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SI-BONE to present iFuse MIS procedure at WCMISST 2010

SI-BONE, Inc., a medical device company that is pioneering the use of a minimally invasive surgical device to treat the sacroiliac joint today announced that iFuse initial post-market clinical experience will be presented at upcoming 2010 minimally invasive spine surgery meetings.

28 Apr 2010

CNN: Hospital markup on supplies can be big

CNN: "When Dr. Linda Galloway learned she needed surgery to save her vision, she scheduled the procedure immediately with her opthamologist. And what an eye-opener it was - when the hospital bill arrived."

28 Apr 2010

Takeda announces submission of azilsartan medoxomil NDA for hypertension to FDA

Takeda Pharmaceutical Company Limited (Takeda) announced today that Takeda Global Research & Development Center, Inc., U.S., submitted a New Drug Application (NDA) to the United States Food and Drug Administration (FDA) for azilsartan medoxomil (development code: TAK-491), an angiotensin II receptor blocker (ARB) under investigation for the treatment of hypertension. Discovered by Takeda, azilsartan medoxomil is designed to lower blood pressure by blocking the action of a vasopressor hormone, angiotensin II.

28 Apr 2010

Hospira reports net sales of $1.0 billion for first-quarter 2010

Hospira, Inc., a leading global specialty pharmaceutical and medication delivery company, today reported results for the first quarter ended March 31, 2010. Net sales for the quarter were $1.0 billion, and adjusted diluted earnings per share were $0.94.

28 Apr 2010

Phase I clinical trial results of AE37 in prostate cancer patients presented at EAU Congress

Generex Biotechnology Corporation today announced presentation of additional results from a recently completed Phase I clinical trial of its novel immunotherapeutic peptide AE37 in prostate cancer patients. AE37 is a synthetic cancer vaccine being developed by Antigen Express, Inc., a wholly owned subsidiary of Generex, for multiple cancer indications.

28 Apr 2010

Life Technologies first-quarter non-GAAP 2010 revenue increases 13% to $887 million

Life Technologies Corporation today announced results for its first quarter ending March 31, 2010. Non-GAAP revenue for the first quarter was $887 million, an increase of 13 percent over the $785 million reported for the first quarter of 2009. Excluding the impact of currency and completed acquisitions and divestitures, organic revenue for the quarter grew 10 percent over the same period in the previous year.

28 Apr 2010

Hana Biosciences announces completion of Marqibo pre-NDA meeting with FDA

Hana Biosciences, a biopharmaceutical company focused on strengthening the foundation of cancer care, today announced that the Company has completed a pre-New Drug Application (NDA) meeting with the U.S. Food and Drug Administration (FDA) related to its lead product candidate, Marqibo for the treatment of relapsed/refractory adult Philadelphia chromosome-negative acute lymphoblastic leukemia (ALL).

28 Apr 2010

Experts debate rationing and end-of-life care; Hospice use rises in Colorado

PBS NewsHour reports on end-of-life decisions and rationing by examining a recent debate at the University of Virginia's Miller Center of Public Affairs. "Arguing for rationing: Ira Byock, a doctor and director of palliative medicine at Dartmouth-Hitchcock Medical Center in Lebanon, New Hampshire, and Arthur Caplan, director of the Center for Bioethics and a professor at the University of Pennsylvania.

28 Apr 2010

Alair Bronchial Thermoplasty System receives FDA approval to treat asthma in adults

The U.S. Food and Drug Administration today approved the first medical device that uses radiofrequency energy to treat severe and persistent asthma in certain adults.

28 Apr 2010

Gangs increasingly involved in Medicare fraud

ABC News: "Gangs across the country are arming themselves with powerful weapons to bilk taxpayers out of billions of dollars through Medicare fraud. What used to be a mostly non-violent, white collar crime has turned potentially deadly, and Federal agents who once combed through paperwork are now firing rounds at the shooting range to prepare for extreme dangers.

28 Apr 2010

Tamiflu and two other drugs used to treat influenza appear safe for pregnant women and babies: Study

Tamiflu and two other drugs used to treat influenza appear safe for pregnant women and their babies, researchers at UT Southwestern Medical Center have found in a retrospective study of 239 cases of women who received the medications during pregnancy.

28 Apr 2010

Freedland Russo announces $520M settlement over Seroquel marketing practice lawsuit against AstraZeneca

Freedland Russo is pleased that Eric Holder, U.S. Attorney General, announced the $520 million dollar settlement of a lawsuit filed against AstraZeneca. The settlement announced today in Philadelphia indicates marketing practices for Seroquel included promotion of the drug by physicians participating in clinical studies and drug sales representatives encouraging doctors to prescribe for the unapproved uses.

28 Apr 2010

Ranibizumab eye injections plus laser therapy result in dramatic visual improvement

Researchers have shown that ranibizumab (Lucentis) eye injections, often in combination with laser treatment, result in better vision than laser treatment alone for diabetes-associated swelling of the retina.

28 Apr 2010

TYRX receives FDA marketing clearance for AIGISRx ST antibacterial patch for soft tissue repair

TYRX, Inc. announced that it has received U.S. Food and Drug Administration (FDA) 510(k) clearance to market AIGISRx® ST, its antibacterial product for the surgical repair of damaged or ruptured soft tissue.

28 Apr 2010

DRCR Network study finds new treatment more effective

A nationwide, government-sponsored study finds that people with a common form of diabetic retinopathy can benefit from a medication first developed to combat another potentially blinding disease, age-related macular degeneration.

28 Apr 2010

Fine print complicates effort to cover young adults

Some parents may have to wait to get children as old as age 26 to be allowed to stay on their health plans because of the health law's fine print, The Associated Press reports. "As a consequence, some families may have to wait until 2011 to get their kids covered, particularly if the parents are working for a large employer, benefits experts and government officials say.

28 Apr 2010

As health reform's specifics continue to emerge, so do questions and answers from stakeholders

Determining how the law will be applied will be the next big battle in health reform and lobbyists are gearing up to influence implementation. "Congress gave sweeping power to federal agencies, especially (HHS), to fill in gaps lawmakers left in the 906-page legislation — an effort that will take years. The law refers more than 1,000 times to Cabinet secretaries who will make decisions on how to carry out the law. For example, the law requires insurance companies to spend 80% of premiums on medical claims, as opposed to administrative costs, by 2011. But it directs the health department to decide whether gray-area expenses, such as health-and-wellness programs offered by insurers, count as care or overhead."

28 Apr 2010

CSI granted FDA unconditional IDE approval for trial of Diamondback 360 System in coronary arteries

Cardiovascular Systems, Inc., has received Food and Drug Administration unconditional Investigational Device Exemption (IDE) approval, allowing the company to proceed with ORBIT II, a pivotal trial to evaluate the safety and effectiveness of CSI's Diamondback 360® System in the coronary arteries. CSI received conditional IDE approval for the ORBIT II study in January 2010.

28 Apr 2010

A bitter pill to swallow

Reporting for Kaiser Health News in collaboration with The Washington Post, Sandra Boodman writes: "When Jere Carpentier learned last year that she had advanced colon cancer -- her third malignancy in a dozen years -- she worried about spending hours in a clinic tethered to an intravenous line, enduring punishing chemotherapy that would make her hair fall out.

28 Apr 2010

AMAG Pharmaceuticals reports Feraheme net product revenues of $13.1M for first-quarter 2010

AMAG Pharmaceuticals, Inc., a biopharmaceutical company focused on the development and commercialization of a therapeutic iron compound to treat iron deficiency anemia and novel imaging agents to aid in the diagnosis of cancer and cardiovascular disease, today reported unaudited consolidated financial results for the first quarter ended March 31, 2010.

28 Apr 2010

Medical News

SI-BONE to present iFuse MIS procedure at WCMISST 2010

CNN: Hospital markup on supplies can be big

Takeda announces submission of azilsartan medoxomil NDA for hypertension to FDA

Hospira reports net sales of $1.0 billion for first-quarter 2010

Phase I clinical trial results of AE37 in prostate cancer patients presented at EAU Congress

Life Technologies first-quarter non-GAAP 2010 revenue increases 13% to $887 million

Hana Biosciences announces completion of Marqibo pre-NDA meeting with FDA

Experts debate rationing and end-of-life care; Hospice use rises in Colorado

Alair Bronchial Thermoplasty System receives FDA approval to treat asthma in adults

Gangs increasingly involved in Medicare fraud

Tamiflu and two other drugs used to treat influenza appear safe for pregnant women and babies: Study

Freedland Russo announces $520M settlement over Seroquel marketing practice lawsuit against AstraZeneca

Ranibizumab eye injections plus laser therapy result in dramatic visual improvement

TYRX receives FDA marketing clearance for AIGISRx ST antibacterial patch for soft tissue repair

DRCR Network study finds new treatment more effective

Fine print complicates effort to cover young adults

As health reform's specifics continue to emerge, so do questions and answers from stakeholders

CSI granted FDA unconditional IDE approval for trial of Diamondback 360 System in coronary arteries

A bitter pill to swallow

AMAG Pharmaceuticals reports Feraheme net product revenues of $13.1M for first-quarter 2010

Achieving and maintaining ISO/IEC 27001 and BS 10012 certifications

Expanding research and clinical options for children with cancer

Examining how pain could play a direct protective role in the gut

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