Hormones, In-Vitro, Production and Regulation

Statement from Pfizer Chairman and CEO Albert Bourla on Testing Positive for COVID-19

Pfizer

AUGUST 15, 2022

Nirmatrelvir has shown consistent in vitro antiviral activity against the following variants: Alpha, Beta, Delta, Gamma, Lambda, Mu, and Omicron BA.1 I am grateful to have received four doses of the Pfizer-BioNTech vaccine and I am feeling well while experiencing very mild symptoms. FDA Emergency Use Authorization Statement. AUTHORIZED USE.

Drugs

Drugs Vaccination Vaccine In-Vitro

Pfizer Responds to Research Claims

Pfizer

JANUARY 27, 2023

and global regulatory requirements for our oral treatment, PAXLOVID™, Pfizer undertakes in vitro work (e.g., and global regulators for all antiviral products and are carried out by many companies and academic institutions in the U.S. It is important to note that these studies are required by U.S. and around the world.

Research

Research Vaccination Vaccine Drugs

Pfizer Receives Positive CHMP Opinion for Conversion of PAXLOVID™ Conditional Marketing Authorization to Full Marketing Authorization in the European Union

Pfizer

JANUARY 27, 2023

This opinion from the CHMP confirms that the benefits of PAXLOVID in helping to reduce severe COVID-19-related outcomes, including hospitalization and death, in high risk patients continue to outweigh its potential risks. PAXLOVID is currently approved or authorized for conditional or emergency use in more than 70 countries to treat COVID-19.

Marketing

Marketing Production Drugs Licensing

Pfizer to Provide U.S. Government with an Additional 3.7 Million Treatment Courses of PAXLOVID™ to Help Combat COVID-19

Pfizer

DECEMBER 13, 2022

Nirmatrelvir has shown consistent in vitro antiviral activity against the following variants: Alpha, Beta, Delta, Gamma, Lambda, Mu, and Omicron BA.1, The additional 3.7 million treatment courses are planned for delivery by early 2023. . In June of 2022, Pfizer submitted a New Drug Application (NDA) to the U.S.

Drugs

Drugs Licensing Licensing Production

U.S. FDA Extends Review of Pfizer’s New Drug Application for PAXLOVID™

Pfizer

DECEMBER 20, 2022

FDA Extends Review of Pfizer’s New Drug Application for PAXLOVID™. Tuesday, December 20, 2022 - 04:30pm. Pfizer oral treatment remains available to eligible U.S. patients under Emergency Use Authorization as a critical tool in the fight against COVID-19. NEW YORK, December 20, 2022 -- Pfizer Inc. NYSE: PFE) announced today that the U.S. In the U.S.,

Drugs

Drugs Licensing Licensing Containment

Global Roundup: Overland Pharma Launches in China to Provide Access to Breakthrough Therapies

The Pharma Data

DECEMBER 9, 2020

OHMX.bio – Belgium-based OHMX.bio and Fujirebio Europe were awarded a €720,000 research grant from Flanders Innovation & Entrepreneurship (VLAIO) to develop a clinical in vitro diagnostics (IVD) platform incorporating third generation sequencing (TGS) technologies. A solution could be at hand with Overland Pharmaceuticals.

In-Vivo

In-Vivo In-Vitro Antibody Development

Pfizer Signs Agreement to Provide the European Union with PAXLOVID™

Pfizer

NOVEMBER 23, 2022

(NYSE: PFE) today announced an agreement with the European Commission (EC) to supply its COVID-19 oral therapy, PAXLOVID™ (nirmatrelvir [PF-07321332] tablets and ritonavir tablets) to countries participating in the Joint Procurement Agreement across Europe. This agreement will supply participating countries up to 3.4

Licensing

Licensing Licensing Drugs Manufacturing

Cardiac Biomarkers in Cardiovascular Clinical Trials: Caveats and Considerations

XTalks

NOVEMBER 19, 2021

Natriuretic peptides like N-terminal (NT)-pro hormone B type natriuretic peptide (NT-proBNP), or BNP, are routinely used for acute and chronic heart failure. They can be used in patient selection, stratification, risk mitigation and assessment of safety and efficacy endpoints.

Clinical Trials

Clinical Trials Clinical Trials Trials In-Vitro

BetterLife Engages Eurofins Discovery for its Next Generation Psychedelics 2-bromo-LSD FDA IND-enabling Pharmacology Studies

The Pharma Data

JANUARY 27, 2021

Eurofins Discovery will be conducting the IND-enabling in-vitro preclinical primary pharmacology and safety pharmacology studies on TD-0148A at its state-of-the-art facilities at Eurofins Cerep, DiscoverX and Panlabs. This approach makes Eurofins Discovery uniquely qualified to fulfill the needed studies for this innovative product.

In-Vitro

In-Vitro Containment Drugs Production

Janssen Presents Results from Phase 3 ACIS

The Pharma Data

FEBRUARY 8, 2021

Janssen Presents Results from Phase 3 ACIS Study in Patients with Metastatic Castration-Resistant Prostate Cancer Treated with ERLEADA ® (apalutamide) and ZYTIGA ® (abiraterone acetate) CombinationS. months; hazard ratio [HR] 0.69 [95% CI, 0.58-0.83]; 0.83]; p<0.0001). months; hazard ratio [HR] 0.69 [95% CI, 0.58-0.83]; 0.83]; p<0.0001).

HR

HR In-Vitro Development Clinical Trials

Roche launches new ways to use their cardiovascular tests empowering clinicians to improve diagnosis and treatment of millions of people

The Pharma Data

APRIL 27, 2021

They are among the first products certified under the new European In Vitro Diagnostics Regulation (IVDR) and available as of today in countries accepting CE mark. These gold standard biomarkers³ have proven to be successful in supporting cardiovascular disease management and can help clinicians diagnose heart attacks?

In-Vitro

In-Vitro Medicine Development Hormones

PFIZER REPORTS STRONG FIRST-QUARTER 2021 RESULTS

The Pharma Data

MAY 4, 2021

Multiple innovative and biosimilar products across our portfolio delivered growth, demonstrating the strength of our business and the depth and breadth of our growth drivers. Raises Full-Year 2021 Guidance (3) for Revenues to a Range of $70.5 Billion and Adjusted Diluted EPS (2) to a Range of $3.55 per share amounts). Adjusted Income (2).

Vaccination

Vaccination Vaccine Production Sales

Accelerating NDA filing through faster carcinogenicity assessment

Drug Discovery World

MAY 10, 2023

This stage is more highly regulated and consists of both preclinical testing and clinical trials. Specific guidelines set forth to regulate these testing processes are issued by the ICH, a non-profit organisation with representation from global regulatory agencies and pharmaceutical companies. billion and take over 10 years.

Bioassay

Bioassay Genotoxicity Drugs In-Vivo

Clinical Research Informer

Statement from Pfizer Chairman and CEO Albert Bourla on Testing Positive for COVID-19

Pfizer Responds to Research Claims

Trending Sources

Pfizer Receives Positive CHMP Opinion for Conversion of PAXLOVID™ Conditional Marketing Authorization to Full Marketing Authorization in the European Union

Pfizer to Provide U.S. Government with an Additional 3.7 Million Treatment Courses of PAXLOVID™ to Help Combat COVID-19

U.S. FDA Extends Review of Pfizer’s New Drug Application for PAXLOVID™

Global Roundup: Overland Pharma Launches in China to Provide Access to Breakthrough Therapies

Pfizer Signs Agreement to Provide the European Union with PAXLOVID™

Cardiac Biomarkers in Cardiovascular Clinical Trials: Caveats and Considerations

BetterLife Engages Eurofins Discovery for its Next Generation Psychedelics 2-bromo-LSD FDA IND-enabling Pharmacology Studies

Janssen Presents Results from Phase 3 ACIS

Roche launches new ways to use their cardiovascular tests empowering clinicians to improve diagnosis and treatment of millions of people

PFIZER REPORTS STRONG FIRST-QUARTER 2021 RESULTS

Accelerating NDA filing through faster carcinogenicity assessment

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