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IGI Laboratories submits third ANDA in 2014 to FDA

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. [More]
FDA accepts Symplmed's Prestalia NDA for hypertension treatment

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. [More]
Researchers develop rapid-acting antidepressants for treatment-resistant depression

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. [More]
8.5 million on Medicare get opioids

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. [More]
First Edition: June 11, 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. [More]
RBCC's injectable technology poised to improve use of addiction treatment drug

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. [More]
Helix Healthcare Group offers individualized treatment for substance abuse, addiction, mental health issues

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. [More]
FDA accepts Pharmacyclics' IMBRUVICA sNDA for review

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. [More]
Cubist Pharmaceuticals publishes positive results from Phase 3 clinical trial of SIVEXTRO

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). [More]
Ocugen's OCU100 gets FDA orphan drug designation for treatment of retinitis pigmentosa

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. [More]
First Edition: June 3, 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. [More]
Viewpoints: GOP needs to refine its message on health law; battle over school lunches

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). [More]
Physicians Interactive eCoupon now available within Greenway Health's PrimeSUITE EHR system

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. [More]
Experts from ProfNet network available to discuss timely issues in coverage area

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. [More]
CMS says it won't review billings despite IG report that it overpays doctors

CMS says it won't review billings despite IG report that it overpays doctors

The move comes even as a report points at $6.7 billion in overspending in Medicare. The HHS inspector general also says that the program paid $457 million in 2012 to detect drugs after a sharp increase in prescription drug abuse. [More]
State highlights: Complaint says Fla. plans tried to keep out AIDS patients; Ill. restores some Medicaid services; Fla. Gov. to sue feds

State highlights: Complaint says Fla. plans tried to keep out AIDS patients; Ill. restores some Medicaid services; Fla. Gov. to sue feds

Four Florida insurance companies offering Affordable Care Act policies are discriminating against people with HIV or AIDS, according to two health-rights organizations that plan to file a formal complaint with the federal government Thursday. [More]
Viewpoints: Michelle Obama and school lunches; more about the VA health system 'scandal'; context and caution on Medicare's physician data release

Viewpoints: Michelle Obama and school lunches; more about the VA health system 'scandal'; context and caution on Medicare's physician data release

When we began our Let's Move! initiative four years ago, we set one simple but ambitious goal: to end the epidemic of childhood obesity in a generation so that kids born today will grow up healthy. [More]
State regulators seek to impose controls on new painkiller

State regulators seek to impose controls on new painkiller

Several outlets look at prescription drug issues, including how to handle Zohydro -- a powerful painkiller approved by the FDA in March, and ethical questions raised by new "smart pills." [More]
State highlights: New abortion restrictions in Louisiana; aging gracefully in the Gopher State

State highlights: New abortion restrictions in Louisiana; aging gracefully in the Gopher State

A bill that could result in the shuttering of up to four of Louisiana's five abortion clinics overwhelmingly received full passage from the Louisiana Legislature Wednesday (May 21), and Gov. Bobby Jindal has indicated he will sign it into law. The legislation is, in part, based on a similar measure passed in Texas last year and led to the closing of several abortion clinics in that state. In its last legislative hurdle, the House concurred an amendment on Wednesday (May 21) that was added to the bill on the Senate side (Lane, 5/22). [More]
First Edition: May 22, 2014

First Edition: May 22, 2014

Today's headlines include coverage of the Senate Finance Committee vote to recommend Sylvia Mathews Burwell to head the Department of Health and Human Services. [More]