Wed.Jul 01, 2020

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A 505(b)(2) Primer: Building the Bridge Between an Approved Drug and Your Novel Therapy

Camargo

This blog features considerations and recommendations for sponsors exploring a 505(b)(2) pathway to drug approval. The post A 505(b)(2) Primer: Building the Bridge Between an Approved Drug and Your Novel Therapy appeared first on Camargo.

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Essential Tips for Enrolling Rare Disease Trials

Imperical Blog

The last decade has seen an explosion in clinical trials for therapies focused on rare diseases. PhRMA reports that there are more than 800 orphan drugs currently in development or regulatory review. While rare diseases are rare in a singular sense, when combined, they affect more than 10 percent of the U.S. population. According to the NIH , 95 percent of rare diseases have no approved medicines and more than 85 percent are serious or life-threatening.

Trials 59
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I Interview A Medical Device Expert On His Career and Pick His Brain On Everything! Ep.337

Clinical Trial Gurus

Many people in the pharmaceutical industry underestimate and are underinformed about the importance of medical device trials. An expert in medical device testing explains the many similarities between Investigational New Drug (IND) and pharmaceutical trials. Entering the IND testing arena may offer many opportunities for growth for people who are highly driven and who are able to identify market needs.

Trials 52
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How to win with a multichannel approach in pharma

pharmaphorum

This webinar will look at how pharma can use modular content in its multichannel and omnichannel strategies.

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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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Federal Court lifts Suspension Period

Pharma in Brief

On June 25, 2020, the Federal Court ( FC ) issued its latest Practice Direction and Order ( FC Update ) regarding Court operations during the pandemic, announcing that its Suspension Period will no longer be in force anywhere in Canada as of June 30, 2020. The FC Update also establishes guidelines for the transition toward more regular operations. Background.

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Syntegon’s North America team is here for you!

Syntegon Technology Pharma Blog

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