Prescription Drug News and Research

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Setting the date: House scheduled to vote Jan. 12 on health law repeal

House GOP leaders have scheduled for Jan. 12 a much-awaited and politically charged vote to repeal the health law. In the background, news organizations report on the positions being taken by Democrats who may have voted against the measure the first time around and how Republicans plan to explain the budget implications of this repeal effort.

5 Jan 2011

Spectrum submits FUSILEV sNDA for treatment of colorectal cancer

Spectrum Pharmaceuticals, a biotechnology company with fully integrated commercial and drug development operations with a primary focus in oncology, today announced it submitted a supplemental New Drug Application with the U.S. Food and Drug Administration (FDA) for a Ready-to-Use formulation of FUSILEV (levoleucovorin) for Injection.

5 Jan 2011

Senator eyes plan to ease prescription drug shortages

As a shortage of some cancer drugs and certain other medications persists, a U.S. senator from Minnesota is proposing legislation she says will help federal regulators address the problem (Snowbeck, 12/28).

4 Jan 2011

FDA grants orphan drug status for Senesco's SNS01-T in treatment of multiple myeloma

Senesco Technologies, Inc., announced today that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation for the company's lead drug candidate SNS01-T for treatment of multiple myeloma.

3 Jan 2011

Clinical Data closes sale of genetic, pharmacogenomic testing and biomarker development business

Clinical Data, Inc. today announced that the Company has closed the sale of its genetic and pharmacogenomic testing and biomarker development business to Transgenomic, Inc. for $15.5 million. The sale completes Clinical Data's transformation into a pharmaceutical company with a deep product pipeline, including two promising late-stage compounds, the most advanced of which is vilazodone, a new treatment in development for Major Depressive Disorder.

30 Dec 2010

Frst wave of baby boomers become eligible for Medicare in 2011

In January, the first wave of baby boomers will start the New Year by reaching a series of significant milestones. This generation will begin turning 65, and as a result of entering into the age of retirement, will start to become eligible for various benefits, including Medicare. It is helpful for this aging population to learn about important benefits programs that may be available to them at this stage in their lives, regardless of whether or not they plan to retire anytime soon.

28 Dec 2010

NDA resubmitted for DURECT's ORADUR technology based REMOXY

DURECT Corporation today reported that King Pharmaceuticals, Inc. and Pain Therapeutics, Inc. have announced that King has resubmitted a New Drug Application (NDA) for REMOXY® to the U.S. Food and Drug Administration (FDA) in response to a Complete Response Letter received by Pain Therapeutics in December 2008. This is a Class 2 resubmission with a six month review cycle.

28 Dec 2010

HIT interventions promising tools in fight to improve medication adherence, despite paucity of data

A new study that reviews more than four decades of medical journal articles about the impact of health information technology (HIT) and electronic communications on medication adherence concludes that while there is evidence to suggest that simple electronic reminders are an effective and low-cost means to improve adherence, there are few studies that show how HIT can be leveraged to more thoughtfully engage or motivate patients to take medications as prescribed.

24 Dec 2010

MigreLief releases safe, proven effective supplement for children with migraines

MigreLief, the first name in migraine prevention, releases a safe and proven effective supplement for children of all ages: Children's MigreLief.

24 Dec 2010

Meda gains exclusive marketing and distribution rights for EpiPen Auto-Injector in Europe

Meda has signed a long-term license agreement with the specialty division of Mylan Inc., Dey Pharma, L.P., for exclusive marketing and distribution rights of EpiPen® (epinephrine) Auto-Injector in Europe. EpiPen is used for emergency treatment of severe allergic reactions (anaphylaxis). Anaphylaxis can occur quickly (often within a couple of minutes) and may be life-threatening.

23 Dec 2010

Delcath completes NDA submission for chemosaturation system

Delcath Systems, Inc. today announced that the Company has submitted the remaining modules of its 505(b)(2) New Drug Application (NDA) for its proprietary chemosaturation system to the U.S. Food & Drug Administration (FDA). The Company had previously submitted Module 4, consisting of literature based non-clinical data, to the FDA in late April 2010. The Company is seeking an indication for the percutaneous intra-arterial administration of melphalan hydrochloride for use in the treatment of patients with metastatic melanoma in the liver.

22 Dec 2010

NAHN and Partnership at Drugfree.org join to address teen drug and alcohol use in the Hispanic community

The Partnership at Drugfree.org today announced a new strategic partner to help support the organization's outreach to address teen drug and alcohol use within the Latino and Spanish-speaking community and equip Hispanic parents with tools from prevention to treatment of drug and alcohol abuse. The National Association of Hispanic Nurses (NAHN) has joined with the national nonprofit to provide bilingual resources to Spanish-speaking parents and caregivers and help promote the group's online tools and resources across various NAHN communication channels.

22 Dec 2010

Priority Health launches health insurance plans for Michigan residents

Priority Health has launched MyPriority, a package of health insurance plans for individuals and families throughout Michigan. The plans feature comprehensive coverage for prevention services and are designed specifically for individuals ages 18 to 64 who are looking to purchase affordable health insurance.

21 Dec 2010

Dey Pharma settles U.S. Department of Justice lawsuit

Dey Pharma L.P. today announced that it has settled a lawsuit brought against it by the U.S. Department of Justice in September 2006 pertaining to Medicare and Medicaid reimbursements paid by the federal government to pharmacists and other healthcare providers. In exchange for a release of claims, Dey has agreed to pay $280 million.

21 Dec 2010

Fibrocell Science submits response to FDA CR letter for azficel-T BLA

Fibrocell Science, Inc., a biotechnology company focused on the development of autologous cell therapies for aesthetic, medical and scientific applications, announced today that it has submitted its complete response to the Complete Response (CR) letter issued by the U.S. Food & Drug Administration (FDA) regarding the Company's Biologics License Application (BLA) for azficel-T, proposed brand name laViv®, for the treatment of moderate to severe nasolabial folds and wrinkles.

20 Dec 2010

Rite Aid third quarter net loss decreases to $79.1 million

Rite Aid Corporation today reported financial results for its third fiscal quarter ended November 27, 2010.

16 Dec 2010

State roundup: Minn. to add more adults to Medicaid; Mass. Gov. seeks savings in pensions and health care costs; Ariz. bishop and hospital spar over control

Minnesota can add 95,000 low-income adults to its Medicaid rolls, vastly improving their medical care, at no additional cost to the state, two officials at the state Department of Human Services told legislators Tuesday (Wolfe, 12/15).

16 Dec 2010

Illegal online drug sellers prey upon 36 million Americans

Illegal online drug sellers have provided tens of millions of Americans prescription medication via the Internet without a valid prescription, recent research has found. These rogue sellers have preyed upon thirty-six million people, or 1 in 6 Americans, exposing them to the potential of taking counterfeit and unapproved medications.

15 Dec 2010

Texas' problem with prescription drug abuse; Vermont's plans for single payer

University of California regents approved controversial rollbacks in pension and retiree health benefits Monday, including raising the earliest retirement age for future employees to 55, to help plug huge financial gaps in the university's plans (Gordon, 12/14).

15 Dec 2010

FDA accepts for filing Pacira's EXPAREL NDA for postsurgical pain management

Pacira Pharmaceuticals, Inc., an emerging specialty pharmaceutical company, announced today that the New Drug Application (NDA) for EXPAREL™, a long-acting bupivacaine for postsurgical pain management, has been accepted for filing by the U.S. Food and Drug Administration (FDA).

14 Dec 2010