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PFIZER CONFIRMS U.S. PATENT TERM EXTENSION FOR IBRANCE UNTIL MARCH 2027

The Pharma Data

RE47,739 (‘739) by more than four years until March 5, 2027. IBRANCE is an oral inhibitor of CDKs 4 and 6, 1 which are key regulators of the cell cycle that trigger cellular progression. Dose interruption, dose reduction, or delay in starting treatment cycles is recommended for patients who develop Grade 3 or 4 neutropenia.

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Article EMA Thank You What we expect European regulators to do in August and September 2024

Agency IQ

What we expect European regulators to do in August and September 2024 In this recurring feature, AgencyIQ, through public data and previous analysis, determines what European medicine and device regulators will likely do in the month ahead, including key deadlines, meetings, events, planned regulations, comment periods, and more.

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Q BioMed’s Uttroside-B Receives U.S. FDA Orphan Drug Designation in the Treatment of Liver Cancer

The Pharma Data

Food and Drug Administration’s Office of Orphan Products Development has granted Orphan Drug Designation to Uttroside-B , a small molecule chemotherapeutic for the treatment of hepatocellular carcinoma (HCC), the most common form of liver cancer. billion by 2027. (OTCQB: QBIO), announced today that the U.S.

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FDA’s LDT Proposal and Its Impact on Clinical and Regulatory Professionals

The Premier Consulting Blog

The FDA is proposing a change to its regulations to explicitly classify In Vitro Diagnostics (IVDs) as devices under the Federal Food, Drug, and Cosmetic Act (FD&C Act), irrespective of the manufacturer being a laboratory that previously conducted business and was certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA).

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No Sleep ‘Til District Court: Jazz Sues FDA Over Sodium Oxybate Clinical Superiority Determination

FDA Law Blog: Biosimilars

This time, rather than use codes and patent certifications, the fight is over orphan drug exclusivity (“ODE”), with Jazz challenging FDA’s clinical superiority decision concerning sodium oxybate in the treatment of narcolepsy. 360cc(c), the statute does not permit FDA to promulgate regulations to use clinical superiority to break ODE.

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Article Periodic Thank You Why comprehensive state-level bans on PFAS in products are faltering

Agency IQ

Generally, how have states attempted to regulate PFAS? States are attempting to regulate PFAS in a variety of ways, including via multiple in-state regulatory and legislative avenues. In addition, the law prohibits the sale of carpets or fabric treatments containing PFAS as of January 1, 2023.

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Sanofi launches 2022 global Employee Stock Purchase Plan for 86.000 people

The Pharma Data

Those taking up this offer will be required to hold the Shares or the corresponding FCPE units for a period of approximately five years, i.e. until 31 May 2027, except upon the occurrence of an early release event provided for under Article R. The voting rights attached to the subscribed Shares will be exercised directly by the employees.