UK approves world's first therapy with gene scissors

Developers of the Crispr method were awarded the Nobel Prize in 2020: a drug using the gene scissors has now been approved for the first time

17-Nov-2023 - (dpa) In the UK, a drug based on the gene-scissor technology Crispr has been approved for the first time worldwide. This was announced by the Medicines and Healthcare products Regulatory Agency (MHRA) on Thursday. The drug, called "Casgevy", has been approved for the treatment of sickle cell ...

Rentschler Biopharma’s ATMP facility in Stevenage, UK, receives MHRA approval

UK site now set for clinical production of adeno-associated virus (AAV) vectors for gene therapy

14-Sep-2023 - Rentschler Biopharma SE, a leading global contract development and manufacturing organization (CDMO) for biopharmaceuticals, including advanced therapy medicinal products (ATMPs), announced that it has received the cGMP Manufacturing Compliance Certificate, following the successful inspection by ...

Successful MHRA Inspection of Almac’s Clinical Services UK Facility

28-Sep-2012 - Almac announced the successful inspection of its Clinical Services operations located in Craigavon by the UK Medicines and Healthcare products Regulatory Agency (MHRA). The inspection, which occurred from 17th to 20th September 2012, was a routine inspection conducted by a MHRA inspector from the ...

MHRA Issues GMP Certification to AMRI UK Facility

19-Jan-2012 - AMRI announced that the Medicines and Healthcare Regulatory Agency (MHRA) of the UK government has issued a Good Manufacturing Practice (GMP) certificate for AMRI's manufacturing facility in Holywell, Wales, UK, following an inspection in October 2011. The MHRA inspection follows a U.S. Food and ...

MediGene Receives Authorization for the Clinical Formulation Study of RhuDex

01-Nov-2011 - MediGene AG announced that the United Kingdom Medicines and Healthcare Products Regulatory Agency (MHRA) granted the authorization of the planned clinical formulation study of RhuDex®, a drug candidate being developed for the treatment of rheumatoid arthritis. The objective of the RapidFACTTM ...

Medigene's RhuDex Clinical Development to Continue Following Feedback from Regulatory Authorities

07-Oct-2009 - MediGene AG received feedback from the UK MHRA (Medicines and Healthcare products Regulatory Agency) regarding the in-vitro studies conducted with the drug candidate RhuDex(TM) for the treatment of rheumatoid arthritis. These in-vitro studies examined potential effects of RhuDex(TM) on the ...

Quotient Clinical Receives MHRA Supplementary Accreditation

08-Jul-2009 - Quotient Clinical announces that it has been awarded Supplementary Accreditation from the Medicines and Healthcare products Regulatory Agency (MHRA). This is one of the highest levels of accreditation in Europe and confirms that Quotient Clinical is qualified to perform the full range of Phase I ...

Intercell Receives Manufacturer's Licence for Future Commercial Manufacturing of its Vaccine Against Japanese Encephalitis

Intercell receives Manufacturer's Licence for its site in Livingston, Scotland

18-Jan-2008 - Intercell AG announced that its fully owned manufacturing site in Livingston, Scotland (Intercell Biomedical Ltd.), has been granted the Manufacturer's Licence for the commercial manufacturing of its vaccine against Japanese Encephalitis. The issuance of the license is following a GMP (Good ...