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.

The six partners of EIT Health met earlier this month in Vienna, ahead of the planned launch of Austria’s new EIT Health Regional Innovation Hub in early 2022. They discussed how the hub is going to operate across Austria and how it is going to be linked into the European network of EIT Health. WHAT’S THE IMPACT The six partners who will jointly establish the regional EIT Health network in Austria are: The Austrian Institute of Technology (AIT) Boehringer Ingelheim RCV The startup SanusX of the UNIQA insurance group Kapsch BusinessCom the Wild Group and the Viennese startup service INiTS. From January 2022, the new hub based in Vienna, together with other network partners, aims to drive forward innovative digital health products and solutions while also supporting startups and small and medium-sized enterprises (SMEs). The EIT Health Regional Innovation Hub is funded by the Austrian Federal Ministry of Digital Affairs and Economy, the Federal Ministry of Social Affairs, Health, Care and Consumer Protection, the Vienna Chamber of Commerce as well as Wirtschaftsagentur Wien. T HE LARGER TREND With the new Austrian hub, EIT Health intends to capitalise on the opportunities of the region and to strengthen its multidisciplinary network. The European Institute of Innovation and Technology (EIT) is an independent EU Body that seeks to innovate European sectors by promoting and supporting ideas and entrepreneurial spirit around technology. EIT Health is the designated body for healthcare to this end. In February 2021, EIT Health funded two startups from Germany and Spain with €1.5 million for a period of two years as part of the Wild Card innovation programme. In December 2020, EIT Health launched the Catapult Competition and funded nine winning startups from the digital health, biotech and medtech sectors with a total of €1 million. ON THE RECORD Dirk Holste, Research Manager and Deputy Head of the AIT Center for Health & Bioresources and Coordinator of EIT Health Austria, commented: “We are excited to be in our new premises today and conduct the first official partner meeting for the new EIT Health Regional Innovation Hub.” He continued: “Austria has many healthcare innovation strengths including a well-developed healthcare system with widely accepted and implemented electronic health record (ELGA). “The newly created EIT Health Austria will integrate well into the already vast and vibrant network, and we look forward to addressing the health challenges facing Europe through synergistic and collaborative working with our EIT Health peers.” Jan-Philipp Beck , CEO of EIT Health, said: “We look forward to fruitful collaborations that can improve the lives of patients and citizens across Europe.”