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ACM Global Central Laboratory celebrates landmark anniversary

ACM Global Central Laboratory, the global central lab that continually defines the customer-service standard with its flexible approach, is this week celebrating its 10th anniversary of providing central laboratory services throughout Europe.

2 Nov 2009

NOXXON Pharma commences human dosing in Spiegelmer NOX-A12 clinical trial

NOXXON Pharma AG, the biopharmaceutical company focusing on the development of novel drugs based on its unique proprietary Spiegelmer® technology, announced today the successful initial dosing of healthy volunteers in a first-in-human clinical trial with Spiegelmer® NOX-A12. NOX-A12 is NOXXON’s second drug candidate entering the clinical stage of development within only five months.

2 Nov 2009

Aflex Hose launches the Corroline hose for transferring process fluids in pharmaceutical plants

Aflex Hose Ltd has today unveiled Corroline, a revolutionary flexible hose developed to stand up to the toughest chemical and process applications.

2 Nov 2009

Eli Lilly selects ICON to provide clinical data management outside the US

ICON plc, a global provider of outsourced development services to the pharmaceutical, biotechnology and medical device industries, today announced that it has signed an extension to its strategic agreement with Eli Lilly and Company (NYSE:LLY) to manage the company’s clinical data management outside the US.

2 Nov 2009

Vertex Pharmaceuticals announces study results of telaprevir-based regimen

More than 80 percent of hepatitis C patients in each arm of the Phase 2 Study C208 achieved a sustained viral response (SVR) with a telaprevir-based regimen according to results of an intent-to-treat (ITT) analysis announced today by Vertex Pharmaceuticals Incorporated.

2 Nov 2009

Optimer Pharmaceuticals presents additional data from Phase 3 fidaxomicin study

Optimer Pharmaceuticals, Inc. today announced the presentation of new data from fidaxomicin's North American phase 3 study at the 47th Annual Meeting of the Infectious Diseases Society of America (IDSA) in Philadelphia, PA.

2 Nov 2009

Sosei and ASKA Pharmaceuticals sign distribution agreement

Sosei Group Corporation ("Sosei"; TSE Mothers Index: 4565), the biopharmaceutical company, today announced that Sosei Co., Ltd., its wholly owned Japanese subsidiary, has entered into a definitive distribution agreement with ASKA Pharmaceuticals Co., Ltd. ("ASKA", TSE First Section Index: 4514) for the commercialisation of the emergency contraceptive pill SOH-075 (NorLevo(R)).

2 Nov 2009

Amylin and Takeda to develop and commercialize pharmaceutical products for obesity

Amylin Pharmaceuticals, Inc. (Nasdaq: AMLN) and Takeda Pharmaceutical Company Limited (TSE: 4502) announced today that they have entered into a worldwide exclusive license, development and commercialization agreement to co-develop and commercialize pharmaceutical products for the treatment of obesity and related indications.

2 Nov 2009

London Genetics enters an intensive partnering programme

London Genetics Limited, an expert in the use of pharmacogenetics in clinical drug discovery and development, has entered an intensive partnering programme following on from its successful pharmacogenetic conference in September.

31 Oct 2009

Shire to present key data on ADHD treatments at national psychiatric meeting

Shire plc, the global specialty biopharmaceutical company, announced today that it will present key scientific data on its Attention-Deficit/Hyperactivity Disorder (ADHD) treatments, INTUNIV- (guanfacine) Extended Release Tablets, Vyvanse- (lisdexamfetamine dimesylate) Capsules CII, and Daytrana- (methylphenidate transdermal system) CII, at a national meeting of psychiatrists to be held October 27 - November 1 in Honolulu.

31 Oct 2009

Performance-focused metrics supporting forward-looking decision making critical for drug companies

Top Performing Drug Developers Are Merging Operational And Strategic Objectives, According To Tufts Center For The Study Of Drug Development

31 Oct 2009

Shire announces Phase IIIb study results of Daytrana

Shire plc, the global specialty biopharmaceutical company, today announced findings at a major medical meeting from a Phase IIIb study of the tolerability and effectiveness of Daytrana® (methylphenidate transdermal system) in adolescents aged 13 to 17 years diagnosed with Attention-Deficit/Hyperactivity Disorder (ADHD).

31 Oct 2009

New study results of INTUNIV presented at a major psychiatric medical meeting

Shire plc, the global specialty biopharmaceutical company, announced new study results on INTUNIV- (guanfacine) Extended Release Tablets, at a major psychiatric medical meeting today.

31 Oct 2009

Shire announces third quarter 2009 financial results

Shire plc, the global specialty biopharmaceutical company, announces results for the three months to September 30, 2009.

31 Oct 2009

Quintiles and Eisai partner to develop potential oncology products

Quintiles today announced a strategic alliance with leading global pharmaceutical company Eisai Co., Ltd. (Tokyo, Japan) to develop six potential oncology products in Eisai’s R&D pipeline. Under the terms of the agreement, Quintiles’ oncology experts will conduct Phase II proof-of-concept studies for 11 solid tumor indications. A key goal of the alliance is to determine the efficacy of the products in the shortest possible time in order to bring therapies to market faster for the benefit of cancer patients worldwide.

31 Oct 2009

Revised standards for four ingredients widely used in prescription and over-the-counter drugs announced

To further protect patients from adulterated medicines, the U.S. Pharmacopeial Convention (USP) today announced revised standards for four ingredients widely used in prescription and over-the-counter drugs.

31 Oct 2009

NovaBay Pharmaceuticals' Aganocide compounds demonstrate potent antifungal activity against onychomycosis

NovaBay Pharmaceuticals, Inc. today announced that its Aganocide® compounds demonstrate potent antifungal activity in an established pre-clinical infected nail model of onychomycosis. The study data will be presented tomorrow at the 47th Annual Meeting of the Infectious Diseases Society of America (IDSA) in Philadelphia.

31 Oct 2009

FDA approves Covidien's Abbreviated New Drug Application for CII

Covidien, a leading global provider of healthcare products, today announced that its subsidiary, Mallinckrodt Inc., has received U.S. Food and Drug Administration (FDA) approval of its Abbreviated New Drug Application (ANDA) for Oral Transmucosal Fentanyl Citrate (CII).

31 Oct 2009

FDA approves an expanded indication for BYETTA injection

Amylin Pharmaceuticals, Inc., and Eli Lilly and Company (NYSE: LLY) today announced that the U.S. Food and Drug Administration (FDA) has approved an expanded indication for BYETTA® (exenatide) injection. BYETTA is now approved for use as a stand-alone medication (monotherapy) along with diet and exercise to improve glycemic control in adults with type 2 diabetes.

31 Oct 2009

Data from multiple clinical and preclinical studies evaluating Hematide announced

Affymax, Inc. and Takeda Pharmaceutical Global Research & Development Center, Inc., today announced data from multiple clinical and preclinical studies evaluating Hematide, including preliminary results of a Phase 2 trial which demonstrated that Hematide increased hemoglobin levels in a group of anemic hemodialysis (HD) patients.

31 Oct 2009