Prescription Drug News and Research

RSS

Amneal enters license and distribution agreement with Hanmi for generic Nexium

Amneal Pharmaceuticals, LLC today announced that it has entered into a license and distribution agreement with South Korea-based Hanmi Pharmaceutical Co., Ltd to acquire exclusive distribution rights to Hanmi's new drug application (NDA), currently under FDA review, for esomeprazole strontium delayed-release capsules.

28 Jan 2013

ED visits involving ADHD stimulant medications are on the rise

A new report shows that the number of emergency department visits involving attention deficit /hyperactivity disorder (ADHD) stimulant medications more than doubled from 13,379 visits in 2005 to 31,244 in 2010.

28 Jan 2013

Gilead commences first of two tenofovir alafenamide Phase 3 trials in HIV

Gilead Sciences, Inc. today announced the initiation of the first of two Phase 3 clinical trials (Study 104) evaluating a single tablet regimen containing tenofovir alafenamide (TAF) for the treatment of HIV-1 infection in treatment-naïve adults.

28 Jan 2013

Actavis seeks FDA approval to market generic Opana ER

Watson Pharmaceuticals, Inc. today confirmed that Actavis South Atlantic LLC, which was acquired by Watson in October, has filed an Abbreviated New Drug Application (ANDA) with the U.S. Food and Drug Administration (FDA) seeking approval to market Oxymorphone Hydrochloride Extended-release Tablets.

23 Jan 2013

Psychiatrists exposed to COI policies during residency less likely to prescribe brand antidepressants

Psychiatrists who are exposed to conflict-of-interest (COI) policies during their residency are less likely to prescribe brand-name antidepressants after graduation than those who trained in residency programs without such policies, according to a new study by researchers from the Perelman School of Medicine at the University of Pennsylvania.

22 Jan 2013

Study shows first empirical evidence of exposure to conflict-of-interest policies

19 Jan 2013

State highlights: Calif. governor earmarks money for Medi-Cal expansion; Mental health reforms take shape in Kan., Colo.

Brown earmarked $350 million in his spending plan to help enroll more Californians in Medi-Cal, the state's health insurance program for the poor. Under the proposal, enrollment rules would be simplified to cover residents who are currently eligible but not enrolled.

15 Jan 2013

Viewpoints: Health care and the 'crushing federal debt;' Optimism about 'grand bargain;' Iowa's premium increase request

The largest issue America will face in 2013 is health care. And it will only get larger. As the national conversation changes, we'll find that by year-end we're talking about it all the time, whether the ostensible topic is politics, government, the economy, our jobs, or our families. Health care will be the unavoidable topic. Medicare and Medicaid are the biggest element of our most serious national problem: crushing federal debt.

9 Jan 2013

Paratek receives FDA QIDP designation for omadacycline to treat ABSSSI, CABP

Paratek Pharmaceuticals, Inc. today announced that the U.S. Food and Drug Administration (FDA) has designated the Company's lead antibiotic candidate, omadacycline (formerly known as PTK 0796), as a Qualified Infectious Disease Product (QIDP) for both intravenous (IV) and oral formulations in the treatment of acute bacterial skin and skin structure infections (ABSSSI) and community-acquired bacterial pneumonia (CABP).

3 Jan 2013

Longer looks: DIY abortions and the law; Helping other parents reach out to mentally ill children; Human growth hormone and Big Pharma

McCormack knew that an abortion would cost $400 to $2,000, depending on how far along she was. ... She couldn't come up with that kind of money. So she called her older sister, who owned a computer, and asked her to order abortion pills for her on the Internet.

3 Jan 2013

Roundup: Medicaid waiver challenges in Texas; Detailing Sandy's impact on NYC's mental care

By 2012's end, health care providers across Texas will have submitted proposals to state leaders to transform the way they care for the poor and uninsured. They have been spurred by a Medicaid waiver Texas officials sought and received in 2011 from the federal government, one that ties financing to cooperation, cost efficiency and better patient outcomes.

2 Jan 2013

Viewpoints: Playing chicken on entitlements; 'Getting serious' about mental illness; Hospital labs devastated by Sandy

This is no time for a Grand Bargain, because the Republican Party, as now constituted, is just not an entity with which the president can make a serious deal. If we're going to get a grip on our nation's problems -; of which the budget deficit is a minor part -; the power of the G.O.P.'s extremists, and their willingness to hold the economy hostage if they don't get their way, needs to be broken. And somehow I don't think that's going to happen in the next few days (Paul Krugman, 12/20).

21 Dec 2012

Maneuvering toward a 'fiscal cliff' deal

Despite progress toward an agreement with the White House, House Republicans appeared to veer off course Tuesday with a "Plan B" if budget talks fail. Some media outlets suggested that both President Barack Obama and Speaker John Boehner, R-Ohio, are attempting to quell backlash within their own parties -- Boehner for agreeing to tax increases, Obama for ceding some entitlement cuts.

20 Dec 2012

NIDA's 2012 Monitoring the Future survey shows rates stable or down for most drugs

Continued high use of marijuana by the nation's eighth, 10th and 12th graders combined with a drop in perceptions of its potential harms was revealed in this year's Monitoring the Future survey, an annual survey of eighth, 10th, and 12th-graders conducted by researchers at the University of Michigan.

20 Dec 2012

Survey shows health care costs projected to increase at slower pace

Projected cost increases for all types of medical plans are anticipated to be down by between 0.2 and 0.6 percent through the first half of 2013, according to a survey by Buck Consultants, A Xerox Company.

17 Dec 2012

Pfizer, Ligand announce FDA acceptance of bazedoxifene/conjugated estrogens NDA

Pfizer Inc. and Ligand Pharmaceuticals Incorporated today announced that the United States Food and Drug Administration (FDA) accepted for review a New Drug Application (NDA) for bazedoxifene/conjugated estrogens (BZA/CE), a potential new medicine for non-hysterectomized women for the treatment of moderate-to-severe vasomotor symptoms (VMS) and vulvar and vaginal atrophy (VVA) associated with menopause, as well as the prevention of postmenopausal osteoporosis.

14 Dec 2012

Takeda, Lundbeck announce FDA acceptance of vortioxetine NDA submission

Takeda Global Research & Development Center, Inc., (Takeda) and H. Lundbeck A/S (Lundbeck) jointly announced today that the U.S. Food and Drug Administration (FDA) has accepted for filing their submission of a New Drug Application (NDA) for vortioxetine for the treatment of major depressive disorder (MDD) in adult patients.

13 Dec 2012

FDA grants Orphan Drug designation to Milo Biotechnology's AAV1-FS344 inhibitor

Milo Biotechnology today announced its AAV1-FS344 has been granted Orphan Drug designation from the FDA's Office of Orphan Products Development for treatment of Becker and Duchenne muscular dystrophy. AAV1-FS344 is a gene therapy-delivered myostatin inhibitor that increases muscle strength.

12 Dec 2012

As clock ticks toward fiscal deadline, Obama, Boehner meet at the White House

Action this week is critical if a deal is to be reached this year, The Washington Post reports. Most analysts appear to agree that the contours of such an agreement are clear, but the specifics -- which include raising taxes as well as spending reductions for Medicare and Medicaid -- remain challenging and politically divisive.

10 Dec 2012

GOP Sen. Corker says party should accept tax hikes to get spending cuts

As pressure builds for a "fiscal cliff" deal, several key players talked about strategy on the Sunday morning news shows. Meanwhile, Politico reports that Republicans' hope of a big victory on cutting entitlement spending has dimmed while The Hill looks at Democrats' new willingness to consider means testing for Medicare.

9 Dec 2012

Prescription Drug News and Research

Amneal enters license and distribution agreement with Hanmi for generic Nexium

ED visits involving ADHD stimulant medications are on the rise

Gilead commences first of two tenofovir alafenamide Phase 3 trials in HIV

Actavis seeks FDA approval to market generic Opana ER

Psychiatrists exposed to COI policies during residency less likely to prescribe brand antidepressants

Study shows first empirical evidence of exposure to conflict-of-interest policies

State highlights: Calif. governor earmarks money for Medi-Cal expansion; Mental health reforms take shape in Kan., Colo.

Viewpoints: Health care and the 'crushing federal debt;' Optimism about 'grand bargain;' Iowa's premium increase request

Paratek receives FDA QIDP designation for omadacycline to treat ABSSSI, CABP

Longer looks: DIY abortions and the law; Helping other parents reach out to mentally ill children; Human growth hormone and Big Pharma

Roundup: Medicaid waiver challenges in Texas; Detailing Sandy's impact on NYC's mental care

Viewpoints: Playing chicken on entitlements; 'Getting serious' about mental illness; Hospital labs devastated by Sandy

Maneuvering toward a 'fiscal cliff' deal

NIDA's 2012 Monitoring the Future survey shows rates stable or down for most drugs

Survey shows health care costs projected to increase at slower pace

Pfizer, Ligand announce FDA acceptance of bazedoxifene/conjugated estrogens NDA

Takeda, Lundbeck announce FDA acceptance of vortioxetine NDA submission

FDA grants Orphan Drug designation to Milo Biotechnology's AAV1-FS344 inhibitor

As clock ticks toward fiscal deadline, Obama, Boehner meet at the White House

GOP Sen. Corker says party should accept tax hikes to get spending cuts

Leveraging the power of automation to boost research

Automating research - solutions and best practices

How can microdialysis benefit drug development

Latest News