News

Patients 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.

FDA has approved codeine polistirex and chlorpheniramine polistirex (Tuzistra XR, Vernalis plc and Tris Pharma) extended-release oral suspension, CIII (DEA Schedule III).

FDA 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.

Generic Vicodin (hydrocodone acetaminophen) was the most widely-prescribed drug to Medicare Part D beneficiaries in 2013, according to new data released by the Centers for Medicare & Medicaid Services last week.

The 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.

Consensus is building on the promise of genetic testing and other technological advances to help individualize testing, prevention and treatment for better outcomes.

Consumers searching for health information on Google will now see results from Mayo Clinic in a feature box at the top of the return screen.

FDA 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.

The number of deaths from prescription pain relievers dropped 5% in 2012, and new tools are helping in the fight against opioid abuse.

Research has been given a shot in the arm by Apple Corp, which recently expanded the use of ResearchKit to include clinical trials.

An ongoing challenge particular to plans serving duals is a gap between the plans’ reimbursement rates and the health status of the populations they serve.

The Supreme Court recently held that the North Carolina Dental Board was not insulated from federal antitrust liability under the so-called “state action” doctrine when it engaged in anticompetitive conduct to restrain non-dentists from performing teeth whitening services.

FDA’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.

Despite 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.

The Centers for Medicare & Medicaid Services on Thursday released new data on Medicare Part D prescription drugs prescribed by physicians and other health care professionals in 2013.

Biologic 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.

Emergency 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.

AbbVie’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.

The FDA approved the first generic versions of Abilify (aripiprazole), an antipsychotic drug approved to treat schizophrenia and bipolar disorder, on April 28.