GLP 1 News and Research

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National Cancer Institute awards PDS Biotechnology $1.28M phase 2 SBIR contract

PDS Biotechnology Corporation today announced that the company has been awarded a $1.28M phase 2 SBIR contract by the National Cancer Institute division of the US National Institutes of Health. The contract provides funding to complete studies required to file an Investigational New Drug Application (IND) with the FDA for the company's lead human papillomavirus (HPV)-cancer product late in 2010.

2 Mar 2010

WuXi PharmaTech, JANSSEN division announce collaboration for preclinical services

WuXi PharmaTech, a leading pharmaceutical, biotechnology and medical device research and development outsourcing company with operations in China and the United States, today announced it has reached an agreement with Johnson & Johnson Pharmaceutical Research & Development, a division of Janssen Pharmaceutica N.V. (JANSSEN), to collaborate in the area of preclinical services.

2 Mar 2010

Using genetic engineering techniques in pigs, scientists create new model of diabetes

The incidence of diabetes is rising worldwide. Using genetic engineering techniques in pigs, scientists at Ludwig-Maximilians-Universität in Munich have created a new model of this metabolic disorder, which recapitulates many features of the disease, and promises to contribute significantly to improvements in diagnosis and therapy.

1 Mar 2010

ADMET tester Absorption Systems joins Society of Toxicology as Affiliate

Absorption Systems, a leader in testing drugs for ADMET (Absorption, Distribution, Metabolism, Excretion and Toxicity), has joined the Society of Toxicology, the premier global professional association of toxicologists, as an SOT Affiliate. The firm, a contract research organization, has more than a decade of experience assisting pharmaceutical and biotechnology companies in determining which compounds in development should be advanced into clinical testing.

27 Feb 2010

Marcadia Biotech commences Phase 1 clinical trial of MAR701 for type 2 diabetes

Marcadia Biotech Inc. today announced that it has initiated a Phase 1 clinical trial of MAR701, a novel dual agonist of the incretin hormone receptors for glucagon-like peptide-1 (GLP-1) and gastric inhibitory peptide (GIP). Marcadia plans to initially develop this compound as a treatment for type 2 diabetes with once-weekly dosing. The Phase 1 trial will evaluate MAR701 in healthy volunteers at escalating dose levels.

17 Feb 2010

Bioactive lipid LPA mediates fibrogenesis in bleomycin mouse model of scleroderma

Amira Pharmaceuticals, Inc. announced today that their collaborators, Andrew Tager, M.D. and Flavia V. Castelino, M.D. of Massachusetts General Hospital, Harvard Medical School, will present a preclinical proof-of-concept study which demonstrates that the bioactive lipid lysophosphatidic acid (LPA), through its high affinity LPA1 receptor, is an important mediator of fibrogenesis in the bleomycin mouse model of scleroderma. Data will be presented as part of a poster session for the 1st Systemic Sclerosis World Congress to be held in Florence, Italy, February 11 to 13, 2010.

11 Feb 2010

Ipsen reports consolidated group sales of €1,032.8M for 2009

Ipsen reported today its sales for the fourth quarter and full year 2009.

1 Feb 2010

MPI Research lauds FDA's current guidance on abuse potential of drugs

On January 26, 2010, the Food and Drug Administration (FDA) released a key draft guidance document, Guidance for Industry Assessment of Abuse Potential of Drugs. When finalized, this guidance will represent the FDA’s current position on the abuse potential of drugs. Noteworthy within the document, Good Laboratory Practices (GLP) specified in the Guidance for Industry S7A Safety 471 Pharmacology Studies for Human Pharmaceuticals and in FDA regulations, 21 CFR 472 part 58, now also apply to abuse potential studies in animals.

30 Jan 2010

FDA approves Victoza to treat type 2 diabetes in some adults

The U.S. Food and Drug Administration today approved Victoza (liraglutide), a once-daily injection to treat type 2 diabetes in some adults.

27 Jan 2010

FDA approves Novo Nordisk's Victoza for type 2 diabetes

Novo Nordisk, a global healthcare company, announced today the U.S. Food and Drug Administration (FDA) approved the new drug application for Victoza® (liraglutide [rDNA origin] injection), the first once-daily human glucagon-like peptide-1 (GLP-1) analog for the treatment of type 2 diabetes. Victoza is indicated as an adjunct to diet and exercise to improve blood sugar control in adults with type 2 diabetes mellitus.

27 Jan 2010

Emisphere Technologies: Novo Nordisk initiates first Phase I clinical trial of GLP-1

Emisphere Technologies, Inc. today announced that Novo Nordisk has initiated its first Phase I clinical trial with a long-acting oral GLP-1 analogue (NN9924). This milestone releases a $2 million payment to Emisphere, whose proprietary Eligen® Technology is used in the formulation of NN9924.

13 Jan 2010

HGS reports commercialization of late-stage products for systemic lupus and chronic hepatitis C

Human Genome Sciences, Inc. today will announce its priority goals for 2010 and report on the Company’s increasing momentum toward commercialization of late-stage products for systemic lupus and chronic hepatitis C in a presentation by H. Thomas Watkins, President and Chief Executive Officer, to financial analysts and investors at the 28th Annual JPMorgan Healthcare Conference in San Francisco.

12 Jan 2010

Pharmaron Holdings acquires Bridge Laboratories China

Pharmaron Holdings Limited, today announced it completed the acquisition of Bridge Laboratories China. Bridge Laboratories China is the leading contract research organization (CRO) in China providing western standard GLP-compliant toxicology services to pharmaceutical and biotech companies from around the world. With this acquisition, Pharmaron becomes the first integrated CRO in China supporting clients with drug discovery and development processes in support of IND filings. This strategic acquisition strengthens Pharmaron's leading position in the fast-growing, highly dynamic pharmaceutical CRO industry.

12 Jan 2010

LAB Research completes research and development program that involves pulmonary monitoring system

LAB Research Inc. ("LAB" or "LAB Research"),a Canadian-based global non-clinical contract research organization, today announced that it recently completed a research and development program that involves real time quantitative pulmonary monitoring of non-human primates using wireless telemetry technology.

8 Jan 2010

Liraglutide FDA feedback expected within weeks, says Novo Nordisk

Novo Nordisk today announced that formal feedback from the United States Food and Drug Administration (FDA) regarding liraglutide, a once-daily human GLP-1 analogue, is expected within weeks.

30 Dec 2009

CSC completes a Series B financing round

California Stem Cell, Inc. (CSC), a leading stem cell company, announced that it has completed a Series B financing round with private investors. The financing will enable the company to support the advancement of its therapeutic products to human clinical trials, as well as the generation and distribution of its tools to aid in stem cell research and drug discovery.

21 Dec 2009

KVCI completes acquisition of former AAIPharma bioanalytical division

Kansas Venture Capital, Inc. (KVCI) has acquired the former AAIPharma bioanalytical division from ZeeCRO Inc. With its 30-year track record of developing entrepreneurial companies, KVCI will grow the bioanalytical business through organic and acquisition strategies to provide best-in-class analytical services for both the pharmaceutical and life sciences sectors.

18 Dec 2009

STERIPLEX HC kills MRSA and other pathogens in record time

STERIPLEX® Health Care (HC) is a new Sterilant/Sporicide, Tuberculocide, and Bactericide, which has recently received Federal EPA Registration. STERIPLEX® HC sets new standards, killing MRSA, spores and other pathogens in a fraction of the time of competing products while remaining safe to people and the environment.

18 Dec 2009

Ocimum Biosolutions ranked 42nd on the Deloitte Technology Fast 500 Asia Pacific 2009

Ocimum Biosolutions, a leading integrated genomics company, today announced that it ranked 42nd on the Deloitte Technology Fast 500 Asia Pacific 2009, a ranking of the 500 fastest growing technology companies in Asia Pacific. Rankings are based on percentage revenue growth over three years. In addition to ranking on Deloitte’s Technology Fast 500, Ocimum ranked fourth on the Technology Fast 50 India Program, which is a ranking of the 50 fastest growing technology firms in India.

18 Dec 2009

Physicians favor agents that can reduce HbA1c levels by 2% in diabetes patients

Decision Resources, one of the world's leading research and advisory firms focusing on pharmaceutical and healthcare issues, finds that over 70 percent of surveyed U.S. physicians indicate there is a high need for diabetes drugs with novel mechanisms of action versus 15 percent who say there is a high need for additional DPP-IV inhibitors.

18 Dec 2009