Prescription Drug News and Research

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State highlights: Calif. rejecting 'free money'; N.C. Medicaid changes, problems; Ill. readies employer contraception coverage vote

Consumer advocates and some legislators were surprised and frustrated when California health officials recently refused a $6 million donation to help people re-up their Medi-Cal health coverage. Now two senators have proposed an unusual solution: a bill to force the state to accept the offer from The California Endowment (Gorman, 7/4).

8 Jul 2014

Prescription drug deaths drop in Fla. after crackdown on doctors

Deaths involving narcotic painkillers dropped 26 percent over two years in Florida after stricter doctor scrutiny, according to a report from the federal Centers for Disease Control and Prevention.

2 Jul 2014

EMA CHMP adopts positive opinion for Bristol-Myers Squibb’s Daklinza for HCV treatment

Bristol-Myers Squibb Company today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending that Daklinza (daclatasvir), an investigational, potent pan-genotypic NS5A complex inhibitor (in vitro), be granted approval for use in combination with other medicinal products for the treatment of chronic hepatitis C virus (HCV) infection in adults.

27 Jun 2014

Study calls for improvements in physicians' inconsistent record of ordering lab tests

Why does one physician in a walk-in practice order laboratory monitoring tests for patients more often than a colleague working down the hallway?

27 Jun 2014

Study proposes moving open enrollment season

Researchers suggest consumers are not willing to spend money on insurance in the busy fall season as they plan for the holidays so sign-ups in the spring after tax returns are received might be better. Also, a look at consumers' reluctance to shop for insurance

27 Jun 2014

Italian Medicines Agency grants marketing authorization to ILUVIEN for chronic DME treatment

pSivida Corp., a leader in the development of sustained release, drug delivery products for treating eye diseases, today announced that the Italian Medicines Agency (Agenzia Italiana del Farmaco) has granted marketing authorization to ILUVIEN for the treatment of vision impairment associated with chronic diabetic macular edema (DME) considered insufficiently responsive to available therapies.

23 Jun 2014

IGI Laboratories submits third ANDA in 2014 to FDA

IGI Laboratories, Inc., a New Jersey based generic topical pharmaceutical company, today announced it has submitted its third abbreviated new drug application (ANDA) in 2014 to the U.S. Food and Drug Administration, which brings the Company's total number of ANDA submissions to sixteen, with fourteen now pending at the FDA.

18 Jun 2014

FDA accepts Symplmed's Prestalia NDA for hypertension treatment

Symplmed announced today that the U.S. Food and Drug Administration has accepted for review its New Drug Application (NDA) for investigational drug Prestalia, the first single-pill, fixed-dose combination (FDC) of perindopril arginine and amlodipine besylate for the treatment of hypertension in the U.S. Symplmed filed the application under section 505(b)(2) consistent with FDA's guidance.

18 Jun 2014

Researchers develop rapid-acting antidepressants for treatment-resistant depression

UT Southwestern Medical Center researchers have generated fresh insights that could aid in the development of rapid-acting antidepressants for treatment-resistant depression.

13 Jun 2014

8.5 million on Medicare get opioids

The number of senior citizens getting narcotic painkillers and anti-anxiety medications under Medicare's prescription drug program is climbing sharply, and those older patients are being put on the drugs for longer periods of time, a USA TODAY examination of federal data shows.

12 Jun 2014

First Edition: June 11, 2014

Today's headlines include a range of stories about the upset of House Majority Leader Eric Cantor -- a Virginia primary election shocker -- as well as continuing coverage of health law implementation issues and congressional responses to the VA's health care troubles.

11 Jun 2014

RBCC's injectable technology poised to improve use of addiction treatment drug

Rainbow Coral Corp. received a boost recently when researchers reported that a medication that could help tens of thousands of alcoholics quit drinking are underused.

11 Jun 2014

Helix Healthcare Group offers individualized treatment for substance abuse, addiction, mental health issues

Helix Healthcare Group is the first integrated facility in Canada to offer a highly individualized approach in the treatment of substance abuse, addiction and mental health issues.

11 Jun 2014

FDA accepts Pharmacyclics' IMBRUVICA sNDA for review

Pharmacyclics, Inc. today announced that the U.S. Food and Drug Administration has accepted for filing its supplemental New Drug Application (sNDA) to support the review of IMBRUVICA (ibrutinib) in the treatment of patients with chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL) who have received at least one prior therapy for a full approval.

9 Jun 2014

Cubist Pharmaceuticals publishes positive results from Phase 3 clinical trial of SIVEXTRO

Cubist Pharmaceuticals, Inc. (NASDAQ: CBST) today announced that The Lancet Infectious Diseases published online the positive results from ESTABLISH-2, a pivotal Phase 3 clinical trial of the investigational antibiotic SIVEXTRO™ (tedizolid phosphate), which is being developed for the treatment of acute bacterial skin and skin structure infections (ABSSSI) and complicated skin and soft tissue infections (cSSTI).

9 Jun 2014

Ocugen's OCU100 gets FDA orphan drug designation for treatment of retinitis pigmentosa

Ocugen, Inc. and the University of Colorado today announced exclusive license agreements that allow for Ocugen to continue developing two drug candidates for the treatment for ophthalmology indications, and that one of the assets, OCU100, recombinant lens epithelium derived growth factor 1-326 (LEDGF1-326), received orphan-drug status from the U.S. Food and Drug Administration for treatment of retinitis pigmentosa (RP), a rare eye disease.

6 Jun 2014

First Edition: June 3, 2014

Today's headlines include coverage of Medicare data released Monday indicating that 2012 charges for some common inpatient hospital procedures dramatically increased over the previous year.

From Medtronic 3 Jun 2014

Viewpoints: GOP needs to refine its message on health law; battle over school lunches

It was supposed to be so easy this election year for Republican congressional candidates. All they would have to do was shout "repeal Obamacare!" and make a crack about government doctors and broken websites, and they could coast into office on a wave of public fury. ... But it has not quite worked out that way. ... That sentiment conflicts with the Republican playbook, which party leaders are suddenly trying to rewrite. The result has been an incoherent mishmash of positions, as candidates try to straddle a widening gap between blind hatred of health reform and the public's growing recognition that much of it is working (6/1).

3 Jun 2014

Physicians Interactive eCoupon now available within Greenway Health's PrimeSUITE EHR system

Physicians Interactive, the leading provider of online and mobile clinical resources and solutions for healthcare professionals (HCPs), today announced that its eCoupon automated voucher and coupon distribution solution is now available within the latest version of Greenway Health's PrimeSUITE electronic health record (EHR) system.

2 Jun 2014

Experts from ProfNet network available to discuss timely issues in coverage area

Below are experts from the ProfNet network that are available to discuss timely issues in your coverage area. If you are interested in interviewing any of the experts, please contact them via the contact information at the end of the listing.

31 May 2014

Prescription Drug News and Research

State highlights: Calif. rejecting 'free money'; N.C. Medicaid changes, problems; Ill. readies employer contraception coverage vote

Prescription drug deaths drop in Fla. after crackdown on doctors

EMA CHMP adopts positive opinion for Bristol-Myers Squibb’s Daklinza for HCV treatment

Study calls for improvements in physicians' inconsistent record of ordering lab tests

Study proposes moving open enrollment season

Italian Medicines Agency grants marketing authorization to ILUVIEN for chronic DME treatment

IGI Laboratories submits third ANDA in 2014 to FDA

FDA accepts Symplmed's Prestalia NDA for hypertension treatment

Researchers develop rapid-acting antidepressants for treatment-resistant depression

8.5 million on Medicare get opioids

First Edition: June 11, 2014

RBCC's injectable technology poised to improve use of addiction treatment drug

Helix Healthcare Group offers individualized treatment for substance abuse, addiction, mental health issues

FDA accepts Pharmacyclics' IMBRUVICA sNDA for review

Cubist Pharmaceuticals publishes positive results from Phase 3 clinical trial of SIVEXTRO

Ocugen's OCU100 gets FDA orphan drug designation for treatment of retinitis pigmentosa

First Edition: June 3, 2014

Viewpoints: GOP needs to refine its message on health law; battle over school lunches

Physicians Interactive eCoupon now available within Greenway Health's PrimeSUITE EHR system

Experts from ProfNet network available to discuss timely issues in coverage area

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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