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FDA launches CDRH Transparency Web site as part of agency's transparency initiative

The U.S. Food and Drug Administration launched the Center for Devices and Radiological Health Transparency Web site today as part of the agency's transparency initiative. The site will provide information about medical device and radiation-emitting product regulatory processes and decisions, and summaries of data that provide the rationale for agency actions.

20 Apr 2010

FDA approves Lannett's ANDA for Ondansetron Injection USP, 2 mg/mL, Multi-Dose Vials

Lannett Company, Inc. today announced that it has received approval from the U.S. Food and Drug Administration (FDA) of its Abbreviated New Drug Application (ANDA) for Ondansetron Injection USP, 2 mg/mL, Multi-Dose Vials. Ondansetron Injection USP, 2 mg/mL is the generic equivalent of GlaxoSmithKline's Zofran® Injection, 2 mg/mL. For the 12 months ending December 2009 U.S. sales of Ondansetron Injection USP, 2 mg/mL were approximately $58 million at Average Wholesale Price (AWP). A launch date for the product has not yet been set.

20 Apr 2010

Array BioPharma signs agreement with Novartis for worldwide development of ARRY-162

Array BioPharma Inc. today announced that it has entered into an agreement with Novartis for the worldwide development of the small-molecule MEK inhibitors ARRY-162, currently in a Phase 1 cancer trial, its back-up, ARRY-300, and other MEK inhibitors.

20 Apr 2010

Health law hits consumers, companies in complex ways

News outlets report on the new health law's impact on various segments of the population, including the self-employed, small business owners and seniors.

20 Apr 2010

Spacelabs Healthcare launches Ultraview DM3 vital signs monitor

Combining the simplistic performance of a spot-check monitor with the sophistication of continuous monitoring, Spacelabs Healthcare's Ultraview DM3 provides caregivers with a dual-mode solution for accurately and efficiently measuring vital signs (SpO2, pulse rate, non-invasive blood pressure, respiration and temperature) on adult and pediatric patients.

20 Apr 2010

FTO gene associated with loss of brain tissue: UCLA researchers

Three years ago, geneticists reported the startling discovery that nearly half of all people in the U.S. with European ancestry carry a variant of the fat mass and obesity associated gene, which causes them to gain weight - from three to seven pounds, on average - but worse, puts them at risk for obesity.

20 Apr 2010

Two large health insurers extend coverage to young adults

The Wall Street Journal / Dow Jones: Two large U.S. health insurers have announced plans "to keep young adults on their parents' policies before a new law requiring such action goes into effect, and the government is working to get others to do the same. Health and Human Services Secretary Kathleen Sebelius, citing the insurers' moves, said Monday her department is 'working hard with other insurers on similar proposals' and sent letters offering to assist them in such efforts.

20 Apr 2010

Pharmacists Mutual Insurance selects Interactive Intelligence's CIC to support employees

Pharmacists Mutual Insurance Company has selected the Interactive Intelligence all-in-one IP communications software suite, Customer Interaction Center, to support its on-site and branch office employees.

20 Apr 2010

Exercise machine for lumbago

Low back pain (or lumbago) is a common ailment often triggered by something as simple as lifting a suitcase. What is the best way to remedy the situation? An exercise machine designed specifically for back muscles could be the solution according to a new study published in the Journal of the American College of Sports Medicine.

20 Apr 2010

Panel to save Medicare costs irks lawmakers

A Medicare panel meant to help lawmakers make tough choices about cutting costs in the program has drawn bipartisan ire, Bloomberg BusinessWeek reports.

20 Apr 2010

LSF gene plays important role in development and progression of HCC: VCU researchers

Virginia Commonwealth University researchers have identified a new tumor-promoting gene that may play a key role in the development of liver cancer. Levels of the gene's expression are significantly higher in more than 90 percent of patients with the disease compared to their healthy counterparts.

20 Apr 2010

ICU Medical's first-quarter revenue up 18.5%

ICU Medical, Inc.,, a leading low cost manufacturer of safe medical connectors, custom medical products and critical care devices, announced results for the first quarter ended March 31, 2010.

20 Apr 2010

Obama camp, industry shift from political battle to implementation focus

President Barack Obama's administration is shifting its focus from the politics of the health overhaul to the work of implementing it, which officials may pursue even more quickly than required by the law, The New York Times reports. Top health officials, including Health and Human Services Secretary Kathleen Sebelius, White House adviser Pete Rouse, and Obama's health care lobbyist Nancy-Ann DeParle will all play central roles in implementing the law.

20 Apr 2010

Gilead Sciences halts Phase II trial of GS 9450 for chronic hepatitis C

Gilead Sciences, Inc. today announced the company is stopping its ongoing Phase II clinical trial of GS 9450, an investigational caspase inhibitor, in patients with chronic hepatitis C. This decision follows reports of significant laboratory abnormalities and adverse events in a number of clinical study participants.

20 Apr 2010

Health care a key factor in some congressional races

USA Today: "In an election year dominated by health care, dozens of candidates for Congress have a catchy campaign slogan at their disposal: Send a doctor to the House. Forty-seven physicians — 41 Republicans and six Democrats — are running for the House or Senate this year, three times the number of doctors serving in Congress today, according to a USA TODAY review" (Fritze, 4/19).

20 Apr 2010

EpiCept announces U.K. launch of Ceplene

EpiCept Corporation today announced that the commercial launch of Ceplene® (histamine dihydrochloride) will take place in the United Kingdom on April 20, 2010 in conjunction with the British Society for Haematology 50th Annual Scientific Meeting in Edinburgh, Scotland. Ceplene is approved in the European Union for the remission maintenance and prevention of relapse in patients with Acute Myeloid Leukemia (AML) in first remission.

20 Apr 2010

HAMLET substance found in breast milk can kill cancer cells: Researchers

A substance found in breast milk can kill cancer cells, reveal studies carried out by researchers at Lund University and the University of Gothenburg, Sweden.

20 Apr 2010

Consumers: How will health reform affect insurance premiums?

Las Vegas Sun: "Like many other Las Vegas Valley residents, Yvette Williams is hoping the new national health insurance law will choke down the siphoning of money from her family's budget." The family spends $12,000 a year on health care. "Because the new national health insurance law is supposed to give consumers more ways to get insurance, it's expected to force industry giants to offer more comprehensive plans at lower prices" (Kanigher, 4/19).

20 Apr 2010

Agilent Technologies introduces user-friendly genomics Web site

Agilent Technologies Inc. today introduced a dynamic and user-friendly genomics Web site, genomics.agilent.com.

20 Apr 2010

Bruker launches new compact, high field NMR magnet series

At the 51st ENC, Bruker launches its new Ascend™ series of compact, high field NMR magnets to make high-field NMR even more powerful, and at the same time more convenient and accessible for numerous NMR laboratories. This new magnet line combines the key advantages of Bruker's well-established UltraShield™ Plus magnets, with further innovations for superior performance and greater convenience.

20 Apr 2010