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Ichnos Glenmark Innovation presents first clinical data from phase 1 study of Trispecific TREAT Antibody, ISB 2001

Express Pharma

ISB2001 Phase 1 Dose Escalation Study Design The Phase 1, first-in-human, open-label study is evaluating the safety and anti-myeloma activity of ISB2001 in patients with RRMM. The post Ichnos Glenmark Innovation presents first clinical data from phase 1 study of Trispecific TREAT Antibody, ISB 2001 appeared first on Express Pharma.

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FDA Releases Draft CPG on Major Food Allergen Labeling and Cross-Contact

FDA Law Blog: Biosimilars

Food and Drug Administration (FDA) released a draft update to its Compliance Policy Guide (CPG) for FDA staff on the Agency’s enforcement of major food allergen labeling and cross-contact. The draft CPG directs FDA field staff to examine possible food product adulteration due to labeling related to allergen cross-contact.

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Heart failure: clinical trials update 2022

European Pharmaceutical Review

NTLA-2001, a novel CRISPR/Cas9-based therapy in the first-ever human gene editing trial ( NCT04601051 ) in vivo (in the body), reduced transthyretin (TTR) proteins by at least 90 percent in amyloidogenic transthyretin (ATTR) cardiomyopathy patients, 28 days after a single IV infusion, with benefits lasting four to six months.

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Nuclear Pharmacist by Day, DJ by Night

Pharmacy Is Right For Me

I worked in Dallas from 95-2001, then moved to NYC, then years later went to the University of Colorado for the NTPD program and received the PharmD. My evenings involve music production, radio show production, podcast production, reviewing new music sent by labels/music promoters, and preparing for gigs.

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Botanical drugs – what is the best way forward for regulatory and market approval?

European Pharmaceutical Review

However, as with drugs, dietary supplements require evidence that they are safe and that claims on product labels are truthful and not misleading. 20 Good manufacturing practice (GMP) Commission Directive (EU) 2017/1572 (which supplemented Directive 2001/83/EC) lays out the principles and guidelines of GMP in the EU. 2012/1916).

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Drugs and Lactation

RX Note

However, the FDA published the Pregnancy and Lactation Labelling Rule (PLLR) on 3 December 2014, which requires data on medication transfer into breast milk to be included in the product inserts of prescription drug and biologic product applications submitted after 30 June 2015, while labelling for prescription drugs approved on or after 30 June 2001, (..)

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EU pharmaceutical legislation revisions: what are the implications for biopharma?

European Pharmaceutical Review

Draft Report on the proposal for a directive of the European Parliament and of the Council on the Union code relating to medicinal products for human use, and repealing Directive 2001/83/EC and Directive 2009/35/EC. analysis (Source: L.E.K) Internet] 2023. cited 2023Dec] Available from: [link] European Parliament.