New Drug Approvals

OCTOBER 12, 2024

Alzheon licensed ALZ-801 from NeuroChem and is developing it for Alzheimer’s disease. Clinical Pharmacokinetics and Safety of ALZ-801, a Novel Prodrug of Tramiprosate in Development for the Treatment of Alzheimer’s Disease. Clin Pharmacokinet. 2007 ; Kocis et al., 2016 ; Abushakra et al., 2018; 32(9): 849–861. [2].

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The Pharma Data

DECEMBER 17, 2020

Previous technologies have been constrained by dose-limiting toxicities, poor pharmacokinetic profiles, and attenuated efficacy. Janux’s proprietary TRACTr technology is designed to integrate tumor-specific activation with crossover pharmacokinetics to produce best-in-class T cell engager therapeutics. It’s a big bet for Merck.

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Immune Response Pharmacokinetics Engineering Licensing 52

New Drug Approvals

OCTOBER 24, 2023

Peyrin-Biroulet L, Christopher R, Behan D, Lassen C (May 2017). Retrieved 13 October 2023. ^ [link] ^ World Health Organization (2017). . | twitter +919321316780 call whatsaapp EMAIL. “Velsipity (etrasimod) tablets, for oral use” (PDF). . 16 (5): 495–503. doi : 10.1016/j.autrev.2017.03.007. 2017.03.007. PMID 28279838.

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FDA Law Blog: Drug Discovery

FEBRUARY 2, 2023

The 2017 Predictive Toxicology Roadmap laid out some of the FDA’s thinking around the need for new toxicology methods driven in part by a desire to find alternatives to animal testing. 42 U.S.C. § 262(k)(2)(A)(i)(I). However, there are signs that FDA is receptive from a policy perspective to alternative methods.

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Animal Testing Biosimilars Cell Based Assays FDA 64

The Pharma Data

MARCH 22, 2021

In December 2017, Roche licensed the investigational molecule from Ionis Pharmaceuticals. Tominersen, previously IONIS-HTTRx or RG6042, is an investigational antisense therapy designed to reduce the production of all forms of the huntingtin protein (HTT), including its mutated variant, mHTT.

Disease 52

Disease Clinical Trials Pharmacokinetics Treatment 52

Agency IQ

AUGUST 16, 2024

The June 2023 guidance recommends that studies involve two monitors (one with graduate-level professional training and clinical experience in psychotherapy, licensed to practice independently) to observe study participants during treatment sessions. At that time, FDA flagged concerns with functional unblinding and inherent expectation bias.

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The Pharma Data

JANUARY 3, 2021

The Phase 1/2 clinical trial will primarily investigate the safety and tolerability of INZ-701 and characterize its pharmacokinetic and pharmacodynamic profile, including plasma pyrophosphate (PPi) and other biomarker levels, to establish a recommended dosing regimen for further clinical development. Demetrios Braddock, M.D.,

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