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Exclusive: Clinton urges U.S. regulators to examine Daraprim price hike

Democratic presidential candidate Hillary Clinton on Monday urged U.S. regulators to determine how to bring lower-cost generic drugs to market more swiftly and combat anticompetitive practices in the pharmaceutical industry. Clinton’s requests to the Food and Drug Administration and the Federal Trade Commission were prompted by what she called the “egregious actions of Turing Pharmaceuticals,” […]

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India’s budget cuts hurt fight against malnutrition: Gandhi

India’s main program to fight child malnutrition has been hit by budget cuts that make it difficult to pay wages of millions of health workers, a cabinet minister said on Monday in a rare public criticism of Prime Minister Narendra Modi’s policies. Modi’s government in February slashed social sector budgets to boost infrastructure spending in […]

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Strong dermatology product sales help Valeant top estimates

Valeant Pharmaceuticals International Inc, which is under fire for massive price hikes of its two heart drugs, reported a better-than-expected quarterly profit, boosted mainly by strong performance in its U.S. dermatology business. Net income attributable to the company fell to $49.5 million, or 14 cents per share, for the third quarter ended Sept. 30, from […]

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Comparative Analysis Of Three Studies Confirms Rapid Action Of Irritable Bowel Syndrome (IBS) Novel Delivery System With Equivalent Amount Of L-menthol (At Same Level As Seen In IBgard)

Novel delivery system, Site Specific Targeting (SST®), demonstrates a pattern of rapid action in three studies for Irritable Bowel Syndrome (IBS) management In one study,  there was a significant reduction reported in intensity of most bothersome IBS symptoms after 2 hours and frequency and intensity at 24 hours In real world study, 75.6 percent of […]

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Johnson & Johnson’s Stelara succeeds in Phase III Crohn’s disease trial

Johnson & Johnson’s Stelara was significantly better than placebo at inducing clinical response and remissions in patients with moderate to severe Crohn’s disease, according to data from a late stage trial, providing ammunition for a potential expanded approval of the medicine. Stelara, a biotech medicine that blocks inflammation, is approved to treat the skin condition […]

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Results Of Clinical Data Presented At The Annual Meeting Of The American College of Gastroenterology Demonstrate Significant Relief Of Irritable Bowel Syndrome (IBS) Symptoms And High Levels Of Patient Satisfaction With IBgard, A Medical Food Using A New Approach In Managing IBS

– More than 85 percent of IBS patients reported a consistently high level of satisfaction with IBgard – High satisfaction ratings for IBgard reported in a patient population historically not satisfied with IBS treatment – More than 90 percent of patients reported willingness to recommend IBgard to friends and family who also suffer from IBS […]

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Genocea stops pneumonia vaccine development after study fails

Drug developer Genocea Biosciences Inc said it was suspending the development of a vaccine for pneumonia-causing bacteria after it failed to significantly reduce infection in a mid-stage study. The company’s shares fell 34 percent to $4.75 in premarket trading. Genocea said it was dropping the development of the vaccine, GEN-004, from its near-term plans to […]

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TARSA Therapeutics’ NDA For TBRIA, The First Oral Calcitonin For The Treatment Of Postmenopausal Osteoporosis, Accepted For Filing

PHILADELPHIA, Oct. 19, 2015 /PRNewswire/ — TARSA Therapeutics, Inc. today announced that its New Drug Application (NDA) for TBRIATM (calcitonin-salmon [rDNA origin] delayed release tablets) submitted to the U.S. Food and Drug Administration (FDA) in July 2015, has been accepted for review, with a PDUFA date of May 30, 2016. Calcitonin has been available as […]

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Eye drug setback hits Shire shares amid Baxalta pursuit

Shares in Shire Plc fell 2 percent on Monday after the U.S. Food and Drug Administration (FDA) decided not to approve its most important pipeline medicine for dry eye disease and asked for more information.   The news is a blow for Shire, which is to trying to buy Baxalta Inc to forge the leading […]

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Guidemark Health Names Chief Strategy Officer

October 19, 2015 (Parsippany, NJ): Guidemark Health furthers its commitment to its strategy and branding efforts by naming Martin Mannion as Chief Strategy Officer. With 25 years spent in marketing and advertising agencies, Mannion brings substantial healthcare strategy knowledge as well as diverse disease category experience to the Guidemark Health family. Previously he was Chief […]

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Orchestrated Customer Engagement

This white paper defines, describes, and documents the journey Life Sciences organizations may take to move from MCM and OCM to OCE.

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CME that Counts for ABIM MOC

Join our webinar on October 14 from 10:00 am–11:30 am Central to find out more about the Accreditation Council for CME (ACCME®) and American Board of Internal Medicine (ABIM) collaboration to simplify the integration of Maintenance of Certification (MOC) and accredited CME. We’ll answer your questions about registering CME activities for ABIM’s MOC program in […]

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The Integrated QC Micro Lab and Data Integrity

Lonza to Host Free Webinar on Integrated QC Processes and Data Integrity   Walkersville, MD, USA / Cologne, Germany, 16 October 2015 – Lonza has announced that it will host a free 60-minute webinar on 3 November 2015 titled “The Integrated QC Micro Lab and Data Integrity.” It will provide details about how laboratory professionals […]

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Technology Enabling Pharma Sales Force in Transforming Practice of Medicine to Science of Medicine

Mobile technology can give Pharmaceutical companies the boost it needs to improve marketing effective­ness and sales performance.

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FDA eye drug rebuff adds to Shire’s woes in Baxalta pursuit

Shire Plc suffered a setback for its most important pipeline medicine late on Friday, adding to the group’s problems as it pursues Baxalta Inc to forge the leading global specialist in rare diseases. The Irish company said the U.S. Food and Drug Administration (FDA) had declined to approve its new eye drug lifitegrast and had […]

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Early smoke exposure tied to increased atrial fibrillation risk

People exposed to secondhand smoke in the womb or as children are at an increased risk later in life for an irregular heart rhythm known as atrial fibrillation, a new study suggests.   “We can’t say that secondhand smoke definitely caused atrial fibrillation” based on this type of study, said senior author Dr. Gregory Marcus […]

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FDA Approves Praxbind (idarucizumab), Specific Reversal Agent for Pradaxa (dabigatran etexilate mesylate)

RIDGEFIELD, Conn., Oct. 16, 2015 /PRNewswire/ — Boehringer Ingelheim Pharmaceuticals, Inc. today announced the U.S. Food and Drug Administration (FDA) granted approval of Praxbind® (idarucizumab). PRAXBIND is indicated for patients treated with Pradaxa® (dabigatran etexilate mesylate), when reversal of the anticoagulant effects of dabigatran is needed for emergency surgery/urgent procedures or in life-threatening or uncontrolled bleeding. […]

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Daiichi Sankyo Inc. Reorganizes its U.S. Commercial Operations to Support Upcoming Specialty Pipeline

PARSIPPANY, N.J., Oct. 16, 2015 /PRNewswire/ — Daiichi Sankyo, Inc. (“the Company”) announced today that it will reorganize its U.S. Commercial organization as it begins to transition from a maturing primary care product portfolio to a differentiated specialty portfolio that will include areas such as cardiovascular, pain management and oncology.  “As we face the loss […]

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Nestle raises its bet on potential $10 billion health business

Nestle, famous for its coffee and chocolate, is stepping up investment in nutritional therapy, a business it believes will eventually generate annual sales of 10 billion Swiss francs ($10.5 billion).   Greg Behar, chief executive of Nestle Health Science, told Reuters that the unit formed in 2011 already had revenue of more than 2 billion […]

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Cempra’s experimental antibiotic succeeds in late-stage study

Cempra Inc moved a step closer to approval of its lead antibiotic after the potential blockbuster was successful in a second late-stage trial in patients with a common bacterial infection. Data announced in January had showed that the oral version of the drug was successful in a separate late-stage study in patients with community-acquired bacterial […]

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