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IDC grants MedImmune global rights to GLA adjuvant

Immune Design Corp. (IDC), a privately held biotechnology company developing novel vaccines and immunotherapies for infectious disease and cancer, announced today that it has entered into a license and development agreement with MedImmune for the use and commercialization of IDC’s proprietary Glucopyranosyl Lipid Adjuvant (GLA) as a component in vaccines for select infectious diseases.

26 Oct 2010

Repros commences randomization in Androxal Phase II study in T2DM men with low testosterone

Repros Therapeutics Inc. today announced it has commenced randomization of subjects into its Phase II Androxal® study in the treatment of type 2 diabetes (T2DM) in men with low testosterone. Low testosterone and T2DM are co-morbid conditions in a significant number of men. The study is being conducted at nine sites across the US including both academic and private practices and will enroll up to 150 patients.

25 Oct 2010

Positive results from Alkermes combination Phase 1 study of ALKS 33 and buprenorphine for cocaine addiction

Alkermes, Inc. today announced positive topline results from a phase 1 clinical study of an investigational combination of ALKS 33, one of Alkermes' proprietary candidates, and buprenorphine, an existing medication for the treatment of opioid addiction, for the treatment of cocaine addiction.

25 Oct 2010

New review outlines Bionovo's platform of estrogen receptor modulators for menopausal conditions

Bionovo, Inc. today announced the publication of a review of results from studies discussing new classes of estrogen receptor modulating drugs with distinct mechanism for pharmacological effect. The review is published in the most recent edition of Current Opinion in Pharmacology.

22 Oct 2010

FDA asks manufacturers to add new warnings to labeling of prostate cancer drugs

The U.S. Food and Drug Administration today asked manufacturers to add new warnings to labeling of gonadotropin-releasing hormone (GnRH) agonists, a class of drugs primarily used to treat men with prostate cancer.

21 Oct 2010

Metabolon receives patent for biomarkers to determine PPAR-affecting drugs

Metabolon, Inc., leaders in global metabolomics, biomarker discovery and biochemical analysis, announced today the grant of US Patent 7,807,138 entitled "Biomarkers of Metabolic Responses to Hepatic Drugs". The USPTO awarded the patent to Metabolon on October 5, 2010. This is the 13th patent issued to Metabolon and the second in its portfolio of biomarker patents.

21 Oct 2010

FDA issues complete response letter for BYDUREON NDA

Amylin Pharmaceuticals, Inc., Eli Lilly and Company and Alkermes, Inc. today announced that the U.S. Food and Drug Administration (FDA) has issued a complete response letter regarding the New Drug Application (NDA) for BYDUREON™ (exenatide extended-release for injectable suspension).

21 Oct 2010

Pearl announces $69 million Series C financing round

Pearl Therapeutics Inc., a privately held company developing clinically differentiated combination therapies for the treatment of highly prevalent chronic respiratory diseases, including chronic obstructive pulmonary disease (COPD), today announced a $69 million Series C financing. The financing round was led by Vatera Healthcare Partners and included existing investors, Clarus Ventures, New Leaf Venture Partners and 5AM Ventures.

20 Oct 2010

Nektar presents data of NKTR-181 mu-opioid analgesic candidate at Pain 2010 Symposium

Nektar Therapeutics presented promising data today from preclinical studies of NKTR-181, a next-generation mu-opioid analgesic candidate with a novel molecular design. NKTR-181 is being developed to effectively treat pain while addressing the abuse liability and serious side effects associated with traditional opioid therapies.

18 Oct 2010

Preliminary Phase 2 data of TZP-102 for diabetic gastroparesis to be presented at ACG annual meeting

Tranzyme Pharma announced today that John Wo, MD, Professor of Medicine and Director, Clinical Research, Division of Gastroenterology, Hepatology and Nutrition, University of Louisville, Louisville, KY, will present preliminary TZP-102 Phase 2 data at this year's ACG annual meeting. The event is being held at the Henry B. Gonzalez Convention Center in San Antonio TX, October 15-20, 2010. Professor Wo is scheduled to speak on Wednesday, October 20th at 8:50am in Ballroom C1.

18 Oct 2010

Omeros receives additional NIDA grant for clinical studies in Addiction program

Omeros Corporation today announced that the National Institute on Drug Abuse (NIDA) has provided an additional grant to fund clinical studies for the Company's Addiction program. This grant, which is for a total of approximately $3.6 million to be paid over a four-year period in equal amounts, will fund direct and indirect costs of Phase 2 clinical studies to be conducted by researchers at the New York State Psychiatric Institute.

14 Oct 2010

Exelixis enters two new collaboration agreements with Bristol-Myers Squibb

Exelixis, Inc. announced today that it has entered into two new collaboration agreements with Bristol-Myers Squibb Company. Under the first agreement, Exelixis will grant to Bristol-Myers Squibb an exclusive license to its small-molecule TGR5 agonist program including backups.

11 Oct 2010

VentiRx announces VTX-1463 trial results for allergic rhinitis treatment

VentiRx Pharmaceuticals, Inc., a biopharmaceutical company focused on the development of novel Toll-Like Receptor 8 (TLR8) candidates for the treatment of cancer, respiratory and inflammatory diseases, announced today results from its randomized, placebo controlled clinical trial evaluating VTX-1463 for the treatment of allergic rhinitis.

8 Oct 2010

Affymax receives arbitration panel decision related to dispute against JNJ subsidiaries

Affymax, Inc. today announced that it has received a decision from the arbitration panel reviewing its dispute against certain subsidiaries of Johnson and Johnson (JNJ).

7 Oct 2010

Synergy reports positive results from plecanatide Phase IIa clinical trial for chronic constipation

Synergy Pharmaceuticals, Inc., a developer of new drugs to treat gastrointestinal disorders and diseases, announced today positive results in a Phase IIa clinical trial of plecanatide (SP-304) in patients with chronic constipation. Oral plecanatide given once daily, over 14 consecutive days, at doses of 0.3, 1.0, 3.0 and 9.0 mg gave improved bowel function in patients with chronic constipation.

6 Oct 2010

Neuraltus achieves last patient out for NP001, NP002 studies

Neuraltus Pharmaceuticals, a privately held biopharmaceutical company dedicated to developing and commercializing high-impact therapeutics that address critical unmet needs, primarily in the treatment of neurodegenerative diseases, announced today the Company has achieved last patient out in two studies: a Phase 1 clinical study of NP001 in patients with Amyotrophic Lateral Sclerosis (ALS, or Lou Gehrig's disease) and a Phase 1/2 clinical study of NP002 in patients with L-dopa-induced dyskinesias (muscle movement disorders).

5 Oct 2010

Celldex Therapeutics presents initial clinical data on CDX-1401 cancer vaccine candidate at iSBTc meeting

Celldex Therapeutics, Inc. today announced that the Company presented initial clinical data on CDX-1401 at the 25th Annual Meeting of the International Society of Biological Therapy of Cancer (iSBTc) in Washington, DC. CDX-1401 is a novel antibody-based targeted cancer vaccine candidate being evaluated as a treatment for patients with melanoma and other cancers that are known to express the tumor antigen NY-ESO-1.

5 Oct 2010

Australian reimbursement committee is set to consider Novo Nordisk's type 2 diabetes treatment

In its November meeting, the Pharmaceutical Benefits Advisory Committee (PBAC) will consider Novo Nordisk's second-to-market glucagon-like peptide-1 (GLP-1) agonist Victoza for reimbursement, which would be essential in order for the drug to compete effectively with Eli Lilly's Byetta. However, its chances of success are uncertain, considering that it took three years to get Byetta on the Pharmaceutical Benefits Scheme (PBS).

4 Oct 2010

Prix Galien USA committee honors life saving innovations

The Prix Galien USA committee honored innovations that are saving lives last night during the Prix Galien Awards Gala. The Pro Bono Humanum Award, the Prix Galien USA 2010 and the Prix Galien International were presented and related accomplishments celebrated.

30 Sep 2010

sanofi-aventis announces top-line results from lixisenatide Phase III GETGOAL-L-ASIA trial for Type-2 Diabetes

Zealand Pharma A/S, the biopharmaceutical company dedicated to the discovery and development of innovative peptide-based drugs, is pleased to note that its partner, sanofi-aventis, has today announced positive top-line results of the Phase III GETGOAL-L-ASIA trial which assessed the efficacy and safety of lixisenatide, a once-daily GLP-1 receptor agonist discovered by Zealand Pharma, in combination with basal insulin.

30 Sep 2010

Agonist News and Research

IDC grants MedImmune global rights to GLA adjuvant

Repros commences randomization in Androxal Phase II study in T2DM men with low testosterone

Positive results from Alkermes combination Phase 1 study of ALKS 33 and buprenorphine for cocaine addiction

New review outlines Bionovo's platform of estrogen receptor modulators for menopausal conditions

FDA asks manufacturers to add new warnings to labeling of prostate cancer drugs

Metabolon receives patent for biomarkers to determine PPAR-affecting drugs

FDA issues complete response letter for BYDUREON NDA

Pearl announces $69 million Series C financing round

Nektar presents data of NKTR-181 mu-opioid analgesic candidate at Pain 2010 Symposium

Preliminary Phase 2 data of TZP-102 for diabetic gastroparesis to be presented at ACG annual meeting

Omeros receives additional NIDA grant for clinical studies in Addiction program

Exelixis enters two new collaboration agreements with Bristol-Myers Squibb

VentiRx announces VTX-1463 trial results for allergic rhinitis treatment

Affymax receives arbitration panel decision related to dispute against JNJ subsidiaries

Synergy reports positive results from plecanatide Phase IIa clinical trial for chronic constipation

Neuraltus achieves last patient out for NP001, NP002 studies

Celldex Therapeutics presents initial clinical data on CDX-1401 cancer vaccine candidate at iSBTc meeting

Australian reimbursement committee is set to consider Novo Nordisk's type 2 diabetes treatment

Prix Galien USA committee honors life saving innovations

sanofi-aventis announces top-line results from lixisenatide Phase III GETGOAL-L-ASIA trial for Type-2 Diabetes

Bringing real-time analytics to downstream bioprocess monitoring

Designing fluidic architecture for scalable diagnostic platforms

Evaluating new approaches for rare disease genomics

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