PSG RxWire
Advancing and protecting our clients' interests in the pharmacy benefit marketplace for more than 20 years.
FDA NEWS

FDA Approves Spiriva Respimat (tiotropium) for the Maintenance Treatment of COPD

FDA Approves Tybost (cobicistat) for use in the treatment of HIV-1 Infection

FDA Approves Vitekta (elvitegravir) for HIV-1 Infection

FDA Approves Iluvien for Diabetic Macular Edema

FDA Approves New Indication for Celgene's Otezla

FDA grants fast track status to MedImmune's MEDI3902 for prevention of P. aeruginosa


Specialty Rx
SUMMARY OF TOP ARTICLES -OCTOBER 2, 2014

Unaffordable lifesaving drugs – the list is growing
AHIP Coverage - September 29, 2014
The FDA is on track to approve a record number of high-priced specialty drugs in 2014, according to a new report from Express Scripts.

Worldwide market for biosimilars at its tipping point
MedCity News - September 30, 2014
Slow market uptake of biosimilars in the EU doesn’t portend the same for the U.S. Unlike most of the EU, the U.S. has thrown interchangeability into the mix. A big benefit, it’s expected to speed adoption and lead to lower prices.

FDA says asthma drug Xolair raises risk of heart, brain problems
Fox News - September 29, 2014
The asthma drug Xolair is associated with a higher risk of heart attack, mini-stroke, chest pain and blood clots in the lungs and veins, among other problems, though the extent of increased risk is unclear, the U.S. Food and Drug Administration said on Friday

Gilead nears EU approval for the next big thing in hep C
FierceBiotech - September 26, 2014
Gilead Sciences, already a trailblazer in hepatitis C treatment, is creeping up on its next milestone: approval for a combination therapy that promises to cure the majority of patients without the need for painful injections.

New anti-cancer peptide vaccines and inhibitors developed
ScienceDaily - September 24, 2014
Two new anticancer peptide vaccines and two peptide inhibitors have been developed as part of a larger peptide immunotherapy effort. The vaccines and inhibitors are designed to target the HER-3 and IGF-1R receptors, which are over-expressed in cancers of the breast, pancreas, esophagus and colon.

Gov't to Reveal Drug Company Payments to Doctors
Associated Press - September 30, 2014
Striving to shine a light on potential ethical conflicts in medicine, the Obama administration is releasing data on drug company payments to tens of thousands of individual doctors.

New cancer therapy comes of age, cost a 'toxic' side effect
Reuters - September 30, 2014
A raft of new cancer drugs promise better, longer-lasting treatments with fewer adverse side effects -- but their high cost is a growing concern.

Common Painkillers Tied to Blood Clot Risk, Study Suggests
HealthDay News - September 24, 2014
NSAID medicines include aspirin, ibuprofen and naproxen/Aleve.

Sale of Health-Related Domains Worries Public Health Advocates
iHealthBeat - September 29, 2014
Public health advocates have raised concerns about the sale of certain health-related domain names, arguing that consumers could be misled about the quality of the information on such sites, NPR's "Shots" reports.

Hospitals' uncompensated care will drop $5.7 billion this year: HHS
Modern Healthcare - September 24, 2014
The Obama administration has a new projection of the benefit hospitals will enjoy this year as they provide less care that no one pays for: $5.7 billion. Hospitals in states that expanded Medicaid are getting most of it.

More critical-access hospital closings likely
Modern Healthcare - September 30, 2014
Amid ongoing federal scrutiny of the extra funding paid small hospitals to serve remote areas, the number of critical-access hospitals in the U.S. continued to fall over the past year, according to Modern Healthcare magazine's annual review of CMS data published in this week's By the Numbers list.

Narrow networks draw few complaints from consumers: study
Modern Healthcare - September 23, 2014
Narrow networks were a popular health insurance option on the exchanges in the first enrollment period, with half of all plans for individuals offering limited groups of lower-cost providers, and new research shows consumers generally aren't griping about the products.

Clues to superbug evolution: Microbiologists sequence entire genome of a Klebsiella pneumoniae strain
ScienceDaily - September 23, 2014
Imagine going to the hospital with one disease and coming home with something much worse, or not coming home at all. With the emergence and spread of antibiotic-resistance pathogens, healthcare-associated infections have become a serious threat. On any given day about one in 25 hospital patients has at least one such infection and as many as one in nine die as a result. Microbiologists, for the first time, recently sequenced the entire genome of a Klebsiella pneumoniae strain, encoding New Delhi Metallo-beta-lactamase (NDM-1).

Medicare Open Enrollment Is Fast Approaching -- Here's What We Know So Far
Kaiser Health News - September 30, 2014
Medicare beneficiaries who want to make changes to their prescription drug plans or Medicare Advantage coverage can do so starting Oct. 15 during the Medicare's program’s annual open enrollment period. There will be somewhat fewer plans to pick from this year, but in general people will have plenty of options, experts say.


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Kristin LaVitola
Marketing Director, PSG
Pharmaceutical Strategies Group (PSG)
Office: 972-244-8388
Email: KLavitola@PSGConsults.com

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