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Novo Nordisk submits rFXIII BLA to FDA for treatment of inherited bleeding disorder

Novo Nordisk announced today that a Biologic License Application has been submitted to the U.S. Food and Drug Administration requesting the approval of a recombinant factor XIII compound for the vast majority of patients with congenital factor XIII deficiency, an inherited bleeding disorder.

From Novo Nordisk 23 Feb 2011

FDA clears Agendia's breast cancer recurrence assay

Agendia, a world leader in molecular cancer diagnostics, today announced that the company has received its fifth U.S. Food and Drug Administration clearance for MammaPrint, its widely used breast cancer recurrence assay.

23 Feb 2011

FDA grants Fast Track designation to Sunesis' vosaroxin for treatment of AML

Sunesis Pharmaceuticals, Inc. today announced that vosaroxin, the Company's lead drug candidate, has been granted Fast Track designation by the U.S. Food and Drug Administration for the potential treatment of relapsed or refractory acute myeloid leukemia in combination with cytarabine.

23 Feb 2011

FDA clears Entellus Medical's new FinESS Endoscope

Entellus Medical, a Minnesota-based medical technology company, announced today that the U.S. Food and Drug Administration cleared the company's new FinESS Endoscope.

23 Feb 2011

GTCR to acquire Sterigenics International

GTCR, a leading private equity firm, today announced it has signed a definitive agreement with Silverfleet Capital and PPM America Capital Partners to acquire Sterigenics International, the leading global provider of contract sterilization and ionization services for medical devices, food products, and advanced applications.

23 Feb 2011

Mass polio vaccination campaigns in Burma and Sudan

After a seven-month-old baby was diagnosed with polio, Myanmar is planning a mass polio vaccination said the United Nations Children’s Fund. UNICEF revealed that just one case is enough to trigger an “emergency response”, and health officials promptly vaccinated 10,000 children in the Mandalay region, central Myanmar, after the illness was first suspected in December 2010.

23 Feb 2011

Norgine, Tranzyme commence dosing in ulimorelin Phase 3 study for restoring GI function after surgery

Tranzyme Pharma and Norgine B.V., have initiated dosing of ulimorelin in the first of two, Phase 3 pivotal studies - ULISES. Ulimorelin is Tranzyme's intravenous promotility agent in development for the management of postoperative ileus in hospital and acute care settings.

23 Feb 2011

Aetna Foundation announces over $1 million for research on root causes of obesity epidemic

The Aetna Foundation today announced significant funding in support of five research studies designed to deepen understanding of the root causes of the nation's well-documented obesity epidemic and drive viable solutions to the core problems.

23 Feb 2011

Haiti's cholera outbreak has plateaued, death rate remains high in rural regions, U.N. says

The U.N. on Friday said Haiti's cholera outbreak appears to be waning overall, but high death rates from the virus in rural regions of the country remain a concern, the Associated Press reports. According to figures released by the Haitian government, 231,070 cholera cases and 4,549 deaths from the disease have been reported since the outbreak first emerged in October.

23 Feb 2011

Amgen announces publication of XGEVA Phase 3 study results against solid tumors in Journal of Clinical Oncology

Amgen today announced the publication of results from a pivotal Phase 3 study of 1,776 advanced cancer patients with different types of solid tumors or multiple myeloma, which compared XGEVA to Zometa in preventing skeletal-related events.

23 Feb 2011

Former U.N. Secretary-General Annan discusses Africa's agriculture potential at IFAD conference

Kofi Annan, the former U.N. secretary-general who now heads the Alliance for a Green Revolution in Africa (AGRA), discussed the possibilities for agriculture in Africa and called for reforms to improve farming on the continent in a speech given Saturday during the opening day of the U.N. International Fund for Agricultural Development's (IFAD) annual meeting in Rome, Italy, the Jakarta Post reports (Asrianti, 2/21).

23 Feb 2011

New study: Cannabis ingredient can improve appetites and sense of taste in cancer patients

The active ingredient in cannabis can improve the appetites and sense of taste in cancer patients, according to a new study published online in the cancer journal, Annals of Oncology today.

23 Feb 2011

As G20 financial leaders discuss food prices, some push for fulfillment of G8 pledges

As G20 financial leaders met in Paris over the weekend, the Washington Post reports on the "debate over how to respond" to the recent increase in food prices. France, the G20 chair, spurred discussion about "whether new regulations on commodity trading might prevent speculators from pushing up prices by investing heavily in grains or other goods on the expectation that they will increase even further in value. Yet it is unclear how much of a role speculation plays in the movement of prices," the Washington Post writes.

23 Feb 2011

UCI study details benefits of physical activity, diet, relationships, fun and spirituality

Getting more exercise, spending time outdoors and helping others are among the activities that can be as effective as drugs or counseling in treating an array of mental illnesses, including depression and anxiety, according to a UC Irvine study.

23 Feb 2011

Biomoda completes sample collection in pilot study of CyPath diagnostic assay for lung cancer

Cancer diagnostics company Biomoda, Inc. today announced that it has completed patient enrollment and sample collection for the pilot study to determine the clinical sensitivity and specificity of its CyPath® diagnostic assay for the early detection of lung cancer.

23 Feb 2011

Breakthrough in Huntington's disease may give patients hope for cure

A huge leap forward in understanding Huntington's disease may give patients hope for a cure.

23 Feb 2011

USPTO issues Notice of Allowance to Somaxon's Silenor patent application

Somaxon Pharmaceuticals, Inc., a specialty pharmaceutical company, today announced that it has received a Notice of Allowance from the United States Patent and Trademark Office for claims in U.S. patent application no. 11/781,165.

23 Feb 2011

FDA grants 510(k) clearance to Vapotherm Flowrest homecare device

Vapotherm, the global leader in High Flow Therapy (HFT™) products, has received 510(k) clearance from the Food and Drug Administration (FDA) for the Flowrest® homecare device. The device also recently received CE marking.

23 Feb 2011

Regeneron submits VEGF Trap-Eye BLA to FDA for treatment of wet AMD

Regeneron Pharmaceuticals, Inc. announced that the company submitted a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for VEGF Trap-Eye for the treatment of the neovascular form of age-related macular degeneration (wet AMD). Under the Prescription Drug User Fee Act (PDUFA), the goal for a standard review time from submission to FDA action is ten months.

22 Feb 2011

Researcher finds antibiotic in Eastern Red Cedar tree effective against MRSA

Most people would never suspect that a "trash tree," one with little economic value and often removed by farmers due to its ability to destroy farmland, could be the key to fighting a deadly bacterium. Now, a University of Missouri researcher has found an antibiotic in the Eastern Red Cedar tree that is effective against methicillin-resistant Staphylococcus aureus, a "superbug" that is resistant to most medications.

22 Feb 2011

Food News and Research

Novo Nordisk submits rFXIII BLA to FDA for treatment of inherited bleeding disorder

FDA clears Agendia's breast cancer recurrence assay

FDA grants Fast Track designation to Sunesis' vosaroxin for treatment of AML

FDA clears Entellus Medical's new FinESS Endoscope

GTCR to acquire Sterigenics International

Mass polio vaccination campaigns in Burma and Sudan

Norgine, Tranzyme commence dosing in ulimorelin Phase 3 study for restoring GI function after surgery

Aetna Foundation announces over $1 million for research on root causes of obesity epidemic

Haiti's cholera outbreak has plateaued, death rate remains high in rural regions, U.N. says

Amgen announces publication of XGEVA Phase 3 study results against solid tumors in Journal of Clinical Oncology

Former U.N. Secretary-General Annan discusses Africa's agriculture potential at IFAD conference

New study: Cannabis ingredient can improve appetites and sense of taste in cancer patients

As G20 financial leaders discuss food prices, some push for fulfillment of G8 pledges

UCI study details benefits of physical activity, diet, relationships, fun and spirituality

Biomoda completes sample collection in pilot study of CyPath diagnostic assay for lung cancer

Breakthrough in Huntington's disease may give patients hope for cure

USPTO issues Notice of Allowance to Somaxon's Silenor patent application

FDA grants 510(k) clearance to Vapotherm Flowrest homecare device

Regeneron submits VEGF Trap-Eye BLA to FDA for treatment of wet AMD

Researcher finds antibiotic in Eastern Red Cedar tree effective against MRSA

Enhancing confidence in chemical ionization spectrometry data eBook

A New Approach to Preventing Bladder Cancer Recurrence

Bringing real-time analytics to downstream bioprocess monitoring

Designing fluidic architecture for scalable diagnostic platforms

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