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Virtual Trials Have (Finally) Arrived

In Clinical Trials by Barbara Jacoby

By: Josh Rose, VP, R&DS Global Strategy and Head of Virtual Trial Solutions, IQVIA From: pharmavoice.com How this remote model is transforming the clinical research experience, leading to lower costs and easier recruiting. The pharma industry has been talking about the benefits of virtual trials for years, but it’s only recently that the promise of conducting complex efficacy studies in …

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Positive CHMP Opinion for TALZENNA® (talazoparib) for Patients with Inherited (Germline) BRCA-Mutated Locally Advanced or Metastatic Breast Cancer

In Clinical Trials by Barbara Jacoby

Source: Business Wire From: yahoo.com Positive opinion based on results from largest Phase 3 trial performed to date of a PARP inhibitor in gBRCA-mutated advanced breast cancer Pfizer Inc. (PFE) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion recommending TALZENNA® (talazoparib), an oral poly (ADP-ribose) polymerase …

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Pfizer Receives European Approval for ZIRABEV™ (bevacizumab), a Biosimilar to Avastin®*

In In The News by Barbara Jacoby

From: argus-press.com Pfizer Inc. (NYSE: PFE) today announced the European Commission (EC) has approved ZIRABEV™ for the treatment of metastatic carcinoma of the colon or rectum, metastatic breast cancer, unresectable advanced, metastatic or recurrent non-small cell lung cancer (NSCLC), advanced and/or metastatic renal cell cancer and persistent, recurrent or metastatic carcinoma of the cervix. 1,2 “Pfizer is dedicated to increasing …

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Phase 3 ARCHES Trial Shows XTANDI® (enzalutamide) Significantly Improved Radiographic Progression-Free Survival in Men with Metastatic Hormone-Sensitive Prostate Cancer

In Clinical Trials by Barbara Jacoby

From: prnewswire.com Pfizer Inc. (NYSE: PFE) and Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., “Astellas”) announced today results from the Phase 3 ARCHES trial in men with metastatic hormone-sensitive prostate cancer (mHSPC). Prostate cancer is considered metastatic once the cancer has spread outside of the prostate gland to other parts of the body.1 Men are considered hormone …

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Pfizer Receives Positive CHMP Opinion for Vizimpro®

In Clinical Trials by Barbara Jacoby

Pfizer Receives Positive CHMP Opinion for Vizimpro® (dacomitinib) for the First-line Treatment of Adult Patients with Locally Advanced Or Metastatic Non-Small Cell Lung Cancer with EGFR-Activating Mutations Pfizer today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending Vizimpro® (dacomitinib) 45 mg, as monotherapy, be granted …

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Aileron Enters Clinical Trial Collaboration With Pfizer To Evaluate ALRN-6924 In Combination With IBRANCE® (Palbociclib) In MDM2-Amplified Cancers

In Clinical Trials by Barbara Jacoby

Source: Aileron Therapeutics, Inc. From: clinicalleader.com Aileron Therapeutics (NASDAQ: ALRN), the clinical-stage leader in the field of stabilized, cell-permeating peptides to treat cancer and other diseases, today announced that it has entered into a clinical trial collaboration with Pfizer to evaluate the combination of Aileron’s ALRN-6924 and Pfizer’s palbociclib, also known as IBRANCE®, in MDM2-amplified cancers. Overexpression of MDM2 in …

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Pfizer Gains Priority Review For Breast Cancer Drug, Can It Succeed?

In In The News by Barbara Jacoby

By: Terry Chrisomalis From: seekingalpha.com Summary Pfizer obtains priority review for talazoparib in treating patients with germline BRCA-mutated breast cancer, with FDA decision date by December 2018. Treatment with talazoparib in BRCA-mutated breast cancer reduced the risk of disease progression by 46%. If talazoparib is approved by the FDA it will have to go up against other competing drugs for the same …

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BCRF Announces the Expansion of the Drug Research Collaborative to Better Understand Potential Treatment Pathways for Breast Cancer Patients

In In The News by Barbara Jacoby

Source: Breast Cancer Resource Foundation From: PR Newswire Ahead of World Cancer Day, the Breast Cancer Research Foundation (BCRF) announced a new, independent research project funded by grants from Astellas and Pfizer to advance understanding of the role of the androgen receptor in breast cancer. This will be part of BCRF’s previously established Drug Research Collaborative. Astellas and Pfizer are …

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Pfizer, Novartis agree UK price cuts for new breast cancer drugs

In In The News by Barbara Jacoby

From: reuters.com Pfizer and Novartis have agreed price cuts for their rival breast cancer drugs Ibrance and Kisqali to ensure they can be used routinely within Britain’s state-funded health service. The National Institute for Health and Care Excellence (NICE), the country’s cost-effectiveness agency, said on Thursday the two drugs were being recommended despite uncertainty about how long they extend overall …

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Pfizer Oncology Launches the This is Living with Cancer™ Program

In In The News by Barbara Jacoby

Pfizer Oncology is launching This is Living with Cancer™, a program that provide tools and resources to support and inspire those who have been affected by cancer, including a mobile app, LivingWith™. The Mission Statement for this new program is provided as follows: To help redefine life with cancer Cancer is a life-changing illness. Today, with advances in treatment and …