21ST CENTURY CURES ACT – PROVISIONS IMPACTING PHARMACEUTICAL REGULATION

| August 13, 2015

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On July 2, 2015 the House passed the 21st Century Cures Act . The focus is on expediting research and development on debilitating diseases, and smoothing the process to get important therapeutic options to patients who need them quickly.

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Lupin Pharmaceuticals

Lupin Pharmaceuticals, Inc. is the U.S. wholly owned subsidiary of Lupin Limited, which is among the top pharmaceutical companies in India. Through our sales and marketing headquarters in Baltimore, MD, Lupin Pharmaceuticals, Inc. is dedicated to delivering high-quality, branded and generic medications trusted by healthcare professionals and patients across geographies.

OTHER ARTICLES

Advance Your Pharma Supply Chain Planning during a Pandemic

Article | March 20, 2020

One predominant and common element within our pharmaceutical industry, is our devotions to patients. Within supply chain there is always a focus on ensuring the right product is delivered to the right place at the right time in order to ensure patient safety and the continuity of medicinal supplies. With the spread of COVID-19 across 117 countries and counting, every supply chain needs to evaluate their global footprint and develop contingency plans within their end to end operations.

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How Pharma Companies Can Scale Up Their Knowledge Discovery with Semantic Similarity Search

Article | March 20, 2020

Pharma has deep roots in human history with centuries of folk pharmaceutical knowledge offering a hit-and-miss range of natural remedies. But the industry as we know it today actually emerged in the second half of the 19th century when the world’s first factory for the sole production of medicines was found. By the late 19th and early 20th century, some chemical companies had already begun using research labs to explore the medical applications for their products. Fast forward to today and the pharmaceutical sector is a global trillion-dollar industry. However, to ensure the safety and efficacy of drugs, the process of drug discovery and development is under extensive scrutiny and control on both national and global levels.

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What do you have to lose taking hydroxychloroquine for coronavirus? Potentially your life

Article | March 20, 2020

The president and some of his close advisors — desperate for a COVID-19 cure — are asking “What do you have to lose?” by taking hydroxychloroquine (HCQ), a strong medication never adequately tested for efficacy or safety in COVID-19 patients. The correct answer to the president’s question, which he doesn’t seem to want to hear, is that we have our lives to lose. The president acknowledges “I’m not a doctor” but this raises the question “What do doctors know about the drug recommended by the president? Most doctors are aware that HCQ can be effective for patients with malaria, arthritis or lupus. If they were to follow the president’s suggestion and prescribe it for COVID-19 patients, they would also like to know that it will benefit some of those patients, at least.

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Clinical Development Risks and Issues in a COVID-19 World

Article | March 20, 2020

Global clinical guidelines have shifted the industry toward risk-based approaches for the planning and execution of clinical trials. The ICH’s guidelines for Good Clinical Practice state that sponsors should evaluate identified risks against existing risk controls by considering “the likelihood of errors occurring, the extent to which such errors would be detectable, and the impact of such errors on human subject protection and reliability of trial results” (ICH E6 R2).

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Spotlight

Lupin Pharmaceuticals

Lupin Pharmaceuticals, Inc. is the U.S. wholly owned subsidiary of Lupin Limited, which is among the top pharmaceutical companies in India. Through our sales and marketing headquarters in Baltimore, MD, Lupin Pharmaceuticals, Inc. is dedicated to delivering high-quality, branded and generic medications trusted by healthcare professionals and patients across geographies.

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