Theorem Clinical Research

Asia

ScinoPharm, Sundia MediTech partner in China

Friday, August 9, 2013 12:59 PM

CROs ScinoPharm Changshu Pharmaceuticals and Sundia MediTech have collaborated to seek more opportunities for contract research and manufacturing services (CRAMS) in mainland China.

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Quest Diagnostics

Daiichi Sankyo extends Medidata use to China

Monday, August 5, 2013 11:53 AM

Japan-based pharmaceutical company Daiichi Sankyo is expanding its use of Medidata Solutions' cloud-based platform to support clinical trials conducted by its division in China, an investment expected to streamline trial activities, improve the efficiency of data capture and increase the productivity of site users and clinical monitors. Daiichi Sankyo will bring Medidata's applications for electronic data capture, clinical data management and randomization and trial supply management to its expanding clinical work in China.

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INC Research opens two offices in Japan

Tuesday, July 30, 2013 01:49 PM

Raleigh, N.C.-based INC Research, a therapeutically focused global CRO, has established INC Research Japan KK, with the opening of locations in Osaka and the Shinagawa ward in Tokyo. The new operations provide INC Research’s global drug development customers access to an increasingly significant market and further expand its presence in the Asia-Pacific region.

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Ascendancy Healthcare, Quintiles collaborate in China

Monday, July 29, 2013 01:30 PM

Ascendancy Healthcare, dedicated to the commercialization of therapeutic products to meet unmet medical needs in China and other high-growth Asian markets, has announced a multi-year collaboration with Quintiles, a provider of biopharmaceutical development and commercial outsourcing services.

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Soligenix, SciClone collaborate in personalized medicine

Monday, July 8, 2013 12:00 PM

Soligenix, a clinical stage biopharmaceutical company focused on developing products to treat inflammatory diseases and biodefense countermeasures where there is an unmet medical need, has announced a personalized medicine collaboration with SciClone Pharmaceuticals in the company's oral mucositis clinical program with SGX942. Soligenix will receive access to SciClone's oral mucositis clinical and regulatory data library in exchange for commercialization rights in China, including Hong Kong and Macau.

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Pfizer, GSK, Siemens and A*STAR form R&D consortium

Monday, June 24, 2013 03:13 PM

Pfizer Asia Pacific, GlaxoSmithKline and Siemens are founding members of the A*STAR R&D consortium program Innovative Processing of Specialties and Pharmaceuticals (iPSP). Launched by A*STAR's Institute of Chemical and Engineering Sciences (ICES), the consortium is a platform for pharmaceutical and specialty chemicals industry companies to address costs, regulatory compliance and responsiveness in production and processes to bring drugs to markets.

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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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BioClinica partners for cardiac safety study in China

Monday, June 17, 2013 01:48 PM
Summary not available

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Abbott initiates trial to evaluate Absorb BVS

Thursday, June 13, 2013 12:00 PM

Abbott has announced the initiation of the Absorb Japan randomized, controlled clinical trial to evaluate the Absorb Bioresorbable Vascular Scaffold (BVS) in patients with coronary artery disease (CAD), the most common form of heart disease. The results of this trial will support regulatory filings with the Japanese Pharmaceutical and Medical Devices Agency (PMDA) for approval of Absorb BVS in Japan.

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Sinovac files NDA for EV71 vaccine

Tuesday, June 4, 2013 08:07 AM

Sinovac Biotech’s NDA for its proprietary EV71 vaccine has been accepted by the Beijing Drug Administration, which will conduct an on-site inspection of Sinovac's clinical trials and submit its  opinion along with the application documentations to the Centers for Drug Evaluation (CDE) of the China Food and Drug Administration (CFDA) for further review and evaluation.

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CWWeekly

March 23

Industry welcomes FDA draft guidance outlining the use of electronic Informed Consent for trials

Apple launches ResearchKit platform to tap millions of iPhone users to enroll in observational studies using apps

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The CenterWatch Monthly

March

Novo Nordisk, Takeda, Servier, Celgene among top sponsors
New gains seen from patient- and site-centric initiatives

Patient reported outcomes take center stage
FDA combining PROs, clinical outcomes in its approval decisions

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The CenterWatch Monthly

February

Study grants market breaks $13 billion
Volume of clinical activity rising while growth in grant spending slows

Revisiting eClinical Technology Solutions Adoption
While use of established solutions grows, sponsors hesitate on newer tools

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