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Belatacept Biologics License Application: FDA drug advisory committee recommends approval

Bristol-Myers Squibb Company today announced that the U.S. Food and Drug Administration’s (FDA) Cardiovascular and Renal Drugs Advisory Committee has voted 13 to 5 to recommend approval of belatacept, a selective co-stimulation blocker, for the prophylaxis of acute rejection in de novo kidney transplant patients.

2 Mar 2010

Biodel seeks FDA marketing approval for VIAject

Biodel Inc. announced today that the U.S. Food and Drug Administration has accepted for review the company’s new drug application (NDA) seeking approval to market VIAject® for the treatment of diabetes. VIAject® is Biodel's proprietary formulation of recombinant human insulin that is designed to be absorbed into the blood faster than currently marketed rapid-acting insulin analogs.

1 Mar 2010

Walgreens donates $2M to American Red Cross Haiti Relief and Development Fund

As Haiti continues its rebuilding efforts from the devastating earthquake that hit its largest city in January, Walgreens wrapped up its in-store giving campaign with customers donating nearly $2 million to the American Red Cross Haiti Relief and Development Fund.

27 Feb 2010

Arena Pharmaceuticals' lorcaserin NDA: FDA assigns PDUFA date

Arena Pharmaceuticals, Inc. announced today that the US Food and Drug Administration (FDA) has assigned a Prescription Drug User Fee Act (PDUFA) date of October 22, 2010, for the review of the lorcaserin New Drug Application (NDA). The acceptance of the lorcaserin NDA filing confirms that the application is sufficiently complete to permit a substantive review, and the PDUFA date is the goal date for the FDA to complete its review of the NDA.

26 Feb 2010

Idaho Health Freedom Act may have severe implications on health care system in Idaho: AARP

As the President and a bipartisan group of members of Congress come together today to discuss how to tackle the nation's growing health care crisis, Idaho Senators are poised to debate a bill tomorrow that could make the issue worse in the state. The Idaho Health Freedom Act (HB 391), taking aim at a component of a non-existent federal health care law, could wreak havoc in Idaho, while costing the state money and jobs.

26 Feb 2010

FDA sets new PDUFA action date for exenatide once weekly NDA

Amylin Pharmaceuticals, Inc., Eli Lilly and Company and Alkermes, Inc. today confirmed that the U.S. Food and Drug Administration (FDA) has set a new Prescription Drug User Fee Act (PDUFA) action date of March 12 for its review of the exenatide once weekly new drug application (NDA).

25 Feb 2010

FEHBP's H.R. 4489 overhaul will undermine cost-saving tools and disrupt prescription drug benefits

“Regrettably, the FEHBP Prescription Drug Integrity, Transparency, and Cost Savings Act (H.R. 4489) would undermine many of the cost-saving tools used in FEHBP and disrupt prescription drug benefits for 8 million federal employees, retirees, and their families.”

25 Feb 2010

Current health reform debate haunted by health bills of the past

Key provisions of the 1993 Republican bill, introduced by Sen. John Chafee, R-R.I., with 19 other Republicans and two Democrats, "may seem familiar, as they bear a strong resemblance to those in the current Democratic Senate bill, and now in President Barack Obama's proposal," Kaiser Health News reports. "A mandate that individuals buy insurance, subsidies for the poor to buy insurance and the requirement that insurers offer a standard benefits package and refrain from discriminating based on pre-existing conditions were all in the 1993 GOP bill."

25 Feb 2010

FDA accepts Arena Pharmaceuticals' lorcaserin NDA

Arena Pharmaceuticals, Inc. announced today that its New Drug Application (NDA) for lorcaserin, Arena's internally discovered and developed drug candidate for weight management, including weight loss and maintenance of weight loss, has been accepted for filing by the US Food and Drug Administration (FDA). Arena submitted the lorcaserin NDA on December 22, 2009, and expects to learn the Prescription Drug User Fee Act (PDUFA) date in the next few weeks. The PDUFA date is the target date for the FDA to complete its review of an NDA.

24 Feb 2010

FEHBP PBM contracts: HR 4489 to reduce fraud and grant OPM greater power to audit

The House Subcommittee for the Federal Workforce, Postal Service, and the District of Columbia heard testimony today on HR 4489, the “FEHBP Prescription Drug Integrity, Transparency, and Cost Savings Act.” The proposed bill would reform many aspects of how the Federal Employee Health Benefits Program (FEHBP) contracts with pharmacy benefit managers (PBMs) to provide prescription drug benefits to federal workers.

24 Feb 2010

AARP tracks upcoming Senate vote on Idaho Health Freedom Act

With the Idaho State Senate expected to vote today on the ill-conceived Idaho Health Freedom Act (HB 391), a bill that could wreak havoc on the state's health care system, AARP has announced it will make the vote a part of it's "accountability vote" efforts.

24 Feb 2010

MAXIMUS receives contract to review reconsiderations of Medicare Part D program

MAXIMUS, a leading provider of government services worldwide, announced today that its Federal Services subsidiary has been awarded a one-year contract by the Centers for Medicare & Medicaid Services (CMS) to continue to serve as an independent review entity for reconsiderations of beneficiary appeals for the Medicare Part D program.

24 Feb 2010

FDA Gastrointestinal Drugs Advisory Committee supports approval of XIFAXAN 550 mg for management of HE

Salix Pharmaceuticals, Ltd. today reported that the Gastrointestinal Drugs Advisory Committee of the FDA has recommended by a vote of 14 to 4 in favor of the approval of XIFAXAN® (rifaximin) Tablets, 550 mg for the maintenance of remission of hepatic encephalopathy (HE).

23 Feb 2010

Shire reports total revenues of $3,008 million for 2009

Shire plc the global specialty biopharmaceutical company, announces results for the year to December 31, 2009.

22 Feb 2010

During open enrollment Medicare recipients may make changes to their Medicare Advantage coverage

Medicare recipients may still make changes to their Medicare Advantage coverage during open enrollment period, which runs Jan. 1 to March 31.

22 Feb 2010

Pelosi releases statement on HHS Secretary's decision to increase aid to states for Medicare Part D payment

I applaud the Administration's decision, which will mean much-needed relief to states facing severe budget constraints in light of the tough economic climate. The California Congressional delegation's diligence in raising this issue with HHS has paid dividends for California, which will be rewarded with an additional $680 million, all due to the FMAP increase included in the Recovery Act that we passed a year ago.

20 Feb 2010

Missing prescription drugs: Cardinal Health Pharmacy Services to pay $1M penalty

U.S. Attorney Thomas Scott Woodward announced today that Cardinal Health Pharmacy Services, LLC, a company engaged in providing hospital pharmacy management services, has agreed to pay a civil penalty in the amount of $1 million for failing to account for large amounts of missing prescription drugs.

20 Feb 2010

Amgen's Prolia Complete Response submission: FDA classifies and sets PDUFA date

Amgen Inc. today announced that the U.S. Food and Drug Administration (FDA) has evaluated the content of the Company's Complete Response submission for Prolia™ (denosumab) in the treatment of postmenopausal osteoporosis and classified it as a Class 2 resubmission. With the Class 2 designation, the FDA set a corresponding Prescription Drug User Fee Act (PDUFA) action date of July 25, 2010.

20 Feb 2010

Medicare Advantage premiums jump 14 percent

The Associated Press: "Millions of seniors who signed up for popular private health plans through Medicare are facing sharp premium increases this year — another sign that spiraling costs are a problem even for those with solid insurance. A study to be released Friday ... found that premiums for Medicare Advantage plans offering medical and prescription drug coverage jumped 14.2 percent on average in 2010, after an increase of only 5.2 percent the previous year. Some 8.5 million elderly and disabled Americans are in the plans, which provide more comprehensive coverage than traditional Medicare."

19 Feb 2010

Cancer patients frequently face barriers to accessing oral drugs: Study

A comprehensive study of oral oncolytic (anti-cancer) drug treatments revealed that while their use is increasingly common, cancer patients frequently face barriers to accessing oral drugs compared to those delivered intravenously in oncology practice settings.

19 Feb 2010

Prescription Drug News and Research

Belatacept Biologics License Application: FDA drug advisory committee recommends approval

Biodel seeks FDA marketing approval for VIAject

Walgreens donates $2M to American Red Cross Haiti Relief and Development Fund

Arena Pharmaceuticals' lorcaserin NDA: FDA assigns PDUFA date

Idaho Health Freedom Act may have severe implications on health care system in Idaho: AARP

FDA sets new PDUFA action date for exenatide once weekly NDA

FEHBP's H.R. 4489 overhaul will undermine cost-saving tools and disrupt prescription drug benefits

Current health reform debate haunted by health bills of the past

FDA accepts Arena Pharmaceuticals' lorcaserin NDA

FEHBP PBM contracts: HR 4489 to reduce fraud and grant OPM greater power to audit

AARP tracks upcoming Senate vote on Idaho Health Freedom Act

MAXIMUS receives contract to review reconsiderations of Medicare Part D program

FDA Gastrointestinal Drugs Advisory Committee supports approval of XIFAXAN 550 mg for management of HE

Shire reports total revenues of $3,008 million for 2009

During open enrollment Medicare recipients may make changes to their Medicare Advantage coverage

Pelosi releases statement on HHS Secretary's decision to increase aid to states for Medicare Part D payment

Missing prescription drugs: Cardinal Health Pharmacy Services to pay $1M penalty

Amgen's Prolia Complete Response submission: FDA classifies and sets PDUFA date

Medicare Advantage premiums jump 14 percent

Cancer patients frequently face barriers to accessing oral drugs: Study

Bringing real-time analytics to downstream bioprocess monitoring

Designing fluidic architecture for scalable diagnostic platforms

Evaluating new approaches for rare disease genomics

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