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Top 10 Global CDMO Enterprises| Top 10 Global Clinical Research Organizations in 2021| The Meaning of IND, NDA and ANDA
Jul 15,2015
House Approves NIH, FDA Funding Hikes
The U.S. House of Representatives today approved a bill intended to advance basic research and drug development, in part by giving the NIH $8.75 billion in additional funds over the next five federal fiscal years, and the FDA, $550 million. The 21st Century Cures Act (HR 6), creates a dedicated "Innovation Fund” from which theRead more
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House Approves NIH, FDA Funding Hikes
Jul 14,2015
In Vitro Diagnostic Reagents Seeking Localization
Some leading in vitro diagnostic reagent companies in Guangdong Province are accelerating the implementation of product serialization, diagnostic accuracy, and reagent instrument integration. Some products have gone abroad and are actively exploring the international market June 11-12, under the guidance of the Medical Device Supervision Department of the State Food and Drug Administration, sponsored byRead more
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Jul 09,2015
FDA offers guidance for running early-phase trials for gene, cell therapies
The FDA's Center for Biologics Evaluation and Research's Office of Cellular, Tissue, and Gene Therapies notes first and foremost that the development of cell and gene therapies differs drastically from the development of small molecule drugs, which means differences in trial design will be necessary. The heightened risk to subject safety is one of thoseRead more
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Jul 09,2015
Animal research ban not possible says EC after rejecting petition
Animal research plays a crucial role in scientists’ understanding of diseases and in the development of effective medical treatments. The European Commission  made the comments today explaining that while it agrees drug toxicity tests using animals should eventually be phased out, at present it is impossible to do so as scientific challenges remain. "Where the toxicologicalRead more
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Jul 07,2015
Mammary glands in a dish: Scientists recreate tissues for better models, spin out CRO planned
The scientists – from Ludwig Maximilian University (LMU) and the Helmholtz Center in Munich, Germany – used the gel to construct mammary gland like structures from breast epithelial cells extracted from healthy donors. Lead researcher Christina Scheel told us "we use a connective tissue component that is abundant in the human mammary gel to make.
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Mammary glands in a dish: Scientists recreate tissues for better models, spin out CRO planned
Jun 26,2015
The European Council agrees to a general approach to the adoption of new regulatory proposals for therapeutic devices and in vitro diagnostic devices
After several weeks of discussion and thinking, the European Council finally agreed to adopt a general approach to the proposal of new regulations for medical devices and in vitro diagnostic devices (IVD). In the EU, the legislative process is that the European Commission (European Commission, EC) proposes a new bill, and then the European ParliamentRead more
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The European Council agrees to a general approach to the adoption of new regulatory proposals for therapeutic devices and in vitro diagnostic devices
Mar 31,2015
Medicilon successfully held CFDA IND seminar in Seoul, South Korea
On March 18, Medicilon and Korea Pharmaceutical Manufacturers Association (KPMA) held a CFDA IND seminar in Seoul, South Korea. The theme of this seminar is "Experience Sharing and Exchange on CFDA's IND Application and Drug Development Collaboration”. About 130 medical experts and scientists from more than 50 companies participated in this seminar. Medicilon CEO Dr.Read more
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Medicilon successfully held CFDA IND seminar in Seoul, South Korea
Jan 29,2015
Dr. Chen was appointed as Chairman of the Drug Metabolism Professional Committee
The Drug Metabolism Professional Committee of 4th Shanghai Pharmacological Societyand the 1st Symposium was held at Zhangjiang campus, Fudan University on January 29.  Dr. Chunlin Chen, Medicilon CEO, was appointed as Chairman of the Drug Metabolism Professional Committee of 4th Shanghai Pharmacological Society.  During the Syposium, Dr. Chen gave a keynote speech on the academicRead more
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Jan 15,2015
Class 1.1 new chemical drug piperidone "AD16” has been accepted by CFDA IND
Alzheimer's disease, the English name is Alzheimer's disease (Alzheimer disease), abbreviated as AD is a neurodegenerative disease with insidious onset and progressive development. Clinically, it is characterized by general dementia such as memory impairment, aphasia, apraxia, agnosia, impairment of visual spatial skills, executive dysfunction, and personality and behavior changes. The etiology is still unknown. ThoseRead more
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