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Genomic Health announces global commercial availability of its Oncotype DX colon cancer test

Genomic Health, Inc. today announced worldwide commercial availability of its Oncotype DX® colon cancer test, the first multigene expression test developed for the assessment of risk of recurrence in patients with stage II disease. The 12-gene advanced diagnostic test is clinically validated to predict individual recurrence risk in stage II colon cancer patients following surgery, as reported at the 2009 American Society of Clinical Oncology (ASCO) meeting.

21 Jan 2010

China Pharma Holdings announces completion of clinical trials for Candesartan

China Pharma Holdings, Inc., which develops, manufactures, and markets specialty pharmaceutical products in China, today announced that the Company has completed clinical trials for Candesartan, an anti-hypertension drug, and submitted the generic drug production application to the SFDA.

21 Jan 2010

Health IT news: Grassley queries hospitals, Microsoft's CEO sees need to boost tech for doctors, hospitals

Modern Healthcare: "Sen. Chuck Grassley (R-Iowa) has sent a letter asking 31 hospitals to report on their relationships with healthcare IT vendors, focusing on errors caused by IT systems and on so-called 'gag order or non-disclosure clauses' in vendor contracts that might prohibit the hospitals from disclosing information about system flaws." Grassley made a similar request to the IT vendors themselves last fall, and said his new letter was prompted by concern about taxpayers' investment in health IT as part of the economic stimulus (Conn, 1/20).

21 Jan 2010

PhotoMedex regains compliance with Nasdaq minimum bid price requirement

PhotoMedex, Inc. today announced that it has regained compliance with the minimum bid price requirement of The Nasdaq Stock Market under Nasdaq Listing Rule 5450(a)(1).

21 Jan 2010

Health care companies assess where they stand on health reform after election

The Wall Street Journal reports that several firms reiterated support for a health care reform bill Wednesday, a day after the overhaul's viability was called into question by the victory of Republican Sen.-elect Scott Brown in Massachusetts. "PhRMA, the drug industry association, as well as companies including Pfizer Inc., Johnson & Johnson, WellPoint Inc. and Humana Inc., voiced support for an overhaul of some kind, despite objections among insurers about the efforts to date."

21 Jan 2010

Fourth-quarter and fiscal year 2009 results announced by Somanetics

Somanetics Corporation today reported financial results for the fourth fiscal quarter and year ended November 30, 2009.

21 Jan 2010

Zirmed achieves EHNAC HNAP accreditation

ZirMed®, a leading national provider of revenue cycle management solutions for healthcare providers, announced yesterday it has achieved full accreditation with the Healthcare Network Accreditation Program (HNAP) from the Electronic Healthcare Network Accreditation Commission (EHNAC). EHNAC's HNAP accreditation recognizes excellence in health data processing and transactions, and indicates compliance with industry-established standards and HIPAA regulations.

21 Jan 2010

Neuralstem announces treatment of first ALS patient with spinal cord stem cells

Neuralstem, Inc. announced that the first ALS patient was treated with its spinal cord stem cells yesterday at the Emory ALS Center at Emory University, in Atlanta, GA. A total of up to 18 patients is planned to be treated in this first U.S. clinical trial to evaluate human neural stem cells for the treatment of ALS (Amyotrophic Lateral Sclerosis, or Lou Gehrig's disease). ALS affects roughly 30,000 people in the U.S., with about 5,600 new diagnoses per year, according to the ALS Association.

21 Jan 2010

Elevation Pharmaceuticals closes $30M tranched Series A financing

Elevation Pharmaceuticals, Inc., a biopharmaceutical company focused on the development of new aerosol therapies for patients with respiratory diseases, announced today the closing of a $30 million tranched Series A financing.

21 Jan 2010

Enrollment complete in Vertos Medical's U.S. IRB I "mild" procedure Patient Outcomes Trial

Medical device company Vertos Medical Inc. has announced the completion of enrollment in its post-market U.S. IRB (Institutional Review Board) I Patient Outcomes Trial, a 75-patient study of the mild procedure. The open-label, single-arm, prospective, IRB-approved study is intended to gather patient outcomes data following treatment for symptomatic central canal spinal stenosis using proprietary mild devices. Results from the trial, which is being conducted by 14 investigators at academic and private practice settings across the United States, are expected to be published during 2010.

21 Jan 2010

Charterhouse Group announces definitive agreement to sell Amerifit Brands to Martek Biosciences

Charterhouse Group, Inc. ("Charterhouse") today announced a definitive agreement to sell Amerifit Brands, Inc. ("Amerifit" or the "Company"), a leading consumer health and wellness company, to Martek Biosciences Corporation ("Martek") in a transaction valued at $200 million.

21 Jan 2010

Applied Biosystems' AmpFℓSTR MiniFiler PCR Amplification Kit receives NDIS approval

Applied Biosystems, part of Life Technologies Corporation today announced that its AmpFℓSTR® MiniFiler™ PCR Amplification Kit has been approved for inclusion in the National DNA Index System (NDIS), a United States Federal Bureau of Investigation database that facilitates the electronic comparison and exchange of DNA profiles between participating local, county, state, and federal law enforcement agencies and forensic laboratories.

21 Jan 2010

Meridian Bioscience announces record first-quarter net sales of $42.5M

Net sales for the first quarter of fiscal 2010 were $42,457,000 as compared to $34,293,000 for the same period of the prior fiscal year, an increase of 24%. Net earnings for the first quarter of fiscal 2010 were $8,921,000 or $0.22 per diluted share, both increases of 10% over the first quarter of fiscal 2009. Diluted common shares outstanding for fiscal 2010 and 2009 were 41,185,000 and 41,125,000, respectively.

21 Jan 2010

Exalenz Bioscience finalizes production of its BreathID System for detecting H. pylori bacteria

Exalenz Bioscience has finalized production of the BreathID® and is preparing to ship the first devices and kits that are used in the detection of Helicobacter pylori bacteria. Additionally, in preparation for its American launch, the company is in the process of establishing national distribution channels. The company has recently announced the appointment of Mr. Dennis Boyle as Vice-President and National Manager in the USA. In his previous position, Mr. Boyle was director of sales and marketing to medical laboratories for Siemens USA.

21 Jan 2010

Pharmasset commences PSI-7977 Phase 2a trial for HCV

Pharmasset, Inc. today announces the initiation of a 28-day Phase 2a study with PSI-7977, a chirally pure isomer form of PSI-7851, a nucleotide analog polymerase inhibitor in development for the treatment of chronic hepatitis C (HCV). The trial will evaluate various doses of PSI-7977 in combination with Pegasys (peginterferon alfa 2a) and Copegus (ribavirin) in patients with HCV genotype 1 who have not been treated previously.

21 Jan 2010

BioNumerik Pharmaceuticals commences patient treatment in Tavocept Phase III trial

BioNumerik Pharmaceuticals, Inc. today announced the treatment of the first patients in a global multi-center Phase III clinical trial of Tavocept (BNP7787) in patients with primary adenocarcinoma of the lung, the most common type of lung cancer. In previous studies, Tavocept demonstrated the potential to substantially increase overall and one year patient survival while concurrently preventing and reducing the incidence and severity of common chemotherapy side-effects as compared to other currently available treatments for advanced lung cancer.

21 Jan 2010

Abaxis' new CRP assay receives FDA marketing clearance

Abaxis, Inc., a medical products company manufacturing point-of-care blood analysis systems, today announced that the U.S. Food and Drug Administration (FDA) has granted 510K marketing clearance of the new C-Reactive Protein (CRP) assay when used by healthcare professionals in conjunction with the Piccolo Xpress™ point-of-care analyzer.

21 Jan 2010

Pfizer and Auxilium Pharmaceuticals announce completion of European MAA validation phase for XIAFLEX

Pfizer Inc. and Auxilium Pharmaceuticals, Inc. today announced that Pfizer received notification from the European Medicines Agency that the Marketing Authorization Application (MAA) for XIAFLEX™ (collagenase clostridium histolyticum), a novel, first-in-class, biologic for the treatment of Dupuytren’s contracture (a condition resulting in the contracture of the fingers into the palm), has completed the validation phase successfully. As a result, the scientific/technical review procedure commenced on 21 January 2010.

21 Jan 2010

First Edition: January 21, 2010

Today's headlines reflect the idea that health reform stakeholders -- be it the White House, congressional Democrats or others -- are all trying to figure out how to proceed in this changed political landscape.

21 Jan 2010

MDS announces unaudited financial results for fiscal 2009

MDS Inc., a leading provider of products and services to the global life sciences markets, today reported preliminary and unaudited financial results for the three-month period ended October 31, 2009 and for the full 2009 fiscal year ended October 31, 2009. MDS intends to file financial results for fiscal 2009 on or before January 29, 2010.

From Danaher 21 Jan 2010

Medical News

Genomic Health announces global commercial availability of its Oncotype DX colon cancer test

China Pharma Holdings announces completion of clinical trials for Candesartan

Health IT news: Grassley queries hospitals, Microsoft's CEO sees need to boost tech for doctors, hospitals

PhotoMedex regains compliance with Nasdaq minimum bid price requirement

Health care companies assess where they stand on health reform after election

Fourth-quarter and fiscal year 2009 results announced by Somanetics

Zirmed achieves EHNAC HNAP accreditation

Neuralstem announces treatment of first ALS patient with spinal cord stem cells

Elevation Pharmaceuticals closes $30M tranched Series A financing

Enrollment complete in Vertos Medical's U.S. IRB I "mild" procedure Patient Outcomes Trial

Charterhouse Group announces definitive agreement to sell Amerifit Brands to Martek Biosciences

Applied Biosystems' AmpFℓSTR MiniFiler PCR Amplification Kit receives NDIS approval

Meridian Bioscience announces record first-quarter net sales of $42.5M

Exalenz Bioscience finalizes production of its BreathID System for detecting H. pylori bacteria

Pharmasset commences PSI-7977 Phase 2a trial for HCV

BioNumerik Pharmaceuticals commences patient treatment in Tavocept Phase III trial

Abaxis' new CRP assay receives FDA marketing clearance

Pfizer and Auxilium Pharmaceuticals announce completion of European MAA validation phase for XIAFLEX

First Edition: January 21, 2010

MDS announces unaudited financial results for fiscal 2009

Evolving spectrophotometry for modern biopharma workflows

Scaling B-cell cloning workflows for antibody development

Fluidics in Modern Healthcare & Medical Device Innovation

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