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Deconstructing the Diligence Process: An Approach to Vetting New Product Theses

LifeSciVC

Additionally, for illustrative reasons this is geared towards a single target / product focus vs. broader platform diligence, though many of these mental models will apply for selecting targets and indications for a platform. In order to start building a case for or against a target, I like to start with genetics – first human and then mouse.

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Elacestrant 

New Drug Approvals

1] [8] Pharmacokinetics Elacestrant has an oral bioavailability of approximately 10%. [1] Jump up to: a b “Orserdu Product information” Union Register of medicinal products. 1] Additionally, elacestrant is a selective estrogen receptor degrader (SERD), meaning it induces the degradation of ER. [1] 18 September 2023.

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Gepirone

New Drug Approvals

5] History Gepirone was developed by Bristol-Myers Squibb in 1986, [5] but was out-licensed to Fabre-Kramer in 1993. Substitution of 2-(piperazin-1-yl)pyrimidine ( GEPI-001 ) with 1,4-dibromobutane ( GEPI-002 ), followed by ring opening and addition, generated the final product Gepirone. 1] It is taken orally. [1]

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Toxicology transformed: Why accuracy now leads the way

Drug Target Review

Purity and radioactive enrichment are key factors in ensuring the IS aligns with product specifications. For these studies, a comprehensive approach to drug metabolism and pharmacokinetics (DMPK), along with immunogenicity is essential, drawing on expertise from multiple disciplines.

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VALILTRAMIPROSATE

New Drug Approvals

Alzheon licensed ALZ-801 from NeuroChem and is developing it for Alzheimer’s disease. The product slowly crystallized. Clinical Pharmacokinetics and Safety of ALZ-801, a Novel Prodrug of Tramiprosate in Development for the Treatment of Alzheimer’s Disease. Clin Pharmacokinet. 2016 ; Abushakra et al., Hey JA, et al.

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Merck Strikes $1B+ Deal to Leverage Janux’s T Cell Engager Program Against Cancer

The Pharma Data

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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AbbVie Snatches Up Antibody from Harbour BioMed to Fight COVID-19 and Related Mutations

The Pharma Data

Harbour BioMed (HBM) announced with Utrecht University on Monday that they have licensed their fully human SARS-CoV-2 neutralizing antibody, 47D11, and its program to AbbVie. The product is designed for the prevention and treatment of COVID-19, along with related coronaviruses. Kate Krav-Rude/Shutterstock.