DIA Biosimilars 2013

Amylin Pharmaceuticals

Aptuit names Maurizio Denaro general manager

Friday, July 26, 2013 03:10 PM

Global pharmaceutical company Aptuit has appointed Dr. Maurizio Denaro general manager of The Aptuit Center for Discovery & Development in Verona, Italy.

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Cenduit: Now with Patient Reminders

BMS acquires Amylin Pharmaceuticals, expands diabetes alliance with AstraZeneca

Monday, July 2, 2012 09:59 AM

Global biopharmaceutical company Bristol-Myers Squibb (BMS) has agreed to acquire Amylin Pharmaceuticals of San Diego for $31.00 per share in cash, pursuant to a cash tender offer and second step merger, or an aggregate purchase price of approximately $5.3 billion.

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CRF Health – eCOA Forum

Burrill wraps up life sciences industry for Q1 2012

Wednesday, April 4, 2012 03:00 PM

Burrill & Company, a diversified global financial services firm focused on the life sciences industry, has identified more than $2.6 billion in expected funding through nine translational research and early-stage initiatives announced since the end of February.

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Europe approves Byetta with basal insulin for T2D

Monday, March 26, 2012 02:47 PM

The European Commission has granted Amylin Pharmaceuticals and Eli Lilly marketing authorization for Byetta (exenatide twice-daily) as an adjunctive therapy to basal insulin for the treatment of type 2 diabetes (T2D).

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FDA approves once-weekly treatment for type 2 diabetes

Monday, January 30, 2012 02:35 PM

The FDA has approved Bydureon (extended-release exenatide), the first once-weekly treatment for type 2 diabetes, developed by Amylin Pharmaceuticals and Alkermes.

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FDA reviews BYDUREON, type 2 diabetes medication

Friday, August 12, 2011 02:48 PM

Amylin Pharmaceuticals, Eli Lilly, and Alkermes have reported that the FDA has acknowledged the companies’ BYDUREON (exenatide extended-release for injectable suspension) resubmission. The FDA has categorized it as a class II resubmission requiring up to six months for review and assigned a new Prescription Drug User Fee Act (PDUFA) action date of January 28, 2012. BYDUREON is an investigational medication for type 2 diabetes.

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Elan cuts 104 jobs

Friday, July 15, 2011 10:13 AM

Following the recent decision to sell its drug manufacturing unit to Alkermes for $960 million, Elan is eliminating 104 jobs from a Pennsylvania facility that is part of the deal, according to a notice filed with the Pennsylvania Department of Labor.

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Study results support BYDUREON’s NDA

Friday, July 8, 2011 12:21 PM

Amylin Pharmaceuticals, Eli Lilly and Alkermes announced results from QT (tQT) study of exenatide to increase the QT interval across a wide range of plasma concentrations. The study was conducted to satisfy a requirement by the FDA in support of the New Drug Application (NDA) for BYDUREON (exenatide extended-release for injectable suspension), an investigational medication for type 2 diabetes.

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Juvenile Diabetes Research Foundation and Amylin to collaborate for diabetes trials

Tuesday, May 10, 2011 11:56 AM

The Juvenile Diabetes Research Foundation (JDRF) and Amylin Pharmaceuticals will enter into a research collaboration agreement to provide financial support for a series of clinical studies to investigate the feasibility of mixing pramlintide, an analog of the human hormone amylin, with insulin to treat type I diabetes.

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Amylin’s metreleptin shows improvement in patients with lipodystrophy

Friday, April 15, 2011 12:38 PM

Amylin Pharmaceuticals reports results from an analysis of an ongoing, long-term research study of the investigational drug metreleptin, an analog of the human hormone leptin, for the treatment of lipodystrophy.  The study is being conducted by investigators from the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) at the National Institutes of Health (NIH).

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September 30

Novartis-Walgreens pilot study blurring the line between retail pharmacy, investigative site

CISCRP to launch traveling science museum exhibit to demystify clinical trial participation

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The CenterWatch Monthly

October

New growth and decline in Asia clinical trials
South Korea, Japan, China see big growth in 1572s, while India posts huge drop

Harnessing Big Data to transform clinical trials
From protocol to patient recruiting, data analytics can yield valuable insights

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September

Sponsors look to collaborate on comparator drugs
Co-therapies, comparators are in 60% of studies, cost $25m per company a year

Early adopters implement risk-based monitoring pilot programs
Experiments aim to offer long-term solutions, despite short-term uncertainties

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