{"id":57442,"date":"2023-05-19T19:03:13","date_gmt":"2023-05-19T17:03:13","guid":{"rendered":"https:\/\/pharma-trend.com\/en\/new-drug-approvals-and-their-contract-manufacture-2023-report-detailed-view-of-cdmo-performance-by-number-of-drug-and-vaccine-approvals-researchandmarkets-com\/"},"modified":"2023-05-19T19:03:13","modified_gmt":"2023-05-19T17:03:13","slug":"new-drug-approvals-and-their-contract-manufacture-2023-report-detailed-view-of-cdmo-performance-by-number-of-drug-and-vaccine-approvals-researchandmarkets-com","status":"publish","type":"post","link":"https:\/\/pharma-trend.com\/en\/new-drug-approvals-and-their-contract-manufacture-2023-report-detailed-view-of-cdmo-performance-by-number-of-drug-and-vaccine-approvals-researchandmarkets-com\/","title":{"rendered":"New Drug Approvals and Their Contract Manufacture: 2023 Report – Detailed view of CDMO Performance by Number of Drug and Vaccine Approvals – ResearchAndMarkets.com"},"content":{"rendered":"
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DUBLIN–(BUSINESS WIRE)–The “New Drug Approvals and Their Contract Manufacture – 2023 Edition”<\/a> report has been added to ResearchAndMarkets.com’s<\/strong> offering.<\/p>\n

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\nIn 2022, the FDA approved c100+ new drug applications (NDAs) and biologics license applications (BLAs). This figure represents a decrease over the 2017-21 period. Both small molecule and biologic new molecular entity (NME) approvals declined substantially, causing overall NDA approvals to drop, which meant fewer commercial-scale production contracts for the most innovative products comparative to other recent years.<\/p>\n

\nIn June 2021, the FDA granted accelerated approval of Biogen’s Aduhelm for Alzheimer’s disease, despite there being little to no evidence of clinical benefit and the majority of an FDA advisory panel voting against the drug’s approval. This event caused controversy and added to pre-existing claims that the FDA approval process may not be as rigorous as it was in the past, the long-standing push for speed in the FDA approval process having meant a reduced level of certainty and evidence related to a drug. As a result of these issues, there may have been an increased reluctance to authorize innovative drugs for use.<\/p>\n

\nCOVID-19 vaccine drives have allowed economies and societies to safely reopen during the pandemic. However, new challenges such as rising inflation will bring uncertainty to the ongoing global recovery. The pharma industry faces increasing cost pressures, shrinking consumer spending power, staff shortages, and geopolitical tensions. Contract Manufacturing Organization’s (CMO’s) will need to find ways to remain competitive in these difficult conditions while maintaining quality and compliance. High inflation will also impact supply chains and R&D activities, and challenge their feasibility.<\/p>\n

\nNew Drug Approvals and Their Contract Manufacture – 2023 Edition; is the 13th edition in the series of long-running analysis of the CMO industry, using the FDA’s NDA approvals as the primary indicator of performance. New Drug Approvals and their Contract Manufacture (formerly called ‘CMO Scorecard’) is critical for benchmarking the performance of the contract manufacturing organization (CMO) industry and the relative performance of major CMOs. This year’s edition includes a discussion of Emergency Use Approvals for COVID-19 and how inflation has impacted pharma manufacturers.<\/p>\n

\nScope<\/strong><\/p>\n

\nThis report gives important, expert insight you won’t find in any other source. 11 tables and 34 figures throughout the report illustrate major points and trends.<\/p>\n

\nThis report is required reading for:<\/p>\n