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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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Novo launches Saxenda in US, sees more launches in 2015

(Reuters) – Novo Nordisk has launched its Saxenda obesity drug in the United States, it said on Wednesday, a long-awaited milestone that will provide a new revenue stream for the Danish drugmaker. The company has said previously it expects sales from the drug to eventually reach $1 billion a year. It said in a statement […]

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MMR vaccine not linked to autism, even in high-risk kids

(Reuters Health) – The measles, mumps and rubella (MMR) vaccine is not linked to development of autism spectrum disorders, even among children considered to be at risk, a large new study finds.  Among nearly 100,000 children, receipt of the MMR vaccine did not increase the risk for autism spectrum disorder (ASD), regardless of whether kids […]

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Indian parliamentary committee recommends price caps for all drugs

(Reuters) – An Indian parliamentary committee has recommended that price caps should be extended to all drugs in the country and that the government should expedite the capping process. Indian law allows the National Pharmaceutical Pricing Authority (NPPA) regulator to fix prices of drugs on a list of essential medicines, thereby keeping prices in check […]

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GlaxoSmithKline Recalls Flu Vaccine Over Potency Issues

U.K.-based GlaxoSmithKline (GSK) announced on April 14, 2015 that it was recalling all remaining lots of its 2014-2015 Flulaval Quadrivalent flu vaccine. The company noted that two of the components of the vaccine, the B strains, appeared to have lost potency below the minimum specifications. The potency issue, according to the company, the U.S. Centers […]

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Oasmia’s Lead Cancer Product Paclical Receives Market Approval in the Russian Federation

UPPSALA, Sweden, April 20, 2015 /PRNewswire/ — Paclical, a novel formulation of paclitaxel based on Oasmia’s XR-17 technology, was approved for treatment of (i.e., it received market authorization for) epithelial ovarian cancer in combination with carboplatin. XR-17 is non-toxic and forms water soluble nanoparticles with paclitaxel.      (Logo: )  The Russia-based company Pharmasyntez holds the […]

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Lupin Launches Zaxine in Canada

MUMBAI and MONTREAL, April 20, 2015 /PRNewswire/ — Zaxine 550mg (rifaximin) is a long term antibiotic treatment for adults living with hepatic encephalopathy (HE), a complication of liver disease (cirrhosis). HE can lead to a wide spectrum of mental and physical symptoms, including confusion, disruption in sleep patterns, personality changes and coma Zaxine® 550mg has approved by […]

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Teva to pay $512 million to settle claims of delayed generic Provigil

(Reuters) – Teva Pharmaceutical Industries Ltd has agreed to pay $512 million to settle a class action claiming that Cephalon Inc, which Teva bought in 2011, used anticompetitive settlements to delay generic versions of its wakefulness drug Provigil, according to court papers. The settlement is the largest ever to be paid to drug buyers that […]

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Merck Cancer Drug Shines Against Skin, Lung Cancer

Merck’s immune-boosting cancer drug, Keytruda, bested the standard of care in advanced melanoma, the deadly skin cancer, and showed promising results in non-small cell lung cancer. Based on these data, Merck says it has filed an application with the Food and Drug Administration for Keytruda to be used in non-small cell lung cancer, and will soon […]

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Opiate overdoses fall after debut of abuse-resistant OxyContin

(Reuters Health) – Opiate prescriptions and overdoses in the U.S. have declined since the debut of an abuse-resistant version of the painkiller OxyContin and the market withdrawal of the narcotic Darvon, a study finds. Researchers reviewed insurance claims records with data on prescriptions and hospitalizations for more than 30 million adults covered by UnitedHealthCare from […]

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Merck Announces Submission of Supplemental Biologics License Application to U.S. FDA for KEYTRUDA in Advanced Non-Small Cell Lung Cancer

KENILWORTH, N.J.–(BUSINESS WIRE)–Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced that the company has submitted a supplemental Biologics License Application to the U.S. Food and Drug Administration (FDA) for KEYTRUDA® (pembrolizumab), the company’s anti-PD-1 therapy, for the treatment of advanced non-small cell lung cancer (NSCLC). KEYTRUDA previously received Breakthrough Therapy […]

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Teva shares slide on generic Copaxone fears

(Reuters) – Teva Pharmaceutical Industries shares slid five percent on Sunday after U.S. regulators approved a generic version of its top-selling multiple sclerosis drug and amid reports it was mulling a bid for rival Mylan. Teva’s Tel Aviv shares fell to 249.80 shekels ($64) late on Sunday, the first day of trading since both news […]

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Bristol’s Opdivo proves effective against second type of lung cancer

A large study of Bristol-Myers Squibb Co’s Opdivo treatment has been halted after proving the drug is effective against the most common form of lung cancer, the company said, positioning the medicine for far wider use than its already approved lung cancer and melanoma indications. The U.S. drugmaker on Friday said the study, called Checkmate-057, […]

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Pfizer wins first U.S. trial over Zoloft birth-defect risk

  Pfizer Inc. scored a key victory Friday when it was cleared of liability in the first U.S. trial involving claims that its antidepressant Zoloft can cause birth defects in children born to women who take the drug while pregnant. Plaintiff Kristyn Pesante claimed that Pfizer failed to warn that using Zoloft during pregnancy could […]

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U.S. FDA approves Amgen’s Corlanor heart failure drug

An Amgen sign is seen at the company’s office in South San Francisco, California, October 21, 2013. Reuters/Robert Galbraith (Reuters) – U.S. health regulators on Wednesday approved Amgen Inc’s Corlanor to treat patients with chronic heart failure, giving the world’s largest biotechnology company its first cardiovascular product. The Food and Drug Administration approved the use […]

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