Theorem Clinical Research

WuXi PharmaTech

FDA approves WuXi’s manufacture of ibalizumab in China for use under a U.S. IND

Wednesday, May 7, 2014 01:32 PM

The FDA has approved the first batch of the ibalizumab (TMB-355) drug substance and sterile drug product, manufactured at WuXi PharmaTech's biologics facilities and developed by TaiMed Biologics for the treatment of HIV/AIDS infection. 

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WuXi PharmaTech invests in TruTag security platform for drug safety

Monday, April 7, 2014 12:36 PM

CRO WuXi PharmaTech, with operations in China and the U.S., and TruTag Technologies, developer of an edible, covert security platform to address the global product counterfeiting challenge, have announced that WuXi Corporate Venture Fund has made an investment in TruTag.

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WuXi PharmaTech, Pharmacyclics to partner

Monday, November 18, 2013 01:48 PM

CRO WuXi PharmaTech, with operations in China and the U.S., said its subsidiary Shanghai SynTheAll (STA) Pharmaceutical has entered into a supply arrangement with Pharmacyclics. This follows a successful multiple-year development and clinical manufacturing partnership that supported Pharmacyclics with an expedited NDA submission and final approval by the FDA of Imbruvica  on Nov. 13, for treatment of patients with mantle cell lymphoma who have received at least one prior therapy.  This indication is based on overall response rate. An improvement in survival or disease-related symptoms has not been established. 

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WuXi’s genomics clinical laboratory receives CLIA certification

Monday, October 21, 2013 01:32 PM

CRO WuXi PharmaTech, with operations in China and the U.S., said its genomics clinical laboratory in Shanghai has successfully passed the survey by the Centers for Medicare and Medicaid Services of the U.S. Department of Health and Human Services relating to CLIA (Clinical Laboratory Improvement Amendments) standards, thereby receiving CLIA certification. WuXi's laboratory is the only CLIA-certified clinical laboratory in China.

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The CenterWatch Monthly, August 2013

Friday, August 2, 2013 10:36 AM

Will end-to-end outsourcing take hold?

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Ambrx, Zhejiang Medicine, WuXi PharmaTech collaborate

Tuesday, June 18, 2013 09:32 AM

Ambrx, a clinical stage biopharmaceutical company, and China-based pharmaceutical Zhejiang Medicine (ZMC) are collaborating to develop and commercialize ARX788, Ambrx’s internally developed, site-specific antibody drug conjugate (ADC) targeting Her2-positive breast cancer.

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WuXi PharmaTech, PRA form joint venture for Chinese market

Thursday, December 20, 2012 10:32 AM

CRO WuXi PharmaTech, with operations in China and the U.S., and CRO PRA have signed a joint venture agreement to offer a broad platform of phase I-IV clinical trial services in China, Hong Kong and Macau, including clinical trial monitoring, project management, regulatory strategy and submissions, data management, biostatistics, drug safety reporting and medical monitoring.

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Drug discovery services market to reach $16.6B in 2015

Monday, December 10, 2012 10:09 AM

A new report by visiongain, an independent media company based in London, predicts that the world market for drug discovery outsourcing will reach $16.6 billion in 2015. That revenue forecast and others appear in “DrugDiscovery Outsourcing: World Market 2013-2023,” published in November 2012.

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WuXi AppTec opens first cGMP biologics facility in China

Monday, October 22, 2012 11:11 AM

WuXi AppTec, a pharmaceutical, biotechnology and medical device R&D outsourcing company, has opened a cGMP biologics facility in China.

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MedImmune, WuXi AppTec form joint venture to develop novel biologic for Chinese market

Monday, September 10, 2012 10:31 AM

MedImmune, the global biologics arm of AstraZeneca, and WuXi AppTec, an R&D outsourcing company, have formed a joint venture to develop and commercialize MEDI5117, a novel biologic for autoimmune and inflammatory diseases, in China.

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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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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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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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