authorized by FDA, under an Emergency Use Authorization (EUA) to prevent Coronavirus Disease 2019 (COVID 19) in individuals 6 months of age and older. The information contained in this release is as of July 27, 2022. Emergency Use Authorization .

Vaccination

Vaccination Vaccine Protein Immune Response

Pfizer and BioNTech Complete Submission to European Medicines Agency for Omicron BA.4/BA.5-Adapted Bivalent Vaccine Booster in Children 5 Through 11 Years of Age

Pfizer

SEPTEMBER 28, 2022

Monovalent refers to any authorized and approved COVID-19 vaccine that contains or encodes the spike protein of only the Original SARS-CoV-2 virus . The information contained in this release is as of September 28, 2022. . • receipt of the most recent booster dose with any authorized or approved monovalent COVID-19 vaccine. .

Vaccination

Vaccination Vaccine Medicine Clinical Trials

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 combines Pfizer’s quadrivalent modRNA-based influenza vaccine candidate, qIRV (22/23), which is currently in Phase 3 clinical development , and Pfizer and BioNTech’s authorized Omicron-adapted bivalent COVID-19 BNT162b2 (Original/Omicron BA.4/BA.5) COMIRNATY® (COVID-19 Vaccine, mRNA). INDICATION. have a fever.

Vaccination

Vaccination Vaccine Clinical Trials Clinical Trials

Pfizer and BioNTech Announce U.S. FDA Approval of their COVID-19 Vaccine COMIRNATY® For Adolescents 12 through 15 Years of Age

Pfizer

JULY 8, 2022

Food and Drug Administration (FDA) approved the companies’ supplemental Biologics License Application (sBLA) for their COVID-19 vaccine, known as COMIRNATY® (COVID-19 Vaccine, mRNA), to include individuals 12 through 15 years of age. Tell your vaccination provider about all of your medical conditions, including if you: have any allergies.

FDA Approval

FDA Approval Vaccination Vaccine Clinical Trials

Pfizer and BioNTech Receive U.S. FDA Fast Track Designation for Single-Dose mRNA-Based Vaccine Candidate Against COVID-19 and Influenza

Pfizer

DECEMBER 8, 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 sublineages BA.4/BA.5, Tell your vaccination provider about all of your medical conditions, including if you: have any allergies. INDICATION.

Vaccination

Vaccination Vaccine Clinical Trials Clinical Trials

Pfizer and BioNTech Complete Submission to European Medicines Agency for Omicron BA.1 Adapted Bivalent Vaccine Candidate

Pfizer

JULY 19, 2022

Emergency uses of the vaccine have not been approved or licensed by FDA, but have been authorized by FDA, under an Emergency Use Authorization (EUA) to prevent Coronavirus Disease 2019 (COVID 19) in individuals 6 months of age and older. The information contained in this release is as of July 19, 2022. Emergency Use Authorization.

Vaccination

Vaccination Vaccine Medicine Clinical Trials

Pfizer and BioNTech Receive Positive CHMP Opinion for Conversion of COMIRNATY® Conditional Marketing Authorization to Full Marketing Authorization in the European Union

Pfizer

SEPTEMBER 16, 2022

Monovalent refers to any authorized and approved COVID-19 vaccine that contains or encodes the spike protein of only the Original SARS-CoV-2 virus . COMIRNATY® (COVID-19 Vaccine, mRNA) INDICATION. Tell your vaccination provider about all of your medical conditions, including if you: have any allergies. EMERGENCY USE AUTHORIZATION.

Marketing

Marketing Vaccination Vaccine Clinical Trials

Pfizer and BioNTech Submit a Variation to EMA for the Vaccination of Children 6 Months to less than 5 Years with COMIRNATY®

Pfizer

JULY 8, 2022

Emergency uses of the vaccine have not been approved or licensed by FDA, but have been authorized by FDA, under an Emergency Use Authorization (EUA) to prevent Coronavirus Disease 2019 (COVID 19) in individuals 6 months of age and older. The information contained in this release is as of July 8, 2022. Emergency Use Authorization.

Vaccination

Vaccination Vaccine Clinical Trials Clinical Trials

Pfizer and BioNTech Receive Positive CHMP Opinion for COMIRNATY® in Children 6 Months to less than 5 Years in the European Union

Pfizer

OCTOBER 19, 2022

Monovalent refers to any authorized and approved COVID-19 vaccine that contains or encodes the spike protein of only the Original SARS-CoV-2 virus. Tell your vaccination provider about all of your medical conditions, including if you: have any allergies. The information contained in this release is as of October 19, 2022.

Vaccination

Vaccination Vaccine Clinical Trials Clinical Trials

Top 30 Pharma and Biotech Companies in 2023: Statistics and Trends

XTalks

AUGUST 2, 2023

It contains the antiviral medications nirmatrelvir and ritonavir. Late in 2022, AbbVie partnered with HotSpot Therapeutics and announced an exclusive worldwide collaboration and option to license agreement for their interferon regulatory factor 5 (IRF5) inhibitor program for autoimmune disease treatment. billion in 2022.

Sales

Sales Manufacturing FDA Approval Life Science

Moderna Announces Primary Efficacy Analysis in Phase 3 COVE Study for Its COVID-19 Vaccine Candidate and Filing Today with U.S. FDA for Emergency Use Authorization

The Pharma Data

NOVEMBER 30, 2020

and is being conducted in collaboration with the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), and the Biomedical Advanced Research and Development Authority (BARDA), part of the Office of the Assistant Secretary for Preparedness and Response at the U.S. “I

Vaccination

Vaccination Vaccine Medicine Containment

Aurobindo Pharma and COVAXX Sign an Exclusive Agreement to Develop and Commercialize COVID-19 Vaccine UB-612 for India and UNICEF

The Pharma Data

DECEMBER 23, 2020

Govindarajan, Managing Director, Aurobindo Pharma Limited , said: “We are proud to partner with COVAXX in developing the first-ever synthetic peptide-based vaccine to combat the COVID-19 pandemic. This vaccine has immense potential in eliminating shedding, and hence containing, the spread of the pandemic.” ” .

Vaccination

Vaccination Vaccine Development Manufacturing

COVAXX and Aurobindo Pharma Announce COVID-19 Vaccine Partnership

The Pharma Data

DECEMBER 23, 2020

Aurobindo Pharma and COVAXX are partnering on clinical development, manufacturing and marketing of COVAXX’s vaccine candidate, UB-612. Under the signed license agreement, Aurobindo Pharma has obtained the exclusive rights to commercialize in India and to UNICEF and non-exclusive rights in other select emerging and developing markets.

Vaccination

Vaccination Vaccine Manufacturing Antibody

Clinical Research Informer

Tiziana announces appointment of Dr Neil Graham MBBS, MD, MPH as Chief Medical Officer

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

Trending Sources

Pfizer and BioNTech Complete Submission to European Medicines Agency for Omicron BA.4/BA.5-Adapted Bivalent Vaccine Booster in Children 5 Through 11 Years of Age

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

Pfizer and BioNTech Announce U.S. FDA Approval of their COVID-19 Vaccine COMIRNATY® For Adolescents 12 through 15 Years of Age

Pfizer and BioNTech Receive U.S. FDA Fast Track Designation for Single-Dose mRNA-Based Vaccine Candidate Against COVID-19 and Influenza

Pfizer and BioNTech Complete Submission to European Medicines Agency for Omicron BA.1 Adapted Bivalent Vaccine Candidate

Pfizer and BioNTech Receive Positive CHMP Opinion for Conversion of COMIRNATY® Conditional Marketing Authorization to Full Marketing Authorization in the European Union

Pfizer and BioNTech Submit a Variation to EMA for the Vaccination of Children 6 Months to less than 5 Years with COMIRNATY®

Pfizer and BioNTech Receive Positive CHMP Opinion for COMIRNATY® in Children 6 Months to less than 5 Years in the European Union

Top 30 Pharma and Biotech Companies in 2023: Statistics and Trends

Moderna Announces Primary Efficacy Analysis in Phase 3 COVE Study for Its COVID-19 Vaccine Candidate and Filing Today with U.S. FDA for Emergency Use Authorization

Aurobindo Pharma and COVAXX Sign an Exclusive Agreement to Develop and Commercialize COVID-19 Vaccine UB-612 for India and UNICEF

COVAXX and Aurobindo Pharma Announce COVID-19 Vaccine Partnership

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