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Recent study shows that eDetailing is a viable means for reaching prescribers

For pharmaceutical sales forces, eDetailing has reemerged as a viable means for reaching prescribers. A recent study by Cutting Edge Information shows that drug companies are implementing eDetailing tools -- and are investing more money than ever in this sales channel.

26 Aug 2009

FDA to review Acorda Therapeutics’ NDA for Fampridine-SR

Acorda Therapeutics, Inc. (Nasdaq: ACOR) today announced that the U.S. Food and Drug Administration (FDA) has confirmed that its Peripheral and Central Nervous System Drugs Advisory Committee will review the Company’s New Drug Application (NDA) for Fampridine-SR on October 14, 2009.

26 Aug 2009

FDA recommends electronic report formats to strengthen postmarket safety data collection

The U.S. Food and Drug Administration is proposing to amend postmarket safety reporting regulations for three of its centers to require that manufacturers and other facilities subject to current reporting requirements submit their reports in an electronic format.

26 Aug 2009

Vision-related patient-reported outcomes used for improving medical product labeling in ophthalmology

The National Eye Institute (NEI) and the Food and Drug Administration (FDA) are sponsoring an October 13 conference to determine how vision-related patient-reported outcomes might be used to improve medical product labeling in ophthalmology.

26 Aug 2009

New drug delivery system for delivering nanoparticles into the tissue

Scientists at UC Santa Barbara have discovered a potential new drug delivery system. The finding is a biological mechanism for delivery of nanoparticles into tissue. The results are published in this week's Proceedings of the National Academy of Sciences.

26 Aug 2009

Adolescents engaged in dangerous activities are associated with increased brain maturity

A new study using brain imaging to study teen behavior indicates that adolescents who engage in dangerous activities have frontal white matter tracts that are more adult in form than their more conservative peers.

26 Aug 2009

Report warns H1N1 could affect half of U.S. population

A U.S. presidential panel report released Monday estimates H1N1 (swine) flu could infect up to half of the country's population, the Washington Post reports.

26 Aug 2009

FDA issues warning letters to eight companies for selling illegal OTC ibuprofen drugs

The U.S. Food and Drug Administration today announced that the agency issued warning letters to eight companies marketing unlawful over-the-counter (OTC) topical drug products containing the pain reliever ibuprofen.

26 Aug 2009

Antimicrobial-resistant typhoid fever in U.S. patients is associated with international travel

Infection with an antimicrobial-resistant strain of typhoid fever among patients in the United States is associated with international travel, especially to the Indian subcontinent (India, Pakistan, and Bangladesh), according to a study in the August 26 issue of JAMA. The study also shows an increase in certain strains of typhoid fever that are resistant to the most commonly used medications for treatment.

26 Aug 2009

Tamoxifen drug poses increased risk of developing ER negative breast cancer

While long-term tamoxifen use among breast cancer survivors decreases their risk of developing the most common, less aggressive type of second breast cancer, such use is associated with a more than four-fold increased risk of a more aggressive, difficult-to-treat type of cancer in the breast opposite, or contralateral, to the initial tumor.

26 Aug 2009

FDA establishes TPSAC to proceed further on the tobacco law

The U.S. Food and Drug Administration today announced an action regarding the implementation of the Family Smoking Prevention and Tobacco Control Act. The Agency has officially established the Tobacco Products Scientific Advisory Committee (TPSAC).

26 Aug 2009

U.S. troops serving overseas to be tested for H1N1 infection

The U.S. Food and Drug Administration today announced it has issued an Emergency Use Authorization (EUA) that allows a 2009 H1N1 influenza virus test to be used to detect the virus in troops serving overseas.

26 Aug 2009

Medicare's Part D program subsidizes cost of prescription drugs for Medicare beneficiaries

Medicare's Part D program, designed to subsidize the cost of prescription drugs for Medicare beneficiaries, has been the subject of much debate. Proponents have touted the plan's ability to expand access to prescription drugs to seniors; critics have long questioned its design and user-friendly appeal.

26 Aug 2009

Prescription assistance program helps Iowa residents to save money on drugs

Iowa residents have saved over $800,000 on prescription drugs through Iowa Drug Card since the launch of the free statewide prescription assistance program. The program, which offers free discount drug cards to Iowa residents, was launched in June, 2008. Every resident of Iowa is eligible to participate in the prescription assistance program.

26 Aug 2009

University of Idaho researchers to develop a chemical probe technology that can treat genetic diseases

Three University of Idaho researchers will embark on an unconventional approach to DNA research as one of 20 teams chosen nationwide by federal officials for the ideas to explore scientific frontiers.

26 Aug 2009

ParagonRx's CEO recommends techniques to effectively manage the FDA-mandated REMS program

While many pharmaceutical and biologics companies are getting accustomed to FDA-mandated Risk Evaluation and Mitigation Strategy (REMS) programs for many new and old drugs, most are not adequately preparing for the equally mandatory program evaluations beginning just 1-1/2 years after each REMS is put into effect.

25 Aug 2009

Venlafaxine alleviates depressive symptoms

The Institute for Quality and Efficiency in Health Care (IQWiG) was commissioned by the Federal Joint Committee (G-BA) to investigate whether patients with depression benefit from taking drugs belonging to the selective serotonin and norepinephrine reuptake inhibitor (SNRI) drug class.

25 Aug 2009

Delcath Systems enrolls 85 patients for its pivotal Phase III Metastatic Melanoma Trial

Delcath Systems, Inc., a medical technology company testing its proprietary treatment method for primary and metastatic cancers to the liver, announced today that it has exceeded 90% enrollment reaching 85 patients for its pivotal Phase III Metastatic Melanoma Trial.

25 Aug 2009

TuBerculosis Vaccine Initiative receives $3 million grant from Gates Foundation

TuBerculosis Vaccine Initiative (TBVI) recently received a $3million grant for a three year term from the Bill & Melinda Gates Foundation. This grant enables the nonprofit organization to strengthen its fundraising and communication activities in order to increase awareness and support for tuberculosis (TB) vaccine research and raise funds for the development of safer and more effective vaccines.

25 Aug 2009

IDenta releases updates on new sales activities

IDenta Corp. (PINKSHEETS: IDTA) today released updates of some of the recent sales activity of IDenta products.

25 Aug 2009

Drugs News and Research

Recent study shows that eDetailing is a viable means for reaching prescribers

FDA to review Acorda Therapeutics’ NDA for Fampridine-SR

FDA recommends electronic report formats to strengthen postmarket safety data collection

Vision-related patient-reported outcomes used for improving medical product labeling in ophthalmology

New drug delivery system for delivering nanoparticles into the tissue

Adolescents engaged in dangerous activities are associated with increased brain maturity

Report warns H1N1 could affect half of U.S. population

FDA issues warning letters to eight companies for selling illegal OTC ibuprofen drugs

Antimicrobial-resistant typhoid fever in U.S. patients is associated with international travel

Tamoxifen drug poses increased risk of developing ER negative breast cancer

FDA establishes TPSAC to proceed further on the tobacco law

U.S. troops serving overseas to be tested for H1N1 infection

Medicare's Part D program subsidizes cost of prescription drugs for Medicare beneficiaries

Prescription assistance program helps Iowa residents to save money on drugs

University of Idaho researchers to develop a chemical probe technology that can treat genetic diseases

ParagonRx's CEO recommends techniques to effectively manage the FDA-mandated REMS program

Venlafaxine alleviates depressive symptoms

Delcath Systems enrolls 85 patients for its pivotal Phase III Metastatic Melanoma Trial

TuBerculosis Vaccine Initiative receives $3 million grant from Gates Foundation

IDenta releases updates on new sales activities

Designing fluidic architecture for scalable diagnostic platforms

Evaluating new approaches for rare disease genomics

Expanding access to NMR with the Fourier 80 Duo

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