Sygnature Discovery

NOVEMBER 29, 2023

Following on from their exclusive license agreement with UCL in January 2022, subsequent preclinical and clinical development was undertaken by Qualigen Therapeutics Inc. In January 2023, QN-302 received Orphan Drug Designation by the FDA for the potential treatment of pancreatic cancer.

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The Pharma Data

NOVEMBER 4, 2020

The Company expects to report topline results from the THRIVE-AA1 trial in 2022. License and research and development revenue. The initiation of the THRIVE-AA1 trial follows an end-of-phase 2 meeting where Concert discussed key aspects of its Phase 3 program and registration strategy with the FDA.

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The Pharma Data

JANUARY 10, 2021

The company submitted its Biologic License Application to the FDA which has set a Prescription Drug User Fee Act (PDUFA) date for June 25, 2021. Independently optimized receptor bias and potency as well as pharmacokinetics to create a potentially best-in-class IL-2 product. ?. .

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The Pharma Data

OCTOBER 27, 2020

License-related fees (5). License-related fees (5). The BREEZE study (NCT03950739) seeks to evaluate 45 patients on a stable dose of Tyvaso after switching to our new dry powder inhaler (DPI) form of treprostinil, which we licensed from MannKind Corporation. .

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The Pharma Data

SEPTEMBER 15, 2020

The results demonstrated that Penta immune responses were robust and noninferior to licensed meningococcal vaccines (MenB and MenACWY) in individuals 10-25 years of age, regardless of prior MenACWY exposure. A Phase 2 proof-of-concept study of Pfizer’s potential first-in-class pentavalent meningococcal vaccine candidate (Penta; MenABCWY).

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FDA Law Blog: Biosimilars

MAY 21, 2024

Even though President Joe Biden had asked the Secretary of HHS and the Attorney General to “initiate the administrative process to review expeditiously how marijuana is scheduled under federal law” in October 2022 , we also wondered how the Department of Justice (“DOJ”) and DEA would receive the HHS recommendation. Basis at 24.

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Agency IQ

FEBRUARY 15, 2024

CDRH FY2024 Guidance Agenda Device software Voluntary Malfunction Summary Reporting (VMSR) Program for Manufacturers CDRH Final By 10/1/24 Priority B List CDRH FY2024 Guidance Agenda Post-approval reporting 3D Printing Medical Devices at the Point of Care CDRH Draft By 10/1/24 New on CDRH’s guidance agenda. Priority B List.

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New Drug Approvals

APRIL 2, 2025

World Health Organization (2022). Article ] Bakker C, van der Aart J, Hart EP, Klaassen ES, Bergmann KR, van Esdonk MJ, Kay DG, Groeneveld GJ: Safety, pharmacokinetics, and pharmacodynamics of Gln-1062, a prodrug of galantamine. Alpha Cognition. 29 July 2024. Archived from the original on 4 August 2024. hdl : 10665/363551. 2015.12.003.

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New Drug Approvals

APRIL 5, 2025

11 October 2022. 21 December 2022. Archived from the original on 3 April 2022. 3 August 2022. Archived from the original on 20 May 2022. References ^ Jump up to: a b “Trecondi APMDS” Therapeutic Goods Administration (TGA). Retrieved 21 April 2020. 31 January 2025. . 57 (10): 12551265. PMC 6132445.

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Codon

FEBRUARY 23, 2025

Because of PEPFAR’s effectiveness, the United Nations (UN) set an ambitious goal in 2022 to end HIV transmission and eliminate AIDS-related deaths by 2030. By 1987, the FDA licensed zidovudine after trials showed it increased survival rates. Half of the participants received lenacapavir, and the other half an injectable placebo.

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