2022, Licensing and Pharmacokinetics

Elacestrant

New Drug Approvals

MAY 9, 2025

1] [8] Pharmacokinetics Elacestrant has an oral bioavailability of approximately 10%. [1] Lloyd MR, Wander SA, Hamilton E, Razavi P, Bardia A (2022). 1] Additionally, elacestrant is a selective estrogen receptor degrader (SERD), meaning it induces the degradation of ER. [1] 21 September 2023. Retrieved 22 September 2023.

FDA

FDA Pharmacokinetics Therapies Treatment

Vamorolone

New Drug Approvals

JULY 25, 2025

79 (2022) 1005–1014. [71] 79 (2022)1005–1014 Bioorg. 16] Population pharmacokinetics (PK) of vamorolone was shown to fit to a 1-compartment model with zero-order absorption, with both adult men and young boys showing dose-linearity of PK parameters for the doses examined, and no accumulation of the drug during daily dosing. .

FDA

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Crinecerfont

New Drug Approvals

APRIL 18, 2025

1 November 2022). 17 February 2022). . “International nonproprietary names for pharmaceutical substances (INN): recommended INN: list 82” WHO Drug Information. hdl : 10665/330879. Further reading Auchus, Richard; Chan, Jean; Farber, Robert; Fechner, Patricia; Giri, Nagdeep; Nokoff, Natalie; et al. (1 6 (Supplement_1): A618.

FDA

FDA FDA Approval Drugs Trials

Landiolol

New Drug Approvals

APRIL 19, 2025

21 December 2022. “Pharmacokinetics of landiolol hydrochloride, a new ultra-short-acting beta-blocker, in patients with cardiac arrhythmias” Clinical Pharmacology and Therapeutics. 24 August 2022. Further reading Shiga T (June 2022). . ^ “Details for: Sibboran” Health Canada. 20 November 2023.

FDA

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Eplontersen

New Drug Approvals

DECEMBER 24, 2023

December 2022). “Population pharmacokinetic/pharmacodynamic modelling of eplontersen, an antisense oligonucleotide in development for transthyretin amyloidosis” British Journal of Clinical Pharmacology. . | Facebook Twitter FACEBOOK join me on twitter Anthony Melvin Crasto Dr. | twitter +919321316780 call whatsaapp EMAIL.

Clinical Trials

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Steep FY2025 PDUFA Fee Increase: Ways to Reduce the Full Fee Rate for Repurposed Drugs

The Premier Consulting Blog

AUGUST 8, 2024

On July 31, 2024, the US Food and Drug Administration (FDA) announced Fiscal Year 2025 (FY2025) Prescription Drug User Fee Amendments of 2022 (PDUFA VII) fee rates for the review of human drug and biological product applications along with prescription drug program fees. patients with renal, hepatic, or cardiovascular concerns).

Drugs

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Etrasimod

New Drug Approvals

OCTOBER 24, 2023

July 2022). . | twitter +919321316780 call whatsaapp EMAIL. “Velsipity (etrasimod) tablets, for oral use” (PDF). . “Etrasimod as induction and maintenance therapy for ulcerative colitis (ELEVATE): two randomised, double-blind, placebo-controlled, phase 3 studies” Lancet. 401 (10383): 1159–1171. PMID 36871574. ^

FDA

FDA FDA Approval International Pharmacokinetics

Concert Pharmaceuticals Reports Third Quarter 2020 Financial Results and Provides Company Update

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.

Pharmaceuticals

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Ascendis Pharma A/S Provides Vision 3×3 Update at 39th Annual J.P. Morgan Healthcare Conference

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. ?. .

Clinical Trials

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United Therapeutics Corporation Reports Third Quarter 2020 Financial Results

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

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ATUZAGINSTAT

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

Small Molecule DNA Disease Trials

Codon Digest: Injected Gene Editors

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

DNA RNA Engineering Licensing

FDA Accepts for Review Pfizer’s Supplemental Application for ABRILADA™ (adalimumab-afzb) Interchangeability

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

First patients dosed in Phase 1a clinical trial of UCL-backed G-Quadruplex (G4) targeting treatment for solid tumors, including pancreatic cancer

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

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First patients dosed in Phase 1a clinical trial of UCL-backed G-Quadruplex (G4) targeting treatment for solid tumors, including pancreatic cancer

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

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Analysis Life Sciences Thank You 166 guidance documents the FDA is actively working on in 2024 (and beyond)

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.

FDA

FDA Science Biosimilars Clinical Trials

Buckle Up: DOJ Initiates Rulemaking to Reschedule Marijuana

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.

Regulations

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Pfizer Investor Day Features Significant Number of Pipeline Advances for COVID-19 Programs and Across Numerous Therapeutic Areas

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

Vaccine Therapies Trials Clinical Trials

Rezafungin

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

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BENZGALANTAMINE

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

FDA FDA Approval Treatment Disease

Omaveloxolone

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

FDA FDA Approval Disease Production

Revumenib

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

FDA Approval FDA Clinical Trials Pharmaceuticals

Lotilaner

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.

FDA Approval

FDA Approval FDA Production International

TREOSULFAN

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.

FDA

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Acoramidis

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

FDA Approval FDA Production Treatment

Making a “Miracle” HIV Medicine

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.

Clinical Trials

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Drug Discovery Digest

Elacestrant

Vamorolone

Trending Sources

Crinecerfont

Landiolol

Eplontersen

Steep FY2025 PDUFA Fee Increase: Ways to Reduce the Full Fee Rate for Repurposed Drugs

Etrasimod

Concert Pharmaceuticals Reports Third Quarter 2020 Financial Results and Provides Company Update

Ascendis Pharma A/S Provides Vision 3×3 Update at 39th Annual J.P. Morgan Healthcare Conference

United Therapeutics Corporation Reports Third Quarter 2020 Financial Results

ATUZAGINSTAT

Codon Digest: Injected Gene Editors

FDA Accepts for Review Pfizer’s Supplemental Application for ABRILADA™ (adalimumab-afzb) Interchangeability

First patients dosed in Phase 1a clinical trial of UCL-backed G-Quadruplex (G4) targeting treatment for solid tumors, including pancreatic cancer

First patients dosed in Phase 1a clinical trial of UCL-backed G-Quadruplex (G4) targeting treatment for solid tumors, including pancreatic cancer

Analysis Life Sciences Thank You 166 guidance documents the FDA is actively working on in 2024 (and beyond)

Buckle Up: DOJ Initiates Rulemaking to Reschedule Marijuana

Pfizer Investor Day Features Significant Number of Pipeline Advances for COVID-19 Programs and Across Numerous Therapeutic Areas

Rezafungin

BENZGALANTAMINE

Omaveloxolone

Revumenib

Lotilaner

TREOSULFAN

Acoramidis

Making a “Miracle” HIV Medicine

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