Patient-controlled pain drug device approved by FDA
May 4th 2015Patients who are recovering from surgery in the hospital now have the opportunity to control their analgesic dosing. Ionsys (fentanyl iontophoretic transdermal system) from The Medicines Company has just been approved by FDA for this use.
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FDA approves Breo Ellipta for treatment for asthma in adults
May 4th 2015FDA has approved fluticasone furoate/ vilanterol (Breo Ellipta) for the treatment of asthma in adults. Breo Ellipta is a fixed-dose combination of fluticasone furoate, which is an inhaled corticosteroid (ICS), and vilanterol, which is a long-acting beta 2 agonist (LABA). The fluticasone reduces inflammation while the vilanterol acts to open the airways. Breo Ellipta is administered using the Ellipta dry powder inhaler and comes in two strengths, 100/25 mcg and 200/25 mcg.
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PCORI approves trial to determine best aspirin dose to help heart disease patients
May 4th 2015The Patient-Centered Outcomes Research Institute (PCORI) Board of Governors this week approved a 3-year, $14 million clinical trial designed to determine the best dose of aspirin to use to prevent heart attacks and strokes in people with heart disease.
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FDA warns supplement firms over unapproved ingredient
May 4th 2015The FDA issued warning letters to 14 dietary supplement manufacturers because they are using an ingredient not approved for use.The ingredient in question is 4-Amino-2-Methylpentane Citrate, also known as 1,3-Dimethylbutylamine, 2-amino-4-methylpentane, AMP citrate, and 4-methyl-2-pentanamine, or DMBA.
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FDA issues biosimilar final guidance
May 1st 2015FDA has issued 3 final biosimilar guidances for industry: Scientific Considerations in Demonstrating Biosimilarity to a Reference Product; Quality Considerations in Demonstrating Biosimilarity of a Therapeutic Protein Product to a Reference Product; and Biosimilars: Questions and Answers Regarding Implementation of the Biologics Price Competition and Innovation Act of 2009.
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Nonsurgical double-chin treatment wins FDA approval
April 30th 2015FDA’s approval of Kybella (deoxycholic acid), a less-invasive, non-surgical option for adults with moderate-to-severe fat below the chin, known as submental fat, or double chin, bodes well for the future of Kythera Biopharmaceuticals.
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Personalized treatments for lung cancer underused: International survey
April 30th 2015Despite the majority of newly diagnosed advanced non-small cell lung cancer (NSCLC) patients being tested for genetic mutations, a gap still exists for providing a personalized treatment plan for patients. An international survey, sponsored by Boehringer Ingelheim, found that 60% of US oncologists do not determine their treatment decision based on patient’s genetic mutation subtype, compared with 50% in Canada and 23% in Asia.
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[BLOG]: Big pharma and the new trend of acquisitions
April 29th 2015Biologic and pharmaceutical companies, along with their financial advisors or venture capital partners, have used mergers and acquisitions over the years to create value to keep their leading positions in a changing market. The era of pharmaceutical companies relying on blockbusters for their growth is over as more and more of these drugs have faced patent expiration, with no indication that new medicinal discoveries will emerge to take their place.
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Opioid addiction treatment in the ED better than referrals
April 29th 2015Emergency department (ED) patients with opioid dependence who receive a brief intervention and ED-initiated treatment with buprenorphine/naloxone and referral to primary care for 10-week follow up, are twice as likely to be engaged in addiction treatment at 30 days compared with standard referral and a brief intervention with a facilitated referral, according to a study published in JAMA.
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AbbVie hopes to advance HCV treatment for genotype 4
April 28th 2015AbbVie’s investigational hepatitis C virus (HCV) cocktail has been granted FDA priority review April 23 for the treatment of adult patients with chronic genotype 4 (GT4) HCV infection-the first investigational drug combination for GT4 infection, which accounts for about 6% of HCV cases in the United States.
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Chronically ill patients fearful of unreported drug switching by insurers, PBMs
April 27th 2015Insurers and pharmacists should not switch effective therapies without patient and physician notification, according to a national survey of stabilized autoimmune patients that explored their perspectives on switching prescribed biological medicines.
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