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The Issue with Reissue: PTE Edition

FDA Law Blog: Biosimilars

Merck applied for a patent term extension on the reissued patent, claiming the start of the regulatory review period as April 2004 and termination at the approval of the BRIDION NDA in December 2015. With this long regulatory review period, the PTO granted the statutory-maximum five-year patent term extension. The plain text of 35 U.S.C.

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USC-licensed startup NeOnc Technologies gets NASDAQ listing

Express Pharma

It was launched in 2004 with a $22 million endowment from Mark and Mary Stevens. Once we demonstrate this for brain cancer, the same approach could be used for any brain disease where theres a potential therapeutic effect, Chen said. USC Stevens works to move the discoveries of USC researchers from the lab to the marketplace.

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

European Pharmaceutical Review

Since establishing a dedicated pathway for biosimilars in 2004, the EU has aimed to balance rigorous evaluation with the practicalities of fostering competition and improving patient access to biologics.

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Beyond instruments: streamlining process technology implementation in biopharmaceutical manufacturing

European Pharmaceutical Review

Food and Drug Administration (FDA), 2004. Q13 Continuous Manufacturing of Drug Substances and Drug Products. International Council for Harmonisation (ICH), 2022. Q14 Analytical Procedure Development and Revision. Process Analytical Technology (PAT) A Guide for Industry. European Commission, 2015. Draft Annex 15: Qualification and Validation.

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FDA Approves Meloxicam Injection For Moderate-to-Severe Pain in Adults

Pharmacy Times

December 21, 2004. PR Newswire. June 10, 2025. Accessed June 10, 2025. Meloxicam: Selective COX-2 inhibition in clinical practice. Seminars in Arthritis and Rheumatism.

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Regulating decentralised manufacturing in the UK – a legal perspective

European Pharmaceutical Review

Available from: [link] Human Medicines Regulations 2012 and Medicines for Human Use (Clinical Trials) Regulations 2004. Under the Human Tissue Act 2004. [Internet] UK Government. Under the Blood Safety and Quality Regulations 2005. Internet] European Parliament.

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Acne

RX Note

Treatment of acne vulgaris with salicylic acid pads, 1992 The use of sulfur in dermatology, 2004 Tea tree oil is a product derived from the Australian Melaleuca alternifolia tree that possesses antimicrobial and anti-inflammatory properties.