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Rentschler Biopharma

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
  • Highly experienced team ready to support ATMP innovators at all stages
  • Offering comprehensive range of services from early process and analytical development through cGMP manufacturing for clinical trials

Stevenage, UK and Laupheim, Germany, September 13, 2023– Rentschler Biopharma SE, a leading global contract development and manufacturing organization (CDMO) for biopharmaceuticals, including advanced therapy medicinal products (ATMPs), today announced that it has received the cGMP Manufacturing Compliance Certificate, following the successful inspection by the UK Medicines & Healthcare Products Regulatory Agency (MHRA) at its UK site. The ATMP business was announced in early 2021 and the facility is located in the Cell and Gene Therapy Catapult’s Manufacturing Innovation Centre in Stevenage.

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Thermo Fisher Scientific

Thermo Fisher Scientific and National Minority Quality Forum Collaborate to Make Clinical Research More Accessible to Historically Underserved Communities

WALTHAM, Mass.--(BUSINESS WIRE)-- Thermo Fisher Scientific Inc. (NYSE: TMO), the world leader in serving science, and the National Minority Quality Forum (NMQF), an independent not-for-profit research and education organization, today announced a collaboration to help bring clinical research to historically underserved patient populations through NMQF’s Alliance for Representative Clinical Trials (ARC). The collaboration supports biopharmaceutical and biotech customers in meeting regulatory expectations to enroll and retain patients in clinical trials who more fully reflect real-world populations experiencing the disease or health condition being studied, including U.S. Food and Drug Administration requirements around diversity action plans.

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Abbott

Abbott to Acquire Bigfoot Biomedical, Furthering Efforts to Develop Personalised, Connected Solutions for People with Diabetes

  • Bigfoot developed Bigfoot Unity, a smart insulin management system that features the first and only FDA-cleared connected insulin pen caps that turn data from a continuous glucose monitor (CGM) into clear and reliable insulin dosing recommendations displayed right on the insulin pen cap
  • Acquisition will bring together two leaders in different aspects of diabetes care: CGM and insulin injection support
  • Together, Abbott and Bigfoot will continue to advance technology-driven solutions for making diabetes management even more personal and precise

ABBOTT PARK, Ill. and MILPITAS, Calif., Sept. 5, 2023 /PRNewswire/ -- Abbott (NYSE: ABT) and Bigfoot Biomedical today announced a definitive agreement for Abbott to acquire Bigfoot, a leader in developing smart insulin management systems for people with diabetes.

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