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Navigating Regulatory Hurdles in Drug Development

DrugBank

A well-known example is Merck’s rofecoxib , approved for pain relief in 1999 but withdrawn from the market in 2004 due to cardiovascular risks that were not sufficiently monitored during post-market surveillance. This means pharmaceutical companies must remain vigilant and adaptable to comply with evolving regulations.

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Gepirone

New Drug Approvals

2] Gepirone was synthesized by Bristol-Myers Squibb in 1986 and was developed and marketed by Fabre-Kramer Pharmaceuticals. [4] 5] History Gepirone was developed by Bristol-Myers Squibb in 1986, [5] but was out-licensed to Fabre-Kramer in 1993. 1] It is taken orally. [1] 1] It is taken orally. [1] J Clin Psychopharmacol.

FDA 62
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Crinecerfont

New Drug Approvals

gmol 1 3D model ( JSmol ) Interactive image show SMILES show InChI Prete A, Auchus RJ, Ross RJ: Clinical advances in the pharmacotherapy of congenital adrenal hyperplasia.

FDA 62
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VALILTRAMIPROSATE

New Drug Approvals

After tramiprosate failed in Phase 3, its maker, NeuroChem, marketed it as a nutritional supplement. 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.

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

LifeSciVC

Different investors will have comfort with varying “starting points” in the drug discovery funnel; company builders will likely have experience across the spectrum from target nomination to Phase 2 asset in-license, while other investors may prefer to invest at development candidate (DC) nomination stage or later. Consider Fig.

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Everest Medicines Announces Amended Agreement with Spero Therapeutics

The Pharma Data

Spero plans to initiate additional Phase 1 studies to assess the penetration of SPR206 into the pulmonary compartment and pharmacokinetics in subjects with renal impairment in 2021. SHANGHAI , Jan. In addition, no evidence of nephrotoxicity was observed in the study.

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Selva Therapeutics Announces First Dosing in Phase 1 Clinical Study of SLV213, a Potential Oral Treatment for COVID-19

The Pharma Data

We now have compelling data showing SLV213 has potent antiviral activity against SARS-CoV-2 as well as data on the safety, tolerability, and pharmacokinetics and pharmacodynamics of SLV213 in several preclinical model systems, including nonhuman primates,” said Felix Frueh, Ph.D., Cofounder and Chief Scientific Officer of Selva Therapeutics.