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Four H1N1 vaccines approved by FDA

The U.S. Food and Drug Administration announced today that it has approved four vaccines against the 2009 H1N1 influenza virus. The vaccines will be distributed nationally after the initial lots become available, which is expected within the next four weeks.

16 Sep 2009

FDA clears Olerup SSP’s Taq-polymerase-free HLA typing kit for sale in the U.S.

Olerup SSP, a wholly owned subsidiary of LinkMed (STO:LMED), has had its Taq-polymerase-free HLA typing kit registered and cleared by the FDA. This means that Olerup SSP’s entire product range for HLA typing, with or without Taq polymerase, can now be marketed and sold to a greater number of healthcare centers in North America.

15 Sep 2009

Council briefing series to examine role of public policy in promoting medical innovation

The Council for American Medical Innovation will host a breakfast briefing on Capitol Hill titled "Translational Research - From Bench to Bedside." Health policy experts will explore important changes needed to improve the process of development and approval for safe and effective drugs, biologics, medical devices and diagnostics.

15 Sep 2009

Biocryst signs agreement with three partners to represent its anti-viral peramivir outside U.S.

BioCryst Pharmaceuticals, Inc. (Nasdaq: BCRX) today announced that it has signed binding letters of intent with three partners who will exclusively represent BioCryst and its anti-viral peramivir for influenza stockpiling opportunities, as well as for marketing and distribution of peramivir for seasonal influenza upon local regulatory approval, within their territories outside the U.S.

15 Sep 2009

RAPS honors award recipients for contributions to healthcare product regulatory profession

The Regulatory Affairs Professionals Society (RAPS) today honored the recipients of its prestigious awards for outstanding contributions to the healthcare product regulatory profession. RAPS' Leonard Stauffer Award for mentoring and furthering regulatory professional education was given to independent consultant Nanci Dexter.

15 Sep 2009

Targeted Molecular Diagnostics to offer digital pathology services in Beijing

Targeted Molecular Diagnostics (TMD), a Quintiles Central Laboratory, announced today the availability of digital pathology services in Beijing, China. The services add to Quintiles offerings used in the development of therapies to treat the world’s most pressing health issues, including cancer.

15 Sep 2009

Dominion develops and validates clinical quantitative assays for tapentadol

Dominion Diagnostics (Dominion) has recently developed and validated one of the first clinical quantitative assays for the drug tapentadol (Nucynta(TM)) performed by liquid chromatography/tandem mass spectrometry (LC/MS/MS). Tapentadol, recently approved for use by the FDA, is a centrally-active analgesic that has demonstrated efficacy in pain relief with improved gastrointestinal tolerability compared to other opioids for pain management.

15 Sep 2009

UCLA receives funds for oral cancer research training

The UCLA School of Dentistry consistently ranks among the country's top dental schools in National Institutes of Health funding. During the past three fiscal years, the school has secured nearly $30 million in grants for oral cancer research and research training. Now, the dental school has received a major infusion of construction funding for the creation of the UCLA Yip Center for Oral/Head & Neck Oncology Research.

15 Sep 2009

Emerging Growth Research to manage investor relations programs for Biomagnetics Diagnostics

Biomagnetics Diagnostics Corp., a producer of revolutionary diagnostic systems and technology for HIV, hepatitis, tuberculosis, and malaria detection, today announced it has retained Emerging Growth Research, LLP to manage its public relations and investor relations programs. Emerging Growth Research specializes in small market capitalization companies in the technology and biotechnology sectors.

14 Sep 2009

Gen-Probe to merge industrial testing assets into an independent company

Gen-Probe Incorporated announced today that it is spinning off its industrial testing assets into a new, independent company focused on developing rapid, highly accurate molecular assays for biopharmaceutical production, water and food safety testing, and other applications.

14 Sep 2009

Natus Medical to purchase Alpine Biomed Holdings

Natus Medical Incorporated today announced that it has entered into an agreement to acquire Alpine Biomed Holdings Corp in a transaction that is expected to close today.

14 Sep 2009

Pharma CI Conference to focus on pharma industry news and challenges

Demand swells and attendance soars for the most accurate and up-to-date information about the constantly changing pharmaceutical industry, especially pharma competitive intelligence. Even in a challenging economic environment, the Pharma CI Conference continues to expand because industry leaders understand that they must face the future together, and the Pharma CI Conference is the one place that can happen.

14 Sep 2009

Quest Diagnostics' OVA1 ovarian cancer test cleared by the FDA

The U.S. Food and Drug Administration (FDA) today cleared the OVA1(TM) Test, the first blood test that, prior to surgery, can help physicians determine if a woman is at risk for a malignant pelvic mass. OVA1 is the first FDA-cleared laboratory test that can indicate the likelihood of ovarian cancer with high sensitivity prior to biopsy or exploratory surgery, even if radiological test results fail to indicate malignancy.

From Quest Diagnostics 14 Sep 2009

InfraReDx to display Lipiscan at TCT scientific meeting

InfraReDx today announced its preliminary schedule of events at the Cardiovascular Research Foundation's (CRF) annual Transcatheter Cardiovascular Therapeutics (TCT) scientific meeting, scheduled from Monday, September 21st to Friday, September 25th, in San Francisco, CA. at the Moscone Center.

14 Sep 2009

Cisco deploys Integrated Medical-Grade Network at HIAE

Cisco today announced the deployment of an Integrated Medical-Grade Network at the Albert Einstein Israeli Hospital (HIAE) in Sao Paulo city. The Hospital is recognized in Latin America for pioneering the innovative use of technology to streamline business processes and deliver value to its patients.

11 Sep 2009

Vitapath Genetics closes $6 million series A round of funding

VitaPath Genetics, a molecular diagnostics company, announced today that it has closed a $6 million series A round of funding led by MDV-Mohr Davidow Ventures. VitaPath was originally seeded by X/Seed Capital, which also co-invested in the Series A. Concurrent with the financing MDV's Michael Goldberg and X/Seed's Michael Borrus took seats on the company's board.

11 Sep 2009

Vitro Diagnostics' novel stem cell technology for cancer treatment

Vitro Diagnostics, Inc., dba Vitro Biopharma, announced advances in its adult stem cell products and technology with application to cell-based therapy of cancer. With the passing of Senator Edward Kennedy from brain cancer, we are reminded of such aggressive cancers without effective treatment.

10 Sep 2009

Labs grumble over co-pays, new fees for Medicare lab work

Roll Call reports that big labs — including ones like Quest Diagnostics — are unhappy with a Senate Finance Committee proposal to increase taxes for labs that perform Medicare services.

10 Sep 2009

QIAGEN's new QIAsafe DNA blood products launched

Biomatrica, Inc. and QIAGEN announce the launch of QIAGEN's new QIAsafe DNA Blood Products, the first dry blood storage available on a matrix based on Biomatrica's innovative SampleMatrix(R) technology.

From QIAGEN Manchester Limited 10 Sep 2009

Non-invasive CR-2000 Research System to be used in START clinical trial

Hypertension Diagnostics, Inc., today announced that its non-invasive HDI/PulseWave CR-2000 Research System (CR-2000) has been selected for use in the Strategic Timing of AntiRetroviral Treatment (START) substudy on Arterial Elasticity that will examine blood vessel function and cardiovascular risk during HIV infection.

10 Sep 2009