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Industry, FDA Meet Over Nitrosamine Impurities in APIs
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A joint industry group of innovator and generic-drug makers and consumer healthcare companies met with the FDA to go over the challenges the industry is facing in implementing a FDA…

CDMOs/CMOs: The Top Moves Thus Far in 2021
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What have been the key deals thus far in 2021 by CDMOs/CMOs? Biomanufacturing, including for cell- and gene-therapies, continues to be an active target for mergers and acquisitions. The largest…

Global Bio/Pharma Industry Outlook Provided at Virtual DCAT Week
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The bio/pharma industry faces challenges in growth as the world seeks to recover from the COVID-19 pandemic. Per an IQVIA analysis, drug sales in most of the world increased in…

CEOs, Senior Executives Outline Growth Strategies and Plans at the Virtual DCAT Member Company Announcement Forum
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CEOs and senior executives from DCAT Member Companies provide the latest major news from their companies impacting the bio/pharmaceutical manufacturing value chain: manufacturing expansions, mergers and acquisitions, and other key…

Nobel Laureate in Chemistry Speaks on CRISPR at Virtual DCAT Week
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Dr. Jennifer Doudna, co-awarded the Nobel Prize in Chemistry in 2020 for her groundbreaking work in developing CRISPR-Cas9 as a genome-engineering technology, explains CRISPR’s impact and its potential in drug…

Executives Provide Insights on The Future of Drug Development at Virtual DCAT Week
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Development of vaccines and treatments for COVID-19 has occurred at an unprecedented pace of scientific innovation. A Pfizer executive tells the story behind how the company brought its mRNA COVID-19…

Bio/Pharma Executives Provide Insights on What’s Next in Supply Management at Virtual DCAT Week
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The industry has risen to a myriad of challenges due to the pandemic, but what is next in supply management? Executives from J&J and Gilead provide their views on adapting…

CPOs Offer Views on What’s Next in Business Continuity Planning at Virtual DCAT Week
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CPOs offer their views on how they see business continuity planning evolving in a post-pandemic world and what actions will be needed by the industry to further mitigate supply risk.…

Global Pharma Watchlist: India
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Last month (June 2021), India’s Department of Pharmaceuticals issued operational guidelines for the country’s new production-linked incentive (PLI) scheme for starting materials, intermediates, and APIs. The PLI scheme is intended…

Mid-Year Review: New Drug Approvals
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At the halfway point in 2021, how are approvals of new molecular entities (NMEs) by the FDA progressing, and how does it compare to prior years? What NMEs have been…