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Tag Archives: biosimilar
Fifth China Medicinal Biotech Forum – Conference Recap
I recently returned from the Fifth China Medicinal Biotech Forum held in Beijing, China from 07-09 November 2011. The purpose of this conference was to update graduate students in China on the latest trends in biotechnology. This forum also allowed … Continue reading
Posted in Clinical Trials, Conferences and Meetings
Tagged biologics, biosimilar, biotech, China, clinical research, clinical trials, conference, DNA, efficacy, FDA, gene therapy, immuno, manufacturing, monoclonal antibody therapy, NIH, Phase 1, recombinant proteins, safety
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Recap of the DIA Annual Meeting 2011
The 47th Annual DIA Meeting was held on 19-23 June 2011 in Chicago and was a great success with thousands of attendees from the health care industry and regulators from around the world including representatives from the FDA, the EMA, … Continue reading
Posted in Uncategorized
Tagged AIDS, biologics, biosimilar, Cato Research, CBER, CDER, clinical trials, DIA, EMA, EU, FDA, follow-on biologics, generic drugs, geriatric, GMP, guidance, HIV, marketing application, oncology, Orphan Drug Designations, pediatric, pharmacovigilance, pre-IND
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Biomarker Qualification and Validation: Where are We Now?
Personalized medicine. The pinnacle of healthcare where treatment for a patient’s disease is specifically tailored for his or her genetics and disease characteristics. As the era of blockbuster drugs is drawing to a close, the era of personalized medicines is … Continue reading
Posted in FDA, Industry News, Regulatory Strategy
Tagged biosimilar, clinical trials, drug development, FDA, guidance, personalized medicine
2 Comments
Generic Lovenox – Moving One Step Closer to Biosimilars
We bleed from similar veins. – Tupac Shakur Lovenox is not, I repeat, not a biologic therapeutic. It is derived from a biological source (pig intestines, yum), but it is not protein-based. However, the FDA’s approval of a generic form … Continue reading
Posted in FDA, Industry News
Tagged biologics, biosimilar, drug development, FDA, generic drugs
1 Comment
FDA Forms Biosimilar Work Group
In the end we are all separate: our stories, no matter how similar, come to a fork and diverge. We are drawn to each other because of our similarities, but it is our differences we must learn to respect. – … Continue reading
Posted in FDA, Industry News
Tagged biologics, biosimilar, CBER, CDER, FDA, Janet Woodcock
1 Comment
