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ProBioGen signs contract with Virdante Biopharmaceuticals

ProBioGen AG, a technology and service provider for the development and production of biopharmaceutical drug substances today announced signing a contract with Virdante Biopharmaceuticals, Inc., a US-based biopharmaceutical development company.

12 May 2010

JHP Pharmaceuticals completes successful GMP/Pre Approval Audit by FDA CDER

JHP Pharmaceuticals' sterile manufacturing site based in Rochester, Michigan completed a successful GMP (Good Manufacturing Practices)/Pre Approval Audit by the U.S. Food and Drug Administration (FDA) drug division (CDER).

11 May 2010

AMRI first-quarter total revenue down 9% to $49.3 million

AMRI today reported financial and operating results for the first quarter ended March 31, 2010.

5 May 2010

BioTime to acquire Singapore-based company, ES Cell International

BioTime, Inc., a biotechnology company that develops and markets products in the field of stem cells and regenerative medicine, today announced that it has agreed to acquire the Singapore-based company ES Cell International Pte Ltd.

30 Apr 2010

Goodwin Biotechnology, Hyprocell sign collaborative agreement to strengthen clinical development services

Goodwin Biotechnology Inc., a full service contract biomanufacturing company, and Hyprocell LLC, a clinical cell line development services company, jointly announced today their collaborative agreement to create a business model enabling customers to access their one stop shop services.

28 Apr 2010

News outlets examine World Malaria Day 2010

Ahead of Sunday's World Malaria Day, news outlets examined global efforts to combat the disease and the mood among advocates.

27 Apr 2010

Rapid diagnostic tests for malaria

A new evaluation of malaria rapid diagnostic tests will help health workers quickly identify which patients have the disease and need immediate treatment, putting into action recent World Health Organization recommendations to confirm diagnosis of malaria before treatment.

24 Apr 2010

Syntagon contract research organisation announces strategic pricing initiative

Leading contract research organisation, Syntagon, has unveiled a strategic pricing initiative that will see substantial cost savings for biotechnology and pharmaceutical customers taking compounds into phase I and phase II clinical trials.

22 Apr 2010

Simcere's diosmectite API in generic drug Biqi passes EU-GMP inspection

Simcere Pharmaceutical Group, a leading pharmaceutical company specializing in the development, manufacturing, and marketing of branded generic and proprietary pharmaceuticals in China, today announced that its diosmectite, the Active Pharmaceutical Ingredient (API) in Simcere's branded generic drug Biqi, has passed EU-GMP inspection. This enables Simcere to market diosmectite in the European Union countries.

22 Apr 2010

FDA approves Sinapis Pharma's IND for IV methamphetamine in treatment of acute stroke

Sinapis Pharma is pleased to announce that it has received notice from the FDA that its Investigational New Drug application (IND) for the use of IV methamphetamine for acute stroke was approved on April 9, 2010. "We have accomplished a great deal of work for a small company on a very tight budget. We have GMP drug ready for the Phase I clinical trial and the Phase I site is prepared to begin this protocol," said Dr. Donald Picker , the company CEO.

12 Apr 2010

Roche NimbleGen to implement GMP for DNA microarrays suite

Roche NimbleGen, announced today a company-wide initiative to implement Good Manufacturing Processes (GMP) for its suite of DNA microarrays. The implementation of GMP will cover the full scope of processes from development through manufacturing and will include all locations. The company plans on achieving GMP compliance followed by subsequent submission for clearance or approval of select array products to the US Food and Drug Administration.

8 Apr 2010

Sigma-Aldrich, Boehringer Ingelheim Pharma enter distribution agreement for RESOMER polymers

Sigma-Aldrich® announced today it has entered into a distribution agreement with Boehringer Ingelheim Pharma GmbH & Co. KG, Germany, to offer its portfolio of RESOMER biodegradable polylactide (PLA) and poly(lactide-co-glycolide) (PLGA) polymers to the research community.

8 Apr 2010

Bioheart presents cutting edge therapies at 2010 Translational Regenerative Medicine Forum

Bioheart, Inc., announced today that Dr. Karl E. Groth, the Company's Chairman and CEO will speak at the 2010 Translational Regenerative Medicine Forum in Winston-Salem, North Carolina, on April 8. Dr. Groth will discuss Bioheart's cell therapies for Congestive Heart Failure.

31 Mar 2010

Westaim completes acquisition of JEVCO

The Westaim Corporation today announced that it has completed the acquisition of all of the shares of JEVCO Insurance Company from Kingsway Financial Services Inc. (KFS) pursuant to the terms of the purchase agreement dated as of January 25, 2010, as amended between Westaim and KFS.

30 Mar 2010

Health Robotics launches global Beta installation of 3 i.v.SOFT Workflow Engine automation modules

Health Robotics today announced the successful global launch of the Beta Installation kick-off for its 3 latest i.v.SOFT Workflow Engine software automation modules [Assist, Label+ and Profile] in Nice [France], the 2010 venue for the European Association of Hospital Pharmacists. i.v.SOFT helps Pharmacy Technicians, I.V. Room Supervisors, and Pharmacy Directors to compound and manage the safe and efficient manual production of IV Admixtures according to hospital-defined sterile compounding guidelines, and to help bring the pharmacies into compliance with USP 797 regulations in the United States and GMP guidelines elsewhere.

29 Mar 2010

China Biologic Products' fourth quarter revenue rises 185.6%

China Biologic Products, Inc., one of the leading plasma-based biopharmaceutical companies in the People's Republic of China, operating through its indirect majority-owned subsidiaries, Shandong Taibang Biological Products Co. Ltd and Guiyang Dalin Biologic Technologies Co., Ltd. and its equity investment in Xi'an Huitian Blood Products Co., Ltd., today reported financial results for the fourth quarter and year ended December 31, 2009.

24 Mar 2010

Robertson Foundation commits $10.2M for Duke Medicine's cell therapy research

A $10.2 million commitment from the Robertson Foundation to create a state-of-the-art Translational Cell Therapy Center (TCTC) will advance Duke Medicine's pioneering cell therapy research and treatment programs for children and adults with cancer, cerebral palsy, stroke and brain injuries suffered at birth.

19 Mar 2010

W. R. Grace earns GMP certification

W. R. Grace & Co.has earned Good Manufacturing Practices certification of its facility in Baltimore, Maryland. The certification encompasses Grace’s Quality Management System that includes the standards, procedures and manufacturing operations used by the company in the production of pharmaceutical grade silica (commonly marketed by Grace under the SYLOID® brand name).

19 Mar 2010

Lotus Pharmaceuticals announces groundbreaking ceremony to construct new building complex in Beijing

Lotus Pharmaceuticals, Inc., a growing developer and producer of prescription drugs and licensed national seller of pharmaceutical products in the People's Republic of China, reported the groundbreaking ceremony on March 9 to construct a new building complex on the grounds of its production facility in Beijing.

11 Mar 2010

WHO issues new guidelines for malaria treatment

The World Health Organization (WHO) is releasing new guidelines for the treatment of malaria, and the first ever guidance on procuring safe and efficacious anti-malarial medicines.

11 Mar 2010