The Pharma Data

JULY 21, 2021

At full operational capacity, the annual production will exceed 100 million finished doses annually. This is why we will continue to evaluate sustainable approaches that will support the development and production of mRNA vaccines on the African continent.”. “We IMPORTANT SAFETY INFORMATION FROM U.S.

Manufacturing 52

Manufacturing Vaccination Vaccine Clinical Trials 52

The Pharma Data

DECEMBER 11, 2020

The vaccine is now authorized under an Emergency Use Authorization (EUA) while Pfizer and BioNTech gather additional data and prepare to file a planned Biologics License Application (BLA) with the FDA for a possible full regulatory approval in 2021. CEO and Co-founder of BioNTech. Today we are another step closer to our vision.

Vaccination 52

Vaccination Vaccine Clinical Trials Clinical Trials 52

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. There are limited clinical data available for baricitinib use in coronavirus 2019 (COVID-19).

Antibody 52

Antibody Medicine FDA Approval Licensing 52

The Pharma Data

APRIL 14, 2021

Healthcare providers should review the Fact Sheet for information on the authorized use of bamlanivimab and etesevimab together and bamlanivimab alone and mandatory requirements of the EUA. Authorized Use and Important Safety Information. Important Safety Information. See Limitations of Authorized Use. Adverse Events.

Antibody 52

Antibody Protein Scientist Development 52

The Pharma Data

MAY 6, 2021

We are honored to be able to contribute vaccines to support the safety of the Olympic and Paralympic Games.”. Please see Emergency Use Authorization (EUA) Fact Sheet for Healthcare Providers Administering Vaccine (Vaccination Providers) including Full EUA Prescribing Information available at www.cvdvaccine.com. .:

Vaccination 52

Vaccination Vaccine Clinical Trials Clinical Trials 52

The Pharma Data

FEBRUARY 12, 2022

” The data supporting this EUA are primarily based on analyses from the Phase 2 BLAZE-4 trial (NCT04634409), treatment arms 9-14. Fact Sheet for Healthcare Providers ?for Fact Sheet for Patients, Parents and Caregivers ?on Clinical data confirm the neutralizing ability of bebtelovimab. Please also see the?

Antibody 40

Antibody Trials Clinical Trials Clinical Trials 40

The Pharma Data

APRIL 16, 2021

This request is not due to any new safety concern. “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., For media resources, including product images and fact sheets, please click here.

Antibody 52

Antibody Development Medicine Protein 52

Pfizer

AUGUST 15, 2022

The emergency use of PAXLOVID is only authorized for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of drugs and biological products during the COVID-19 pandemic under Section 564(b)(1) of the Act, 21 U.S.C. IMPORTANT SAFETY INFORMATION. Herbal Products: St.

Drugs 99

Drugs Vaccination Vaccine In-Vitro 99

The Pharma Data

DECEMBER 29, 2020

NASDAQ: REGN) today announced encouraging initial data from an ongoing Phase 1/2/3 clinical trial of the Regeneron antibody cocktail, casirivimab and imdevimab, in hospitalized COVID-19 patients requiring low-flow oxygen. Evaluation of its safety and efficacy is ongoing in multiple clinical trials. Regeneron Pharmaceuticals, Inc.

Antibody 52

Antibody Trials Production Clinical Trials 52

The Pharma Data

NOVEMBER 16, 2020

November 16, 2020 — An independent data and safety monitoring board (DSMB) overseeing the Phase 3 trial of the investigational COVID-19 vaccine known as mRNA-1273 reviewed trial data and shared its interim analysis with the trial oversight group on Nov. The co-principal investigators for the study are Hana M. Baden, M.D.,

Clinical Trials 52

Clinical Trials Clinical Trials Vaccination Vaccine 52

Pfizer

JULY 19, 2022

Pfizer and BioNTech Complete Submission to European Medicines Agency for Omicron BA.1 Pfizer and BioNTech Complete Submission to European Medicines Agency for Omicron BA.1 The bivalent vaccine candidate was well-tolerated with a favorable safety profile. Pfizer and BioNTech previously shared these data with the U.S.

Vaccination 100

Vaccination Vaccine Medicine Clinical Trials 100

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 111

Vaccination Vaccine Protein Immune Response 111

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 in this age group is supported by safety and immunogenicity data from the companies’ Omicron BA.1-adapted

Vaccination 101

Vaccination Vaccine Medicine Clinical Trials 101

The Pharma Data

MARCH 22, 2021

Roche’s Chief Medical Officer and Head of Global Product Development. Regeneron will share new data with the U.S. Food and Drug Administration (FDA) and Roche and Regeneron will continue to work with the European Medicines Agency (EMA) and other health authorities across the globe. of patients in the 1,200 mg group, 1.3%

Antibody 52

Antibody Trials Clinical Trials Clinical Trials 52

The Pharma Data

DECEMBER 19, 2020

The Committee based its recommendation on clinical evidence supporting the Moderna COVID-19 Vaccine including data from Moderna’s 30,000 participant Phase 3 study and ACIP’s interim guidance on the allocation of initial vaccine doses. FDA and a Conditional Marketing Authorization (CMA) with the European Medicines Agency.

Vaccination 52

Vaccination Vaccine Licensing Licensing 52

The Pharma Data

JUNE 26, 2021

Roche’s Chief Medical Officer and Head of Global Product Development. ” The four randomised, controlled studies included in the EUA submission investigated the safety and efficacy of Actemra/RoActemra in more than 5,500 hospitalised patients with COVID-19. Both studies were published in the New England Journal of Medicine.

Clinical Trials 40

Clinical Trials Clinical Trials In-Vitro Antibody 40

Pfizer

JULY 8, 2022

Approval of the two-dose primary series is based on the totality of data through six months post-dose 2 in individuals 12 through 15 years of age. Favorable safety profile observed across more than 2,200 adolescents who participated in the clinical trial. IMPORTANT SAFETY INFORMATION . have completed a primary series.

FDA Approval 102

FDA Approval Vaccination Vaccine Clinical Trials 102

Pfizer

JANUARY 27, 2023

We then make this data available through peer reviewed scientific journals and use it as one of the steps to determine whether a vaccine update is required. In addition, to meet U.S. and global regulators for all antiviral products and are carried out by many companies and academic institutions in the U.S. and around the world.

Research 112

Research Vaccination Vaccine Drugs 112

The Pharma Data

OCTOBER 14, 2020

“With the Court’s approval of our First Day motions, we can ensure uninterrupted patient access to our medicines while we move through this process. . “With the Court’s approval of our First Day motions, we can ensure uninterrupted patient access to our medicines while we move through this process.

Production 40

Production Branding Development Regulation 40

Pfizer

JULY 8, 2022

The 3-µg dose was carefully selected as the preferred dose for children less than 5 years of age based on safety, tolerability, and immunogenicity data. The submission included data from a Phase 2/3 randomized, controlled trial that included 4,526 children 6 months to less than 5 years of age. INTERCHANGEABILITY.

Vaccination 81

Vaccination Vaccine Clinical Trials Clinical Trials 81

Pfizer

SEPTEMBER 16, 2022

The recommendation to convert the cMA to full MA is based on the totality of available efficacy and safety data provided by Pfizer and BioNTech, which confirm the benefits of the vaccine continue to outweigh its potential risks. IMPORTANT SAFETY INFORMATION. NEW YORK and MAINZ, GERMANY, SEPT 16, 2022 — Pfizer Inc. have a fever.

Marketing 75

Marketing Vaccination Vaccine Clinical Trials 75

The Pharma Data

MAY 4, 2021

Lilly is offering donations of baricitinib to the Indian government through Direct Relief while simultaneously working with local Indian pharmaceutical companies to execute royalty-free voluntary licensing agreements to accelerate the manufacturing and distribution of the medicine in India during the pandemic.

Licensing 40

Licensing Licensing FDA Approval Development 40

The Pharma Data

MARCH 2, 2021

This decision was based on the totality of scientific evidence, including data from the Phase 3 ENSEMBLE study that demonstrated the vaccine was 85 percent effective in preventing severe disease across all regions studied, and showed protection against COVID-19 related hospitalization and death, beginning 28 days after vaccination.

Vaccination 52

Vaccination Vaccine Clinical Trials Clinical Trials 52

Pfizer

OCTOBER 19, 2022

Today’s recommendation is based on data from a Phase 2/3 randomized, controlled trial that included 4,526 children aged 6 months to less than 5 years. The 3-µg dose was carefully selected as the preferred dose for children under 5 years of age based on safety, tolerability, and immunogenicity. IMPORTANT SAFETY INFORMATION.

Vaccination 40

Vaccination Vaccine Clinical Trials Clinical Trials 40

The Pharma Data

NOVEMBER 11, 2020

. Submitted Clinical Trial Application (CTA) for INZ-701 for the treatment of ENPP1 deficiency – Inozyme recently submitted its first CTA to initiate a Phase 1/2 clinical trial of INZ-701 for the treatment of ENPP1 deficiency to the United Kingdom’s Medicines and Healthcare products Regulatory Agency (MHRA).

Clinical Trials 40

Clinical Trials Clinical Trials Trials Development 40

The Pharma Data

NOVEMBER 5, 2020

. “Last week, Regeneron achieved an important milestone in the fight against COVID-19 with prospective Phase 2/3 results showing REGN-COV2 significantly reduced virus levels and the need for further medical attention in non-hospitalized patients; we have shared these important data with regulatory authorities,” said Leonard S.

Sales 52

Sales Production Manufacturing Antibody 52

Pfizer

DECEMBER 13, 2022

The emergency use of PAXLOVID is only authorized for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of drugs and biological products during the COVID-19 pandemic under Section 564(b)(1) of the Act, 21 U.S.C. IMPORTANT SAFETY INFORMATION . Herbal Products: St.

Drugs 110

Drugs Licensing Licensing Production 110

The Pharma Data

AUGUST 3, 2021

Product sales increased 3% globally, driven by double digit volume growth across a number of our products including Prolia ® (denosumab), Repatha ® (evolocumab) and our biosimilar products MVASI ® (bevacizumab-awwb) and KANJINTI ® (trastuzumab-anns). Product Sales Performance. driven by the write-off of $1.5

Sales 52

Sales Production Antibody Development 52

Pfizer

DECEMBER 20, 2022

Results from these analyses are consistent with previously disclosed efficacy and safety data for the trials. The extension of the NDA review period will not impact the Emergency Use Authorization (EUA) or the current availability of the medicine for eligible patients. IMPORTANT SAFETY INFORMATION. In the U.S.,

Drugs 69

Drugs Licensing Licensing Containment 69

The Pharma Data

DECEMBER 1, 2020

The data from the open-label COMET-TRD trial demonstrate substantial benefit in patients with depression who had failed to respond to two or more prior antidepressant treatments, a population that is known to be difficult to treat,” said Herriot Tabuteau, MD, Chief Executive Officer of Axsome. of patients at Week 1, 48.5% References.

Trials 52

Trials Clinical Trials Clinical Trials Production 52

pharmaphorum

AUGUST 19, 2022

But as we continue to digitise clinical trials, has access to new streams of valuable data become easier because “the data is IN the cloud”? Since DiMe’s launch in October 2019, there has been a 929% increase in the number of digital endpoints being used by the life sciences industry for the safety and efficacy of new drug development.

Development 52

Development Drugs Clinical Trials Clinical Trials 52

Pfizer

NOVEMBER 23, 2022

Clinical data and real-world evidence for PAXLOVID have shown that it can be an important tool in helping to reduce hospitalizations and deaths in those at increased risk of serious illness from COVID-19,” said Albert Bourla, Chairman and Chief Executive Officer, Pfizer. billion people living in lower-income countries. AUTHORIZED USE.

Licensing 40

Licensing Licensing Drugs Manufacturing 40

Drug Discovery World

JULY 22, 2022

Psychedelic plants and fungi have been used medicinally by indigenous populations over thousands of years. Psylo has imported and categorised all of the data into CDD. Manually curating all this data just wouldn’t have been possible, Ismin suggests. . “We Psylo launched using a virtual drug discovery model.

Drugs 98

Drugs In-Vitro In-Vivo Clinical Trials 98

The Pharma Data

NOVEMBER 20, 2020

The criteria for ‘high-risk’ patients are described in the Fact Sheet for Health Care Providers. The science and technology investments Regeneron has made over three decades positioned us to move rapidly to invent, study and maximize production of our antibody cocktail. Schleifer, M.D., Yancopoulos, M.D.,

Antibody 52

Antibody Production Clinical Trials Clinical Trials 52

The Pharma Data

JANUARY 26, 2021

. “These exciting results, which replicate positive Phase 2 data in a much larger set of patients, add valuable clinical evidence about the role neutralizing antibodies can play in fighting this pandemic. Lilly’s chief scientific officer and president of Lilly Research Laboratories. have reached record highs.

Antibody 52

Antibody Trials Clinical Trials Clinical Trials 52

The Pharma Data

NOVEMBER 9, 2020

” The EUA is based on data from BLAZE-1, a randomized, double-blind, placebo-controlled Phase 2 study in patients with recently diagnosed mild to moderate COVID-19 in the outpatient setting. Evaluation of its safety and efficacy is ongoing across a range of patient populations impacted by COVID-19.

Antibody 52

Antibody Medicine Manufacturing Trials 52

The Pharma Data

NOVEMBER 4, 2020

Progressed European regulatory review and commercial preparations : Continued to support regulatory review of VASCEPA by the European Medicines Agency (EMA) with the expectation of an early 2021 approval of VASCEPA for commercial sale in Europe. Final results from these studies are expected to be available some time in 2021.

Sales 40

Sales Production Cardiology Marketing 40