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FDA, European regulators restrict Avandia use

The Food and Drug Administration and European regulators said they were taking action on Avandia, made by GlaxoSmithKline PLC, because of data tying it to increased risk of heart attacks.

27 Sep 2010

Research Roundup: Medical homes; Drug samples and prescribing; The health law and disparities; Women's health; CBO projections

Institute of Medicine: Women's Health Research: Progress, Pitfalls, and Promise -"Substantial progress has been made since the expansion of investment in women's health research. Research findings have changed the practice of medicine and public-health recommendations in several prominent contexts, including changes in standards of care for women. There have also been decreases in mortality in women from breast cancer, heart disease, and cervical cancer. In other contexts, however, there has been less progress..."

24 Sep 2010

Pharmaceutical manufacturers to provide 50% discount on brand-name prescription drugs

Vice President Joe Biden, the U.S. Department of Health and Human Services and the Centers for Medicare & Medicaid Services (CMS) today announced that the nation's pharmaceutical manufacturers will provide 50 percent discounts on the cost of covered brand-name prescription drugs for beneficiaries in the Medicare Part D coverage gap, or donut hole, starting in 2011.

24 Sep 2010

Rite Aid second quarter revenue decreases to 2.5%

Rite Aid Corporation today reported financial results for its fiscal second quarter ended August 28, 2010.

23 Sep 2010

FDA and EMA accept regulatory submissions of vandetanib for advanced medullary thyroid cancer

AstraZeneca today announced that the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have accepted regulatory submissions for review of the investigational drug vandetanib in the treatment of patients with advanced medullary thyroid cancer (MTC). The FDA also granted priority review status for the new drug application and set a Prescription Drug User Fee Act (PDUFA) action date of 7 January 2011.

23 Sep 2010

Merck expands patient assistance programs to provide medicines to needy people

Today, Merck announced that it has significantly expanded the number of Merck medicines available through its Merck Helps patient assistance programs, which include the Merck Patient Assistance Program, the Merck Vaccine Patient Assistance Program, the ACT Program for Oncology and Hepatitis C medicines, and the SUPPORT Program for HIV/AIDS medicines.

23 Sep 2010

FDA grants priority review status for Endo’s oxymorphone oral formulation

Endo Pharmaceuticals announced that it recently received notification from the U.S. Food and Drug Administration (FDA) that Endo's new drug application (NDA) for its new oral formulation of long-acting oxymorphone, which is designed to be crush resistant, has been granted priority review status.

23 Sep 2010

PA State Police, PCCD join national effort to collect medications on Sept. 25

Pennsylvanians are urged to turn in expired, unused and unwanted prescription medications at collection sites statewide during the first National Prescription Drug Take-Back Day on Saturday, Sept. 25, State Police and the Pennsylvania Commission on Crime and Delinquency said today.

22 Sep 2010

Sebelius: Medicare Advantage premium costs to decline slightly in 2011

The Associated Press: "Seniors enrolled in popular private health insurance plans through Medicare will pay a little less on average next year, the Obama administration said Tuesday. The average monthly premium in so-called Medicare Advantage plans will dip to $35.69 in 2011, a 45-cent reduction from $36.14 this year, Medicare officials said."

22 Sep 2010

FDA grants orphan-drug designation to Catalyst's CPP-115 investigational drug

Catalyst Pharmaceutical Partners, Inc. today announced that its investigational drug, CPP-115, a novel GABA aminotransferase inhibitor, has been granted orphan-drug designation for the treatment of infantile spasms (West Syndrome) by the U.S. Food and Drug Administration (FDA).

22 Sep 2010

HealthWarehouse.com, Columbia Medical Associates announce partnership to provide generic prescription medications

HealthWarehouse.com, Inc., a leading retail mail-order online pharmacy and Columbia Medical Associates, an outpatient clinic system offering medical services in the Spokane, Washington metropolitan area, announced a partnership to offer patients a 30-day supply of more than 300 generic prescription medications for $3.50 with free home delivery.

21 Sep 2010

First Edition: September 21, 2010

In today's headlines, news about major insurers' plans to stop offering child-only health policies in advance of new rules.

21 Sep 2010

Medicare receives increased scrutiny regarding fraud, payment issues

USA Today: "Proposed regulations being unveiled today seek to crack down on Medicare and Medicaid fraud by subjecting operators of certain medical firms to fingerprinting and stopping payments when credible fraud allegations are made, documents show. The rules would give federal health officials key powers to identify fraud early and reduce the estimated $55 billion in improper payments made each year in the Medicare and Medicaid programs, said Peter Budetti, director of the new anti-fraud office at the federal Centers for Medicare & Medicaid Services" (Young, 9/20).

20 Sep 2010

CBO finds generic drugs save Medicare $33 billion in 2007

A new government report finds that the use of generic medications saved the Medicare program and its beneficiaries about $33 billion in 2007, The Associated Press/BusinessWeek report. The Congressional Budget Office report "says an additional $14 billion is expected as first-time generics enter the market through 2012. Medicare Part D is Medicare's prescription drug program" (9/15).

18 Sep 2010

FDA Advisory Committee recommends approval of Alkermes' VIVITROL for opioid dependence

Alkermes, Inc. today announced that the U.S. Food and Drug Administration (FDA) Psychopharmacologic Drugs Advisory Committee voted 12 to 1 that VIVITROL® (naltrexone for extended-release injectable suspension) should be approved for the treatment of opioid dependence.

17 Sep 2010

Forest Pharmaceuticals to pay $300 million as penalty for criminal actions

The U.S. Food and Drug Administration (FDA), working in close coordination with the U.S. Department of Justice (USDOJ), today announced that Forest Pharmaceuticals, Inc. entered into a plea agreement in which the company accepted responsibility for criminal actions including distribution of an unapproved new drug, distribution of a misbranded drug, and obstruction of an FDA inspection.

16 Sep 2010

Survey reveals physicians’ misperception on misuse, abuse of opioids

Findings from a new national survey, sponsored by the American Pain Foundation, reveal misperceptions among physicians regarding the misuse and abuse of opioids. The results come in light of government statistics to be released today looking at the broader U.S. population, showing 2009 rates of nonmedical use of these products nationwide.

16 Sep 2010

Generics drugs in Medicare program saved $33 billion in 2007: CBO

New research released today by the Congressional Budget Office (CBO) found that the use of generic medications rather than brand-name medications in Medicare Part D saved beneficiaries and the program about $33 billion in 2007, while an additional $14 billion in savings is expected as first-time generics enter the market through 2012.

16 Sep 2010

Milwaukee sees fast rise in costs of benefits; N.J. Gov. outlines cuts to public workers' benefits; Hawaii teachers file suit over health changes

"The cost of health benefits appears to be rising at a much faster pace in the Milwaukee area than the national average. Employers reported that the cost of health benefits increased 11% to 13% on average in the Milwaukee area this year, according to the 2010 Greater Milwaukee Employer Health Care Benefits Survey

16 Sep 2010

Medicare confronts issues with prescription drug program and medical equipment purchases

Carper wrote to the Centers for Medicare and Medicaid Services on July 29 and requested the agency establish a process to ensure valid identification numbers on reimbursed prescriptions under the Part D program.

16 Sep 2010