Blockbuster Watch: Small Molecules and Biologics
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Which of the new drugs expected to launch in 2021 have blockbuster potential (defined as products with sales of $1 billion or more)? What are revenue projections, and what is…
FDA

FDA, GMP Inspections and COVID-19: What’s Next?
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The FDA cut back inspections in 2020 due to COVID-19 and reverted to remote inspections and alternative tools, but what has been the impact? The FDA conducted 52 domestic inspections…

Tracking Biologics: What’s in Store for 2021?
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Which biologics are slated for the strongest sales growth in 2021, and how do they compare with sales growth for small-molecule drugs? What biologics were approved as new molecular entities…

What’s on the Pharma Industry’s Radar for 2021?
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COVID-19 will continue to be a defining issue for the pharmaceutical industry in 2021 as new vaccines and treatments enter the market. Across the broader industry, oncology drugs continue to…

The Biopharmaceutical Industry and Bioprocessing: What to Expect in 2021
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The most important developments impacting the biopharma industry and bioprocessing in 2021 are COVID-19-related as vaccine and therapeutic development and biomanufacturing continue at a rapid pace. The pandemic is also…

First COVID-19 Vaccine OK’d for Emergency Use
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Pfizer and BioNTech have received approval for emergency use of their COVID-19 vaccine from UK regulatory authorities, making it the first COVID-19 vaccine to be approved for emergency use. What…

The Year in Review: 2020
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The COVID-19 pandemic dominated the headlines in 2020 and will again in 2021 as vaccines and treatments move through development, regulatory approval, and distribution. But what have been the other…

Biosimilars in the US: Approvals and Market Outlook
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It has been 10 years since the Biologics Price Competition and Innovation Act (BPCIA) was signed into law, which authorized the regulatory pathway for biosimilars in the US. Since then,…

Challenging Years Are Ahead for the Biopharma Industry
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A recent DCAT webinar, featuring Graham Lewis, Vice President, Global Pharma Strategy, IQVIA, evaluates the market impact on the COVID-19 pandemic on pharmaceutical industry performance and how fundamentals and growth…

Solid-Dosage Mfg: CDMO Market and Product Trends
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Solid dosage products are a mainstay, but how are they faring compared to other dosage forms in terms of CDMO growth rates, product mix of new molecular entities approved thus…