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FDA Approves Veklury (remdesivir) for the Treatment of COVID-19

The Pharma Data

reflect the shared commitment of Gilead, government agencies and clinical trial investigators to advance well-tolerated, effective treatment options for the fight against COVID-19. Previously authorized by the FDA for emergency use to treat COVID-19, Veklury is now the first and only approved COVID-19 treatment in the United States.

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

Pfizer

The European Commission (EC) will review the CHMP recommendation and is soon expected to make a final decision. 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.

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News from AACR 2024: Wednesday’s highlights

Drug Discovery World

In clonogenic assay, BRCA2-deficient DLD1 cells were ~15-fold more sensitive to FEN1 inhibition than their isogenic BRCA2-wild-type counterparts (EC50 of 350nM and 5µM, respectively), confirming the increased susceptibility of HR deficient cancer cells to FEN1 inhibition. And thanks to the city of San Diego for its hospitality.”

HR 52
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Patient-Reported Outcomes from the Positive Phase 3 monarchE Trial for Verzenio® at St. Gallen Virtual Congress 2021

The Pharma Data

This analysis revealed the addition of Verzenio to ET did not result in a clinically meaningful difference in patients reporting being bothered by treatment side effects. Tolaney, MD, MPH, Harvard Medical School, Dana-Farber Cancer Institute. Overall, patient compliance for PROs was greater than 90 percent.

HR 52
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Roche announces positive CHMP opinion for Venclyxto-based combinations in certain patients with acute myeloid leukaemia

The Pharma Data

Results of the VIALE-A study showed Venclyxto plus azacitidine significantly reduced the risk of death by 34% (overall survival; OS), compared to azacitidine alone (HR=0.66; 95% CI: 0.52, 0.85; p<0.001). Roche announces positive CHMP opinion for Venclyxto-based combinations in certain patients with acute myeloid leukaemia.

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

Pfizer

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.

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

Pfizer

Results from these analyses are consistent with previously disclosed efficacy and safety data for the trials. Results from these analyses are consistent with previously disclosed efficacy and safety data for the trials. FDA Extends Review of Pfizer’s New Drug Application for PAXLOVID™. Tuesday, December 20, 2022 - 04:30pm. In the U.S.,

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