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WHO establishes the Global Centre for Traditional Medicine in India

The Pharma Data

The World Health Organization (WHO) and the Government of India today signed an agreement to establish the WHO Global Centre for Traditional Medicine. I’m grateful to the Government of India for its support, and we look forward to making it a success.”. Around 80% of the world’s population is estimated to use traditional medicine.

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Mechanisms, Challenges, and Future Use Cases of Epigenetic Drugs

DrugBank

Epigenetic changes are governed by chemical modifications such as DNA methylation, histone modifications, RNA-mediated processes, and all-controlling chromatin structure and gene accessibility. These mechanisms form a complex, reversible regulatory network governing cellular identity and behavior.

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Separating the Hype from the Hyperbole Surrounding FDORA’s Alternatives to Animal Testing under the FD&C Act

FDA Law Blog: Drug Discovery

While these changes to the IND and the biosimilarity provisions represent real changes to the words governing FDA’s authority under the FD&C Act, we think it is worth asking just how measurable and immediate an impact they will have on day-to-day decision-making of the FDA and its review staff. 42 U.S.C. § 262(k)(2)(A)(i)(I).

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Amgen To Acquire Privately Held Teneobio For $900 Million In Cash With Future Contingent Milestone Payments

The Pharma Data

. “Over the last five years, Teneobio developed leading-edge expertise in efficiently engineering differentiated multispecific and bispecific therapeutics for numerous indications with potentially better safety, efficacy and pharmacokinetic profiles than the first generation of T-cell engagers. ” In June 2021, AbbVie Inc.

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Novartis announces positive results from Phase II study of LNP023 in patients with paroxysmal nocturnal hemoglobinuria (PNH)

The Pharma Data

About the Study NCT03439839 is a Phase II, multicenter, open-label, sequential 2-cohort trial to assess the safety, efficacy, tolerability and pharmacokinetics/pharmacodynamics of LNP023 in PNH patients (cohort 1: n=10) with active hemolysis despite treatment with eculizumab.

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Hepion Pharmaceuticals Completes 75 mg CRV431 Dosing, Initiates 225 mg Dosing in Phase 2a ‘AMBITION’ Clinical Trial for NASH

The Pharma Data

The open-label Phase 2a ‘AMBITION’ study is designed to assess safety, tolerability, pharmacokinetics and biomarker analyses for early assessments of efficacy of 75 mg and 225 mg CRV431, administered orally to F2 and F3 NASH patients (n=18/dosing group), once daily for 28 days.

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Molecular Partners Doses First Cohort in Phase 1 Trial of COVID-19 DARPin(R) Therapeutic Candidate MP0420

The Pharma Data

Molecular Partners is also collaborating with AGC Biologics, Baccinex, and Ivers-Lee Clinical Supply Management (IL-CSM) to support development of its anti-COVID-19 program, and has reached an agreement with the Swiss Government regarding rights to purchase up to 3.2 About Molecular Partners’ anti-COVID-19 program.

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