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Tagrisso Granted Breakthrough Therapy Designation by US FDA for the 1st-Line Treatment of Patients with EGFR Mutation-Positive Non-Small Cell Lung Cancer

AstraZeneca today announced that the US Food and Drug Administration granted Breakthrough Therapy Designation for Tagrisso (osimertinib) for the first-line treatment of patients with metastatic epidermal growth factor receptor mutation-positive non-small cell lung cancer.

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Acerta Pharmaceuticals Falsified Early Data on Cancer Compound, Now in Clinical Trials

Acerta Pharmaceuticals is being forced to retract claims of a therapeutic benefit of acalabrutinib in a mouse model of pancreatic cancer that was published in three medical journals two years ago due to falsified data.

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U.S. court reverses ban on sale of Sanofi, Regeneron drug Praluent

A U.S. appeals court threw out a ban on the sale of Sanofi SA and Regeneron Pharmaceuticals Inc.’s cholesterol-lowering drug Praluent.

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Neurocrine Announces FDA Approval of 80 mg Ingrezza Capsules for the Treatment of Adults with Tardive Dyskinesia

Neurocrine Biosciences Inc. announced today that the U.S. Food and Drug Administration approved an 80-mg Ingrezza (valbenazine) capsule strength to be used for the treatment of adults with tardive dyskinesia.

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Sarepta Jumps Despite DMD Safety Issues in FDA Database

Shares of Sarepta Therapeutics recovered from a dip of about 8 percent as investors seem to have rallied behind the company’s Duchenne muscular dystrophy (DMD) drug Exondys 51.

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Celgene Teams Up With Cambridge Biotech Nimbus To Tackle Autoimmune Diseases

Celgene entered into a partnership to take on autoimmune diseases with two of New Jersey-based Nimbus Therapeutics’ preclinical therapeutics.

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Shire sues Allergan in U.S. over dry eye drug

Allergan Plc was sued by Shire Plc for allegedly scheming to block doctors from prescribing its new treatment for dry eye disease.

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Merck & Co. Terminates Hep C Development Programs

Following a review of Phase II efficacy data and a scan of the “evolving marketplace,” Merck & Co. announced that the company was terminating two hepatitis C programs.

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U.S. picks companies to help make rules for advanced personal health monitors

Digital devices designed to monitor the wearer’s health in much greater detail than current models will need regulatory approval, and Apple Inc., Fitbit Inc. and seven other companies will take part in a program to speed the approval process, the U.S. health regulator said.

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FDA pours cold water on PTC Therapeutics’ Duchenne drug application

PTC Therapeutics Inc. failed to supply persuasive evidence that its experimental drug to treat a form of Duchenne muscular dystrophy is effective, the U.S. Food and Drug Administration said, dealing a blow to the company’s years-long effort to bring the drug to market.

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