Theorem Clinical Research

Amylin Pharmaceuticals

FDA approves Myalept to treat rare metabolic disease

Wednesday, February 26, 2014 11:42 AM

The FDA has approved Myalept (metreleptin for injection) as replacement therapy to treat the complications of leptin deficiency, in addition to diet, in patients with congenital generalized or acquired generalized lipodystrophy. 

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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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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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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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September 2

Roche's $8.3B InterMune buy continues its buying spree with 'bolt-on' deal, fueling record M&A activity

FDA action plan seeks to close gap in women and minority patient representation in clinical trials

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August

Reality of costs and impact rain on Sunshine Act
Concerns mount over compliance burden on CROs, sponsors, unanticipated consequences for research

Cloud computing expanding into all areas of clinical trial conduct
Benefits outweigh the complexities, challenges of finding right vendors

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July

IRB market consolidating rapidly
Private equity driving a new commercial ethical review landscape

Lessons learned from medical device trials
Smaller, faster, more flexible trials hold important insights for pharmaceutical innovation

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