Boehringer Ingelheim RCV GmbH & Co. KG

DUBLIN--( BUSINESS WIRE )--The "New Drug Approvals and Their Contract Manufacture - 2023 Edition" report has been added to ResearchAndMarkets.com's offering. In 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. In 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. COVID-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. New 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. Scope This 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. This report is required reading for: CMO executives who must have deep understanding of drug approvals and outsourcing to make strategic planning and investment decisions Sourcing and procurement executives who must understand crucial components of the supply base in order to make decisions about supplier selection and management Private equity investors that need a deeper understanding of the market to identify and value potential investment targets Reasons to Buy Overview of NDA drug and vaccine approvals and the levels of outsourcing associated with NDA sub segments Detailed view of CDMO performance by number of drug and vaccine approvals An assessment of pharmaceutical companies' propensity to outsource manufacture, by their market caps, based on the publisher's Contract Service Providers database Outsourcing propensity for New Molecular Entities (NMEs), different dosage forms, and other drug attributes Analysis of NME special product approvals such as those with Accelerated Approval, Orphan, Breakthrough or Fast Track designations and assessment of outsourcing Key Topics Covered: Executive Summary Players Technology Briefing Innovative drug approvals Dose outsourcing of drug approvals Trends Industry Analysis Introduction FDA NDA approvals overview More biologic NME approvals than small molecule equivalents Cell and gene therapies First-in-class First-time approvals Rejected drugs Predicted approvals for 2023 Sponsor trends US vs. EU approval performance FDA EUAs in 2022 for COVID-19 FDA: outsourced dose manufacture Dosage form outsourcing Special product categories Accelerated approvals Orphan drug designation Fast track designation Breakthrough therapy designation Containment Solubility enhancement Outsourcing by company market cap CMO performance Dosage form Outsourced API approvals ANDA approvals What it means FDA approvals decline with a large decrease of NMEs approved COVID-19 vaccine demand waning but there are still lucrative contracts A few large CMOs gain majority of dose contracts High inflation and other business conditions Record high number of ATMP approvals in 2022 Value Chain Companies Appendix Methodology Bibliography Primary research - key opinion leaders Further reading About the Authors Contact the Publisher Companies Mentioned AbbVie Inc ACS Dobfar SpA Aenova Holding GmbH Afton Scientific Corp AGC Biologics Inc Ajinomoto Bio-Pharma Services Akorn Operating Company LLC Alcami Corp Alfasigma SpA Allergopharma GmbH & Co KG Almac Group Ltd Alpex Pharma SA Altasciences Co Inc Alvogen Inc AOP Health ARx LLC ASM Aerosol-Service AG AstraZeneca Plc Astrea SA AtomVie Global Radiopharma Inc Aurobindo Pharma Ltd AustarPharma LLC Avara Pharmaceutical Services Inc Baccinex SA Basic Pharma Bausch & Lomb Pharmaceuticals Inc Baxter Biopharma Solutions Bayer AG Berkshire Sterile Manufacturing LLC BioRamo LLC BioReliance Corp Boehringer Ingelheim Biopharmaceuticals GmbH Boehringer Ingelheim RCV GmbH & Co KG Bora Pharmaceuticals Co Ltd Bristol Myers Squibb Co BSP Pharmaceuticals SpA Bushu Pharmaceuticals Ltd Cambrex Corp Catalent Inc Cenexi SAS Cerovene Inc Chia Tai Tianqing Pharmaceutical Group Co Ltd Contract Pharmaceuticals Ltd Corden Pharma International GmbH CoreRx Inc Corium Inc Curia Global Inc Delpharm SAS Dexcel PT Israel Ltd DPT Laboratories Ltd Eisai Co Ltd EMD Serono Inc Emergent BioSolutions Inc EuroAPI SAS Eurofins Scientific SE And Many More Companies! For more information about this report visit https://www.researchandmarkets.com/r/a0j1ls Source: GlobalData About ResearchAndMarkets.com ResearchAndMarkets.com is the world's leading source for international market research reports and market data. We provide you with the latest data on international and regional markets, key industries, the top companies, new products and the latest trends.

Michigan State University biotechnology startup accelerates commercialization of novel protein carriers for vaccine development EAST LANSING, Mich., Jan. 25, 2023 /PRNewswire/ -- Iaso Therapeutics, a Michigan State University startup developing novel technologies for next-generation vaccines, recently closed the first tranche of the company's $1.25M Series Seed Preferred round of financing. Proceeds from the funding will be used to advance Iaso's customizable drug delivery and vaccine platform based on bacteriophage mQβ to boost immune system responses against weakly immunogenic antigens. Participating in the round was the Michigan Rise Pre-Seed III Fund, Red Cedar Ventures Pre-Seed Fund and Michigan-based angel investors. Iaso Therapeutics is also eligible to receive up to $125K in funding from the Michigan Small Business Development Center and Michigan Economic Development Corporation's Emerging Technology Fund, leveraging a successful National Science Found Phase II SBIR grant in March 2022. "Iaso Therapeutics has successfully supported the early development of our mQβ vaccine platform with NSF and NIH SBIR grants," said Robert Forgey, President and CEO of Iaso Therapeutics. "This funding will accelerate the development of this technology as we begin our journey." Based in East Lansing, Michigan, Iaso Therapeutics was founded in 2018 by Dr. Xuefei Huang, Ph.D., utilizing carbohydrate-based vaccine chemistry technology research in partnership with Michigan State University. Iaso Therapeutics hired Forgey as the president and CEO who brings two decades of biotechnology start-up experience. "It has been rewarding to follow the progress of the Iaso Therapeutics since its early inception at Michigan State University," said Jeff Wesley, Executive Director of Michigan Rise Pre-Seed III. "The company is developing a platform with the potential to create vaccines for both infectious diseases and cancers, but also with the potential to deliver therapeutics to target tissues. In addition, the company, over a short period of time, has amassed strong pre-clinical animal data and can point to initial success in getting vaccines to the clinic as proof of concept." The mQβ carrier has been conjugated with various molecules, such as small molecules, sugars, peptides, proteins, polysaccharides and glycoproteins. Thus has the potential to be a widely used carrier for both human and animal vaccines. "Iaso Therapeutics' technology has substantial potential to be a new safe and highly efficient vaccine platform," said Don Parfet, Managing Director of the Apjohn Group LLC and Iaso Therapeutics investor. "I really like the team and am impressed by the progress that has been made under the support and oversight of Spartan Innovations and MSU Technologies." The overall increase in infectious and noninfectious diseases, growing population and recent technological advancements in vaccines and enabling technologies create considerable scope for the overall vaccine market. The resurgence of vaccine preventable diseases and the emergence of new pandemics and immunization programs in emerging economies also heavily influence the global vaccine market. Iaso Therapeutics expects to complete this Series Seed Preferred round of financing later this year. About IASO Therapeutics: Iaso Therapeutics, Inc. is a biotechnology startup company spun out from Michigan State University. The company was founded in 2018 by Dr. Xuefei Huang. Dr. Huang is an MSU Foundation Professor jointly appointed in the Department of Chemistry and the Department of Biomedical Engineering at Michigan State University. Also, he is a member of the newly formed Institute for Quantitative Health Science & Engineering. With over 25 years of experience, his research program is focused on developing novel technologies for next-generation vaccines, including vaccines targeting both cancer and infectious diseases. Iaso Therapeutics, Inc. aims to translate the cutting-edge technologies developed in the Huang laboratory to promote human health and treat diseases. About Red Cedar Ventures: Red Cedar Ventures (RCV) was founded in 2014 and is the first venture fund in Mid-Michigan. RCV's objective is to help accelerate the commercialization of startups, creating opportunities for MSU technologies, ecosystem partners, and Pure Michigan. Our vision is to be the leading Mid-Michigan Venture Fund providing economic impact for the region and the state with new jobs, new companies, and value-added partnerships. About Michigan Rise Pre-Seed III Fund Founded in 2020, the Michigan Rise Pre-Seed III Fund provides debt, equity, and purchase order financing for early-stage high-tech businesses located in Michigan. Funded by the Michigan Economic Development Corporation and the Michigan State University Research Foundation, Michigan Rise is dedicated to helping early-stage companies in Michigan succeed. For more information on Michigan Rise, visit . CONTACT: Jeremy Witt [email protected] 269-370-1097 SOURCE Iaso Therapeutics