Prescription Drug News and Research

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First Edition: Sept. 13, 2012

Today's headlines include news from the Census Bureau that, although record numbers of poor people persist, the number of uninsured Americans dropped by 1.3 million.

13 Sep 2012

Ways and Means panel to review IRS mission in health law

A prominent House committee will continue its case against the healthcare law just one day after the conclusion of August recess. On Sept. 11, the Ways and Means Subcommittee on Oversight will look at how the law's implementation could strain the Internal Revenue Service.

6 Sep 2012

Janssen receives FDA Priority Review for bedaquiline NDA to treat MDR-TB

Janssen Research & Development, LLC (Janssen) announced today that the U.S. Food and Drug Administration (FDA) has granted Priority Review to the New Drug Application (NDA) for bedaquiline (TMC207) to treat pulmonary, multi-drug resistant tuberculosis (MDR-TB) in adults as part of combination therapy.

6 Sep 2012

Real-time prescription system reduces inappropriate prescribing of medications

A centralized prescription network providing real-time information to pharmacists in British Columbia, Canada, resulted in dramatic reductions in inappropriate prescriptions for opioid analgesics and benzodiazepines, widely used and potentially addictive drugs. The findings are reported in a study in CMAJ (Canadian Medical Association Journal).

5 Sep 2012

Roundup: Texas probes Xerox in Medicaid overbilling; Miss. abortion clinic fights to stay open

Texas authorities are investigating whether Xerox Corp. played a role in allowing dentists to allegedly overbill the state's Medicaid system by millions of dollars.

5 Sep 2012

Health Net helps to increase awareness about importance of whooping cough vaccination

According to the Centers for Disease Control and Prevention (CDC), the number of whooping cough cases in the United States could reach a 50-year high in 2012. The CDC's forecast is based on the fact that, as of July 2012, twice as many cases of whooping cough - or pertussis as it's referred to clinically - had been reported to the CDC thus far this year as compared to the same point in 2011.

1 Sep 2012

Astellas Pharma receives FDA approval for Xtandi to treat metastatic CRPC

The U.S. Food and Drug Administration today approved Xtandi (enzalutamide) to treat men with late-stage (metastatic) castration-resistant prostate cancer that has spread or recurred, even with medical or surgical therapy to minimize testosterone.

1 Sep 2012

Veterans Affairs San Diego Healthcare System initiates Pathway Fit clinical trial in obesity

Pathway Genomics Corporation, a San Diego-based genetic testing laboratory, has announced a clinical trial with the Veterans Affairs San Diego Healthcare System (VASDHS).

1 Sep 2012

Surveying Romney's health advisers; The pressures he faces if he wins

News outlets examine the role Micheal Leavitt and his followers will have on Romney's health policy and the expectation that a new president can change the health law quickly.

31 Aug 2012

Janssen receives FDA Priority Review for ZYTIGA sNDA to treat mCRPC

Janssen Research & Development, LLC, announced today that the U.S. Food and Drug Administration (FDA) has granted Priority Review to the supplemental New Drug Application (sNDA) for ZYTIGA (abiraterone acetate) administered in combination with prednisone for the treatment of patients with metastatic castration-resistant prostate cancer (mCRPC) who are asymptomatic or mildly symptomatic after failure of androgen deprivation therapy.

30 Aug 2012

Sleep disorder treatment: an interview with Dr Seth Lederman, President and CEO of Tonix Pharmaceuticals

Sleep disorders are a large area. We are focused on one particular type of sleep disturbance called “non-restorative” sleep. People with this problem do sleep, but they don’t wake up feeling refreshed or feeling that their sleep has had the restorative effects of healthy sleep.

29 Aug 2012

Obama, Romney trade more Medicare barbs

President Barack Obama went on the Medicare attack, using his weekly address to challenge Republican charges that he cut Medicare. Obama also launched a new ad saying that the Romney-Ryan ticket would end Medicare as it exists today. But the Romney campaign has Medicare messages of its own.

28 Aug 2012

First Edition: August 27, 2012

Today's headlines include reports about this week's GOP convention, the politics of Medicare and abortion, and the latest health policy news from the states.

27 Aug 2012

Prescription drug monitoring systems alert abuse

Electronic prescription monitoring programs may significantly improve drug-abuse detection and could alert clinicians to “doctor shopping,” say researchers.

24 Aug 2012

Proposed U.S. legislation would 'set the standard' for global efforts to combat counterfeit drugs

In this Forbes opinion piece, John Lechleiter, president and chief executive officer of Eli Lilly and Company, examines the business of counterfeit medicines, writing, "With global sales last year estimated as high as $200 billion, counterfeit medicine is big business, and it's growing."

24 Aug 2012

Romney vow to restore Medicare funding raises tough fiscal issues; GOP platform adds revamping of Medicare

In the short term, the Republican presidential candidate's promise to restore the Medicare cuts included in the health law would increase beneficiaries' costs. Meanwhile, the GOP draft platform embraces the Medicare changes advanced as part of Paul Ryan's House budget plan.

23 Aug 2012

FDA warns consumers about potential health risks of two natural dietary supplements

The U.S. Food and Drug Administration today issued a new warning to consumers about the potential health risks of two products marketed as natural dietary supplements for treating arthritis, muscle pain, osteoporosis, bone cancer, and other conditions.

22 Aug 2012

FDA extends action date for Pfizer’s tofacitinib NDA review

Pfizer Inc. announced today that the U.S. Food and Drug Administration (FDA) has extended the action date by three months for the New Drug Application (NDA) for tofacitinib, an investigational oral treatment for adults with moderately to severely active rheumatoid arthritis (RA).

22 Aug 2012

Poll finds Calif. voters strongly support federal health law; Montana lawmakers consider Medicaid expansion

States are confronting a bevy of issues in implementing the health care law including gauging public support for the law, fights over a contraception coverage mandate, expanding Medicaid and assessing the Medicare prescription drug "doughnut hole."

22 Aug 2012

FDA committee to review NPS’ Gattex NDA in October

NPS Pharmaceuticals, Inc., a specialty pharmaceutical company developing therapeutics for rare gastrointestinal and endocrine disorders, today announced that the U.S. Food and Drug Administration (FDA) has notified the Company that its New Drug Application (NDA) for Gattex (teduglutide) will be discussed at the Gastrointestinal Drugs Advisory Committee meeting scheduled for October 16, 2012.

22 Aug 2012

Prescription Drug News and Research

First Edition: Sept. 13, 2012

Ways and Means panel to review IRS mission in health law

Janssen receives FDA Priority Review for bedaquiline NDA to treat MDR-TB

Real-time prescription system reduces inappropriate prescribing of medications

Roundup: Texas probes Xerox in Medicaid overbilling; Miss. abortion clinic fights to stay open

Health Net helps to increase awareness about importance of whooping cough vaccination

Astellas Pharma receives FDA approval for Xtandi to treat metastatic CRPC

Veterans Affairs San Diego Healthcare System initiates Pathway Fit clinical trial in obesity

Surveying Romney's health advisers; The pressures he faces if he wins

Janssen receives FDA Priority Review for ZYTIGA sNDA to treat mCRPC

Sleep disorder treatment: an interview with Dr Seth Lederman, President and CEO of Tonix Pharmaceuticals

Obama, Romney trade more Medicare barbs

First Edition: August 27, 2012

Prescription drug monitoring systems alert abuse

Proposed U.S. legislation would 'set the standard' for global efforts to combat counterfeit drugs

Romney vow to restore Medicare funding raises tough fiscal issues; GOP platform adds revamping of Medicare

FDA warns consumers about potential health risks of two natural dietary supplements

FDA extends action date for Pfizer’s tofacitinib NDA review

Poll finds Calif. voters strongly support federal health law; Montana lawmakers consider Medicaid expansion

FDA committee to review NPS’ Gattex NDA in October

Leveraging the power of automation to boost research

Automating research - solutions and best practices

How can microdialysis benefit drug development

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