The Pharma Data
FEBRUARY 8, 2021
RE47,739 (‘739) by more than four years until March 5, 2027. The pharmacokinetics of IBRANCE have not been studied in patients requiring hemodialysis. Patent Term Extension (PTE) certificate for IBRANCE® (palbociclib). The certificate extends the term of U.S. About Pfizer Oncology.
Drug Discovery World
AUGUST 3, 2023
Michael Sassano, CEO at SOMAÍ Pharmaceuticals, shared with DDW that it is estimated that there will be 340,000 medicinal cannabis users in Europe in 2022 alone, and the overall market is estimated to grow over 500% over the next three years – with the market value in Germany alone poised to hit over €7 billion by 2027 5.
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Agency IQ
MAY 17, 2024
GDUFA III), which reauthorized the program through 2027. For the in vivo portion, the guidance states that applicants should conduct: 1) An in vivo pharmacokinetics (PK) study in fasting condition for both product strengths with healthy volunteers, and 2) an in vivo comparative clinical endpoint or pharmacodynamic (PD) study with patients.”
Drug Target Review
JUNE 5, 2023
It also displayed favourable pharmacokinetics (PK) and is well tolerated in non-human primates (NHP) at exposure levels above those projected to be efficacious. ZW191 also displayed favourable pharmacokinetics (PK) and is well tolerated in non-human primates (NHP) at exposure levels above those projected to be efficacious.
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be released 18 months after the public comment period ends PDUFA Commitment Letter Digital Health Technologies Publish draft guidance describing a process to evaluate a predetermined change control plan for digital health devices. primary and secondary). primary and secondary).
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