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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

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.

31 May 2014

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.

30 May 2014

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.

30 May 2014

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."

28 May 2014

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).

23 May 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.

22 May 2014

How the health law played on a big day for primary elections

Six states voted for candidates Tuesday to run for congressional and Senate seats. Some viewed these contests as important to watch because they highlighted face-offs between the GOP establishment and its tea party wing.

22 May 2014

First Edition: May 21, 2014

Today's headlines include status reports on the health exchanges in Nevada and Oregon.

21 May 2014

State highlights: Calif. bill on keeping small biz health plans; Colo. rating area plan approved

A selection of health policy stories from California, Colorado, Connecticut, Washington state and Massachusetts.

21 May 2014

NIDA guides target both teens and parents with up-to-date science-based facts on marijuana

Two updated booklets about marijuana for teens and their parents will help families sort out marijuana myths from science-based facts. The revamped tools come from the National Institute on Drug Abuse (NIDA), part of the National Institutes of Health.

21 May 2014

U.S. urges daily pill for those at risk of AIDS

The recommendation could transform AIDS prevention from reliance on condoms to a regimen that relies on an antiretroviral drug. Meanwhile, a report analyzes the costs and benefits of treating prison inmates for hepatitis C and a study finds that nearly half of American adults take prescriptions.

16 May 2014

Study: Wider use of medications may help reduce substance abuse, related hospital admissions

A comparatively new form of a medication for alcohol and opioid dependence that's injected once a month instead of taken orally once a day appears to be significantly more effective than some other medications - because more patients actually continue the prescribed regimen.

15 May 2014

Eagle Pharmaceuticals total revenue increases by $2.5 million for Q2 2014

Eagle Pharmaceuticals, Inc. today announced its financial results for the three-month period ended March 31, 2014. This marks the first period for which Eagle is reporting financial results as a public company.

14 May 2014

Prescription Drug News and Research

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

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

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

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

State regulators seek to impose controls on new painkiller

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

First Edition: May 22, 2014

How the health law played on a big day for primary elections

First Edition: May 21, 2014

State highlights: Calif. bill on keeping small biz health plans; Colo. rating area plan approved

NIDA guides target both teens and parents with up-to-date science-based facts on marijuana

U.S. urges daily pill for those at risk of AIDS

Study: Wider use of medications may help reduce substance abuse, related hospital admissions

Eagle Pharmaceuticals total revenue increases by $2.5 million for Q2 2014

Leveraging the power of automation to boost research

Automating research - solutions and best practices

How can microdialysis benefit drug development

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