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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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