The U.S. Food and Drug Administration approved four biosimilar drugs in 2021 under the provisions of the Biologics Price Competition and Innovation Act (BPCIA, codified at 42 U.S.C. §.
9:00 p.m. – 9:05 p.m.
Introduction
8:05 a.m. – 8:10 a.m.
9:05 p.m. – 9:10 p.m.
Delivering an Innovative Pipeline to Our Patients: Spotlight on Select Wave 1 Programs
Andy Plump, president of Research and Development
8:10 a.m. – 8:35 a.m.
9:10 p.m. – 9:35 p.m.
Maribavir (TAK-620): Potential Game Changer in the Treatment for Post-Transplant Cytomegalovirus (CMV) Infection Obi Umeh, global program lead, Rare Genetic and Hematology Therapeutic Area Unit
Claus Jepsen, head of Global Product and Launch Strategy, Rare Genetic and Hematology Therapeutic Area Unit
8:35 a.m. – 8:40a.m.
9:35 p.m. – 9:40p.m.
Break
9:40 p.m. – 10:00 p.m.
Soticlestat (TAK-935): Novel MoA for Treatment of Dravet Syndrome and Lennox-Gastaut Syndrome
Veristat Supported Marketing Applications for 10% of All FDA Novel Drug Approvals in 2020
Strengthening its Track Record of Successful Client Regulatory Approval Outcomes
SOUTHBOROUGH, Mass. (BUSINESS WIRE) #FDA Veristat, a scientific-minded global clinical research organization (CRO), announced today that they supported the marketing applications for 10% of the 2020 US Food and Drug Administration (FDA) novel drug approvals. The FDA approved 53 novel drugs, defined by the FDA as New Molecular Entities (NMEs)
i, and Veristat regulatory, statistical, and medical writing experts were integral in preparing five of these NME New Drug Applications. Veristat also prepared NDA/BLAs for three non-NME FDA approvals and one Marketing Authorization Application (MAA) that received approval in Europe.
Takeda Pharmaceutical Company Limited
Takeda Provides Pipeline Update and Shares Goal to Increase Revenue 50% by FY2030 at the 39th Annual J.P. Morgan Healthcare Conference
Tuesday, January 12, 2021 3:15PM IST (9:45AM GMT)
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Wave 1 Pipeline Portfolio Includes 12 New Molecular Entities Targeted for Launch by FY2024 Representing Best-in-Class/First-in-Class Therapies with Significant Market Potential
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Rapid Deleveraging On Track to Achieve Target of 2x Net Debt / adjusted EBITDA within Fiscal Years 2021 to 2023
Takeda Pharmaceutical Company Limited
(TSE:4502/NYSE:TAK) (“Takeda”) provided an update on the progress of its continued transformation and growth today at the virtual 39th Annual J.P. Morgan Healthcare Conference. President and Chief Executive Officer, Christophe Weber, shared details on Takeda’s portfolio and pipeline strategy and financial outlook, including key programs expected to contribute to the company’s revenue growth over the ne
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IMAGE: Estimated probability (Kaplan-Meier) of a company with IPO from 1997-2016 having at least one product approved by year after IPO for small molecules versus biologicals. view more
Credit: Center for Integration of Science and Industry, Bentley University
A large scale study from Bentley University of the biotechnology companies that completed Initial Public Offerings from 1997-2016 estimates that 78% of these companies are associated with products that reach phase 3 trials and 52% are associated with new product approvals. The article, titled Late-stage product development and approvals by biotechnology companies after IPO, 1997-2016, shows that these emerging, public biotechnology companies continue to have a role in initiating new product development, but are no longer distinctively focused on novel, biological products.