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New biosimilar pathways – key takeaways from the EMA’s draft reflection paper

European Pharmaceutical Review

Guideline On Similar Biological Medicinal Products Containing Biotechnology-Derived Proteins As Active Substance: Non-Clinical and Clinical Issues, EMEA/CHMP/BMWP/42832/2005 Rev1. Document 9286/25. European Medicines Agency. Guillen E, Ekman N, Barry S, et al. 2023;113:108-123. Brussels: Council of the European Union; 2 June 2025.

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Beyond instruments: streamlining process technology implementation in biopharmaceutical manufacturing

European Pharmaceutical Review

To give examples, such a work package focuses on the identification of regulations (ICH Q2 R2, 3 Q8-Q14, 4-10 FDA PAT guidance, 11 EMA Annex 15 12 ), some of which may be mainly guidance documents with recommendations and flexibility when it comes to PAT.

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Regulating decentralised manufacturing in the UK – a legal perspective

European Pharmaceutical Review

Master file the manufacturing dossier in which the main regulatory documents are collected and to which all subordinate sites refer. Under the Blood Safety and Quality Regulations 2005. Other manufacturing sites are subordinate to the control site and do not need their own separate regulatory approvals. One file per product.

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What You Need to Know as a Breastfeeding Hashi’s Mama

The Thyroid Pharmacist

2005 Sep;51(9):1209-11. The effect of fennel (Foeniculum Vulgare) seed oil emulsion in infantile colic: a randomized, placebo-controlled study. Altern Ther Health Med. 2003 Jul-Aug;9(4):58-61. PMID: 12868253. 139] Rogovik AL, Goldman RD. Treating infants’ colic. Can Fam Physician. PMID: 16190173; PMCID: PMC1479474. 140] Romm A.

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207 community hospital presidents and CEOs to know | 2025

Beckers Hospital Review

Mr. Kleinhanzl has also championed the use of AI documentation tools like Dragon DAX and Dragon Co-Pilot to combat clinician burnout and enhance care delivery. Dr. Unger became president and CEO of Poudre Valley Hospital — the hospital where he was born — in 2005. and UCHealth Medical Center of the Rockies (Loveland, Colo.).

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EU fines Teva and Cephalon €60.5m for ‘pay for delay’ scheme

pharmaphorum

Although Teva and Cephalon are now the same company, the case dates back to June 2005 when the firms were separate entities. The deal was agreed well before Teva bought Cephalon in 2011 for $6.8 billion and involved a complex series of transactions instead of an up-front payment.

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The Ripple Effect: How Pharmaceutical Advertisements Impact the Industry and Beyond

Pharma Marketing Network

Narrative review: the promotion of gabapentin: an analysis of internal industry documents. Knopf Doubleday Publishing Group. Goozner, M. The $800 Million Pill: The Truth Behind the Cost of New Drugs. University of California Press. Steinman, M. Landefeld, C. S., & Bero, L. Annals of Internal Medicine, 155(1), 43-53.