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Santarus, Pharming Group announce FDA acceptance of RUCONEST BLA

Santarus, Pharming Group announce FDA acceptance of RUCONEST BLA

Santarus, Inc. and Pharming Group NV today announced that the U.S. Food and Drug Administration has accepted for filing the Biologics License Application for the investigational drug RUCONEST (recombinant human C1 esterase inhibitor) 50 IU/kg. [More]
NeuroVive signs agreement with Isomerase Therapeutics to develop and commercialize cyclophilin-inhibiting molecules

NeuroVive signs agreement with Isomerase Therapeutics to develop and commercialize cyclophilin-inhibiting molecules

NeuroVive Pharmaceutical AB (publ) (STO:NVP), a leading mitochondrial medicine company, has signed a collaboration agreement with Isomerase Therapeutics to develop the molecules that were recently acquired from Biotica. [More]

Insider probe over Medicare rate decision hits Congress

News outlets report on developments in the story of alleged insider trading after a Medicare rate decision. [More]

Missed savings opportunities in Medicare program

The Wall Street Journal details a report from the Department of Health and Human Services' Office of the Inspector General. Meanwhile, Kaiser Health News reports on a study that details missed savings of prescription drug costs. [More]

CLAAD urges FDA to implement Obama administration's policy on safer opioid medications

The Center for Lawful Access and Abuse Deterrence joined in signing a Citizen Petition filed today urging the Food and Drug Administration to fully implement the Obama administration's policy supporting a market transition to safer opioid medications. [More]
Novel approach to pain therapy paves way for lower dosage painkillers

Novel approach to pain therapy paves way for lower dosage painkillers

For patients managing cancer and other chronic health issues, painkillers such as morphine and Vicodin are often essential for pain relief. The body's natural tendency to develop tolerance to these medications, however, often requires patients to take higher doses - increasing risks of harmful side effects and dependency. [More]

State highlights: N.Y. hospital struggles to reopen post-Sandy; Aetna eyes acos in Ga., Fla.; doc-assisted suicide denied in Maine

Officials at the last hospital still closed because of damage from Superstorm Sandy are no longer predicting when they will be able to reopen. [More]

Sebelius defends phone calls to urge outreach support

At a House hearing Tuesday, Health and Human Services Secretary Kathleen Sebelius said she did not seek funds from companies, but did ask them to support the outreach efforts of Enroll America, a nonprofit group. She told panel members she made five calls on behalf of the organization. [More]
First Edition: June 5, 2013

First Edition: June 5, 2013

Today's headlines include reports about the questions about fundraising phone calls faced by HHS Secretary Kathleen Sebelius during a Capitol Hill hearing. [More]

Rubio proposes constitutional amendment to invalidate the health law's individual mandate

In other Capitol Hill action, the House approved a measure on Monday to set out how the government should track prescription drugs through the distribution chain. [More]

Young adults reduce drug misuse if they are part of community-based prevention effort

Prevention is often the best medicine, not only for physical health, but also public health, according to researchers at Penn State and Iowa State University. [More]

State highlights: Mo. Gov. worried tax cut bill raises prescription drug sales tax; deadline day for bonus for Fla. Medicaid docs

St. Louis Beacon: Nixon Says Tax Cut Bill Removes Missouri's Sales Tax Break For Prescription Drugs. Gov. Jay Nixon has upped the ante in his criticism of a broad-based tax cut bill awaiting his decision, saying Thursday that it removes a sales tax exemption for prescription drugs that will raise taxes for millions of Missourians. One sponsor of the bill says there's plenty of time for the legislature to correct what he deemed a drafting error (Rosenbaum, 5/30). [More]
Medicare forecast: Solvent until 2026, though baby boomer costs loom

Medicare forecast: Solvent until 2026, though baby boomer costs loom

The government said Friday that Medicare's giant hospital trust will not be exhausted until 2026, two years later than projected last year, ... The reasons given for the improved financial outlook for Medicare were an overall slowdown in health care spending, particularly on skilled nursing care, as well as lower projected costs for popular insurance plans available within the Medicare program. [More]

Catamaran achieves five-star medication safety ratings

Catamaran Corp., a leading provider of pharmacy benefit management services and technology, today announced it has received a 2013 PQA Quality Award recognizing its five-star rating on all PQA measures in the Part D Star Ratings program. [More]

Research sheds new light on the increasing use of prescription drugs among young people

Young people are increasingly turning to prescription drugs to get high. Research out of the University of Cincinnati sheds new light on what could increase or lower that risk. [More]

CEO of Comprehensive Care named to 'America's Agenda: Health Care for All' board

Comprehensive Care Corporation, a leading behavioral health, substance abuse and pharmacy management provider for employers, Taft-Hartley health and welfare funds, and managed care companies, announced today that its Chairman and CEO, Clark A. Marcus , has been named to the Board of Directors of "America's Agenda: Health Care for All." [More]
Viewpoints: Sen. Alexander sees reflections of Oliver North in Sebelius' quest to raise funds; vaccine scare's legacy

Viewpoints: Sen. Alexander sees reflections of Oliver North in Sebelius' quest to raise funds; vaccine scare's legacy

Major news outlets in recent days have reported that U.S. Department of Health and Human Services Secretary Kathleen Sebelius is raising money from the private sector -- including from health care executives -- for use by a private entity that is helping to implement ObamaCare. ... Is Ms. Sebelius raising funds for a private entity and then coordinating with that entity to do something Congress has refused to authorize, or for which it has refused to appropriate funds? [More]
FDA gives Priority Review to Celgene's ABRAXANE sNDA for advanced pancreatic cancer

FDA gives Priority Review to Celgene's ABRAXANE sNDA for advanced pancreatic cancer

Celgene International Sàrl, a subsidiary of Celgene Corporation today announced that the U.S. Food and Drug Administration has assigned a Priority Review designation to the supplemental New Drug Application for the use of ABRAXANE (paclitaxel protein-bound particles for injectable suspension) (albumin-bound) in combination with gemcitabine for the first-line treatment of patients with advanced pancreatic cancer. [More]

As Hill panels focus on Medicare, marketplace examines how Part D changed the pharmaceutical industry

Medicare is a topic of conversation on Capitol Hill as a Senate committee holds a hearing on the Medicare Part D drug program. Meanwhile, on the House side, members of the Ways and Means Health Subcommittee heard testimony on patient cost-sharing that triggered a broad discussion of health care incentives within the program. [More]
Upsher-Smith completes USL255 Phase III clinical trial in patients with refractory POS

Upsher-Smith completes USL255 Phase III clinical trial in patients with refractory POS

Upsher-Smith Laboratories, Inc. today announced the successful completion of its global Phase III clinical trial for USL255 (extended-release topiramate), an internally developed program for the management of epilepsy in adults, using the company's proprietary formulation technology. [More]