Fri.Jan 31, 2020

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Rapid Nonclinical Planning and Coordination Keep Post-Marketing Requirements on Track

Camargo

After a biotech company received paper NDA approval for their drug, Camargo contributed to successful commercialization, planning and executing Phase 4 post-marketing requirements with a short timeline. The post Rapid Nonclinical Planning and Coordination Keep Post-Marketing Requirements on Track appeared first on Camargo.

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UK withdrawal from the EU on 31 January 2020

Drug Discovery Today

The United Kingdom will formally leave the European Union on 31 January 2020 and will become a third country to the EU. On 1 February 2020 a transition period will start which is due to end on 31 December 2020.

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Real World Evidence Saves Project

Camargo

When a biotech company could not afford the time and expense to conduct intended studies, we stepped in and quickly and creatively turned things around with the FDA. The post Real World Evidence Saves Project appeared first on Camargo.

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Pinpointing rare disease mutations

Drug Discovery Today

New resource that categorises genes essential for supporting life could be used to identify rare disease mutations

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Unlocking Excellence: How Catalent Is Transforming Japan’s Clinical Research

Planning on running clinical trials in Japan? How can you reliably supply these studies? Discover Catalent’s clinical supply packaging facility in Shiga, Japan. Strategically located between Tokyo and Osaka, and one of largest in Japan, this 6,000 square meter facility offers comprehensive services including primary and secondary clinical packaging and labelling, comparator sourcing, cold chain storage, local and global distribution, local language support and white glove service to support stud

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Strategic Submission Preparation Redefines Product Value

Camargo

With strategic submission support, a biotech company gained approval for an improved delivery technology of an already-approved drug, setting the potential to become a new “gold standard” treatment in oncology. The post Strategic Submission Preparation Redefines Product Value appeared first on Camargo.

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Combination Product Expertise and Target Market Knowledge Create Commercial Success

Camargo

By identifying the proper product category, we worked with an international company to correctly reposition its drug-device combination product for FDA approval and drive market penetration. The post Combination Product Expertise and Target Market Knowledge Create Commercial Success appeared first on Camargo.