Search results for " clinical trials"
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The Tide Stays High
The significance of external funding can be seen by looking at early-phase clinical trials sponsored by emerging bio/pharma companies. Phase I and II clinical trial registrations by emerging bio/pharm…
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Biopharma Manufacturers Respond to Ebola Crisis
Vaccine industry executives and biotech innovators joined the discussion about conducting effective and ethical clinical trials and ramping up production of promising vaccines and therapies. A main ai…
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Single-Domain Antibodies for Brain Targeting
With 25 mAb products on the market and more than 100 undergoing clinical trials (1-3), it is evident that engineered antibodies have come of age as biopharmaceuticals (4).
Intact antibodies (immun…
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Biopharma Seeks Balance
In the traditional model, process development progressed slowly as large, slow clinical trials progressed. FDA’s expedited approval process moves drugs to market faster, requiring developers to shorte…
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Biotechnology Innovation and Growth in Israel
Israel has become an increasingly significant location for international companies conducting multinational pharmaceutical clinical trials. One important factor has been the fact that the entire Israe…
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FDA Approves First Biosimilar
In fact, FDA said in a briefing earlier this year that six batches of the EU-approved Neupogen used in the Zarxio clinical trials were “lower in protein content than the comparator products and do not…
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Climate Change in Outsourcing
As 2013 draws to a close, the bio/pharmaceutical industry continues to be reshaped by changes in the business climate. Financial, political, and scientific developments that began 10 years ago conti…
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Ajinomoto Bio-Pharma Services, CytoDyn in Manufacturing Partnership for COVID-19 Drug
…ency investigational new drug (EIND), granted by FDA as part of Phase I, Phase II, and Phase IIb/III clinical trials. CytoDyn is currently enrolling patients in two placebo-controlled randomized clin…
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Emerging Therapies Test Existing Bioanalytical Methods
FDA, Guidance for Industry: Gene Therapy Clinical Trials—Observing Subjects for Delayed Adverse Events (Rockville, MD, November 2006).
4. FDA, Guidance for Industry: Preclinical Assessment of Inve…
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Taking a “Development-by-Design” Approach to Cell Therapies
In 2013, according to the Pharmaceutical Research and Manufacturers Association, 69 cell therapies, six of them autologous, or patient-specific treatments, were in clinical trials or being reviewed in…