pharmaphorum

DECEMBER 29, 2021

Sanofi and Regeneron have another challenger to their big-selling drug Dupixent for atopic dermatitis, now that the FDA has approved Leo Pharma’s rival antibody tralokinumab. The market research firm thinks tralokinumab will carve out its own share of the market however with worldwide sales of $1.6 billion in 2020.

Sales 111

Sales Dermatology Marketing Allergies 111

Pfizer

SEPTEMBER 16, 2022

Pfizer and BioNTech Receive Positive CHMP Opinion for Conversion of COMIRNATY® Conditional Marketing Authorization to Full Marketing Authorization in the European Union. Standard marketing authorization recommendation applies to all indications and formulations in the European Union, including COMIRNATY® Original/Omicron BA.4-5

Marketing 75

Marketing Vaccination Vaccine Clinical Trials 75

The Pharma Data

JULY 11, 2021

3 These data are being presented at the 2021 European Academy of Allergy and Clinical Immunology (EAACI) Hybrid Congress in Krakow, Poland and Madrid, Spain. TAKHZYRO is a fully human monoclonal antibody that specifically binds and decreases plasma kallikrein activity. All antibody titres were low.

Allergies 52

Allergies Antibody Recombinant DNA Technology Production 52

pharmaphorum

JULY 8, 2021

The FDA has started a priority review of AstraZeneca and Amgen’s severe asthma antibody tezepelumab, setting a date for a decision in the first quarter of 2022. Overall, the antibody cut the annual asthma exacerbation rate (AAER) by 56% over 52 weeks, which was consistent with the benefit seen in the phase 2 PATHWAY trial.

Drugs 52

Drugs Antibody Trials Sales 52

The Pharma Data

JANUARY 12, 2021

Virology, Respiratory, Dermatology, Allergy, & Rheumatology) in early & late stage Clinical Development and in Medical Affairs, with a strong track record for Developing and Accelerating Phase I–IV programs. He has in depth Global Development Expertise (e.g. Previously, he held roles as CMO at Trimeris Inc. Graham earned an M.D.,

Life Science 52

Life Science Antibody In-Vivo In-Vitro 52

pharmaphorum

NOVEMBER 3, 2022

Regeneron’s main rival was Pfizer with tanezumab , which got as far as marketing applications in the US and EU for osteoarthritis-related pain before being shot down by regulators on safety grounds. The demise of fasinumab draws a line under the NGF inhibitor class, although there could be footnote.

Drugs 52

Drugs Antibody Allergies Development 52

pharmaphorum

SEPTEMBER 29, 2022

The disorder – driven by type 2 inflammation characterised by an antibody-based immune response – causes hard lumps or nodules to form on the skin that are so itchy they can lead patients to scratch themselves to the point of bleeding or pain. Development in peanut allergy has also been discontinued, said Sanofi in its second-quarter update.

Drugs 69

Drugs Immune Response Allergies Sales 69

XTalks

OCTOBER 26, 2023

variant was selected in June and within a few months, both Pfizer-BioNTech and Moderna were able to get vaccines for it to market by September, which Dr. Kierstead says is “astonishingly fast.” While levels of neutralizing antibodies can be used to determine protection, it is not a defined universal criterion.

Vaccine 105

Vaccine Vaccination RNA Manufacturing 105

XTalks

MAY 2, 2024

Some treatments already on the market have grabbed additional approvals in 2024, including Novo Nordisk’s Wegovy (semaglutide) for cardiovascular risk reduction, Dupixent (dupilumab) for eosinophilic esophagitis (EoE) in young children and Xolair (omalizumab) for food allergies. It is also entering late into the market.

Drugs 52

Drugs FDA Approval Vaccination Vaccine 52

The Pharma Data

JULY 29, 2021

today announced that the US Food and Drug Administration (FDA) has approved Nucala (mepolizumab), a monoclonal antibody that targets interleukin-5 (IL-5), as a treatment for patients with chronic rhinosinusitis with nasal polyps (CRSwNP). It is approved for paediatric use in SEA from ages six to 17 in Europe, the US and several other markets.

FDA Approval 52

FDA Approval Clinical Trials Clinical Trials Trials 52

The Pharma Data

JULY 6, 2021

Current data for the eight months studied so far show that the single-shot Johnson & Johnson COVID-19 vaccine generates a strong neutralizing antibody response that does not wane; rather, we observe an improvement over time. Demonstrated strong neutralizing antibody activity against the Delta (B.1.617.2) 1.351), the Gamma (P.1)

Vaccination 52

Vaccination Vaccine Immune Response Antibody 52

XTalks

AUGUST 2, 2023

Join us as we present an in-depth analysis of each company’s revenue, net income, R&D investments, core therapeutic areas, market presence and strategic collaborations. is a global pharmaceutical company, working across both developed and emerging markets. 2022 Revenue: Pfizer reported an annual revenue of $100.33 Pfizer Inc.

Sales 98

Sales Manufacturing FDA Approval Life Science 98

The Pharma Data

JULY 8, 2021

” “Current data for the eight months studied so far show that the single-shot Johnson & Johnson COVID-19 vaccine generates a strong neutralizing antibody response that does not wane; rather, we observe an improvement over time. ” Demonstrated strong neutralizing antibody activity against the Delta (B.1.617.2)

Vaccination 52

Vaccination Vaccine Immune Response Antibody 52

Pfizer

SEPTEMBER 28, 2022

This application for a variation of the marketing authorization (MA) to include the Omicron BA.4/BA.5-adapted Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time. 5-adapted bivalent vaccine.

Vaccination 101

Vaccination Vaccine Medicine Clinical Trials 101

Pfizer

JULY 8, 2022

A two-dose primary series of the vaccine (30-µg dose) elicited SARS-CoV-2–neutralizing antibody geometric mean titers (GMTs) of 1,239.5, In the European Union the conditional marketing authorization in this age group was granted by EMA in August 2021. GMTs) in an earlier analysis. IMPORTANT SAFETY INFORMATION . have a fever.

FDA Approval 102

FDA Approval Vaccination Vaccine Clinical Trials 102

The Pharma Data

DECEMBER 17, 2020

MacroGenics, a biopharma company working to make cancer history with the development of innovative monoclonal antibody-based therapeutics, had its first product , MARGENZA , approved by the FDA on Wednesday. When Pigs Fly Allergy-friendly. at the time of the announcement. The product launch is expected to take place in March of 2021.

FDA Approval 52

FDA Approval Genomics Genome Production 52

The Pharma Data

NOVEMBER 9, 2020

About Tezepelumab Tezepelumab is an investigational, potential first-in-class human monoclonal antibody that works on the primary source of inflammation: the airway epithelium, which is the first point of contact for viruses, allergens, pollutants, and other environmental insults. Amgen will record sales in the U.S. Outside the U.S.,

Trials 52

Trials Production Sales Manufacturing 52

The Pharma Data

MARCH 5, 2021

of regulation 726/2004 provides a harmonized, EU-level opinion on the efficacy, quality, and safety of the antibodies. The opinion can now be considered by the EU member states when making decisions on the use of the therapies at a national level before a formal marketing authorization is issued. Ricks, Lilly’s chairman and CEO.

Antibody 40

Antibody Medicine Regulation Trials 40

Pfizer

JULY 26, 2022

BioNTech is the Marketing Authorization Holder in the United States, the European Union, the United Kingdom, Canada and other countries, and the holder of emergency use authorizations or equivalents in the United States (jointly with Pfizer) and other countries. IMPORTANT SAFETY INFORMATION . has a fever.

Vaccination 111

Vaccination Vaccine Protein Immune Response 111

The Pharma Data

MARCH 24, 2021

The vaccine has been granted a conditional marketing authorisation or emergency use in more than 70 countries across six continents, and with the Emergency Use Listing granted by the World Health Organization this accelerates the pathway to access in up to 142 countries through the COVAX Facility. Source link:[link].

Vaccination 52

Vaccination Vaccine Radiology Trials 52

Pfizer

JULY 19, 2022

BioNTech is the Marketing Authorization Holder in the United States, the European Union, the United Kingdom, Canada and other countries, and the holder of emergency use authorizations or equivalents in the United States (jointly with Pfizer) and other countries. IMPORTANT SAFETY INFORMATION. has a fever. has received another COVID-19 vaccine.

Vaccination 100

Vaccination Vaccine Medicine Clinical Trials 100

The Pharma Data

NOVEMBER 25, 2020

This included the ACTT-1 trial sponsored by National Institute of Allergy and Infectious Disease (NIAID) and the “SIMPLE” trials (GS-US-540-5774 and GS-US-540-5773) sponsored by Gilead Sciences Inc. The most compelling evidence of effectiveness was provided by the NIAID-sponsored ACTT-1 trial, with its rigorous trial design. .

Trials 52

Trials Clinical Trials Clinical Trials Drugs 52

Pfizer

JULY 8, 2022

BioNTech is the Marketing Authorization Holder in the United States, the European Union, the United Kingdom, Canada and the holder of emergency use authorizations or equivalents in the United States (jointly with Pfizer) and other countries. The companies also plan to submit these data to other regulatory agencies around the world. .

Vaccination 81

Vaccination Vaccine Clinical Trials Clinical Trials 81

The Pharma Data

MARCH 22, 2021

The vaccine has been granted a conditional marketing authorisation or emergency use in more than 70 countries across six continents, and with the Emergency Use Listing granted by the World Health Organization this accelerates the pathway to access in up to 142 countries through the COVAX Facility. Source link:[link].

Trials 52

Trials Vaccination Vaccine Radiology 52

The Pharma Data

DECEMBER 21, 2020

About Tezepelumab Tezepelumab is an investigational, potential first-in-class human monoclonal antibody that works on the primary source of inflammation: the airway epithelium, which is the first point of contact for viruses, allergens, pollutants, and other environmental insults. Amgen will record sales in the U.S. Outside the U.S.,

Trials 40

Trials Production Sales Manufacturing 40

Pfizer

DECEMBER 8, 2022

Tell your vaccination provider about all of your medical conditions, including if you: have any allergies. Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time. have a fever.

Vaccination 81

Vaccination Vaccine Clinical Trials Clinical Trials 81

Pfizer

NOVEMBER 2, 2022

Tell your vaccination provider about all of your medical conditions, including if you: have any allergies. Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time. have a fever.

Vaccination 85

Vaccination Vaccine Clinical Trials Clinical Trials 85

The Pharma Data

DECEMBER 23, 2020

Stanley Plotkin , Professor Emeritus at The Wistar Institute, said, “INOVIO’s DNA vaccine appeared to be quite safe with few significant reactions but yet induced both antibody and T cell responses to SARS-CoV-2.” mg dose group and 84% demonstrating neutralizing antibodies in the 2.0 . mg and 2.0

DNA 40

DNA Vaccination Vaccine Immune Response 40

Pfizer

JANUARY 27, 2023

This research provides a way for us to rapidly assess the ability of an existing vaccine to induce antibodies that neutralize a newly identified variant of concern. This work is undertaken once a new variant of concern has been identified by public health authorities.

Research 112

Research Vaccination Vaccine Drugs 112

The Pharma Data

JANUARY 4, 2021

We hope to continue to see authorizations in additional markets in the coming days, weeks and months.”. FDA and a Conditional Marketing Authorization (CMA) with the European Medicines Agency. The MOH has secured 6 million doses of the COVID-19 Vaccine Moderna. About Moderna.

Vaccination 40

Vaccination Vaccine Medicine Containment 40

The Pharma Data

APRIL 27, 2021

and strong uptake in global markets, including China. to €137 million reflecting continued growth in AD in key countries and additional launches in asthma in European markets. In Europe, generic competition has started in certain countries after the expiration of Jevtana ® ’s market exclusivity in March 2021. to €127 million.

Sales 52

Sales Vaccination Vaccine Medicine 52

The Pharma Data

FEBRUARY 8, 2021

to €115 million reflecting continued growth in AD in key countries and additional launches in asthma in European markets. In Rest of the World, sales decreased 4.1%, reflecting some COVID-19 impact on the out-of-pocket market as well as an unfavorable phasing effect. Allergy Cough & Cold. at CER) to €2,276 million.

Sales 52

Sales Vaccination Vaccine Production 52

The Pharma Data

FEBRUARY 4, 2021

to €115 million reflecting continued growth in AD in key countries and additional launches in asthma in European markets. In Rest of the World, sales decreased 4.1%, reflecting some COVID-19 impact on the out-of-pocket market as well as an unfavorable phasing effect. Allergy Cough & Cold. at CER) to €2,276 million.

Sales 52

Sales Vaccination Vaccine Production 52

Pfizer

OCTOBER 19, 2022

BioNTech is the Marketing Authorization Holder in the United States, the European Union, the United Kingdom, Canada and the holder of emergency use authorizations or equivalents in the United States (jointly with Pfizer) and other countries. COMIRNATY® and its adapted vaccine variations (COMIRNATY® Original/Omicron BA.1 have a fever.

Vaccination 40

Vaccination Vaccine Clinical Trials Clinical Trials 40

The Pharma Data

APRIL 28, 2021

About Dupixent Dupixent is a fully human monoclonal antibody that inhibits the signaling of the interleukin-4 (IL-4) and interleukin-13 (IL-13) pathways and is not an immunosuppressant. ESPD21-0322: AD-GAP: A Global, Cross-sectional, Qualitative Survey of Children/Adolescents Aged 6?17

Dermatology 40

Dermatology Trials Clinical Trials Clinical Trials 40

XTalks

DECEMBER 24, 2020

Most antibody drugs and vaccines have been developed to target parts of the spike protein. These include remdesivir, baricitinib, dexamethasone and three antibody drugs. Antibody drugs were also developed as targeted COVID-19 treatments. Drug Approvals. Vaccine Considerations.

Life Science 111

Life Science Vaccination Vaccine Gene 111

The Pharma Data

JANUARY 27, 2021

” The good news is that the two COVID-19 vaccines now on the market still appear capable of heading off illness from the new mutant variants of coronavirus that have been surfacing, said Dr. Anthony Fauci, director of the U.S. National Institute of Allergy and Infectious Diseases, and President Joe Biden’s chief medical advisor.

Nurses 52

Nurses Doctors Doctor Vaccination 52