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Keytruda succeeds in late-stage lung cancer study

Merck & Co.’s cancer drug Keytruda helped extend survival and prevented disease progression when tested in a late-stage study in combination with chemotherapy for a type of lung cancer.

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Sesen Bio Shares Plunge Despite Reporting Positive Interim Phase III Results

Shares of newly dubbed Sesen Bio plunged 23 percent after the company released positive, three-month data from its ongoing Phase III high-grade non-muscle invasive bladder cancer trial.

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Nabriva shares tumble as safety worries plague pneumonia drug

Nabriva Therapeutics Plc’s potential new antibiotic to treat a common form of pneumonia met the main goal of a key clinical trial.

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Roche drug dramatically reduces bleeds in key hemophilia tests

Roche’s recently launched medicine Hemlibra dramatically reduced bleeding in a broad population of hemophilia patients, results from two clinical trials showed.

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J&J Ends Early Alzheimer’s Program

Johnson & Johnson’s Janssen division decided to end clinical trials of atabacestat, a BACE inhibitor, for Alzheimer’s disease.

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Alecensa Beats Out Xalkori in Late-Stage Study

Genentech, a Roche company, released follow-up data from its Phase III ALEX trial comparing its Alecensa (alectinib) to Pfizer’s Xalkori (crizotinib) in late-stage non-small cell lung cancer.

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AstraZeneca’s drug Fasenra flops in COPD trial

AstraZeneca’s first respiratory biologic medicine Fasenra failed to meet its target in a clinical trial treating patients with moderate to very severe chronic obstructive pulmonary disease (COPD).

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Rhythm Pharmaceuticals Publishes Longer-Term Data on LEPR Deficiency Obesity Study

As Boston-based Rhythm Pharmaceuticals moves its lead obesity treatment into a second Phase III trial, the company was bolstered by the publication of longer-term data from its Phase II study of setmelanotide in Nature Medicine.

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Roche’s Tecentriq fails key cancer trial

Roche’s hopes of Tecentriq catching rival medicines from Merck and Bristol-Myers Squibb were dealt a blow after the immunotherapy failed a key combination trial.

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Janssen Closes in on Seeking FDA Approval for Ketamine-Based Depression Treatment

Janssen Pharmaceuticals is eying a potential breakthrough in treating refractory major depressive disorder.

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Celgene Plans To File 2nd NDA for Ozanimod in 2019

Celgene is eying the first quarter of 2019 to submit a second New Drug Application (NDA) for the multiple sclerosis treatment ozanimod.

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Scientists devise more accurate peanut allergy test

British scientists have developed a far more accurate blood test to diagnose peanut allergy, offering a better way to monitor a significant food hazard.

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More sauna visits tied to lower risk of stroke

A Finnish study suggests a regular sauna habit is associated with a lower risk of strokes.

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Bristol-Myers Squibb Abandons Two Phase III Trials of IDO1 Inhibitor Program

Bristol-Myers dropped two Phase III clinical trials of the IDO1 inhibitor acquired from Flexus Biosciences.

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Migraine drug succeeds in second late-stage trial

Allergan Plc announced positive results from a second Phase III trial for a 50-milligram dose of the company’s drug for acute migraine, reproducing results from the previous clinical study.

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Study: 44 genetic risk factors for major depression

International scientists identified 44 genetic variants that can increase the risk of developing major depression and found that all humans carry at least some of them.

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Boehringer Ingelheim R&D Pushes to Transcend Disease Boundaries

Boehringer Ingelheim presented the family-owned pharmaceutical company’s latest pipeline updates at an R&D press conference entitled ‘Transcending Disease Boundaries’ at its global headquarters in Ingelheim, Germany.

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Cancer immunotherapy combo flops in study

The concept of combining two immunotherapy drugs to fight lung cancer suffered a fresh blow from the failure of an AstraZeneca clinical study.

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FDA panel against higher dose of arthritis drug

An arthritis drug developed by Eli Lilly and Co. and Incyte Corp. should not be approved at a 4-milligram dose, advisers to the U.S. FDA voted.

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Bluebird Bio One Step Closer to First Approved Drug

Bluebird bio announced interim data from two different two-year clinical trials of LentiGlobin gene therapy for transfusion-dependent beta-thalassemia (TDT).

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April 2018 Focus: Agency Profiles, Manny Awards and Annual Review


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