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08/05/08  Amylin Initiates Phase 2B Dose-Ranging Clinical Study of Pramlintide/Metreleptin

SAN DIEGO, May 5 /PRNewswire-FirstCall/ -- Amylin Pharmaceuticals, Inc. today announced the initiation of a Phase 2B clinical study evaluating various dosing combinations of pramlintide, an analog of the natural hormone amylin, and recombinant human leptin (r-metHuLeptin; metreleptin) for the treatment of obesity. The objective of this dose-ranging study is to support dose selection for Phase 3, and to inform the ongoing development of a convenient delivery system for this combination regimen. The six-month, randomized, double-blind, placebo-controlled multi-center study will enroll approximately 600 overweight and obese subjects and is expected to complete in mid-2009.

01/05/08  Merck Serono and ZymoGenetics Initiate Atacicept Phase 2 Trial

SEATTLE--(BUSINESS WIRE)--April 30, 2008 - ZymoGenetics, Inc. (NASDAQ:ZGEN), today announced that its development partner Merck Serono, a division of Merck KGaA, Darmstadt, Germany, has initiated a Phase 2 clinical trial to evaluate the safety and efficacy of atacicept in patients with relapsing multiple sclerosis (RMS).

01/05/08  Insmed Provides Update on Follow-On Biologics and IPLEX Programs

RICHMOND, Va., April 29, 2008 /PRNewswire-FirstCall/ -- Insmed Inc. , a developer of follow-on biologics (FOBs) and biopharmaceuticals, today provided an update of the status of its initial FOB development candidates, INS-19 (a FOB of Neupogen(R)) and INS-20 (a FOB of Neulasta(R)) which represent combined 2007 sales of over $4 billion. The Company also reported recent progress made with its IPLEX(TM) development program.

29/04/08  Synexus(R) Achieves Record With More Than 10,000 Patients Enrolled In Clinical Studies

Synexus® has achieved a new record for an organisation, which recruits and runs clinical trials, with more than 10,000 patients currently enrolled in late stage clinical trials at 14 hub sites in six countries.

Synexus® has found that its hub site model is increasingly being taken up by the pharma industry as it dramatically reduces costs - often by a factor of 10 - increases the quality of the data and speeds up recruitment.

29/04/08  Two Merck Medicines Recommended For Approval In The European Union

Merck & Co., Inc. announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has recommended two medicines for marketing approval in the European Union (EU).

The CHMP recommended marketing approval for TREDAPTIVE™ (nicotinic acid/ laropiprant, MSD) 1000 mg/20 mg tablets for patients with dyslipidemia or primary hypercholesterolemia. Separately, the U.S. Food and Drug Administration (FDA) is currently reviewing the combination of extended release (ER) niacin and laropiprant under the trademark CORDAPTIVE™ (ER niacin/laropiprant). The CHMP recommendation does not apply to regulatory decisions by the FDA and no inferences should be made about pending FDA regulatory actions based on the recommendation of the CHMP.

18/01/08  Synta Pharmaceuticals Initiates Second Phase 1 Clinical Trial of STA-9090

LEXINGTON, Mass.--(BUSINESS WIRE)--Jan 17, 2008 - Synta Pharmaceuticals Corp. (NASDAQ: SNTA), a biopharmaceutical company focused on discovering, developing, and commercializing small molecule drugs to treat severe medical conditions, today announced that it has initiated a second Phase 1 clinical study of its novel heat shock protein 90 (Hsp90) inhibitor, STA-9090, with a once-a-week dosing schedule. In November, Synta announced the start of a Phase I clinical study of STA-9090 with a twice-a-week dosing schedule. STA-9090 is a synthetic, small molecule Hsp90 inhibitor with a novel chemical structure that is unrelated to the Hsp90 inhibitor geldanamycin or its family of related compounds, such as 17-AAG.

07/01/08  Morphotek Announces Initiation of MORAb-009 Phase II Study in Treatment of Pancreatic Cancer

EXTON, Pa.--(BUSINESS WIRE)--Jan 7, 2008 - Morphotek(R), Inc., a subsidiary of Eisai Co., Ltd., today announced that it has commenced a multi-centered Phase II study of its MORAb-009 monoclonal antibody. The study will evaluate MORAb-009, plus the chemotherapy drug gemcitabine, as a first line treatment for patients with pancreatic cancer. The randomized, controlled, double-blinded trial will compare MORAb-009 plus gemcitabine with a placebo plus gemcitabine.

07/01/08  Infinity and MedImmune Initiate Phase 1b Trial of IPI-504

Infinity Pharmaceuticals, Inc. (Nasdaq:INFI) and MedImmune announced that they have initiated a Phase 1b clinical trial of IPI-504 in combination with Taxotere(r) (docetaxel) in patients with advanced solid tumors. IPI-504, the companies' lead heat shock protein 90 (Hsp90) inhibitor, is currently in clinical development for a number of solid tumor cancers. Enrollment for this new study has commenced at Memorial Sloan-Kettering Cancer Center in New York, N.Y., with additional sites expected to be added as the study progresses.

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