Drug Patent Watch

DECEMBER 10, 2024

The Importance of Scientific Expertise Generic drug development involves a deep understanding of the scientific principles underlying drug development, including pharmacology, pharmacokinetics, and bioequivalence. Scientific experts in these fields are critical in ensuring that generic drugs are developed to meet the required standards.

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Sygnature Discovery

NOVEMBER 29, 2023

It was conceived, invented and developed by Professor Stephen Neidle and his team in the School of Pharmacy at University College London with the involvement of Sygnature Discovery scientists. A total of up to 36 patients will be enrolled in the dose escalation (Phase 1a) portion of the study.

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Clinical Trials Treatment Trials Small Molecule 52

Agency IQ

SEPTEMBER 15, 2023

The committee also made recommendations regarding pharmacokinetic and safety assessments. Other comments from the American College of Clinical Pharmacy (ACCP) and American Association of Colleges of Pharmacy (AACP) also endorsed the actions sought in the Citizen Petition. Overall, 2022 phenylephrine retail sales reached $1.8

Science 40

Science FDA Clinical Trials Clinical Pharmacology 40

Sygnature Discovery

NOVEMBER 29, 2023

It was conceived, invented and developed by Professor Stephen Neidle and his team in the School of Pharmacy at University College London with the involvement of Sygnature Discovery scientists. A total of up to 36 patients will be enrolled in the dose escalation (Phase 1a) portion of the study.

Clinical Trials 40

Clinical Trials Treatment Trials Small Molecule 40

The Pharma Data

OCTOBER 27, 2020

We commenced launch activities for the Remunity Pump for Remodulin, including shipping training devices to specialty pharmacies and certain health care practitioners, and entering into agreements with specialty pharmacies to purchase Remunity Pumps and accessories and to pre-fill the Remunity cartridges exclusively with Remodulin.

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FDA Production Licensing Licensing 40

Agency IQ

DECEMBER 11, 2023

While Project Beyond Breakthrough (anticipated to launch its pilot program at the end of 2022) and Project Site Selector (slated to host several meetings in 2023) never quite materialized, others like Project FrontRunner , Project Optimus , and Project Orbis saw frequent mentions throughout the year.

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FDA Science Clinical Trials Trials 40

Agency IQ

FEBRUARY 15, 2024

CDRH FY2024 Guidance Agenda Clinical application Recommendations for Investigational and Licensed COVID-19 Convalescent Plasma CBER Final By 12/31/24 CBER CY 2024 Guidance Agenda Blood Considerations for the Development of Blood Collection, Processing, and Storage Systems for the Manufacture of Blood Components Using the Buffy Coat Method CBER Draft (..)

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FDA Science Biosimilars Clinical Trials 40