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TessArae's RM-Flu test granted FDA EUA

TessArae, LLC, a privately held company, and Affymetrix Inc., (NASDAQ:AFFX) today announced that the Food and Drug Administration (FDA) has granted Emergency Use Authorization (EUA) to TessArae for its TessArray® Resequencing Influenza A Microarray Detection Panel for the Detection of the 2009 H1N1 Influenza A Virus (TessArray RM-Flu test) for the duration of the declaration of emergency unless revoked earlier. The declaration of emergency will expire on April 26, 2010, unless terminated earlier or renewed.

21 Dec 2009

Cermetek Microelectronics launches UL 60601-1 compliant modem module

Cermetek Microelectronics, Inc. today announced the CH24606 modem module. The CH24606, a V.22bis modem module (2400 bits per second), is the first Cermetek modem designed to comply with UL 60601-1 requirements for medical equipment safety. Cermetek has targeted the CH24606 as a low-cost communications solution for medical monitoring equipment. The CH24606 sells for less than $15 in 1000 piece quantities.

21 Dec 2009

Walgreens discloses record first-quarter fiscal 2010 results

Walgreens today announced record earnings and sales for the first quarter of fiscal year 2010.

21 Dec 2009

Teva Pharmaceutical Industries, OncoGenex Pharmaceuticals announce collaboration in cancer therapy

Teva Pharmaceutical Industries Ltd. and OncoGenex Pharmaceuticals, Inc. announced today that they have entered into a global license and collaboration agreement to develop and commercialize OGX-011, as well as an agreement to purchase shares in OncoGenex. OGX-011 is a Phase III cancer therapy designed to inhibit cancer treatment resistance.

21 Dec 2009

OncoGenex Pharmaceuticals to pay Isis Pharmaceuticals $10M for license of OGX-011 to Teva Pharmaceutical Industries

Isis Pharmaceuticals, Inc. today announced that it will receive a $10 million payment from OncoGenex Pharmaceuticals, Inc. as a result of OncoGenex' license of OGX-011 to Teva Pharmaceutical Industries Ltd. ( TEVA). OGX-011 is a second-generation antisense drug co-discovered by Isis and OncoGenex that has completed a successful Phase 2 program in patients with advanced prostate cancer and advanced non-small cell lung cancer.

21 Dec 2009

Believe only half of what men say

We hear a new story in the media every month: Celebrities, politicians, and high-profile businessmen cheating on their spouses. With these stories being so common, it's easy for single women to doubt that they could ever have a "happily ever after" ending in their own lives.

21 Dec 2009

CPEX Pharmaceuticals completes enrollment in Nasulin Phase 2a clinical trial

CPEX Pharmaceuticals, Inc. today announced that the ongoing Phase 2a clinical trial of Nasulin™, the Company’s intranasal insulin candidate, has now completed enrollment. The study was initiated in February of this year and randomized 94 subjects. Results are expected at the end of the first quarter or beginning of the second quarter of 2010.

21 Dec 2009

FDA clears Dilon Diagnostics' GammaLoc lesion-localization system

Dilon Diagnostics announced today that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for its lesion-localization system for molecular imaging biopsy guidance.

21 Dec 2009

Investigation of IDH1 gene mutations in brain cancer receives new funds

Agios Pharmaceuticals, the leading biopharmaceutical company focused on discovering and developing novel drugs in the emerging field of cancer metabolism, announced today that it has received funding from Accelerate Brain Cancer Cure (ABC2), a non-profit organization that supports brain cancer research. ABC2’s funding will enable new research investigating IDH1 gene mutations in brain cancer, with the goal of supplementing Agios’s ongoing research into the development of new IDH1 therapeutics and diagnostics.

21 Dec 2009

Organogenesis files a PMA with the FDA for its CelTx living cell-based technology

Organogenesis, Inc. announced today that it has filed a Premarket Approval Application (PMA) with the U.S. Food and Drug Administration (FDA) for its CelTx(TM), a living cellular construct for oral soft tissue regeneration. If approved, CelTx will be the first, living cell-based technology that is FDA-approved for use in the dental market.

21 Dec 2009

Eli Lilly, Incyte announce collaboration for development and commercialization of INCB28050 oral inhibitor

Eli Lilly and Company and Incyte Corporation announced today that they have entered into an exclusive worldwide license and collaboration agreement for the development and commercialization of Incyte's oral JAK1/JAK2 inhibitor, INCB28050, and certain follow on compounds, for inflammatory and autoimmune diseases. The lead compound, INCB28050, is currently being studied in a six-month dose-ranging Phase II trial for rheumatoid arthritis.

21 Dec 2009

Durata Therapeutics acquires Vicuron Pharmaceuticals

Durata Therapeutics, Inc. announced today that it has acquired Vicuron Pharmaceuticals from Pfizer (PFE). Durata is a newly formed biopharmaceutical company that was created by a five-member venture capital syndicate to pursue late-stage clinical development of novel antibiotic programs. The acquisition was funded through a stock purchase by New Leaf Venture Partners, LLC, Domain Associates, LLC, Aisling Capital, Sofinnova Ventures Inc. and Canaan Partners.

21 Dec 2009

Intra-Cellular Therapies announces results of its ITI-007 antipsychotic drug Phase I study

Intra-Cellular Therapies, Inc. (ITI) announced at a recent conference on neuropsychiatric diseases the results from a recently completed Phase I clinical study demonstrating ITI-007, the Company's lead antipsychotic drug, interacts with important targets in the living human brain. These key targets are critical to drug action in many neuropsychiatric and related disorders.

21 Dec 2009

Sanofi-aventis to acquire Chattem for $1.9 billion

Sanofi-aventis and Chattem, Inc. announced today that they have entered into a definitive agreement under which sanofi-aventis is to acquire 100 percent of the outstanding shares of Chattem in a cash tender offer for $93.50 per share, or approximately $1.9 billion.

21 Dec 2009

AcuMedSpa Holdings plans multiple acquisitions

AcuMedSpa Holdings, Inc. has been evaluating many acquisition prospects and currently is focused on multiple acquisition targets.

21 Dec 2009

First Edition: December 21, 2009

From today's headlines, the biggest overnight news is the Senate's vote to move its sweeping health reform bill one step closer to the finish line.

21 Dec 2009

Swedish agency approves Medivir's Xerclear for treatment of cold sores

The Swedish Medical Products Agency has now approved Xerclear™ for treatment of cold sores. It is the first and only topical treatment that has been demonstrated to prevent the incidence of cold sores and shorten healing-times. Xerclear™ will be available from pharmacies in the first half-year 2010.

21 Dec 2009

Book on physiology of eating and weight regulation

The development of effective preventive and therapeutic measures to control eating and body weight involves basic physiology as well as cognitive and social psychology.

21 Dec 2009

Positive interim results from Medicago's H5N1 vaccine Phase I human clinical trial

Medicago Inc. a biotechnology company focused on developing highly effective and affordable vaccines based on proprietary manufacturing technologies and Virus-Like Particles (VLPs), today reported positive interim results from a Phase I human clinical trial with its H5N1 Avian Influenza vaccine candidate ("H5N1 vaccine"). The vaccine was found to be safe, well tolerated and also induced a solid immune response.

21 Dec 2009

Seattle Genetics and GSK sign ADC collaboration agreement

Seattle Genetics, Inc., announced today that it has entered into a collaboration agreement with GlaxoSmithKline (GSK) under which GSK will pay an upfront fee of $12 million for rights to utilize Seattle Genetics’ antibody-drug conjugate (ADC) technology with multiple antigens to be named by GSK.

21 Dec 2009