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U.S. FDA accepts application for Indivior’s new schizophrenia drug

The FDA accepted Indivior’s application for its new once-monthly injectable schizophrenia treatment.

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FDA proposes new fast path to market for certain medical devices

The U.S. Food and Drug Administration proposed creating a new fast track to market for certain medical devices and a potential reduction in the amount of safety data required for approval.

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Kyprolis improves overall survival in blood cancer

Amgen Inc. said a final analysis of late-stage trial data showed that its Kyprolis combined with two other drugs helped blood cancer patients live longer.

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Promising responses seen with Agios leukemia drug in study

Nearly a third of patients with an advanced form of a fast-progressing leukemia who carry a specific genetic mutation experienced a complete or near complete response to an experimental Agios Pharmaceuticals drug, according to data from an early-stage trial.

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FDA OKs Sanofi follow-on biologic

The U.S. Food and Drug Administration approved Sanofi SA’s Admelog as the first follow-on biologic version of Eli Lilly and Co.’s fast-acting insulin Humalog.

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Genentech’s Hemlibra Data Wows at ASH

At the American Society of Hematology meeting, Genentech revealed long-term data showing the drug maintains its efficacy over an extended period of time.

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bluebird, Celgene Tout ‘Unheard of’ Early-Stage Multiple Myeloma Data

Summit, NJ-based Celgene and Cambridge, Mass.-based bluebird bio released updated data from an ongoing Phase I clinical trial of bb2121 at the American Society of Hematology (ASH) Annual Meeting in Atlanta.

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‘Ground-breaking’ new drug gives hope in Huntington’s disease

Scientists have for the first time fixed a protein defect that causes Huntington’s disease by injecting a drug from Ionis Pharmaceuticals into the spine, offering new hope for patients with the devastating genetic disease.

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Verastem Announces Pivotal Clinical Data

The DUO study showed statistically significant PFS improvement for duvelisib versus standard of care treatment ofatumumab.

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PhRMA sues to stop California drug price law

The trade group representing U.S. drugmakers filed a lawsuit to stop California from implementing a law aimed at reining in prescription drug prices.

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