article thumbnail

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

Pfizer

In preclinical studies, nirmatrelvir did not demonstrate evidence of mutagenic DNA interactions. Nirmatrelvir has shown consistent in vitro antiviral activity against the following variants: Alpha, Beta, Delta, Gamma, Lambda, Mu, and Omicron BA.1 FDA Emergency Use Authorization Statement.

Drugs 99
article thumbnail

Pfizer Receives Positive CHMP Opinion for Conversion of PAXLOVIDâ„¢ Conditional Marketing Authorization to Full Marketing Authorization in the European Union

Pfizer

In preclinical studies, nirmatrelvir did not demonstrate evidence of mutagenic DNA interactions. The European Commission (EC) will review the CHMP recommendation and is soon expected to make a final decision. PAXLOVID is currently approved or authorized for conditional or emergency use in more than 70 countries to treat COVID-19.

Insiders

Sign Up for our Newsletter

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.

article thumbnail

News from AACR 2024: Wednesday’s highlights

Drug Discovery World

Treatment of BRCA2-deficient but not wild-type DLD1 cells with BSM-1516 resulted in cell cycle arrest accompanied by DNA damage signalling and accumulation of chromatin-bound RPA32, a marker of ssDNA. It was announced that the next AACR Annual Meeting will take place in Chicago on 25-30 April 2025.

HR 52
article thumbnail

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

Pfizer

In preclinical studies, nirmatrelvir did not demonstrate evidence of mutagenic DNA interactions. 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. .

Drugs 110
article thumbnail

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

Pfizer

In preclinical studies, nirmatrelvir did not demonstrate evidence of mutagenic DNA interactions. 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. NEW YORK, December 20, 2022 -- Pfizer Inc. NYSE: PFE) announced today that the U.S.

Drugs 69
article thumbnail

Pfizer Signs Agreement to Provide the European Union with PAXLOVIDâ„¢

Pfizer

In preclinical studies, nirmatrelvir did not demonstrate evidence of mutagenic DNA interactions. This agreement, negotiated with the Health Emergency Preparedness and Response Authority (HERA) of the EC, is in addition to the bilateral agreements Pfizer has previously signed with 17 EU Member States. .

article thumbnail

Transforming high-throughput screening with mass spectrometry

Drug Discovery World

Arndt Aspe r ger , Senior Applications Scientist , Bruker Daltonics and M ei ke Hamester , Vice President Label-Free Technologies , Bruker Daltonics , examine how challenges in mass spectrometry for high-throughput screening can be overcome using a label-free approach. . The rapid evolution of HTS to meet industry demand .

Drugs 52