Recent FDA Approvals (through August 2012) related to (CSL Limited, GlaxoSmithKline Biologicals, ID Biomedical Corp, MedImmune Vaccines, Novartis Vaccines and Diagnostics Limited, Sanofi Pasteur, Genentech, Talon Therapeutics, Amarin, Regeneron Pharmaceuticals, Horizon Pharma, Forest Pharmaceuticals, Onyx Pharmaceuticals, Novartis, Pfizer, Sagent Pharmaceuticals)
New molecular entity: FDA approved Lorcaserin (Belviq, Arena Pharmaceuticals GMBH), as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in adults with an initial body mass index deemed obese and the presence of at least 1 weight-related comorbid condition.
A significant number of men who developed persistent sexual side effects from taking finasteride (Propecia and Proscar) also suffer from depressive symptoms and suicidal thoughts, according to a study published online in the Journal of Clinical Psychiatry.
Incretin-based therapies are now the most promising therapies for type 2 diabetes.
Teduglutide is a recombinant analog of human glucagon-like peptide-2 that is awaiting FDA approval for the treatment of short bowel syndrome (SBS) as a once-daily subcutaneous injection.
Real-time data sharing plays big role in effective, high-quality care.
Reduction in uncompensated care benefits insurers
Integrating mental health and behavioral health unlocks a value proposition
As the industry moves toward a retail environment, the importance of becoming member-centric can't be understated.
Symptoms of insomnia can be treated with several different drugs, but be aware of side effects.
Some hospitals are feeling the pinch of the Great Recession.
With implant-device costs on the rise, encourage members to seek preferred sites of care.
Paul B. Ginsburg discusses how new payment models are progressing
Lower courts will decide on the lingering concerns of uncertain PPACA provisions.
Early efforts by states drive value with Medicaid ACOs, coordinated care.
Ryan's proposals for radical changes in Medicare and Medicaid are at the center of the presidential campaign.
A recent study underscores the intuitive fact that a small percentage of patients consume a disproportionate share of healthcare dollars.
Watch healthcare spending shift and increase over the last 50 years.
FDA approved enzalutamide (Xtandi, Astellas Pharma U.S. Inc. and Medivation) to treat men with late-stage (metastatic) castration-resistant prostate cancer that has spread or recurred, even with medical or surgical therapy to minimize testosterone.
FDA issued a Drug Safety Communication on sildenafil (Revatio, Pfizer), following the observation in a long-term extension of a clinical trial in pediatric patients with pulmonary arterial hypertension of an increase in mortality with increasing Revatio dose.
Missouri study indicates LGBT discrimination and poorer health outcomes
Children with cystic fibrosis who are taking ivacaftor (Kalydeco) may be at potential risk for cataracts, according to an FDA notification.
FDA has approved tbo-filgrastim (Sicor Biotech UAB, a member of Teva Corporation), or XM02 filgrastim, the first new granulocyte colony-stimulating factor to be approved in the United States in more than 10 years to reduce the time certain patients receiving cancer chemotherapy experience severe neutropenia.
FDA has approved everolimus tablets for oral suspension (Afinitor Disperz, Novartis), a new pediatric dosage form of the anti-cancer drug everolimus (Afinitor, Novartis) used to treat a rare brain tumor called subependymal giant cell astrocytoma.
FDA has approved elvitegravir 150 mg/cobicistat 150 mg/emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg (Stribild, Gilead Sciences), a complete once-daily single tablet regimen for HIV-1 infection for treatment-naïve adults.
FDA has approved the supplemental New Drug Application for tapentadol extended-release tablets (Nucynta ER, Janssen), an oral analgesic taken twice daily, for the management of neuropathic pain associated with diabetic peripheral neuropathy in adults when a continuous, around-the-clock opioid analgesic is needed for an extended period of time.
WellPoint has a history of major acquisitions, and the new CEO already has something on the to-do list.
FDA has approved Watson’s lidocaine topical patch 5%, the first generic version of Lidoderm (Endo) for the relief of pain associated with post-herpetic neuralgia.
FDA has approved buprenorphine and naloxone (Suboxone, Reckitt Benckiser Pharmaceuticals) sublingual film in the 4-mg and 12-mg strengths for the maintenance treatment of dependence on prescription opioid painkillers and heroin.
FDA approved Mylan Pharmaceutical's 15-mg, 30-mg, and 45-mg pioglitazone hydrochloride tablets, the first generic version of Actos (Takeda), along with diet and exercise to improve blood glucose control in adults with type 2 diabetes.
