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Electronic PMP use may have impact on demand for drug treatment programs, painkiller abuse

A Rhode Island Hospital researcher has found that the use of electronic prescription drug monitoring programs (PMPs) may have a significant impact on the demand for drug treatment programs and how prescribers detect and respond to abuse of painkillers.

17 Aug 2012

George Washington University releases 'Obesity Drug Outcome Measures'

The George Washington University School of Public Health and Health Services (GW) today released a report representing consensus findings from a cross-section of stakeholders that could help transform the process used to evaluate interventions to treat obesity, a public health crisis that now affects one in three adults. The report, "Obesity Drug Outcome Measures," results from a stakeholder dialogue group convened by GW that, over a period of nine months, explored why development and approval of obesity drugs have proven so difficult.

15 Aug 2012

Viewpoints: Romney's gamble; The return of 'Mediscare;' Klein and Roy offer competing views on differences in Ryan, Obama plans

It doesn't take a political genius to see where the contest between President Obama and Mitt Romney is heading. With Rep. Paul Ryan on the Republican ticket, the campaign is looking at a full-throated debate over the future of Medicare. Are Romney and Ryan ready?

15 Aug 2012

AstraZeneca enters agreement with Pfizer for OTC NEXIUM

Pfizer Inc. today announced that it has entered into an agreement with AstraZeneca for the over-the-counter (OTC) rights for NEXIUM (esomeprazole magnesium), a leading prescription drug currently approved to treat the symptoms of gastroesophageal reflux disease (GERD).

14 Aug 2012

FDA extends PDUFA target action date for review of Santarus' UCERIS NDA

Santarus, Inc. today announced that the U.S. Food and Drug Administration (FDA) has extended the Prescription Drug User Fee Act (PDUFA) target action date for the review of the New Drug Application (NDA) for UCERIS (budesonide) tablets 9 mg for the induction of remission of mild to moderate active ulcerative colitis from October 16, 2012 to January 16, 2013.

14 Aug 2012

FDA extends PDUFA action date for NPS Gattex NDA

NPS Pharmaceuticals, Inc., a specialty pharmaceutical company developing therapeutics for rare gastrointestinal and endocrine disorders, today announced that it has received a communication from the U.S. Food and Drug Administration extending the Prescription Drug User Fee Act action date for its New Drug Application for Gattex (teduglutide) by three months to December 30, 2012.

13 Aug 2012

AbilTo, Aetna announce new program to help members with diabetes combat depression

The combination of depression and diabetes is common and potentially dangerous. People with depression can find it hard to make the lifestyle changes needed to manage diabetes. If not well managed, diabetes often leads to additional health issues, like heart, circulatory and kidney disease. Today, Aetna and AbilTo are announcing a new program to help members with diabetes combat depression and take control of their diabetes.

9 Aug 2012

Omeros completes enrollment in first of two OMS103HP Phase 3 meniscectomy trials

Omeros Corporation today reported the completion of enrollment in the first of two planned Phase 3 clinical trials evaluating OMS103HP in patients undergoing arthroscopic partial meniscectomy surgery.

8 Aug 2012

Drug companies developing novel treatments for MDR-TB

With incentives to find new antibiotics signed into U.S. law last month, "multiple players are vying for the lead in the [multi-drug resistant tuberculosis (MDR-TB)] drug development niche," Nature Medicine reports.

8 Aug 2012

Viewpoints: Orszag on CAP cost-control proposals; High-tech and health costs

The Center for American Progress proposals thus wisely recognize that there is no single strategy to continue the recent progress in slowing the growth in health-care costs. In contrast, the Republican budget plan put forward by Representative Paul Ryan of Wisconsin seems based on a belief that all that's needed is to shift risks: from Medicare to beneficiaries through a premium-support program, and from the federal government to state governments by turning Medicaid into block grants.

3 Aug 2012

New FDA risk management plan aims to reduce opioid abuse in the U.S.

A new risk management plan from the U.S. Food and Drug Administration to help clinicians properly prescribe drugs with addiction potential aims to help reduce the growing epidemic of opioid abuse in the United States.

2 Aug 2012

Roundup: Most high-ranking Iowa gov't employees to pay more for health care; Federal judge strikes Fla. law on docs asking about guns

The New Jersey state Legislature endorsed a constitutional amendment Monday requiring judges to contribute more to their government benefits, sending to voters an issue that some consider a linchpin of judicial independence. In a rare midsummer voting session, lawmakers responded quickly and almost unanimously to a state Supreme Court decision last week that said judges can't be forced to pay more for pension and health benefits, as other government workers were in a historic 2011 law.

31 Jul 2012

FibroGen receives FDA Orphan Drug Designation for FG-3019 to treat IPF

FibroGen, Inc., today announced that FG-3019, the Company's human monoclonal antibody against connective tissue growth factor (CTGF), has been granted Orphan Drug Designation by the U.S. Food and Drug Administration (FDA) for the treatment of idiopathic pulmonary fibrosis (IPF).

31 Jul 2012

Top-line results from Pfizer's tofacitinib Phase 3 study on moderate-to-severe active RA

Pfizer Inc. announced today top-line results from ORAL Start (A3921069), a Phase 3 study of the investigational agent tofacitinib, a novel, oral Janus kinase (JAK) inhibitor for the treatment of adults with moderate-to-severe active rheumatoid arthritis (RA).

31 Jul 2012

McKesson settles Rx drug pricing case with 29 states

The nation's largest drug wholesaler by revenue will pay $151 million to settle a lawsuit that alleged the company inflated prescription drug prices for state Medicaid programs.

31 Jul 2012

FDA grants Senesco's SNS01-T orphan-drug designation to treat lymphomas

Senesco Technologies, Inc. reported today that it was informed on July 26th that the U.S. Food and Drug Administration has granted orphan-drug designation for the company's lead drug candidate SNS01-T for treatment of both mantle cell lymphoma and diffuse large B-cell lymphoma.

30 Jul 2012

Watson seeks FDA approval to market Epiduo Gel for severe acne

Watson Pharmaceuticals, Inc. today confirmed that its subsidiary, Watson Laboratories, Inc., filed an Abbreviated New Drug Application (ANDA) with the U.S. Food and Drug Administration seeking approval to market Epiduo (adapalene and benzoyl peroxide) Gel, 0.1% / 2.5%.

30 Jul 2012

First Edition: June 30, 2012

Today's headlines include recent reports about both the policies and politics related to the health law's implementation.

30 Jul 2012

FDA accepts Exelixis’ cabozantinib NDA for filing

Exelixis, Inc. today announced that the U.S. Food and Drug Administration (FDA) has accepted for filing the New Drug Application (NDA) for cabozantinib as a treatment for patients with progressive, unresectable, locally advanced, or metastatic medullary thyroid cancer (MTC).

30 Jul 2012

Roundup: Mass. lawmakers struggle to reach agreement on cost controls; $100M grant for Calif. stem cell research; N.C. to move mentally ill from elderly homes

The House and Senate are under the gun to reach an agreement on how to lower health care costs while improving care. A conference committee aims to have a bill out on Sunday. Their deadline is Monday evening. In the meantime, several major issues are still unresolved, including what to do about hospitals that use their market clout to demand high prices that are not based on higher quality. Attorney General Martha Coakley, the state's top insurers and several consumer groups argue that price is a critical issue.

28 Jul 2012