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Serious side effects seen with failed Merck niacin drug -study

Posted: Published on March 9th, 2013

By Bill Berkrot March 9 (Reuters) - Unexpected serious side effects arose in a huge study of a Merck & Co long-acting niacin drug aimed at raising good HDL cholesterol, according to data released on Saturday, possibly adding a final nail to the coffin of niacin therapy for heart patients. Merck (Other OTC: MKGAY - news) has already given up on the drug that combines extended-release niacin with an experimental agent called laropiprant, designed to prevent the uncomfortable facial flushing associated with niacin. When it was announced that the drug called Tredaptive had failed to show benefit in preventing heart attacks, strokes, death and other complications in heart patients also taking statins to lower bad LDL cholesterol, Merck said it would not seek U.S. approval and stop selling it in the dozens of other countries where it was already available. A European medical journal last week said the drug caused concerning muscle weakness, especially in Asian patients. But the final results presented on Saturday at the American College of Cardiology scientific meeting in San Francisco painted an even more troubling picture of the medicine. Researchers found patients taking the Merck drug had significantly higher rates of bleeding - 2.5 percent … Continue reading

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Web searches could expose new drug side effects

Posted: Published on March 9th, 2013

Scientists acknowledge that an individual's search data doesn't always reflect an accurate picture. STORY HIGHLIGHTS (TIME.com) -- Researchers looking for previously undiscovered drug side effects are turning to web searches for answers. When drugs are approved by the Food and Drug Administration, they are vetted for potential side effects, and drug makers are required to divulge these on their products' labels. But not all side effects emerge in the short term studies that manufacturers conduct, so many only come to light when hundreds of thousands, and even millions of people start using a medication. And what better way, a group of researchers from the Stanford University School of Medicine and Microsoft Research decided, to suss out some of these unexpected side effects than to turn to where people are most likely to report, share and ask about them -- the internet. The researchers combed through a year of web search history from 6 million Internet user volunteers. Using automated tools, the scientists were able to to mine anonymous data from 82 million drug-symptom and condition searches made by the participants who agreed to let the users install a Microsoft plug-in to monitor their history. The team was rewarded with a … Continue reading

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UPDATE 1-Serious side effects seen with failed Merck niacin drug

Posted: Published on March 9th, 2013

By Bill Berkrot SAN FRANCISCO, March 9 (Reuters) - Unexpected serious side effects arose in a huge study of a Merck & Co long-acting niacin drug aimed at raising good HDL cholesterol, according to data released on Saturday, possibly adding another nail to the coffin of niacin therapy for heart patients. Merck (Other OTC: MKGAY - news) has already given up on the drug that combines extended-release niacin with an experimental agent called laropiprant, designed to prevent the uncomfortable facial flushing associated with niacin. When it was announced that the drug called Tredaptive had failed to prevent heart attacks, strokes, death and other complications in heart patients also taking drugs to lower bad LDL cholesterol, Merck said it would not seek U.S. approval and would stop selling it in the dozens of other countries where it was already available. A European medical journal last week said the drug caused concerning muscle weakness, especially in Asian patients. But the results presented on Saturday at the American College of Cardiology scientific meeting in San Francisco painted an even more troubling picture of the medicine. Researchers found patients taking the Merck drug had significantly higher rates of bleeding - 2.5 percent vs 1.9 … Continue reading

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Serious side effects seen with failed Merck niacin drug

Posted: Published on March 9th, 2013

SAN FRANCISCO (Reuters) - Unexpected serious side effects arose in a huge study of a Merck & Co long-acting niacin drug aimed at raising good HDL cholesterol, according to data released on Saturday, possibly adding another nail to the coffin of niacin therapy for heart patients. Merck has already given up on the drug that combines extended-release niacin with an experimental agent called laropiprant, designed to prevent the uncomfortable facial flushing associated with niacin. When it was announced that the drug called Tredaptive had failed to prevent heart attacks, strokes, death and other complications in heart patients also taking drugs to lower bad LDL cholesterol, Merck said it would not seek U.S. approval and would stop selling it in the dozens of other countries where it was already available. A European medical journal last week said the drug caused concerning muscle weakness, especially in Asian patients. But the results presented on Saturday at the American College of Cardiology scientific meeting in San Francisco painted an even more troubling picture of the medicine. Researchers found patients taking the Merck drug had significantly higher rates of bleeding - 2.5 percent vs. 1.9 percent - and infections - 8.0 percent vs. 6.6 percent … Continue reading

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Fred Sales Slip in January

Posted: Published on March 9th, 2013

Recently, Fred's Inc. (FRED) reported total sales and comparable sales for Feb 2012. While total sales increased marginally from the comparable period in the prior year, comparable sales declined. Deferred sales related to the spring layaway program would have added 60 bps of growth to both total and comparable store sales. Comparable store sales for the month fell 1.5% compared to a slip of 0.7% in the year-ago month. The decline was attributed to lower transactions due to economic headwinds, ongoing tax processing and refunds, and higher payroll taxes. Comparable store sales for general merchandise was however positive for the second straight quarter, helped by new products in auto/hardware and strength at its discount tobacco shop. Pharmacy department sales saw positive script growth that was offset by the ongoing brand-to-generic shift in the pharmacy industry, which affected comparable sales by 280 basis points. Total sales for Feb 2013 marginally increased to $159.2 million compared to $159.0 million a year ago. The company opened one store and an Xpress pharmacy during the month. Guidance Lowered Keeping in view higher insurance and operating cost and lowering of prices on basic and consumable products, the company lowered its fourth quarter 2012 earnings to … Continue reading

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The Obesity Drug War Continues

Posted: Published on March 9th, 2013

Motley Fool health care analyst Max Macaluso and Fool contributor Brian Orelli sat down to discuss the impending launch of Arena Pharmaceuticals' (NASDAQ: ARNA) obesity drug Belviq and the obesity drug market in general. Their conversation follows: Max Macaluso: So, Brian, let's start by talking about Arena Pharmaceuticals' fourth-quarter results. I listened to the conference call on Monday and was hoping to get a clearer picture of when Belviq will actually be available. The drug is ready to be launched by Arena's partner Eisai, but the DEA scheduling is still not complete. Why is this process taking so long? Brian Orelli: Belviq has the potential for abuse, so in addition to the FDA approval, the companies had to get the DEA involved. The drug's potential for abuse is pretty low. The FDA recommended a Schedule IV designation, which shouldn't hamper marketing the drug beyond filling out some additional DEA paperwork. Sleeping aids are usually Schedule IV; Pain medications like OxyCotin or Viodin are either Schedule II or Schedule III and have more restrictions since they have more potential for abuse. The DEA agreed with the FDA and gave it a Schedule IV designation. But then there's a 30-day public comment … Continue reading

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Injectable Drug Delivery – Drugs , Devices, Targets, Therapeutics and Forecasts to 2018

Posted: Published on March 9th, 2013

DUBLIN, Ireland, March 8, 2013 /PRNewswire/ -- Research and Markets has announced the addition of the "Injectable Drug Delivery to 2018 Drugs, Devices, Targets, Therapeutics and Forecasts" market research report to their offering. (Logo: http://photos.prnewswire.com/prnh/20130307/600769 ) The past decade has seen a dramatic shift in terms of the types of approved injectable drugs, the diseases they target, and the devices used to deliver them. This shift has fostered change on several levels of the healthcare sector. The injectable drug segment has seen a marked increase in the level of drug/device integration, as prefilled syringes and specialized injection devices proliferate in response to safety and economic challenges posed by recombinant protein drugs, while administration of injectables has moved increasingly from practitioner offices and healthcare facilities to patient homes. This report examines the key therapeutic, product, market and regulatory factors for injectable drugs across ten major disease and therapeutic classes, providing essential insight and forecasts into the implications of this evolving landscape. Highlights - Analyzes and evaluates the shifting landscape for injectable drug delivery and assesses the market impact of new and emerging injectable drug products by therapeutic indication - Analyzes syringe and injector device designs, feature/functionality, product branding, competing technologies and … Continue reading

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New WVU center will do human trials for new drugs

Posted: Published on March 9th, 2013

MORGANTOWN, W.Va. (AP) -- West Virginia University has launched a research center to conduct human clinical trials on new drugs that are being developed, and its first partner is the generic drug maker Mylan Inc. The Clinical and Pharmacological Research Center will recruit volunteers from Morgantown and beyond to participate in the trials, which could lead to partnerships with other companies in the pharmaceutical and biotechnology industries, said WVU Health Sciences Chancellor Christopher Colenda. "This is an important investment for the economic future of our community," he said. The venture was created by the WVU Research Corp. and the WVU Health Sciences Center. It already has a contract with Pennsylvania-based Mylan, which has a manufacturing facility in Morgantown. Mylan officials didn't immediately comment Friday on what kind of drugs the center would test first or when those trials would begin. Dr. Dorian Williams, the center's interim director, said the health and safety of volunteers is the top priority, and all will be fully informed of the risks they face. Participants are paid, but Williams said those payments are strictly regulated and related to the amount of time and blood draws required. "Short, two-weekend studies would typically pay around $200-500," he … Continue reading

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Wasted lives: Queensland's drugs battle

Posted: Published on March 9th, 2013

The increasing threat posed by synthetic drugs readily available online or in stores as "legal highs" and the rise of social drug users are causing serious concern among those at the pointy end of Queensland's drug battle. The evidence of the social drug culture is on display every Saturday night in pubs and clubs across the state. The fall-out is acutely felt by emergency workers from hospital casualty departments to frontline police. Experts are concerned about the rise of the social drug user. Over the past month, Fairfax Media has explored the issues around the production and distribution of drugs in Queensland, the effects on users, and the impacts on those desperately working to stem the tide and tackle the toll. Advertisement In this special series Wasted Lives: Queensland's Drug Battle, police, emergency physicians, the state's corruption watchdog, and those most affected by illicit substances describe the drug scene as they see it today. About one in six Queenslanders had used illicit drugs in the 12 months leading up to the 2010 National Drug Survey involving almost 27,000 Australians. The Queensland figure outstripped the national average of 14.7 per cent and was the third highest behind the Northern Territory with … Continue reading

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Drugs .com Launches iOS and Android Mobile App to Empower Patients and Providers Alike

Posted: Published on March 9th, 2013

NEW YORK, March 8, 2013 /PRNewswire/ -- Drugs.com, the leading online clinical drug resource, today announced they have launched the Drugs.com Medication Guide, a mobile app to facilitate patient engagement in their own medication management. The "Drugs.com Medication Guide" app is now available as a free download on the popular iOS and Android mobile platforms. Utilizing the Drugs.com Medication Guide app, patients and caregivers can have instant access to their most recent personal medication records, saved drug interactions lists, and breaking FDA and health news tailored to their needs. In addition, consumers can easily navigate through the most trusted and unbiased sources of medical information to make educated health decisions. "As the U.S. healthcare system moves through the upcoming stages of meaningful use, patients will be empowered to utilize mobile health apps to manage their medications and maintain wellness," said Philip Thornton, CEO of Drugs.com. "The latest Drugs.com Medication Guide app is a practical tool to shorten this learning curve for both patients and caregivers alike. Medication management, safety and adherence will simply become easier." The Drugs.com app provides consumers with easy access to vital health information tools such as MedNotes, the Symptom Checker, and the Complete Drugs A to … Continue reading

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