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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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India’s Wockhardt to recall some drugs made in India after U.S. FDA concerns

(Reuters) – Indian generic drugmaker Wockhardt Ltd said on Tuesday it would recall some drugs manufactured at its two plants in India before the U.S. Food and Drug Administration (FDA) banned those sites due to quality concerns. The FDA banned U.S. exports from Wockhardt’s Waluj and Chikalthana plants in central India in 2013, citing manufacturing […]

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Progress In Cancer Drug Lifts Merck Earnings, Sending Stock Higher

Like nearly every other company that does any business overseas, pharmaceutical giant Merck saw its revenue take a hit from foreign exchange during the first quarter of 2015. But because the company’s ultimate profit and revenue results were above what Wall Street was expecting to see — and because sales were helped by a promising new […]

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How Lead Product Dependency Shapes Corporate Strategy In Pharma

A number of recent high-profile events in the pharmaceutical industry have showcased the significance of lead product dependency – that is, the proportion of revenues a company derives from its largest selling drug – on corporate strategy. Indeed, lead product dependency has played an integral role in two recently proposed acquisitions with a combined value […]

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FDA approves first generic for blockbuster antipsychotic Abilify

The headquarters of the U.S. Food and Drug Administration (FDA) is shown in Silver Spring, Maryland, November 4, 2009. Reuters/Jason Reed (Reuters) – The U.S. Food and Drug Administration said it approved the first copycat versions of Otsuka Pharmaceutical Co Ltd’s antipsychotic drug Abilify. Generic versions of the drug have been approved for mental illnesses […]

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Astellas Launches CRESEMBA® (isavuconazonium sulfate) in the United States for the Treatment of Invasive Aspergillosis and Invasive Mucormycosis

NORTHBROOK, Ill., April 27, 2015 /PRNewswire/ — Astellas announced today that CRESEMBA® (isavuconazonium sulfate), the prodrug for isavuconazole, is now available in the United States for the treatment of adult patients with invasive aspergillosis and invasive mucormycosis (also known as zygomycosis). These are life-threatening fungal infections predominantly occurring in immunocompromised patients. On March 6, 2015, the […]

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Merck’s diabetes drug Januvia succeeds in heart safety trial

(Reuters) – Merck and Co’s diabetes drug Januvia achieved the main goal of a long-awaited heart safety study, according to preliminary results released by the drugmaker on Monday, likely removing a cloud of uncertainty from its biggest product. Merck shares rose nearly 4 percent in after-hours trading following the announcement on Januvia, which had sales […]

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Lilly's CYRAMZA® (ramucirumab) Receives Fourth FDA Approval

INDIANAPOLIS, April 24, 2015 /PRNewswire/ — Eli Lilly and Company (NYSE: LLY) has received its fourth U.S. Food and Drug Administration (FDA) approval for CYRAMZA® (ramucirumab). CYRAMZA (ramucirumab injection 10 mg/mL solution) is now also indicated in combination with FOLFIRI (irinotecan, folinic acid, and 5-fluorouracil) chemotherapy for the treatment of patients with metastatic colorectal cancer (mCRC) with disease […]

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Researchers find alarming rise in cost of MS drugs over past two decades

PORTLAND, Ore., April 24, 2015 /PRNewswire/ — A new study shows an “alarming rise” over the last 20 years in the costs of drugs used to slow the progression of multiple sclerosis or reduce the frequency of attacks, according to a study led by researchers at Oregon Health & Science University (OHSU) and Oregon State University […]

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Expanding Naloxone use could reduce drug overdose deaths and save lives

ATLANTA, April 24, 2015 /PRNewswire-USNewswire/ — Allowing more basic emergency medical service (EMS) staff to administer naloxone could reduce drug overdose deaths that involve opioids, according to a Centers for Disease Control and Prevention (CDC) study, “Disparity in Naloxone Administration by Emergency Medical Service Providers and the Burden of Drug Overdose in Rural Communities,” published […]

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Bristol wins EU green light for immune system cancer drug

(Reuters) – European regulators have recommended approval of Bristol-Myers Squibb’s Opdivo, paving the way for it to become the first of a closely watched group of immune system-boosting cancer medicines to go on sale in Europe. The drug, also known as nivolumab, was given a green light on Friday by the European Medicines Agency (EMA) […]

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