Shire’s phase III VONVENDI study meets primary endpoint

Monday, December 5, 2016

Shire, a biotechnology company focused on serving individuals with rare diseases and other highly specialized conditions, has announced topline results from a phase III clinical trial of VONVENDI [von Willebrand factor (Recombinant)] to treat bleeds in elective surgical settings for adults with severe von Willebrand disease (VWD), the most common inherited bleeding disorder.

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bluebird bio hires Susanna High and Andrew Obenshain

Monday, December 5, 2016

bluebird bio, a clinical-stage company committed to developing potentially transformative gene therapies for severe genetic diseases and T cell-based immunotherapies for cancer, has announced two new appointments as part of the company’s ongoing preparation for commercial readiness. Susanna High was named chief operating officer and Andrew Obenshain was named senior vice president and head of Europe.

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Shire to establish rare disease innovation hub in Massachusetts

Wednesday, November 23, 2016

Shire will expand its operations in Cambridge, Massachusetts, establishing a rare disease innovation hub and increasing its footprint in the heart of Kendall Square. Shire and BioMed Realty have signed a lease for a 343,000-square-foot building at 500 Kendall Street. Shire’s lease begins in Q3, 2018, with occupancy anticipated for Q1, 2019.

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INC Research and CISCRP name C2 winner of Inspiring Hope Ideathon

Thursday, September 29, 2016

INC Research Holdings, a global phase I to IV CRO, together with the Center for Information and Study on Clinical Research Participation (CISCRP), a nonprofit organization dedicated to engaging the public and patients as partners in the clinical research process, has announced Team “C2: The Clinical Study Change Agent Collective” was chosen as the winner of the 2016 “Inspiring Hope” Ideathon.

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David Meek appointed Ipsen’s chief executive officer

Monday, July 11, 2016

The board of directors of Ipsen appointed David Meek as chief executive officer, effective July 18, 2016. On this date, Marc de Garidel will assume the role of non-executive chairman and will continue to serve the board of directors through his deep industry expertise. In addition, Marc de Garidel will advise Mayroy, the Ipsen controlling holding company.

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Shire’s retinopathy treatment fails phase II trial

Monday, July 4, 2016

Shire has announced that its phase II study evaluating an investigational protein replacement, SHP607, did not meet its primary endpoint of reducing the severity of retinopathy of prematurity (ROP), a rare eye condition. The study, however, demonstrated clinically relevant effects in secondary endpoints related to the development of severe bronchopulmonary dysplasia (BPD), a chronic lung disease, and severe intraventricular hemorrhage (IVH), a type of brain injury, both of which have lifelong negative implications for normal development. 

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Shire, Kamada announce FDA Emphysema treatment GLASSIA

Friday, June 17, 2016

Shire and Kamada, a plasma-derived protein therapeutics company focused on orphan indications, has announced that the FDA has approved an expanded label for GLASSIA [Alpha-1 Proteinase Inhibitor (Human)], marking the first treatment for adult patients with emphysema due to severe Alpha-1 Antitrypsin (AAT) Deficiency that can be self-infused at home after appropriate training.

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Baxalta, Shire merger approved by shareholders

Wednesday, June 1, 2016

Baxalta has announced the results of a vote on the proposals identified in the definitive proxy statement/prospectus, dated April 18, 2016, at a special meeting of shareholders relating to the proposed combination with Shire. Baxalta shareholders approved the definitive merger agreement with Shire, dated as of January 11, 2016, and the merger transaction, with approximately 76.9% of shares outstanding cast in favor of the proposal, which represents approximately 98.9% of the votes cast at the meeting.

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Welcoming procurement onto the team

Sunday, May 15, 2016

For decades, procurement professionals have been the Rodney Dangerfields of the pharmaceutical industry: they got no respect. Procurement held up projects, got bogged down in protracted budget and contract negotiations, and was a hassle.

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