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ICON opens purpose-built clinical pharmacology unit within CMFT campus

ICON plc,, a global provider of outsourced development services to the pharmaceutical, biotechnology and medical device industries, today announced the official opening of a purpose-built clinical pharmacology unit within the Central Manchester University Hospitals Foundation Trust (CMFT) campus in Manchester, UK. Initial studies in the unit utilising translational medicine methodologies to expedite drug development projects began in June, and already 110 volunteers have participated in studies there.

17 Jul 2010

Apicore announces successful conclusion of Somerset API manufacturing plant's FDA inspection

Apicore LLC announced today that the U.S. Food and Drug Administration (FDA) completed an inspection of its API manufacturing plant in Somerset, New Jersey on July 13, 2010.

17 Jul 2010

Columbia scientists discover new way to alleviate chronic pain

Columbia scientists working to combat injury-related depression, substance abuse and suicide due to unremitting, persistent pain may have discovered a new way of treating that pain: a powerful analgesic dubbed N60 that leads to neither tolerance nor addiction.

16 Jul 2010

Microtest white paper guides medical device manufacturers in applying new FDA regulations to combination products

A new free, white paper that guides medical device manufacturers in the complicated process of applying new U.S. Food and Drug Administration (FDA) regulations to combination products embedded with pharmaceutical or biologic components is now available from Microtest Laboratories (http://www.microtestlabs.com/combination-products-20/)

14 Jul 2010

Epeius Biotechnologies receives notice of allowance from USPTO for gene delivery platform

Epeius Biotechnologies Corporation, an emerging leader in the field of targeted genetic medicine, received a notice of allowance from the USPTO for another crucial patent covering its leading tumor-targeted gene delivery platform. The issuance of this high-value patent protection for targeting metastatic disease follows on the heels of two major patent issuances covering tumor-targeted gene delivery and precision-targeted cancer immunotherapy, respectively.

7 Jul 2010

PROLOR Biotech receives EU GMP certification for hGH-CTP biobetter version of human growth hormone

PROLOR Biotech, Inc., a company developing next generation biobetter therapeutic proteins, today announced that it has received formal Good Manufacturing Practice (GMP) certification for hGH-CTP, the company's proprietary biobetter version of human growth hormone. GMP certification is required by the European Union (EU) clinical trials legislation as a precondition for conducting clinical trials in EU member countries.

29 Jun 2010

Boston Therapeutics submits structure, function claims of SUGARDOWN to FDA

Boston Therapeutics, Inc. has announced that it has submitted structure and function claims of its SUGARDOWN™ to the US Food and Drug Administration on June 21, 2010.

28 Jun 2010

Kaplan EduNeering, DIA announce strategic alliance to create online educational offerings

Kaplan EduNeering, a leading provider of compliance and knowledge management solutions, and the Drug Information Association (DIA), a global professional member association, announced a new strategic alliance to create online educational offerings for biotechnology, pharmaceutical, academic, and regulatory professionals around the world.

17 Jun 2010

AMRI announces acquisition of Hyaluron

AMRI today announced the acquisition of Hyaluron Inc., expanding AMRI's contract manufacturing capabilities to include cGMP manufacturing and sterile filling of parenteral drugs to the biopharmaceutical industry. AMRI has acquired all facilities and equipment as well as a highly trained and experienced staff of professionals with expertise in sterile GMP manufacturing. Purchase price, including debt, was approximately $27 million.

15 Jun 2010

China-Biotics fourth-quarter revenues up 64.4% to $25.5 million

China-Biotics, Inc., a leading developer, manufacturer and distributor of probiotics products in China, today reported its financial results for the fourth quarter and the fiscal year ended March 31, 2010.

11 Jun 2010

Protagen, Bayer Schering Pharma close cooperation contract for biomarker discovery in Endometriosis

Protagen AG, a specialist for in-vitro diagnostics and GMP-compliant protein analysis, and Bayer Schering Pharma AG, a global leading specialty pharmaceuticals company, announced today the closing of a cooperation contract for discovery of novel biomarkers in Endometriosis.

10 Jun 2010

Enavail to build new cGMP facility in Abilene Life Sciences Accelerator

Enavail, LLC, a particle engineering company founded on pioneering drug delivery research from the University of Texas at Austin, announced today the company's plans for the construction of a new state-of-the-art current Good Manufacturing Practices (cGMP) facility in the Abilene Life Sciences Accelerator (ALSA). The Enavail facility will be the first of its kind in the West Texas region.

9 Jun 2010

GE Healthcare highlights molecular imaging technologies to help clinicians improve patient experiences

Focusing on helping clinicians improve experiences for their patients, GE Healthcare is highlighting an innovative portfolio of molecular imaging technologies and agents at the 57th annual meeting of the Society of Nuclear Medicine, June 5-9, in Salt Lake City.

7 Jun 2010

Researchers develop biosensors to monitor concentration of c-di-GMP within single living bacteria cells

Some species of bacteria perform an amazing reproductive feat. When the single-celled organism splits in two, the daughter cell - the swarmer - inherits a propeller to swim freely. The mother cell builds a stalk to cling to surfaces.

4 Jun 2010

Particle Sciences adds Dried Blood Spot Analysis capability to Analytic Services offerings

Particle Sciences has expanded its Bioanalytic Service's offerings to include Dried Blood Spot LC/MS/MS analysis (DBS). DBS is a growing area of interest because of its advantages in sample collection, stability, and simplified storage requirements. By using DBS, sample collection and processing is greatly simplified resulting in decreased costs, increased safety and greater comfort for test subjects.

4 Jun 2010

t2c001 product obtains certificate under EMA regulations for ATMPs

t2cure GmbH, a biopharmaceutical company developing and marketing stem cell-based regenerative therapies, announced today that the quality of its lead product t2c001 has been certified by the European Medicines Agency.

25 May 2010

BioLife Solutions first-quarter revenue up 36% to $513,000

BioLife Solutions, Inc., announced today that Chairman and Chief Executive Officer Mike Rice issued the following letter to shareholders providing a general corporate update.

20 May 2010

Simcere Pharmaceutical first-quarter total revenue up 3.7% to $67.2 million

Simcere Pharmaceutical Group, a leading pharmaceutical company specializing in the development, manufacturing, and marketing of branded generic and proprietary pharmaceuticals in China, today reported preliminary unaudited financial results for the quarter ended March 31, 2010.

18 May 2010

Jiangbo Pharmaceuticals third-quarter revenue decreases 0.6% to $25.6 million

Jiangbo Pharmaceuticals, Inc., a pharmaceutical company with its principal operations in the People's Republic of China, today announced financial results for the third quarter fiscal year 2010 ended March 31, 2010.

17 May 2010

BioGenes study documents insufficient sensitivity of ELISA-based generic HCP assay

BioGenes GmbH, a supplier of GMP-compliant immunoassays and antibodies, completed a study that documents the insufficient sensitivity of an ELISA-based generic host cell protein assay. The results confirm the observation of several contract manufacturers that generic HCP assays are only of limited use for detection of HCPs during manufacturing processes.

12 May 2010