Theorem Clinical Research

Pfizer

Treasury’s tax inversion changes scuttle some big biopharma mergers, modify others, prompting calls for Congressional corporate tax reform

Thursday, October 23, 2014 03:50 PM

The widely-discussed $54.6 billion acquisition of Dublin-based Shire by AbbVie is officially canceled, having crumbled after a notice by the U.S. Treasury Department to tighten tax rules that deter U.S. companies from moving their legal headquarters to countries with lower business taxes.

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Inversion rule change prompts AbbVie to halt Shire takeover

Thursday, October 16, 2014 02:21 PM

In what could have been a major pharmaceutical acquisition and one of the biggest tax inversion deals, Chicago-based AbbVie has recommended its shareholders vote against its proposed $54 billion takeover of Shire, a Dublin-headquartered pharmaceutical company specializing in medications to treat attention deficit disorder and rare diseases

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Synthetic Biologics fills irritable bowel syndrome Clinical Advisory Board

Thursday, October 16, 2014 12:29 PM

Synthetic Biologics, a biotechnology company developing novel anti-infective biologics and drugs targeting specific pathogens that cause serious infections and diseases, has expanded its Clinical Advisory Board (CAB) created to support development of SYN-010, the company's statin-class candidate intended to reduce the impact of methane producing organisms on constipation-predominant irritable bowel syndrome (C-IBS).

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Accenture launches Cloud for R&D, forms Cloud Coalition

Wednesday, October 15, 2014 01:19 PM

Accenture, an Ireland-based global management consulting, technology services and outsourcing company, has launched Accenture Life Sciences Cloud for R&D, which speeds clinical development, helps improve patient outcomes and creates greater R&D efficiency through a new single analytics platform that brings together multiple internal and external data sources across clinical, safety, regulatory and operational functions.

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PPD acquires X-Chem

Tuesday, October 7, 2014 10:30 AM

Pharmaceutical Product Development (PPD), a Wilmington, N.C.-based CRO, has exercised its option to acquire the remaining minority ownership interest of X-Chem. X-Chem, a biotechnology company based in Waltham, Mass., will continue to operate as a biotechnology company with its entire existing staff, including its management team led by CEO and founder Richard W. Wagner, Ph.D., along with executive management team members Diala Ezzeddine, Ph.D., chief business officer; Matthew Clark, Ph.D., sr. vice president of research; and Lee Babiss as chairman of the board.

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Mast Therapeutics appoints Edwin L. Parsley chief medical officer

Thursday, October 2, 2014 01:21 PM

Mast Therapeutics, a clinical-stage biopharmaceutical company, has announced that Edwin L. Parsley, D.O., has joined the company as its chief medical officer and senior vice president.

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Pfizer, Kyowa Hakko Kirin collaborate on immuno-oncology combination study

Wednesday, October 1, 2014 01:07 PM

Pfizer and Tokyo-based Kyowa Hakko Kirin have entered into an agreement to explore the therapeutic potential of the combination of Pfizer’s PF-05082566, an investigational, fully humanized monoclonal antibody (mAb) that stimulates signaling through 4-1BB (CD-137), a protein involved in regulation of immune cell activation, proliferation and survival, with Kyowa Hakko Kirin’s anti-CCR4 antibody mogamulizumab, which suppresses some of the immune cells that shield the tumor from the immune system, in a phase Ib clinical study evaluating the safety and tolerability of the combination in patients with solid tumors.

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Thermo Fisher Scientific inks agreement with GlaxoSmithKline, Pfizer

Friday, September 26, 2014 03:01 PM

Thermo Fisher Scientific, a Waltham, Mass.-based healthcare equipment company, has inked an agreement with GlaxoSmithKline and Pfizer to develop a universal next-generation sequencing (NGS) oncology test for solid tumors that will serve as a companion diagnostic for multiple drug programs.

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AAHRPP accredits two organizations in U.S., one in Mexico

Friday, September 19, 2014 01:28 PM

The nonprofit Association for the Accreditation of Human Research Protection Programs (AAHRPP) has accredited three more organizations, including two independent institutional review boards in Massachusetts and a second organization in Mexico.

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MedGenesis, Pfizer ink agreement for Parkinson's disease

Wednesday, September 17, 2014 02:13 PM

MedGenesis Therapeutix, a Canada-based, privately held biotechnology company focused on the development and precision delivery of definitive treatments for neurologic diseases, has entered into an agreement with Pfizer, granting Pfizer an exclusive, worldwide option to license its glial cell line-derived neurotrophic factor (GDNF) protein and convection enhanced delivery (CED) technology to be used in research for potential treatments for Parkinson's disease.

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October 20

Toronto Star, with FDA data, exposes weaknesses in Health Canada's clinical trial, inspection oversight

Crowdsourcing effort aims to fund updated online social media guide for sponsor interaction with patients

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The CenterWatch Monthly

September

Today's fastest, most economical sponsors
Standout sponsors reveal how they shorten regulatory, clinical cycle times

From the trenches: Sites' eye view of state of the industry
CW’s first site focus groups uncover frustration with 'progress,' but a passion for their mission

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The CenterWatch Monthly

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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