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Cubist Begins Phase 3 Trial for Opioid-Induced Constipation

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Cubist Pharmaceuticals initiates a Phase 3 clinical study of CB-5945 in patients with opioid-induced constipation.

Changes Made in Cellular, Tissue, and Gene Therapies Meeting

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Federal Register Notice: FDA amends a notice of a 11/29 meeting of the Cellular, Tissue and Gene Therapies Advisory Committee to m...

Track and Trace Begins at Lot Level: Law Firm

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A bill being floated on Capitol Hill to establish a nationwide drug tracking system allows tracking at the lot level and not at th...

FDA OKs GI Dynamics EndoBarrier Trial in Diabetics

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FDA grants approval for GI Dynamics to initiate a clinical trial of EndoBarrier for treating patients who have uncontrolled Type 2...

Neuraltus Looking to Phase 3 ALS Drug Trial

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Neuraltus says it is planning a Phase 3 trial of its NP001 in patients with Lou Gehrigs disease.

FDA Approves First PMA Module for Surgical Adhesive

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FDA approves the first of four PMA modules submitted by Cohera Medical for its TissuGlu Surgical Adhesive product.

FDA Accepts Applications for Latuda Expanded Indications

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FDA accepts for review two applications from Sunovion for expanded indications for its schizophrenia drug Latuda.

Ortho Molecular Selling Unapproved New Drugs: Letter

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FDAs Minneapolis District Office warns Ortho Molecular Products that it is selling unapproved new drugs that are mislabeled.

Quality Violations Found at Atrium Medical Corp

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FDAs New England District Office warns Atrium Medical Corp. about Quality System violations in its manufacturing of several medica...

FDA Continuing to Look at OTC with Special Conditions

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CDER Office of Medical Policy deputy director Rikin Mehta says FDA is moving forward with its exploration of whether some drugs co...