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China's SFDA approves Celsion’s global Phase III ThermoDox HEAT trial for treating liver cancer

Celsion Corporation announced today that it has received official approval from China’s State Food and Drug Administration (“SFDA”) for its Clinical Trial Application for ThermoDox that permits Celsion to include Chinese clinical trial sites in its Phase III ThermoDox HEAT trial for the treatment of primary liver cancer, also known as hepatocellular carcinoma (HCC).

15 Oct 2009

Access Pharmaceuticals' update on its European commercial launch of Mugard

ACCESS PHARMACEUTICALS, INC. today provided an update on its European commercial launch of MuGard, an FDA approved treatment for oral mucositis, a debilitating side effect of radiation treatment and chemotherapy.

15 Oct 2009

Inspire to present its denufosol tetrasodium cystic fibrosis program data at the 23rd NACFC

Inspire Pharmaceuticals, Inc. announced today Inspire scientists and collaborators will present data from the denufosol tetrasodium cystic fibrosis (CF) program in a poster presentation at the 23rd Annual North American Cystic Fibrosis Conference (NACFC) October 15 - 17, 2009 in Minneapolis, MN.

15 Oct 2009

Positive results from Protalix BioTherapeutics Phase III UPLYSO clinical trial

Protalix BioTherapeutics, Inc., announced today positive top-line results from the Company's pivotal Phase III clinical trial of UPLYSO (taliglucerase alfa, previously referred to as prGCD) in treatment naive patients diagnosed with Gaucher disease.

15 Oct 2009

Negative symptoms represent an attractive target for drug development

A half-day workshop on issues in the design of clinical trials to evaluate treatments for negative symptoms of schizophrenia, chaired by Stephen Marder, MD, UCLA Department of Psychiatry and David Daniel, M.D., United BioSource Corporation was held 5 October 2009, as part of the International Society for CNS Clinical Trials and Methodology (ISCTM) Autumn Conference in San Diego, CA.

15 Oct 2009

Medifacts International bags $2.7 million contract with a top ten pharmaceutical company

MEDIFACTS INTERNATIONAL, INC., one of the largest global providers of noninvasive cardiac diagnostic services, today announced the award of a $2.7 million contract with a top ten pharmaceutical company to provide comprehensive cardiac safety and efficacy services for a large late stage clinical trial.

15 Oct 2009

Survey reports patients' concern about the safety and access to flu vaccines

Although some parents may be lukewarm to the H1N1 vaccination, Lakeside Community Healthcare www.LakesideCommunityHealthcare.com, one of Southern California's largest integrated, comprehensive healthcare organizations, reports broader patient concern about both the safety of and access to the vaccine.

15 Oct 2009

Human populations may have some level of existing immunity to the pandemic H1N1 influenza, say researchers

University of California, Davis, researchers studying the 2009 H1N1 influenza virus, formerly referred to as "swine flu," have identified a group of immunologically important sites on the virus that are also present in seasonal flu viruses that have been circulating for years. These molecular sites appear to result in some level of immunity to the new virus in people who were exposed to the earlier influenza viruses.

15 Oct 2009

Decision Resources forecasts biosimilar insulins and insulin analogues to erode $6.1 billion in brand sales

Decision Resources, one of the world's leading research and advisory firms for pharmaceutical and healthcare issues, forecasts that biosimilar insulins and insulin analogues stand to erode $6.1 billion in brand sales in the U.S. and Europe (France, Germany, Italy, Spain and U.K.) by 2018, saving healthcare systems $3.8 billion in the process.

15 Oct 2009

Critical Pharmaceuticals to develop hGH nasal spray

Critical Pharmaceuticals, the speciality pharmaceuticals company, today announced that it had secured a £1.5m translation award from the Wellcome Trust to develop a nasal spray of Human Growth Hormone (hGH) using its proprietary CriticalSorb technology as an alternative to injection.

15 Oct 2009

Environmental Solutions launches alcohol-free hand sanitizer

Environmental Solutions International announces alcohol-free Smart & Silky Instant Foaming Hand Sanitizer and Smart & Silky Kids Instant Foaming Hand Sanitizer now are available at more than 975 OfficeMax® locations nationwide and on www.officemax.com beginning this week, in addition to nationwide Target® stores.

15 Oct 2009

Jazz Pharmaceuticals to present Phase III sodium oxybate trial data at ACR 2009 meetings

Jazz Pharmaceuticals, Inc. announced that data from the company's first Phase III clinical trial of sodium oxybate (JZP-6) for the treatment of fibromyalgia will be presented during the American College of Rheumatology 2009 Annual Meeting (ACR) in Philadelphia, Pennsylvania and also in November during the US Psychiatric and Mental Health Congress (US Psych Congress) in Las Vegas, Nevada.

15 Oct 2009

ACRO urges Congress to include clinical testing in biosimilars legislation

The Association of Clinical Research Organizations has called on Congress to ensure that any biosimilars legislation it passes requires clinical testing to ensure patient safety, efficacy, purity and potency. ACRO’s recommendations were included in a letter to the congressional committees with jurisdiction over health care policy.

15 Oct 2009

Five research teams receive $2.4 million to help breast cancer survivors

A total of $2.4 million has been awarded to five research teams in the Canadian Breast Cancer Research Alliance/Canadian Breast Cancer Foundation Special Research Competition on Psychosocial Aspects of Breast Cancer.

15 Oct 2009

Positive data from Cardium Therapeutics' Matrix Phase 2b Excellarate trial

Cardium Therapeutics today reported positive data from its Matrix Phase 2b clinical trial of Excellarate(TM) for the potential treatment of patients with chronic non-healing diabetic foot ulcers based on the Company's Gene Activated Matrix (GAM) technology platform.

15 Oct 2009

Atlantic examines flu vaccine, antiviral skepticism

As countries around the world roll out H1N1 (swine flu) virus vaccine campaigns, the Atlantic examines, "[W]hat if everything we think we know about fighting influenza is wrong?"

15 Oct 2009

FDA approves ZyStor Therapeutics' ZC-701 for Phase I human safety trial

ZyStor Therapeutics, Inc., a biotechnology company developing a new class of targeted protein therapeutics for the treatment of Lysosomal Storage Diseases using the Company's proprietary Glycosylation Independent Lysosomal Targeting technology, today announced that it has received clearance from the U. S. Food and Drug Administration to proceed into a clinical trial for its first drug candidate, ZC-701, an enzyme replacement therapy for the treatment of Pompe disease.

14 Oct 2009

Positive data from ZIOPHARM's palifosfamide sarcoma Phase II trial

ZIOPHARM Oncology, Inc. announced today positive top line interim data from the multicenter randomized Phase II trial of palifosfamide (ZymafosTM, ZIO-201) treating patients with unresectable or metastatic soft tissue sarcoma. The analysis evaluated 62 patients treated as of the end of September, with 58 being analyzed.

14 Oct 2009

Provectus Pharmaceuticals commences compassionate use program of PV-10 for cancer

Provectus Pharmaceuticals, Inc., a development-stage oncology and dermatology biopharmaceutical company, has expanded its compassionate use program for PV-10, making the agent, which is being developed as a therapeutic agent for a broad spectrum of cancers, available for select cancer patients in the United States. The program is already in progress in Australia, where it was initiated in June 2009.

14 Oct 2009

Progenics Pharmaceuticals and Wyeth Pharmaceuticals sign license agreement

Progenics Pharmaceuticals, Inc. today announced that it has entered into an agreement with Wyeth Pharmaceuticals, a division of Wyeth under which Progenics is regaining all worldwide rights to the RELISTOR® franchise from Wyeth Pharmaceuticals, which Progenics had previously licensed to Wyeth Pharmaceuticals.

14 Oct 2009