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FDA puts partial clinical study hold on Venclexta

The U.S. Food and Drug Administration placed a partial clinical hold on all trials of AbbVie’s Venclexta for multiple myeloma, after a review of data found a higher proportion of deaths in the cancer drug arm of the late-stage study.

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AMAG’s PROLONG Study Fails to Hit Endpoints

Shares of AMAG Pharmaceuticals plunged after the company’s Phase III PROLONG trial of Makena failed to show a statistically significant difference from placebo in preventing preterm births.

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New Test Measures Pain Levels Using Biomarkers in the Blood

As the United States continues to grapple with the opioid epidemic, researchers have developed a new test that can measure pain biomarkers in the blood.

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Nektar, Bristol combo drug shows signs of tumor reduction in bladder cancer patients

Nektar Therapeutics said some patients with advanced bladder cancer treated with a combination of the company’s experimental treatment and Bristol-Myers Squibb’s immunotherapy Opdivo showed signs of tumor reduction in an early-stage study.

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Bayer, Janssen and BMS Unveil Promising Data for Prostate Cancer at ASCO GU

At the American Society of Clinical Oncology 2019 Genitourinary Cancers Symposium (ASCO GU), companies have showcased more clinical data in presentations for prostate cancer treatment.

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J&J acquires Auris Health for $3.4 billion

Johnson & Johnson plunked down $3.4 billion in cash to acquire privately held Auris Health Inc., a company that has developed robotic endoscopic technologies for the treatment of lung cancer.

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Navitas Life Sciences Announces Acquisition of DataCeutics to Augment Global Clinical Data Science Services

Navitas Life Sciences, a TAKE Solutions Enterprise, announced that the company will acquire Life Sciences services player DataCeutics in North America.

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Top 10 Pipelines To Watch: 2019 Annual Report

The return on R&D investment for leading biopharmaceutical manufacturers fell to a nine-year low while the U.S. FDA approved a record-breaking amount of novel medicines during 2018.

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Phase 3 ARCHES Trial Shows Xtandi Significantly Improved Radiographic Progression-Free Survival in Men with mHSPC

Pfizer Inc. and Astellas Pharma Inc. announced results from the Phase 3 ARCHES trial in men with metastatic hormone-sensitive prostate cancer (mHSPC).

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FDA Rejects Alkermes’ Opioid Modulator Treatment for Depression

The U.S. FDA rejected marketing approval of Alkermes’ major depressive disorder treatment ALKS-5461.

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February 2019 Focus: Agenda 2019, Top 10 Pipelines To Watch, Value Of Pharmaceuticals, and more!

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