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CSL Biotherapies statement on FDA warning letter

Today the US Food and Drug Administration (FDA) published a Warning Letter issued by its Office of Compliance and Biologics Quality to CSL Biotherapies, a division of CSL Limited. The FDA regulates the manufacture, marketing and distribution of CSL Biotherapies’ influenza vaccine, Afluria®, in the US market.

21 Jun 2011

BioLife becomes the leading supplier of pre-formulated cord blood stem cell freeze media products

BioLife Solutions, Inc., a leading developer and manufacturer of clinical grade biopreservation media products for cells and tissues, today announced that it has become the leading supplier of pre-formulated GMP cryopreservation media for umbilical cord blood stem cells, a key segment of the Company's strategic biobanking market.

21 Jun 2011

Sunshine enters Adva-27a cancer research and development agreement with The Jewish General Hospital

Sunshine Biopharma, Inc. a development stage pharmaceutical company focused on the research, development and commercialization of drugs for the treatment of various forms of cancer, today announced that it has executed an agreement with The Jewish General Hospital, one of McGill University's Hospital Centers, to conduct the necessary research and development to advance Sunshine's lead compound, Adva-27a, through the various stages of preclinical studies and Phase I clinical trials.

17 Jun 2011

Repligen total revenue increases 30% to $27,291,000 for fiscal year 2011

Repligen Corporation today reported results for the fourth quarter and fiscal year 2011, ended March 31, 2011.

9 Jun 2011

Bionovo's Menerba Phase 2 trial data to be presented at Annual World Congress on Menopause

Bionovo, Inc., a pharmaceutical company focused on the discovery and development of safe and effective treatments for women's health and cancer, today announced it will be presenting data from the Phase 2 clinical trial of their lead drug candidate for postmenopausal symptoms, Menerba, to the international community at the 13th Annual World Congress on Menopause in Rome, Italy on June 11, 2011.

4 Jun 2011

NIH approves BioTime's two human embryonic stem cell lines for clinical use

BioTime, Inc., a biotechnology company that develops and markets products in the field of regenerative medicine, today announced that two human embryonic stem (hES) cell lines, ESI-014 and ESI-017, developed by a BioTime subsidiary have been approved by the National Institutes of Health (NIH) for inclusion in the NIH Human Embryonic Stem Cell Registry.

4 Jun 2011

AIS releases stainless steel HMI color LCD monitors for pharma industries

American Industrial Systems, Inc. is an ISO 9001:2008 certified supplier and manufacturer of 15" to 20" industrial LCD monitor with stainless steel front bezels and touch screens, designed for use in the food, beverage, pharmaceutical and tobacco industries for operator control and monitoring.

31 May 2011

ShangPharma first quarter net revenues increase 25.6% to $24.8 million

ShangPharma Corporation, a leading China-based pharmaceutical and biotechnology research and development outsourcing company, today announced its financial results for its first quarter ended March 31, 2011.

19 May 2011

Nordic Naturals' dietary supplements earn NSF certification

Nordic Naturals has earned certification from NSF International, verifying that its new LEED-designed corporate headquarters complies with Good Manufacturing Practices as set forth in NSF/ANSI Standard 173-2008, Dietary Supplements, Section 8.

17 May 2011

AgenoLAB acquires Roche´s RTCA Cardio Instrument

AgenoLAB, the Stuttgart-based service provider, is the first company in Germany to expand its service offering with the latest cell analysis technology from Roche. The company will use the RTCA Cardio Instrument to complement their analytical service portfolio for drug development.

13 May 2011

Sinovac first quarter sales increase 5.3% to $4.7 million

Sinovac Biotech Ltd., a leading provider of biopharmaceutical products in China, announced today its unaudited first quarter financial results for the period ended March 31, 2011.

13 May 2011

Miltenyi Biotec enters partnership with TeutoCell to develop novel cell culture techniques

Miltenyi Biotec, the only company to offer a seamless experimental integration path from sample preparation through cell separation, culture, and analysis for primary cells, today entered into a strategic alliance with TeutoCell, a provider of cutting edge cell culture technology.

12 May 2011

EMD Millipore inaugurates new Shanghai Biopharmaceutical Technical Center

EMD Millipore, the Life Science division of Merck KGaA of Germany, today opened its state-of-the-art Biopharmaceutical Technical and Training Center in Shanghai, China. The 28,000 square foot facility will provide support, training and validation services to EMD Millipore's biopharmaceutical customers with operations in China.

11 May 2011

Elan Drug Technologies, Alkermes merge to form new company in Ireland

Alkermes, Inc. and Elan Corporation, plc today announced the execution of a definitive agreement under which Alkermes will merge with Elan Drug Technologies, the profitable, world-class drug formulation and manufacturing business unit of Elan, in a cash and stock transaction currently valued at approximately $960 million.

9 May 2011

Almac launches six enzyme screening kits

As anticipated, Almac's biocatalysis business has expanded from its 2009 launch with the sale of six enzyme screening kits, to the current supply of 100s of kgs of chiral intermediates for drug substance manufacture, regular enzyme supply to specialty chemical companies and continued growth of its screening kits offering. Biocatalysis is increasingly recognised as an alternative solution for solving complex chemistry problems due to its rapid implementation, economic benefits and 'green' reputation.

4 May 2011

New nano-vault delivery system can fight cancer

UCLA scientists have discovered a way to wake up the immune system to fight cancer by delivering an immune system-stimulating protein in a nanoscale container called a vault directly into lung cancer tumors, harnessing the body's natural defenses to fight disease growth.

4 May 2011

Bioniche Life Sciences opens new livestock vaccine manufacturing facility

Bioniche Life Sciences Inc., a research-based, technology-driven Canadian biopharmaceutical company, today officially opened its new Animal Health and Food Safety Vaccine Manufacturing Centre at its corporate headquarters in Belleville, Ontario, Canada.

30 Apr 2011

Taro's Brampton facility regains FDA acceptable regulatory status

Taro Pharmaceutical Industries Ltd. today announced that the U.S. Food and Drug Administration has informed the Company that after a February 2011 re-inspection of its Canadian manufacturing facility, the site has an acceptable regulatory status. Therefore, the issues noted in the February 5, 2009 warning letter are considered to be resolved.

25 Apr 2011

USPTO issues patent to Oragenics ProBiora3 for oral care

Florida-based biopharmaceutical company Oragenics, Inc. announced today the issuance of patent number 7931892 from the United States Patent and Trademark office for ProBiora3, a proprietary blend of naturally occurring oral bacteria shown to produce a wide range of oral care benefits.

22 Apr 2011

Tissue Genesis commences PVD clinical trials with adipose-derived adult stem cell-coated vascular grafts

Tissue Genesis, Inc., an emerging leader in adult stem cell and regenerative medicine, announced today that it has begun clinical trials for peripheral vascular disease (PVD) with adipose (fat) derived adult stem cell-coated vascular grafts at the University of Louisville Hospital. Tissue Genesis is the first to initiate a FDA-approved trial using the patient's own adipose-derived adult stem cells (ASCs) prepared at the point-of-care.

20 Apr 2011