Prescription Drug News and Research

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Gilead resubmits NDA for single-tablet regimen of Truvada/TMC278

Gilead Sciences, Inc. announced today that it has refiled a New Drug Application (NDA) with the U.S. Food and Drug Administration (FDA) for the single-tablet regimen of Truvada® (emtricitabine and tenofovir disoproxil fumarate) and Tibotec Pharmaceuticals' investigational non-nucleoside reverse transcriptase inhibitor TMC278 (rilpivirine hydrochloride) for HIV-1 infection in adults.

10 Feb 2011

Florida pain clinic society opposes Gov. Scott's proposal to repeal Prescription Drug Monitoring Program

The Florida Society of Pain Management Providers opposes Governor Scott's proposal to repeal the Prescription Drug Monitoring Program (PDMP). The PDMP system is the single most important weapon in the war on Rx drug abuse, not only in Florida but in the other 42 states where legislators have approved their operation.

10 Feb 2011

State and federal efforts to monitor drug prescriptions and payments face challenges

The Center For Public Integrity reports on the challenges Medicare faces in trying to ensure that prescription drugs paid for by its contracting health plans are actually prescribed by doctors. Meanwhile, The Miami Herald chronicles the latest chapter in the ongoing story about the state's pill mills.

10 Feb 2011

Health Foundation grants $50,000 to Good News to improve medical care

The Good News Care Center, located in Florida City, is pleased to announce a $50,000 grant received from Health Foundation of South Florida for the Coming Home: ER Diversion and Medical Homes Project, an initiative that increases the provision of primary care services, and integrates primary and tertiary medical care intervention with health education.

10 Feb 2011

Sugary snacks and lax dental hygiene put kids at risk for tooth decay

While the most prevalent focus of February is on Valentine's sweethearts, parents are well advised to also focus on the proverbial sweet tooth - particularly when it comes to their children. That's because February is National Children's Dental Health Month, an ideal time - according to Health Net, Inc. - for moms and dads to make sure that sugary snacks, as well as lax dental hygiene - aren't putting their kids at risk for tooth decay.

7 Feb 2011

Humana fourth quarter diluted EPS decreases to $0.63

Humana Inc. today reported diluted earnings per common share (EPS) for the quarter ended December 31, 2010 (4Q10) of $0.63, compared to $1.48 per share for the quarter ended December 31, 2009 (4Q09).

7 Feb 2011

The Lancet journal publishes BENLYSTA BLISS-52 study against SLE

Human Genome Sciences, Inc. and GlaxoSmithKline PLC today announced publication of the BLISS-52 study of BENLYSTA in autoantibody-positive patients with active systemic lupus erythematosus in The Lancet.

7 Feb 2011

Patient need to share medication side effects with health care team: Retired family doctor

"I had a wonderful gentleman patient who had resistant blood pressure," recalls Vicki Koenig, M.D., a retired family doctor in Exmore, VA. "When he came for a blood pressure check on the latest new med and it was great, I was ecstatic. Then he said, 'But I notice my urine's a little dark.' His was one of the first cases of fatal liver complications from this medication."

5 Feb 2011

Waismann Method examines link between chronic pain and Opioid-Induced Hyperalgesia

Results from a recent study issued by the Substance Abuse & Mental Health Services Administration revealed that treatment admissions for prescription painkiller abuse rose 345 percent over a 10 year period extending from 1998 to 2008.

5 Feb 2011

FDA sets new PDUFA date for AstraZeneca's ticagrelor

AstraZeneca announced today that the US Food and Drug Administration (FDA) has acknowledged receipt of the company's reply to the Complete Response Letter (CRL) for the ticagrelor New Drug Application (NDA).

4 Feb 2011

Study finds increased prescription drug abuse among teens

Illicit drugs like marijuana, cocaine and heroin have always been a parent's nightmare. But perfectly legal and easily accessible prescription medications are now the recreational drugs of choice for many teenagers, prompting physicians at Johns Hopkins Children's Center to urge pediatricians to screen specifically for their abuse during routine visits.

4 Feb 2011

New England Journal publishes fidaxomicin Phase 3 trial results against CDI

Optimer Pharmaceuticals, announced The New England Journal of Medicine has published results from the North American Phase 3 trial evaluating the safety and efficacy of the Company's novel antibiotic fidaxomicin as a treatment for patients with Clostridium difficile infection.

3 Feb 2011

Survey finds 75% of workers use their employers for medical and health information

The number of U.S. employees who turn to their employer and health plan for medical and health information has increased sharply over the past few years, according to a nationwide survey of employees conducted by the National Business Group on Health, a non-profit association of more than 300 large employers.

2 Feb 2011

French guy says Parkinson’s drug induced gambling and gay sex addiction, tries to sue GSK for $610,000

GlaxoSmithKline is being sued this week by a French father-of-two, alleging the British pharmaceutical firm’s drug – Reqip (Ropirnirole) to treat Parkinson’s disease turned him into a gay sex and gambling addict. Parkinson’s disease is a seriously and progressively debilitating disease that leads to tremors, slowing of movements and ultimately total immobility.

1 Feb 2011

King Pharmaceuticals awards payment to Pain Therapeutics for abuse-resistant medications

Pain Therapeutics, today announced that it had received a $5,000,000 milestone payment from King Pharmaceuticals, its exclusive commercial partner for abuse-resistant prescription pain medications.

29 Jan 2011

FDA accepts Pain Therapeutics NDA resubmission for REMOXY

Pain Therapeutics, Inc. today announced that the U.S. Food and Drug Administration (FDA) has accepted a New Drug Application (NDA) resubmission for REMOXY (controlled-release oxycodone) and has classified it as a Class 2 resubmission.

27 Jan 2011

Medisafe to develop barcoded system to confirm origin of prescription medications

Medisafe 1 Technologies Corp., a developer of patented technologies that physically prevent unauthorized administration of prescription medications, announced today that the company intends to begin development of a barcoded system to confirm the origin and authenticity of prescription medications. The product is aimed at reducing ingestion of counterfeit medications.

27 Jan 2011

FDA accepts Optimer's fidaxomicin NDA for filing

Optimer Pharmaceuticals, Inc. today announced that the U.S. Food and Drug Administration (FDA) has accepted for filing the Company's New Drug Application (NDA) for fidaxomicin for the treatment of Clostridium difficile infection (CDI) and for reducing the risk of recurrence when used for treatment of initial CDI.

24 Jan 2011

R-Tech Ueno announces completion of RK-023 Phase 2a study for androgenetic alopecia

R-Tech Ueno, is pleased to announce that the Phase 2a clinical study of RK-023 to treat androgenetic alopecia was completed by January 21, 2011.

24 Jan 2011

SuppreMol completes successful pre-IND meeting with U.S. FDA

SuppreMol GmbH, a privately held biopharmaceutical company developing innovative therapeutics for the treatment of autoimmune diseases, today announced that it has successfully completed a pre-Investigational New Drug Application (pre-IND) meeting with the U.S. Food and Drug Administration (FDA) for its lead compound SM101, which is being developed for the treatment of Primary Immune Thrombocytopenia (ITP) and Systemic Lupus Erythematosus (SLE).

24 Jan 2011

Prescription Drug News and Research

Gilead resubmits NDA for single-tablet regimen of Truvada/TMC278

Florida pain clinic society opposes Gov. Scott's proposal to repeal Prescription Drug Monitoring Program

State and federal efforts to monitor drug prescriptions and payments face challenges

Health Foundation grants $50,000 to Good News to improve medical care

Sugary snacks and lax dental hygiene put kids at risk for tooth decay

Humana fourth quarter diluted EPS decreases to $0.63

The Lancet journal publishes BENLYSTA BLISS-52 study against SLE

Patient need to share medication side effects with health care team: Retired family doctor

Waismann Method examines link between chronic pain and Opioid-Induced Hyperalgesia

FDA sets new PDUFA date for AstraZeneca's ticagrelor

Study finds increased prescription drug abuse among teens

New England Journal publishes fidaxomicin Phase 3 trial results against CDI

Survey finds 75% of workers use their employers for medical and health information

French guy says Parkinson’s drug induced gambling and gay sex addiction, tries to sue GSK for $610,000

King Pharmaceuticals awards payment to Pain Therapeutics for abuse-resistant medications

FDA accepts Pain Therapeutics NDA resubmission for REMOXY

Medisafe to develop barcoded system to confirm origin of prescription medications

FDA accepts Optimer's fidaxomicin NDA for filing

R-Tech Ueno announces completion of RK-023 Phase 2a study for androgenetic alopecia

SuppreMol completes successful pre-IND meeting with U.S. FDA

Industry Focus eBook - Neurology/Neuroscience - 2nd 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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