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

The Pharma Data

DECEMBER 23, 2020

COVAXX is committed to providing an equitable distribution of UB-612 vaccine by prioritizing markets where the unmet need is greatest,” said Mei Mei Hu, co-founder and CEO of COVAXX. Aurobindo Pharma and COVAXX are partnering on clinical development, manufacturing and marketing of COVAXX’s vaccine candidate, UB-612.

Vaccination 52

Vaccination Vaccine Manufacturing Antibody 52

The Pharma Data

DECEMBER 23, 2020

. Under the signed agreement, Aurobindo Pharma has obtained the exclusive rights to develop, manufacture and sell COVAXX’s UB-612 vaccine in India and to UNICEF, as well as non-exclusive rights in other select emerging and developing markets. The Company is marketing these products globally, in over 150 countries.

Vaccination 52

Vaccination Vaccine Development Manufacturing 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

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

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

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

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

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

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

Pharmaceutical Technology

JUNE 9, 2023

Also known as palivizumab, Sobi ‘s Synagis was the first FDA-approved monoclonal antibody used in children at high risk of RSV disease. Marketed under the name Beyfortus in the EU, nirsevimab is a long-acting human recombinant monoclonal antibody. The single seasonal dosing of the drug is a large advance, he noted.

FDA Approval 147

FDA Approval Antibody Allergies Packaging 147

XTalks

FEBRUARY 4, 2021

Abionic first developed abioSCOPE in 2010 for allergy testing, and subsequently for sepsis and infection. Dr. Durand explains how “Abionic started with allergy testing [and] also developed tests for iron deficiency and other things. PSP is a novel biomarker that Abionic has already clinically validated and marketed.

Allergies 98

Allergies Bacteria Development Containment 98

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.

Vaccination 105

Vaccination Vaccine RNA Manufacturing 105

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

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

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

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

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 Genome Genomics Production 52

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

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

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

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

pharmaphorum

NOVEMBER 8, 2021

A single dose of the COVID-19 monoclonal antibody therapy developing Regeneron reduced the risk of contracting the virus by around 82% for up to eight months, according to new trial data. The post One dose of Regeneron’s COVID antibody protects for eight months appeared first on. That was down from almost $2.6

Antibody 105

Antibody Vaccination Vaccine Immune Response 105

pharmaphorum

AUGUST 12, 2021

A single dose of a monoclonal antibody developed by scientists at the US National Institutes of Health (NIH) has provided protection for people exposed to malaria parasites for up to nine months. The post More malaria hope as antibody protects against infection appeared first on.

Antibody 64

Antibody Vaccination Vaccine Allergies 64

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

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

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

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

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

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