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Mayo Clinic initiates enrollment in first U.S. clinical Hand Transplant Program

Mayo Clinic has initiated the first clinical Hand Transplant Program in the United States and is now enrolling patients. This program offers hand transplantation as a clinically available option for patients with bilateral hand injuries or amputations. This allows patients to embark on this option of reconstructive surgery without being required to enroll in experimental trials.

24 Sep 2010

Critics say school lunch bill could damage food stamp program

The New York Times: "In her campaign to reduce childhood obesity and improve school nutrition, Michelle Obama has become entangled in a fight with White House allies, including liberal Democrats and advocates for the poor." The bill, which the House is expected to consider in the next few days, "would come up with some of the money by cutting future food stamp benefits. When the Senate passed the bill in early August, Mrs. Obama said she was thrilled. But anti-hunger groups were not.

24 Sep 2010

Enobia announces positive results from ENB-0040 Phase II juvenile clinical trial for hypophosphatasia

Enobia Pharma today announced positive results for its Phase II juvenile clinical trial of ENB-0040 (asfotase alfa), an experimental bone-targeted enzyme replacement therapy intended for the treatment of hypophosphatasia (HPP). Hypophosphatasia is a rare, inherited, and sometimes fatal metabolic bone disease that affects individuals of all ages.

24 Sep 2010

Democratic pollster: White House needs to go 'back to basics' to sell health law

Kaiser Health News staff writer Jenny Gold spoke with Peter Hart, a Democratic pollster and chairman of Peter D. Hart Research Associates, who said he doesn't expect a sea change in public opinion in coming weeks and that Democrats might want to avoid discussing the health care law in their campaigns (Gold, 9/23).

24 Sep 2010

FDA grants ArthroCare marketing clearance for Parallax Contour Vertebral Augmentation Device

ArthroCare Corp., a leader in developing state-of-the-art, minimally invasive surgical products, announced today that it has received clearance from the U.S. Food and Drug Administration (FDA) to market its Parallax® Contour® Vertebral Augmentation Device (Contour) specifically for void creation in a vertebral body followed by injection of bone cement. Vertebral body void creation followed by bone cement augmentation is commonly used to treat painful vertebral compression fractures.

24 Sep 2010

Research Roundup: Medical homes; Drug samples and prescribing; The health law and disparities; Women's health; CBO projections

Institute of Medicine: Women's Health Research: Progress, Pitfalls, and Promise -"Substantial progress has been made since the expansion of investment in women's health research. Research findings have changed the practice of medicine and public-health recommendations in several prominent contexts, including changes in standards of care for women. There have also been decreases in mortality in women from breast cancer, heart disease, and cervical cancer. In other contexts, however, there has been less progress..."

24 Sep 2010

Political Cartoon: 'A nation divided'

Kaiser Health News provides a fresh perspective on health policy developments with "A Nation Divided" by John Rose.

24 Sep 2010

Amgen announces voluntary recall of certain lots of EPOGEN and PROCRIT

Amgen announced today that certain lots of EPOGEN® and PROCRIT® (Epoetin alfa) vials are being voluntarily recalled from specialty distributors, wholesalers, pharmacies and healthcare providers as a precaution. The product that is being recalled may contain extremely thin glass flakes (lamellae) that are barely visible in most cases. The lamellae result from the interaction of the formulation with glass vials over the shelf life of the product.

24 Sep 2010

Health law's 8 new changes – and 7 caveats

Kaiser Health News staff writer Mary Agnes Carey writes: "If you've tuned out the health care law you might want to tune back in. A set of new consumer protections goes into effect today, the six-month anniversary of the law. Here's a guide to some of the changes - and some of the caveats. Keep in mind that how they affect you will depend on what kind of insurance you have" (Carey, 9/23).

24 Sep 2010

25% of all Medicare beneficiaries enrolled in Medicare Advantage plans

As the annual open enrollment period approaches Medicare Advantage plan enrollment continues to inch upwards, with nearly 11.8 million people enrolled as of August 2010, almost 25% of all Medicare beneficiaries. Despite conservative growth strategies, stricter marketing regulations and legislation which reined in popular Private-Fee-For-Service plans, Medicare Advantage companies are still experiencing single digit growth rates, according to a new report by Mark Farrah Associates, a leading provider of market data and intelligence solutions.

24 Sep 2010

Perrigo files NDA with FDA for generic Zegerid OTC

Perrigo Company announced that it has filed with the U.S. Food and Drug Administration (FDA) an Abbreviated New Drug Application (ANDA) for omeprazole 20mg/sodium bicarbonate 1100mg, the generic equivalent of Zegerid OTC™, and that it provided prior notice of this filing to Schering-Plough HealthCare Products, Inc. a subsidiary of Merck & Co., Inc., the owner of the brand regulatory approval and the Curators of the University of Missouri, the listed patent owner.

24 Sep 2010

Results of Argos' Arcelis Phase 2 study for RCC accepted for presentation at International Kidney Cancer Symposium

Argos Therapeutics today announced that results from its Arcelis™ immunotherapy Phase 2 study for the treatment of renal cell carcinoma (RCC) have been accepted for a poster presentation at the Ninth International Kidney Cancer Symposium on Oct. 1-2 in Chicago.

24 Sep 2010

Gore completes enrollment in study of VIABAHN Endoprosthesis with Heparin Bioactive Surface

W. L. Gore & Associates (Gore) reported the complete enrollment in a post-market approval study designed to better characterize the performance of the GORE VIABAHN Endoprosthesis with Heparin Bioactive Surface in treating peripheral vascular disease (PVD) of the superficial femoral artery (SFA). The 11 participating sites enrolled a total of 120 patients in the Gore VIPER (GORE® VIABAHN® Endoprosthesis with Heparin Bioactive Surface for SuPERficial Femoral Artery Endoluminal Bypass) Study since initiation.

24 Sep 2010

Microfluidic Systems ranked #3035 on Inc. 5000

Microfluidic Systems, a privately-held company, announced today that they received an award from Inc. Magazine. The Fourth Annual Exclusive List of America's Fastest-Growing Private Companies—the Inc. 5000 ranked Microfluidic Systems number 3035 with a growth rate of 68%. The list represents the most comprehensive look at the most important segment of the economy—America's independent-minded entrepreneurs.

24 Sep 2010

Warner Chilcott subsidiaries to issue $500 million of 7-3/4% senior notes in private placement

Warner Chilcott plc today announced that its subsidiaries, Warner Chilcott Company, LLC and Warner Chilcott Finance LLC (together, the "Issuers"), plan to issue an aggregate principal amount of $500 million of 7-3/4% senior notes due 2018 (the "Notes") in a private placement. The notes are additional notes constituting a part of the same series as the $750 million aggregate principal amount of 7-3/4% senior notes due 2018 issued on August 20, 2010.

24 Sep 2010

Yaupon reports positive results from mechlorethamine gel study for early-stage cutaneous T-cell lymphoma

Yaupon Therapeutics, a privately held specialty pharmaceutical company, today announced positive top-line results from the pivotal multi-center study of its lead product candidate, a proprietary topical mechlorethamine gel for the treatment of early-stage cutaneous T-cell lymphoma (CTCL - stages I-IIa). The top-line data show that the study, which was conducted under a Special Protocol Assessment (SPA), achieved its primary and secondary endpoints.

24 Sep 2010

Vical prices underwritten common stock public offering

Vical Incorporated today announced the pricing of an underwritten public offering of 15,000,000 shares of its common stock at a price to the public of $2.25 per share. The gross proceeds to us from this offering are expected to be approximately $33.8 million, before deducting underwriting discounts and commissions and other estimated offering expenses payable by us. The offering is expected to close on or about September 29, 2010, subject to customary closing conditions.

24 Sep 2010

Oncothyreon to receive $14.9 million on close of private placement

Oncothyreon Inc., announced it has entered into a securities purchase agreement in connection with a private placement. Upon the closing of the private placement, Oncothyreon will receive gross proceeds of approximately $14.9 million resulting from the sale of approximately 4.24 million units at a purchase price of $3.50 per unit.

24 Sep 2010

Cylene commences CX-4945 Phase I trial in multiple myeloma

Cylene Pharmaceuticals, Inc. announced today the initiation of a Phase I clinical trial of their first-in-class, oral CK2 inhibitor CX-4945 in patients with multiple myeloma. Cylene also announced the simultaneous closing of a $12 million financing with participation from existing investors including Sanderling Ventures, HBM BioVentures (Cayman) Ltd., Novartis BioVenture Fund, BioVentures Investors, Lilly Ventures, Mitsui & Co. and Morningside Venture Investments Ltd.

24 Sep 2010

Health Council of Canada applauds Nova Scotia for initiative towards ensuring low drug prices

The Health Council of Canada applauds the Nova Scotia Department of Health for their steps towards ensuring low drug prices in their province. The plan includes meeting with groups, such as community pharmacies, doctors, medical staff at health authorities, senior groups and drug manufacturers for input on how to lower prices for prescription drugs and contain drug costs.

24 Sep 2010

Medical News

Mayo Clinic initiates enrollment in first U.S. clinical Hand Transplant Program

Critics say school lunch bill could damage food stamp program

Enobia announces positive results from ENB-0040 Phase II juvenile clinical trial for hypophosphatasia

Democratic pollster: White House needs to go 'back to basics' to sell health law

FDA grants ArthroCare marketing clearance for Parallax Contour Vertebral Augmentation Device

Research Roundup: Medical homes; Drug samples and prescribing; The health law and disparities; Women's health; CBO projections

Political Cartoon: 'A nation divided'

Amgen announces voluntary recall of certain lots of EPOGEN and PROCRIT

Health law's 8 new changes – and 7 caveats

25% of all Medicare beneficiaries enrolled in Medicare Advantage plans

Perrigo files NDA with FDA for generic Zegerid OTC

Results of Argos' Arcelis Phase 2 study for RCC accepted for presentation at International Kidney Cancer Symposium

Gore completes enrollment in study of VIABAHN Endoprosthesis with Heparin Bioactive Surface

Microfluidic Systems ranked #3035 on Inc. 5000

Warner Chilcott subsidiaries to issue $500 million of 7-3/4% senior notes in private placement

Yaupon reports positive results from mechlorethamine gel study for early-stage cutaneous T-cell lymphoma

Vical prices underwritten common stock public offering

Oncothyreon to receive $14.9 million on close of private placement

Cylene commences CX-4945 Phase I trial in multiple myeloma

Health Council of Canada applauds Nova Scotia for initiative towards ensuring low drug prices

Redefining control and consistency in anaerobic microbiome workflows

AI in Healthcare: How generative tools are transforming clinical practice

The future of automation: Machine learning–driven hepatocyte and organoid counting

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