HR, In-Vitro and Trials - Clinical Research Informer

Roche to present a broad range of data across multiple cancer types at the ESMO Virtual Congress 2020

The Pharma Data

SEPTEMBER 16, 2020

Blueprint Medicines will present new data from the registrational phase I/II ARROW trial, investigating Gavreto TM (pralsetinib) for the treatment of people with RET-mutant medullary thyroid cancer. New and updated data from across our broad cancer portfolio including phase III results in breast, lung and prostate cancers.

HR

HR Medicine Hormones Trials

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

The Pharma Data

OCTOBER 22, 2020

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.

FDA Approval

FDA Approval Trials Clinical Trials Clinical Trials

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

Pfizer

DECEMBER 20, 2022

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.,

Drugs

Drugs Licensing Licensing Containment

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

Top 20 Drugs in 2023 by 2022 Sales Statistics

XTalks

DECEMBER 19, 2023

In the fast-evolving pharmaceutical landscape, tracking the top-selling drugs offers valuable insights into trends, healthcare priorities and the dynamics of the global market. As we approach the end of 2023, a retrospective look at the statistics from 2022 reveals the top 20 drugs dominating retail sales. 2) Humira (adalimumab) Sales in 2022: $21.24

Sales

Sales FDA Approval Drugs Vaccination

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.

Drugs

Drugs Vaccination Vaccine In-Vitro

News from AACR 2024: Wednesday’s highlights

Drug Discovery World

APRIL 11, 2024

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

HR Antibody In-Vitro DNA

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

The Pharma Data

MARCH 17, 2021

The data builds on the primary outcome analysis of the positive Phase 3 monarchE trial that previously showed Verzenio, in combination with ET, decreased the risk of breast cancer recurrence by 28.7 Tolaney, MD, MPH, Harvard Medical School, Dana-Farber Cancer Institute. Overall, patient compliance for PROs was greater than 90 percent.

HR

HR Trials In-Vitro Manufacturing

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., Pfizer Responds to Research Claims carterda Fri, 01/27/2023 - 19:48 Pfizer Responds to Research Claims Friday, January 27, 2023 - 08:00pm Share New York, N.Y., It is important to note that these studies are required by U.S.

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

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.

Marketing

Marketing Production Drugs Licensing

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

The Pharma Data

APRIL 23, 2021

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.

Medicine

Medicine In-Vitro Antibody Branding

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

Janssen Presents Results from Phase 3 ACIS

The Pharma Data

FEBRUARY 8, 2021

Patients in the trial received either a combination of ERLEADA ® and ZYTIGA ® plus prednisone (combination arm) or placebo and ZYTIGA ® plus prednisone (control arm). [i] months; hazard ratio [HR] 0.69 [95% CI, 0.58-0.83]; months; hazard ratio [HR] 0.69 [95% CI, 0.58-0.83]; months: HR 0.70 [95% CI, 0.60-0.83]).

HR

HR In-Vitro Development Clinical Trials

PFIZER REPORTS STRONG FIRST-QUARTER 2021 RESULTS

The Pharma Data

MAY 4, 2021

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 Now Anticipates Revenues of Approximately $26 Billion for BNT162b2, Reflecting 1.6 Billion Doses Expected to be Delivered in 2021 Under Signed Contracts as of Mid-April 2021. per share amounts). Reported Diluted EPS (1).

Vaccination

Vaccination Vaccine Production Sales

Clinical Research Informer

Roche to present a broad range of data across multiple cancer types at the ESMO Virtual Congress 2020

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

Trending Sources

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

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

Top 20 Drugs in 2023 by 2022 Sales Statistics

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

News from AACR 2024: Wednesday’s highlights

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

Pfizer Responds to Research Claims

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

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

Pfizer Signs Agreement to Provide the European Union with PAXLOVID™

Janssen Presents Results from Phase 3 ACIS

PFIZER REPORTS STRONG FIRST-QUARTER 2021 RESULTS

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