AiCure

Pfizer

Merck, Pfizer ink alliance on anti-PD-L1

Monday, November 17, 2014 02:28 PM

Merck has entered into a global agreement with Pfizer to co-develop and co-commercialize MSB0010718C, an investigational anti-PD-L1 antibody currently in development by Merck as a potential treatment for multiple tumor types to accelerate the two companies’ presence in immuno-oncology.

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Spark Therapeutics receives FDA Breakthrough Therapy designation for SPK-RPE65

Friday, November 7, 2014 01:29 PM

Spark Therapeutics, a late-stage gene therapy company developing treatments for debilitating genetic diseases, has announced that its lead product candidate, SPK-RPE65, has received Breakthrough Therapy designation from the FDA. Breakthrough Therapy designation is intended to expedite the development and review of investigational therapies for serious or life-threatening conditions where initial clinical evidence demonstrates a significant improvement over existing therapies. SPK-RPE65 targets a group of blinding conditions known as inherited retinal dystrophies (IRDs) caused by autosomal recessive mutations in the RPE65 gene, and for which there currently is no pharmacologic treatment available.

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Lexicon expands management

Thursday, November 6, 2014 03:13 PM

Lexicon Pharmaceuticals has announced management additions directed toward the completion of phase III development and commercial preparations for telotristat etiprate in carcinoid syndrome and preparation for phase III initiation and commercial readiness for sotagliflozin (LX4211) in type 1 diabetes.

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Cancer Innovation Coalition calls for reinvigorated U.S. cancer innovation

Friday, October 31, 2014 02:10 PM

The Cancer Innovation Coalition (CIC) has gone to Capitol Hill to call for early legislative and regulatory action in 2015 that will reinvigorate cancer innovation in the U.S.

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Cancer Innovation forum calls for improving cancer research ecosystem

Monday, October 27, 2014 12:58 PM

Accelerating the delivery of promising new cancer treatments depends on one critical requirement—ensuring patients are actively involved in the cancer research and drug development process from beginning to end.

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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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CWWeekly

November 17

PPD, Medidata join their technologies for risk-based monitoring, adaptive trial design

ERT acquires eClinical Insights in "strategic combination" to gain cloud-based trial software platform, expertise

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The CenterWatch Monthly

November

Private equity driving dynamic CRO growth
Enables CROs to pursue long-term strategies, while giving the space credibility

Baby boomers poised to reshape clinical trials industry
Millions of tech-savvy consumers already track their health, expect new treatments as they age

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The CenterWatch Monthly

October

CROs driving changes in patient recruitment
Data- and tech-aided enrollment services a competitive advantage

Trials with in-home nurses poised to grow
Higher expense, but may improve recruitment and retention for select trials

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