Allergies, Containment, Immune Response and Manufacturing

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). Therapyx will develop and manufacture the IL-12-containing microspheres in the vaccine called GneX12.

Vaccination

Vaccination Vaccine Development Bacterium

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.

Clinical Trials

Clinical Trials Clinical Trials Trials Immune Response

Symvivo’s Oral COVID-19 Vaccine Enters Clinical Trials

XTalks

NOVEMBER 6, 2020

Related: Red Meat Allergy Test Gets FDA Clearance. “We We are exceptionally pleased to commence dosing of our oral DNA vaccine for COVID-19 as we continue scale-up and manufacturing activities for future clinical development,” Symvivo’s chief medical officer Eric Sievers said in a press release from the company.

Clinical Trials

Clinical Trials Clinical Trials Vaccination Vaccine

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

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. Department of Defense have contributed significant funding to the advancement and manufacturing of INO-4800. ClinicalTrials.gov identifier: NCT04336410.

DNA

DNA Vaccination Vaccine Immune Response

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

Pfizer

NOVEMBER 2, 2022

The flexibility and manufacturing speed of the mRNA technology has demonstrated that it is well-suited for other respiratory diseases. 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

Vaccination

Vaccination Vaccine Clinical Trials 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. IMPORTANT SAFETY INFORMATION Tell your vaccination provider about all the vaccine recipient’s medical conditions, including if the vaccine recipient: has any allergies.

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

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. The information contained in this release is as of July 8, 2022. IMPORTANT SAFETY INFORMATION . have a fever. Pfizer Disclosure Notice.

FDA Approval

FDA Approval Vaccination Vaccine Clinical Trials

Emotional empathy is driving brand equity

pharmaphorum

AUGUST 13, 2020

In the Philippines, Coca-Cola handed over its precious advertising space to support the COVID-19 relief and response efforts of local communities. Bacardi switched production from its famous rum to ethanol so that hand sanitiser could be manufactured in bulk. Louis Vuitton did much the same thing in France. AbbVie has donated $1.5

Branding

Branding Vaccination Vaccine Filler

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

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

.” The company intends to file for regulatory authorizations in the third quarter, upon completion of the final phases of process qualification and assay validation needed to meet chemistry, manufacturing and controls (CMC) requirements. NVX-CoV2373 contains purified protein antigen and can neither replicate, nor can it cause COVID-19.

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

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. All aspects of the collaboration are under the oversight of joint governing bodies.

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

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. All aspects of the collaboration are under the oversight of joint governing bodies.

Trials

Trials Production Sales Manufacturing

Sanofi delivered close to double-digit Q4 2020

The Pharma Data

FEBRUARY 8, 2021

At the same time we want to make a more immediate contribution to help saving lives, which is why we have decided to provide manufacturing support to BioNTech and Pfizer. Effective April 1, 2020, Sanofi has sole responsibility for Praluent ® outside the U.S. while Regeneron has sole responsibility for Praluent ® in the U.S.

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

At the same time we want to make a more immediate contribution to help saving lives, which is why we have decided to provide manufacturing support to BioNTech and Pfizer. Effective April 1, 2020, Sanofi has sole responsibility for Praluent ® outside the U.S. while Regeneron has sole responsibility for Praluent ® in the U.S.

Sales

Sales Vaccination Vaccine Production

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

The Pharma Data

APRIL 27, 2021

to €283 million, reflecting growth of Digestive and Mental Wellness categories as well as Allergy partially offset by the decline of the Pain category. Development for Dupixent ® for grass allergy has been discontinued. At CER, BOI increased 48.6%. The ratio of BOI to net sales was 40.5% (and 27.5% Consumer Healthcare. Change at CER.

Sales

Sales Vaccination Vaccine Medicine

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

The Pharma Data

MAY 13, 2021

In addition, these vectors carry the genetic code of several Ebola virus proteins in order to trigger an immune response. The Ebola vaccine regimen was developed and is manufactured using Janssen’s proprietary AdVac ® technology. Learn more at www.janssen.com. Follow us at @JanssenGlobal.

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

The Company’s anticipated manufacturing timeline will enable it to meet its 2021 supply commitments, including those signed with governments and global organizations. HHSO100201700018C, and in collaboration with the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH) at the U.S.

Vaccination

Vaccination Vaccine Trials Immune Response

Clinical Research Informer

Intravacc gets NIAID contract for intranasal gonorrhoea vaccine development

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

Trending Sources

Symvivo’s Oral COVID-19 Vaccine Enters Clinical Trials

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

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

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

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

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

Emotional empathy is driving brand equity

COVID-19 Pandemic Coverage

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 delivered close to double-digit Q4 2020

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

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

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

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