Allergies, Containment, Development and Immune Response

Intravacc gets NIAID contract for intranasal gonorrhoea vaccine development

Pharmaceutical Technology

OCTOBER 6, 2022

from the US National Institutes of Health (NIH) unit National Institute of Allergy and Infectious Diseases (NIAID) to develop a prophylactic intranasal vaccine against Neisseria gonorrhoeae (NG). Leveraging its outer membrane vesicles (OMV) platform technology, Intravacc will develop the vaccine.

Vaccination

Vaccination Vaccine Development Bacterium

AZ expands phase 3 trials of COVID-19 vaccine frontrunner into US

pharmaphorum

SEPTEMBER 1, 2020

AstraZeneca has expanded development of COVID-19 vaccine AZD1222 into the US, beginning a phase 3 clinical trial across all adult age groups. The UK pharma said that the trial will recruit up to 30,000 adults aged 18 years or over to assess the safety, efficacy and immune response.

Vaccination

Vaccination Vaccine Trials Immune Response

Symvivo’s Oral COVID-19 Vaccine Enters Clinical Trials

XTalks

NOVEMBER 6, 2020

Canadian clinical-stage biotech company Symvivo Corporation has developed an oral COVID-19 vaccine that entered clinical trials this week. Related: Red Meat Allergy Test Gets FDA Clearance. “We The first healthy volunteer was dosed with the vaccine in Australia as part of the bacTRL-Spike COVID-19 Phase I clinical trial.

Clinical Trials

Clinical Trials Clinical Trials Vaccination Vaccine

NIH begins clinical trial evaluating second COVID-19 booster shots in adults

The Pharma Data

MARCH 31, 2022

The trial aims to understand if different vaccine regimens – prototype and variant vaccines alone and in combinations – can broaden immune responses in adults who already have received a primary vaccination series and a first booster shot. Fauci, M.D. Investigators aim to have initial findings available by August 2022.

Clinical Trials

Clinical Trials Clinical Trials Trials Immune Response

Mymetics to Advance Preclinical Studies for Virosome-based COVID-19 Vaccine through Innosuisse Grant

The Pharma Data

NOVEMBER 17, 2020

Mymetics continues to progress its Covid-19 vaccine development plan based on its virosome-vaccine platform. Since April 2020, Mymetics’ goal is to develop a safe and highly effective virosome-based Covid-19 vaccine that can be easily administered to all age groups, particularly to immune compromised and elderly populations.

Vaccination

Vaccination Vaccine Containment Immune Response

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

All 38 subjects who were evaluable for immunogenicity had balanced cellular and humoral immune responses following the second dose of INO-4800. INOVIO has assembled a global coalition of collaborators, partners and funders to rapidly advance the development of INO-4800. Department of Defense.

DNA

DNA Vaccination Vaccine Immune Response

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

(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. IMPORTANT SAFETY INFORMATION . has a fever.

Vaccination

Vaccination Vaccine Protein Immune Response

Emotional empathy is driving brand equity

pharmaphorum

AUGUST 13, 2020

One Pfizer brand getting plenty of attention is Xeljanz, their blockbuster anti-JAK rheumatoid arthritis pill that could damp down the massive immune response that overwhelms some COVID-19 patients. Kaletra (also known as Aluvia) contains anti-viral components that block virus replication. AbbVie has donated $1.5

Branding

Branding Vaccination Vaccine Filler

New Dupixent® (dupilumab) analyses reinforce long-term safety and efficacy profile in patients with atopic dermatitis as young as 6 years

The Pharma Data

APRIL 28, 2021

Head of Global Development in Immunology and Inflammation at Sanofi. “ In addition , o ur expanded efforts in research and development in the immunology space , including rilzabrutinib , underscores our long-term commitment to addressing serious dermatological conditions with unmet patient needs. ”. IR main line: Tel.: +33

Dermatology

Dermatology Trials 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

The companies’ previously announced safety, tolerability and immunogenicity data from a Phase 2/3 trial that found a 30 µg booster dose of the Omicron-adapted bivalent vaccine candidate elicited a superior immune response against Omicron BA.1 is immunocompromised or are on a medicine that affects the immune system. has a fever.

Vaccination

Vaccination Vaccine Medicine 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

Following a third dose in this age group , the vaccine was found to elicit a strong immune response, with a favorable safety profile similar to placebo. COMIRNATY, which is based on BioNTech’s proprietary mRNA technology, was developed by both BioNTech and Pfizer. The information contained in this release is as of July 8, 2022.

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

COMIRNATY, which is based on BioNTech’s proprietary mRNA technology, was developed by both BioNTech and Pfizer. 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. IMPORTANT SAFETY INFORMATION .

FDA Approval

FDA Approval Vaccination Vaccine Clinical Trials

Novavax COVID-19 vaccine demonstrates 90% overall efficacy and 100% protection against moderate and severe disease in PREVENT-19 Phase 3 trial

The Pharma Data

JUNE 25, 2021

President of Research and Development, Novavax. government, including the Department of Defense, the Biomedical Advanced Research and Development Authority (BARDA), part of the Office of the Assistant Secretary for Preparedness and Response at the U.S. Glenn, M.D., PREVENT-19 is being conducted with support from the U.S.

Vaccination

Vaccination Vaccine Trials Immune Response

Tezepelumab NAVIGATOR Phase 3 Trial Met Primary Endpoint Of A Statistically Significant And Clinically Meaningful Reduction In Exacerbations In A Broad Population Of Patients With Severe Asthma

The Pharma Data

NOVEMBER 9, 2020

executive vice president of Research and Development at Amgen. AstraZeneca continues to lead development and Amgen continues to lead manufacturing. TSLP is released in response to multiple triggers associated with asthma exacerbations, including allergens, viruses and other airborne particles. Reese , M.D.,

Trials

Trials Production Sales Manufacturing

Update On SOURCE Phase 3 Trial For Tezepelumab In Patients With Severe, Oral Corticosteroid-Dependent Asthma

The Pharma Data

DECEMBER 21, 2020

executive vice president of Research and Development at Amgen. 4 Tezepelumab is being developed by AstraZeneca in collaboration with Amgen (see AstraZeneca and Amgen collaboration below). AstraZeneca continues to lead development and Amgen continues to lead manufacturing. Reese , M.D.,

Trials

Trials Production Sales Manufacturing

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

The Pharma Data

APRIL 27, 2021

Developed as part of a joint-partnership between Sanofi and Merck, Vaxelis ® is the first and only hexavalent combination vaccine approved in the U.S. to €283 million, reflecting growth of Digestive and Mental Wellness categories as well as Allergy partially offset by the decline of the Pain category. In the U.S., PPH sales were up 40.4%

Sales

Sales Vaccination Vaccine Medicine

Sanofi delivered close to double-digit Q4 2020

The Pharma Data

FEBRUARY 8, 2021

Allergy Cough & Cold. to €238 million, reflecting growth in the Allergy (Allegra ® and Xyzal ® ) and Digestives categories. sales decreased 1.6%, reflecting the impact of the Zantac ® recall which offset the growth in the Allergy and Nutritionals categories. Full-year 2020, BOI of Vaccines increased 4.4% (up 11.2%

Sales

Sales Vaccination Vaccine Production

Sanofi delivered close to double-digit Q4 2020 business EPS(1) growth at CER

The Pharma Data

FEBRUARY 4, 2021

Allergy Cough & Cold. to €238 million, reflecting growth in the Allergy (Allegra ® and Xyzal ® ) and Digestives categories. sales decreased 1.6%, reflecting the impact of the Zantac ® recall which offset the growth in the Allergy and Nutritionals categories. Full-year 2020, BOI of Vaccines increased 4.4% (up 11.2%

Sales

Sales Vaccination Vaccine Production

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) The companies will share the development costs. Ugur Sahin, M.D.,

Vaccination

Vaccination Vaccine Clinical Trials Clinical Trials

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

The Pharma Data

MAY 13, 2021

The vaccine regimen, developed by the Janssen Pharmaceutical Companies of Johnson & Johnson (Janssen) in collaboration with Bavarian Nordic A/S, is being donated to the WHO by Janssen for the purposes of the early access clinical program. Global Head, Global Public Health Research & Development, Johnson & Johnson. “We

Vaccination

Vaccination Vaccine Medicine Clinical Trials

Positive New Data for Johnson & Johnson Single-Shot COVID-19 Vaccine on Activity Against Delta Variant and Long-lasting Durability of Response

The Pharma Data

JULY 6, 2021

In addition, the data showed that the durability of the immune response lasted through at least eight months, the length of time evaluated to date. In addition, we observe a persistent and particularly robust, durable cellular immune response,” said Mathai Mammen, M.D., 2) variants during the study period.

Vaccination

Vaccination Vaccine Immune Response Antibody

Positive new data for Johnson & Johnson single-shot COVID-19 vaccine on activity against Delta variant and long-lasting durability of response

The Pharma Data

JULY 8, 2021

In addition, the data showed that the durability of the immune response lasted through at least eight months, the length of time evaluated to date. In addition, we observe a persistent and particularly robust, durable cellular immune response,” said Mathai Mammen, M.D., variant. .

Vaccination

Vaccination Vaccine Immune Response Antibody

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. These companies include Moderna, a US biotech company which has formed a partnership with the National Institute of Allergy and Infectious Diseases (NIAID), Oxford University who has partnered with AstraZeneca, and Johnson & Johnson, Merck and Pfizer.

Vaccination

Vaccination Vaccine Antibody Life Science

Clinical Research Informer

Intravacc gets NIAID contract for intranasal gonorrhoea vaccine development

AZ expands phase 3 trials of COVID-19 vaccine frontrunner into US

Trending Sources

Symvivo’s Oral COVID-19 Vaccine Enters Clinical Trials

NIH begins clinical trial evaluating second COVID-19 booster shots in adults

Mymetics to Advance Preclinical Studies for Virosome-based COVID-19 Vaccine through Innosuisse Grant

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

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

Emotional empathy is driving brand equity

New Dupixent® (dupilumab) analyses reinforce long-term safety and efficacy profile in patients with atopic dermatitis as young as 6 years

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

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

Novavax COVID-19 vaccine demonstrates 90% overall efficacy and 100% protection against moderate and severe disease in PREVENT-19 Phase 3 trial

Tezepelumab NAVIGATOR Phase 3 Trial Met Primary Endpoint Of A Statistically Significant And Clinically Meaningful Reduction In Exacerbations In A Broad Population Of Patients With Severe Asthma

Update On SOURCE Phase 3 Trial For Tezepelumab In Patients With Severe, Oral Corticosteroid-Dependent Asthma

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

Sanofi delivered close to double-digit Q4 2020

Sanofi delivered close to double-digit Q4 2020 business EPS(1) growth at CER

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

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

Positive New Data for Johnson & Johnson Single-Shot COVID-19 Vaccine on Activity Against Delta Variant and Long-lasting Durability of Response

Positive new data for Johnson & Johnson single-shot COVID-19 vaccine on activity against Delta variant and long-lasting durability of response

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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