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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Clinical Trials Clinical Development Small Molecule Trials 40

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. .

FDA 40

FDA Production Licensing Licensing 40

New Drug Approvals

SEPTEMBER 29, 2024

link] 01 Aug 2022 Cortexyme is now called Quince Therapeutics You need to be a logged in or subscribed to view this content This small molecule is an orally available protease inhibitor targeting the lysine proteases of the periodontal pathogen Porphyromonas gingivalis. Results were expected in May 2022. 2022 Oct;31(10):987-993.

Small Molecule 62

Small Molecule DNA Disease Trials 62

Codon

APRIL 2, 2023

Read Safety and pharmacokinetics of escalating doses of neutralising monoclonal antibody CAP256V2LS administered with and without VRC07-523LS in HIV-negative women in South Africa (CAPRISA 012B): a phase 1, dose-escalation, randomised controlled trial. from 2021 to 2022, up to $625 million. Ricciardi M.J. Will Bedingfield.

DNA 52

DNA RNA Engineering Licensing 52

The Pharma Data

FEBRUARY 25, 2022

Food and Drug Administration (FDA) has accepted for review the Prior Approval Supplement (PAS) to the Biologics License Application (BLA) for ABRILADA™ (adalimumab-afzb) as an interchangeable biosimilar to Humira® (adalimumab). The Biosimilar User Fee Act (BsUFA) goal date for an FDA decision is in Q4 2022. “An

Biosimilars 52

Biosimilars FDA FDA Approval Small Molecule 52

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.

Clinical Trials 52

Clinical Trials Treatment Trials Small Molecule 52

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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Clinical Trials Treatment Trials Small Molecule 40

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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FDA Science Biosimilars Clinical Trials 40

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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Regulations FDA Drugs Treatment 69

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).

Vaccine 52

Vaccine Therapies Trials Clinical Trials 52

New Drug Approvals

MAY 14, 2025

7] This pharmacokinetic property has supported its investigation for the treatment of deep-seated Candida infections, including osteomyelitis. [8] Epub 2022 Nov 25. 2022 Jan 18;66(1):e0139021. Rezafungin acetate shows potent antifungal activity against Candida spp. Aspergillus spp. , and Pneumocystis spp. SYN Hughes, D.,

Pharmacokinetics 62

Pharmacokinetics FDA FDA Approval Treatment 62

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.

FDA 57

FDA FDA Approval Treatment Disease 57

New Drug Approvals

MAY 11, 2025

2022 Sep 27;13:952950. eCollection 2022. 2022 Aug 12;9:890653. eCollection 2022. 2] [5] It is taken by mouth. [2] 5] Omaveloxolone was approved for medical use in the United States in February 2023, [2] [5] [6] [7] [8] and in the European Union in February 2024. [3] 9] SYNTHESIS PATENT Sheikh, AY et al. Epub 2020 Sep 21.

FDA 57

FDA FDA Approval Disease Production 57

New Drug Approvals

APRIL 21, 2025

World Health Organization (2022). Revumenib SNDX-5613 2169919-21-3 LZ0M43NNF2 SNDX5613 C 32 H 47 FN 6 O 4 S, 630.82 nonan-2-yl]pyrimidin-5-yl]oxy-5-fluoro- N -propan-2-ylbenzamide N-Ethyl-2-[4-[7-[[4-(ethylsulfonylamino)cyclohexyl]methyl]-2,7-diazaspiro[3.5]nonan-2-yl]pyrimidin-5-yl]oxy-5-fluoro-N-propan-2-ylbenzamide Syndax Pharmaceuticals.

FDA Approval 67

FDA Approval FDA Clinical Trials Pharmaceuticals 67

New Drug Approvals

MAY 30, 2025

Archived from the original on 27 January 2022. Archived from the original on 18 May 2022. Archived from the original on 7 December 2022. gmol 1 3D model ( JSmol ) Interactive image show SMILES show InChI Toutain CE, Seewald W, Jung M: Pharmacokinetics of lotilaner following a single oral or intravenous administration in cats.

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FDA Approval FDA Production International 70

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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FDA FDA Approval Production Treatment 62

New Drug Approvals

APRIL 21, 2025

“First-in-Human Study of AG10, a Novel, Oral, Specific, Selective, and Potent Transthyretin Stabilizer for the Treatment of Transthyretin Amyloidosis: A Phase 1 Safety, Tolerability, Pharmacokinetic, and Pharmacodynamic Study in Healthy Adult Volunteers” Clinical Pharmacology in Drug Development. March 2022). 9 (1): 115129.

FDA Approval 62

FDA Approval FDA Production Treatment 62

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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Clinical Trials Virus Vaccine DNA 77