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U.S. Food and Drug Administration Accepts Supplemental Biologics License Application for Opdivo (nivolumab) in Patients with Previously Untreated Advanced Melanoma

PRINCETON, N.J.–(BUSINESS WIRE)–Bristol-Myers Squibb Company (NYSE:BMY) today announced that the U.S. Food and Drug Administration (FDA) has accepted for filing and review the supplemental Biologics License Application (sBLA) for Opdivo (nivolumab) for the treatment of previously untreated patients with unresectable or metastatic melanoma. The FDA also granted Priority Review for this application. The projected FDA […]

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Breckenridge Announces Approval for Repaglinide Tablets, USP

BOCA RATON, Fla., April 29, 2015 /PRNewswire/ — Breckenridge Pharmaceutical, Inc. announces the final approval by the U.S. Food and Drug Administration of the Abbreviated New Drug Application for Repaglinide Tablets USP, which is being manufactured and supplied by Standard Chem. & Pharm. Co., Ltd. Taiwan, and will be available in 0.5mg, 1mg, and 2mg strengths. […]

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Express Scripts says controlling cancer-drug costs a tough new focus

(Reuters) – Pharmacy benefit manager Express Scripts Holding Co, which has aggressively negotiated lower costs of new hepatitis C drugs, on Wednesday said a new “focus area” will be subduing costs of a growing wave of pricey biotech cancer drugs. “This is going to be a much slower and much bigger effort over time than […]

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DNA Sequencing Market Will Exceed $20 Billion, Says Illumina CEO Jay Flatley

Illumina, one of the most important companies in biomedicine, is still barely known to the public. But scientists, diagnostics makers, physicians, and Wall Street look at the company with a mix of fear and awe. Just as Intel became the company that sparked so much of the computer revolution, Illumina has risen to prominence as […]

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BONESUPPORT Announces CE-Mark of CERAMENT|V, the First Injectable Vancomycin Eluting Bone Substitute in the Management of Osteomyelitis

LUND, Sweden, April 29, 2015 /PRNewswire/ — BONESUPPORT, an emerging leader in injectable bone substitutes for orthopedic trauma, bone infections and instrument augmentation related to orthopedic surgery, announced that it has received CE-mark for CERAMENT™|V, the first injectable vancomycin eluting bone substitute indicated to promote and protect bone healing in the management of osteomyelitis.  CERAMENT™|V is […]

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FDA could approve drugs for new uses on less data: draft law

(Reuters) – Draft U.S. legislation released on Wednesday could make it easier for drug companies to win Food and Drug Administration approval of products for new uses. Currently a company with a drug approved for lung cancer must conduct additional studies if it wants to market it for breast cancer. A bill drafted by the […]

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No Benefit For A Commonly Used Cardiac Device

Once again, after decades of common use, a frequently implanted device has been found to confer no benefit whatsoever over a much less invasive therapy. Cardiologists and radiologists often implant the device, called a retrievable inferior vena cava filter, inside people who are at high risk for developing potentially lethal blood clots. The filter is designed to prevent […]

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PCMA Statement on Safe Pharmacy Provision in the 21st Century Cures Draft

WASHINGTON, April 29, 2015 /PRNewswire-USNewswire/ — The Pharmaceutical Care Management Association (PCMA) issued the following statement regarding the Energy & Commerce Committee’s draft language on the 21st Century Cures initiative: “While we continue to review the latest draft language, we are pleased the Committee has included new patient protection programs aimed at reducing prescription drug […]

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FDA approves injection for ‘double chin’ reduction

(Reuters) – The U.S. Food and Drug Administration said on Wednesday it approved an injection for “double chin” reduction, developed by Kythera Biopharmaceuticals Inc. The drug, Kybella, is a formulation of synthetically-derived deoxycholic acid, which destroys fat under the chin, leaving surrounding tissue largely unaffected. Other injectables such as Allergan Inc’s Botox and other dermal […]

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Boston Scientific says atrial fibrillation device in demand

(Reuters) – Boston Scientific Corp expects more hospitals will be able to offer its new atrial fibrillation treatment starting by the end of the third quarter as it paces the product’s rollout to give physicians time to learn how to use it, its chief executive said. The device, called Watchman, was approved by U.S. regulators […]

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