Allergies, Licensing, Medicine and Protein - Clinical Research Informer

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

Pfizer and BioNTech Advance COVID-19 Vaccine Strategy With Study Start of Next-Generation Vaccine Candidate Based on Enhanced Spike Protein Design. Pfizer and BioNTech Advance COVID-19 Vaccine Strategy With Study Start of Next-Generation Vaccine Candidate Based on Enhanced Spike Protein Design. deliesschef. Tue, 07/26/2022 - 17:41.

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

Pfizer and BioNTech Complete Submission to European Medicines Agency for Omicron BA.4/BA.5-Adapted Pfizer and BioNTech Complete Submission to European Medicines Agency for Omicron BA.4/BA.5-Adapted 5-Adapted Bivalent Vaccine Booster in Children 5 Through 11 Years of Age. Tue, 09/27/2022 - 16:15. Wednesday, September 28, 2022 - 11:45am.

Vaccination

Vaccination Vaccine Medicine Clinical Trials

Pfizer Responds to Research Claims

Pfizer

JANUARY 27, 2023

Working with collaborators, we have conducted research where the original SARS-CoV-2 virus has been used to express the spike protein from new variants of concern. In the ongoing development of the Pfizer-BioNTech COVID-19 vaccine, Pfizer has not conducted gain of function or directed evolution research.

Research

Research Vaccination Vaccine Drugs

Lilly’s bebtelovimab receives Emergency Use Authorization for the treatment of mild-to-moderate COVID-19

The Pharma Data

FEBRUARY 12, 2022

Bebtelovimab (LY-CoV1404; LY3853113) is a neutralizing IgG1 monoclonal antibody (mAb) directed against the spike protein of SARS-CoV-2 that maintains binding and neutralizing activity across currently known and reported variants of concern, including Omicron and BA.2. About BLAZE-4. Across the globe,?Lilly?employees

Antibody

Antibody Trials Clinical Trials 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 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 BA.4/BA.5 Hemagglutinin is a surface protein of the influenza virus which plays a role in the initiation of infection. INDICATION.

Vaccination

Vaccination Vaccine Clinical Trials Clinical Trials

Switzerland Exercises Increased Option for 7.5 Million Doses of mRNA Vaccine Against COVID-19 (mRNA-1273)

The Pharma Data

DECEMBER 8, 2020

Nasdaq: MRNA) a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines to create a new generation of transformative medicines for patients, today announced the Swiss Federal Government has increased its confirmed order commitment from 4.5 .–(BUSINESS WIRE)–Dec. 8, 2020– Moderna, Inc., million to 7.5

Vaccination

Vaccination Vaccine Manufacturing Containment

Lilly plans donation of COVID-19 therapies to Direct Relief for use in low- and lower-middle-income countries | Eli Lilly and Company

The Pharma Data

MAY 4, 2021

This donation furthers both Lilly and Direct Relief’s charitable goal of providing access to COVID-19 treatments to patients in need by providing these medicines free of charge to low- and lower-middle-income countries. Click here for resources related to Lilly ‘s COVID-19 efforts and here for baricitinib’s EUA.

Antibody

Antibody Medicine FDA Approval Licensing

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.

Vaccination

Vaccination Vaccine Clinical Trials Clinical Trials

INOVIO Announces Publication of Phase 1 Data from its COVID-19 DNA Vaccine Candidate, INO-4800 in The Lancet’s EClinicalMedicine

The Pharma Data

DECEMBER 23, 2020

Cellular (T cell) response were observed to multiple regions of the spike protein including the RBD region. The lead Principal Investigator for the INNOVATE trial is Dr. Pablo Tebas , Professor of Medicine at the Hospital of the University of Pennsylvania. About INOVIO’s DNA Medicines Platform.

DNA

DNA Vaccination Vaccine Immune Response

Bamlanivimab alone with the U.S. government and is focusing on supply of bamlanivimab and etesevimab together

The Pharma Data

APRIL 14, 2021

Bamlanivimab is a recombinant, neutralizing human IgG1 monoclonal antibody (mAb) directed against the spike protein of SARS-CoV-2. Results from the Phase 2 cohorts of BLAZE-1 were published in the New England Journal of Medicine and The Journal of the American Medical Association. About bamlanivimab.

Antibody

Antibody Protein Scientist Development

bamlanivimab and etesevimab together for treatment of COVID-19 in the U.S.

The Pharma Data

APRIL 16, 2021

“Lilly moved quickly to make bamlanivimab alone available as a potentially lifesaving medicine at a time when Americans were hardest hit by COVID-19,” said Daniel Skovronsky, M.D., Bamlanivimab is a recombinant, neutralizing human IgG1 monoclonal antibody (mAb) directed against the spike protein of SARS-CoV-2.

Antibody

Antibody Development Medicine Protein

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

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

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. are immunocompromised or are on a medicine that affects the immune system.

Vaccination

Vaccination Vaccine Clinical Trials Clinical Trials

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

XTalks

AUGUST 2, 2023

With each passing year, pharmaceutical companies around the globe strive to deliver cutting-edge medicines, therapies and vaccines that impact the lives of millions. In this in-depth article, we embark on a captivating journey to uncover the top 30 pharma and biotech companies that have been instrumental in shaping the future of medicine.

Sales

Sales Manufacturing FDA Approval Life Science

What to expect from PEGS Europe 2023: Day 2

Drug Discovery World

NOVEMBER 9, 2023

Ahead of protein and antibody engineering conference PEGS Europe 2024 in Lisbon, DDW’s Megan Thomas looks at what to expect from each track of the annual biologics technology meeting. James Cooke, PhD, Associate Director, Bicycle Therapeutics, on: ‘Engineering bicyclic peptides for precision targeted medicine’.

Engineer

Engineer Antibody Protein In-Vivo

Best OINTMENT or CREAM for insect bites

Druggist

FEBRUARY 17, 2021

Hydrocortisone cream is classified as pharmacy-only medicine (P), which means it can only be sold in pharmacies, including online chemists and sellers on Amazon.co.uk. Anthisan Cream contains a medicine called mepyramine maleate. Lanacane is licensed for adults and children from 12 years of age. Rashes caused by allergies .

Pharmacy

Pharmacy Containment Production Sales

New Data Show Treatment with Lilly’s Neutralizing Antibodies Bamlanivimab (LY-CoV555) and Etesevimab (LY-CoV016) Together Reduced Risk of COVID-19 Hospitalizations and Death by 70 Percent

The Pharma Data

JANUARY 26, 2021

About bamlanivimab Bamlanivimab is a recombinant, neutralizing human IgG1 monoclonal antibody (mAb) directed against the spike protein of SARS-CoV-2. Lilly licensed etesevimab from Junshi Biosciences after it was jointly developed by Junshi Biosciences and Institute of Microbiology, Chinese Academy of Science (IMCAS).

Antibody

Antibody Trials Clinical Trials Clinical Trials

Sanofi continued its growth trajectory. Strong increase in Q1 2021 business EPS(1) at CER

The Pharma Data

APRIL 27, 2021

General Medicines core assets grew 4.4%, while GBU sales were down 3.8%. Sanofi has become a member of the top five companies of the 2021 Access to Medicine index. General Medicines. General Medicines sales were down 3.8% Specialty Care sales grew 15.3%, due to strong Dupixent ® performance (+45.6% CHC decreased 7.3%

Sales

Sales Vaccination Vaccine Medicine

Lilly’s Neutralizing Antibody Bamlanivimab (LY-CoV555) Receives FDA Emergency Use Authorization for the Treatment of Recently Diagnosed COVID-19

The Pharma Data

NOVEMBER 9, 2020

” The FDA grants emergency use authorization to provide availability of a medicine that may help diagnose, treat or prevent a life-threatening disease when no adequate and approved alternatives are available. Bamlanivimab remains an investigational drug and has not been approved under a Biologics License Application (BLA).

Antibody

Antibody Medicine Manufacturing Trials

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

Nasdaq: MRNA), a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines to create a new generation of transformative medicines for patients, today announced that the primary efficacy analysis of the Phase 3 study of mRNA-1273 conducted on 196 cases confirms the high efficacy observed at the first interim analysis.

Vaccination

Vaccination Vaccine Medicine Clinical Trials

Israeli Ministry of Health Authorizes COVID-19 Vaccine Moderna for Use in Israel

The Pharma Data

JANUARY 4, 2021

The Moderna COVID-19 Vaccine is an mRNA vaccine against COVID-19 encoding for a prefusion stabilized form of the Spike (S) protein, which was co-developed by Moderna and investigators from National Institute of Allergy and Infectious Diseases’ (NIAID) Vaccine Research Center. About the Moderna COVID-19 Vaccine. Authorized Use.

Vaccination

Vaccination Vaccine Medicine Containment

EMA issues advice on Lilly’s bamlanivimab (LY-CoV555) alone and administered together with etesevimab (LY-CoV016) for the treatment of confirmed COVID-19 in the European Union

The Pharma Data

MARCH 5, 2021

Eli Lilly and Company (NYSE: LLY) announced today that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive scientific opinion for bamlanivimab alone and bamlanivimab administered together with etesevimab. About bamlanivimab. patients who recovered from COVID-19.

Antibody

Antibody Medicine Regulation Trials

Lilly’s bamlanivimab and etesevimab together reduced hospitalizations and death in Phase 3 trial for early COVID-19

The Pharma Data

MARCH 11, 2021

Food and Drug Administration (FDA) and a positive scientific opinion by the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP). Bamlanivimab is a recombinant, neutralizing human IgG1 monoclonal antibody (mAb) directed against the spike protein of SARS-CoV-2. About bamlanivimab.

Trials

Trials Antibody Medicine Protein

Clinical Research Informer

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

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

Trending Sources

Pfizer Responds to Research Claims

Lilly’s bebtelovimab receives Emergency Use Authorization for the treatment of mild-to-moderate COVID-19

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

Switzerland Exercises Increased Option for 7.5 Million Doses of mRNA Vaccine Against COVID-19 (mRNA-1273)

Lilly plans donation of COVID-19 therapies to Direct Relief for use in low- and lower-middle-income countries | Eli Lilly and Company

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

INOVIO Announces Publication of Phase 1 Data from its COVID-19 DNA Vaccine Candidate, INO-4800 in The Lancet’s EClinicalMedicine

Bamlanivimab alone with the U.S. government and is focusing on supply of bamlanivimab and etesevimab together

bamlanivimab and etesevimab together for treatment of COVID-19 in the U.S.

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

Experimental vaccine protects against deadly Sudan virus

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

What to expect from PEGS Europe 2023: Day 2

Best OINTMENT or CREAM for insect bites

New Data Show Treatment with Lilly’s Neutralizing Antibodies Bamlanivimab (LY-CoV555) and Etesevimab (LY-CoV016) Together Reduced Risk of COVID-19 Hospitalizations and Death by 70 Percent

Sanofi continued its growth trajectory. Strong increase in Q1 2021 business EPS(1) at CER

Lilly’s Neutralizing Antibody Bamlanivimab (LY-CoV555) Receives FDA Emergency Use Authorization for the Treatment of Recently Diagnosed COVID-19

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

Israeli Ministry of Health Authorizes COVID-19 Vaccine Moderna for Use in Israel

EMA issues advice on Lilly’s bamlanivimab (LY-CoV555) alone and administered together with etesevimab (LY-CoV016) for the treatment of confirmed COVID-19 in the European Union

Lilly’s bamlanivimab and etesevimab together reduced hospitalizations and death in Phase 3 trial for early COVID-19

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