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

European Pharmaceutical Review

4,6 Traditional Herbal Registration The Traditional Herbal Medicines Directive (Directive 2004/24/EC) is implemented in the UK by the Medicines (Traditional Herbal Medicinal Products for Human Use) Regulations 2005 and came into force on 30 April 2011. 13 Currently, over 350 herbal remedies have been granted a THR licence. 2012/1916).

Marketing 103
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T-cell targeting Candid Therapeutics launches with $370m

Pharmaceutical Technology

The new biotech has inherited two T cell engager antibodies as part of a three-way merger with Vignette and TRC 2004.

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Optimus Drugs Pvt. Ltd.-Walk-In Interview for Quality Control/ Microbiology 11th Jan’ 2023

Pharma Pathway

Ltd was Established in the year 2004 as Custom synthesis laboratory by a team of Technocrats. Optimus Drugs Pvt. Walk-In Interview for Quality Control/ Microbiology 11th Jan’ 2023. Job Description. Optimus Drugs Pvt. It is one off the fastest growing Manufacturer in Active Pharmaceutical Ingredients (APIs) and dosages.

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European Commission revokes marketing authorisation for Novartis’ crizanlizumab

European Pharmaceutical Review

Novartis said the decision to revoke the authorisation was based on a review of crizanlizumab under Article 20 of Regulation (EC) No 726/2004. If new data show that the medicine’s benefits no longer outweigh its risks, EMA can take regulatory action, such as suspending or revoking the marketing authorisation.

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2022 spells change for EU pharmaceutical legislation

European Pharmaceutical Review

Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency (Text with EEA relevance).

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EMA revises guidance on nitrosamine impurities

European Pharmaceutical Review

The assessment report of the Committee for Medicinal Products for Human Use (CHMP)’s Article 5(3) of Regulation (EC) No 726/2004 opinion on nitrosamine impurities in human medicinal products offers guidance and recommendations on mitigation and prevention of nitrosamine-contaminated human medicinal products.

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Teva appoints Eric Hughes as head of R&D and Chief Medical Officer

European Pharmaceutical Review

At the beginning of his career in 2004, Dr Hughes was responsible for early clinical research at Bristol Myers-Squibb Company and then at Schering-Plough Research Institute. .” Since September 2021, Dr Hughes has been Senior Vice President of Clinical Development and Translational Medicine at Vertex Pharmaceuticals, based in Boston.

Medical 98