The Pharma Data

SEPTEMBER 7, 2021

5.500% Notes due 2027. 3.100% Notes due 2027. In any jurisdiction where the laws require the tender offer to be made by a licensed broker or dealer, the tender offer will be deemed made on behalf of Lilly by the dealer managers, or one or more registered brokers or dealers under the laws of such jurisdiction. 284,112,000.

Licensing 52

Licensing Licensing Marketing 52

The Pharma Data

JANUARY 26, 2021

billion by 2027. is a biotech acceleration and commercial stage company focused on licensing and acquiring undervalued biomedical assets in the healthcare sector. An estimated 700,000 people are diagnosed with HCC each year, with the global market for liver cancer drugs expected to grow to $3.9 About Q BioMed Inc.

FDA 40

FDA Treatment Small Molecule Drugs 40

Agency IQ

AUGUST 25, 2023

The most recent reauthorization, BsUFA III, extended the program for fiscal years 2023 through 2027, and was authorized at the end of 2022. In these cases, “such text should be written in a manner that does not imply” that the biosimilar product is licensed for these additional use(s).

Biosimilars 40

Biosimilars FDA Production Licensing 40

Agency IQ

FEBRUARY 15, 2024

CDER, CBER 9/30/2027 Revised or final guidance to be released 18 months after the public comment period ends PDUFA Commitment Letter Digital Health Technologies Publish draft guidance describing a process to evaluate a predetermined change control plan for digital health devices. Priority B List. primary and secondary).

FDA 40

FDA Science Biosimilars Clinical Trials 40

The Pharma Data

MAY 4, 2021

RE47,739 for Ibrance by more than four years until March 2027. 7) BNT162b2 has not been approved or licensed by the U.S. In February 2021, Pfizer announced that the U.S. Patent and Trade Office issued a U.S. Patent Term Extension certificate extending the term of U.S. If approved, TicoVac would be the first vaccine in the U.S.

Vaccine 40

Vaccine Production FDA Clinical Trials 40

Agency IQ

JUNE 16, 2023

Final Rule Stage Clean Water Act Section 401: Water Quality Certification 2040-AG12 August 2023 Clean Water Act (CWA) section 401 provides States and Tribes with a powerful tool to protect the quality of their waters from adverse impacts resulting from federally licensed or permitted projects.

Regulations 40

Regulations Compliance Production Science 40

Agency IQ

JULY 28, 2023

September 2023 Final Rule Stage Biologics License Applications and Master Files The Biologics Price Competition and Innovation Act of 2009 (BPCI Act) deemed any biological product approved in a new drug application (NDA) to be a biologics license application (BLA) on March 23, 2020.

FDA 40

FDA Science Biosimilars Regulations 40