Prescription Drug News and Research

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152 research and training grants awarded to researchers at 93 institutions nationwide

The American Cancer Society, the largest non-government, not-for-profit funding source of cancer research in the United States, has awarded 152 new national research and training grants totaling $50,717,000 in the first of two grants cycles for 2010. The grants, primarily to early career researchers, cover a broad range of investigator-initiated ideas at 93 institutions nationwide, from whether cadmium exposure increases the risk of endometrial cancer, to studies of plant and bacterial-bourne compounds, to a study on a protein called survivin that could lead to novel drugs targeting prostate cancer.

18 May 2010

BUSM researchers identify clinical characteristics associated with PDUD in primary care patients

Researchers at Boston University School of Medicine have identified clinical characteristics associated with prescription drug use disorder in primary care patients with chronic pain. The study found that by identifying characteristics of prescription drug abuse, primary care clinicians can identify those at risk and provide appropriate treatment.

15 May 2010

Lotus Pharmaceuticals first-quarter net income up 38%

Lotus Pharmaceuticals, Inc., a growing developer, manufacturer and seller of medicine and drugs in the People's Republic of China today reported its financial results for the first quarter ended March 31, 2010.

15 May 2010

Amgen submits BLA for denosumab subcutaneous RANK Ligand inhibitor

Amgen Inc. today announced the submission of a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for denosumab, a subcutaneous RANK Ligand inhibitor. The BLA submission summarizes clinical experience from nearly 6,900 patients across 18 clinical studies, including approximately 5,700 patients with advanced cancer in the three, pivotal, Phase 3, head-to-head trials versus Zometa® (zoledronic acid).

15 May 2010

FDA assigns Cadence Pharmaceuticals' OFIRMEV NDA new PDUFA action date

Cadence Pharmaceuticals, Inc. announced today that the U.S. Food and Drug Administration (FDA) has classified the OFIRMEV™ (acetaminophen) injection New Drug Application (NDA) resubmission as a complete Class 2 response to the FDA's February 10, 2010 action letter and assigned a new Prescription Drug User Fee Act (PDUFA) action date of November 4, 2010.

15 May 2010

Convergent procedure promising for longstanding persistent atrial fibrillation

nContact Surgical, Inc. announced today the presentation of data collected from 43 patients as a result of a closed chest convergent atrial fibrillation (AF) procedure at the Heart Rhythm Society 2010 Conference in Denver, Colorado.

14 May 2010

Off-label use of AAs among elderly associated with increased risk of diabetes: Study

A new study yields important new evidence that the use of atypical antipsychotics among the elderly for off-label purposes is associated with increased risk of developing diabetes.

14 May 2010

Fibrocell Science commences histology study of azficel-T for treatment of nasolabial fold wrinkles

Fibrocell Science, Inc., a biotechnology company focused on the development of autologous cell therapies for aesthetic, medical and scientific applications, announced the initiation of a small histology study (IT-H-001) of azficel-T, an autologous cell therapy currently under review by the U.S. Food and Drug Administration (FDA) for the treatment of moderate to severe nasolabial fold wrinkles.

14 May 2010

FDA Advisory Committee planned to review Lux Biosciences' NDA for voclosporin

Isotechnika Pharma Inc. today announced that the Dermatology and Ophthalmology Drugs Advisory Committee of the U.S. Food and Drug Administration is scheduled to review partner, Lux Biosciences', New Drug Application for voclosporin on June 28, 2010.

13 May 2010

Prescription costs more likely to keep Hispanics away from pharmacy counter: Study

Drug costs could prevent some people from filling their prescriptions, which can interfere with optimal health care. A new study of Medicare beneficiaries finds that cost concerns are more likely keep Hispanics away from the pharmacy counter than non-Hispanics.

13 May 2010

Prescription drug instructions often lost in translation

Chicago Tribune: "Pharmacies that print prescription labels translated into Spanish often issue inaccurate or confusing instructions that could be potentially hazardous to a patient's health, according to a report in the May issue of Pediatrics journal."

13 May 2010

Sebelius heralds early successes of health law

"In a letter to leaders of Congress, the secretary of health and human services, Kathleen Sebelius, reported on Monday that the Obama administration is moving quickly to carry out the expansive new health care law, particularly provisions that she referred to as 'early insurance market reforms,'" The New York Times reports.

12 May 2010

USP panel recommends to establish universal standards for prescription medication labels

To promote the establishment of universal standards for prescription medication labels-and to address the widespread problem of patient misinterpretation of medication instructions-an advisory panel formed by the U.S. Pharmacopeial Convention (USP) recently issued a set of recommendations to bring consistency to labeling on dispensed prescription packaging.

11 May 2010

Consumers, officials work to sort out new health law

For at least one state, implementing health reform is starting to appear easier said than done. The Daily Record, a Baltimore legal newspaper, reports, "Maryland's new Health Care Reform Coordinating Council held its first meeting last week, resolving to find the best way to implement provisions of the landmark federal health care overhaul.

11 May 2010

Alexza Pharmaceuticals first-quarter net loss increases to $13.4 million

Alexza Pharmaceuticals, Inc. today reported financial results for the first quarter ended March 31, 2010 and provided a business update.

11 May 2010

PCMA releases statement on PBM Audit Reform and Transparency Act of 2010

Pharmacy benefit managers (PBMs) have pioneered tools - including incentivizing the use of generic medications, e-prescribing, and mail-service pharmacies - that improve savings, access, and safety for consumers and payers. Since the key to access is affordability, payers and policymakers alike should explore broader use of PBMs' cost-savings tools and reject approaches that make prescription drugs more expensive.

7 May 2010

Arena Pharmaceuticals reports lower net loss of $31.3 million in first-quarter 2010

Arena Pharmaceuticals, Inc. today reported financial results for the first quarter ended March 31, 2010.

7 May 2010

New changes to 'Extra Help' program enables more people save on prescription drug costs

Medicare beneficiaries who qualify for "Extra Help" may be eligible to pay no more than $2.50 for generic drugs and $6.30 for each brand name drug thanks to changes to Medicare's Low-Income Subsidy Program for Part D prescription drug costs (also known as LIS or "Extra Help") that take effect this year. These changes make it easier than ever for people on Medicare with limited incomes to save on their drug costs.

7 May 2010

M-3 Information introduces iPhone application for depression, anxiety disorders

M-3 Information entered the smart phone application environment by offering the M-3 Checklist, a scientifically validated screen for depression and anxiety disorders, at the iTunes store on Friday, April 30, 2010. Adapted from M-3 Information's existing mymoodmonitor.com website, this mobile version, called mym3, provides the same validated mental health questionnaire optimized for smart phones. A first in iPhone applications, mym3 is designed to create a bridge between user responses and recommendations set forth in the content-rich M3 website application.

7 May 2010

DUSA Pharmaceuticals receives notice of allowance for patent covering blue light technology

DUSA Pharmaceuticals, Inc.®, a dermatology company that is developing and marketing Levulan® Photodynamic Therapy (PDT), today announced that the United States Patent and Trademark Office has issued a notice of allowance for a key patent related to its proprietary PDT light source, the BLU-U®, Blue Light Photodynamic Therapy Illuminator.

7 May 2010

Prescription Drug News and Research

152 research and training grants awarded to researchers at 93 institutions nationwide

BUSM researchers identify clinical characteristics associated with PDUD in primary care patients

Lotus Pharmaceuticals first-quarter net income up 38%

Amgen submits BLA for denosumab subcutaneous RANK Ligand inhibitor

FDA assigns Cadence Pharmaceuticals' OFIRMEV NDA new PDUFA action date

Convergent procedure promising for longstanding persistent atrial fibrillation

Off-label use of AAs among elderly associated with increased risk of diabetes: Study

Fibrocell Science commences histology study of azficel-T for treatment of nasolabial fold wrinkles

FDA Advisory Committee planned to review Lux Biosciences' NDA for voclosporin

Prescription costs more likely to keep Hispanics away from pharmacy counter: Study

Prescription drug instructions often lost in translation

Sebelius heralds early successes of health law

USP panel recommends to establish universal standards for prescription medication labels

Consumers, officials work to sort out new health law

Alexza Pharmaceuticals first-quarter net loss increases to $13.4 million

PCMA releases statement on PBM Audit Reform and Transparency Act of 2010

Arena Pharmaceuticals reports lower net loss of $31.3 million in first-quarter 2010

New changes to 'Extra Help' program enables more people save on prescription drug costs

M-3 Information introduces iPhone application for depression, anxiety disorders

DUSA Pharmaceuticals receives notice of allowance for patent covering blue light technology

Industry Focus eBook - Cell biology (5th edition) eBook

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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