The 65,000-square-foot facility is designed with the capacity and capability to help scale the next generation of CGTs for human trials and beyond. eXmoor pharma, the full-service cell and gene therapy (CGT) manufacturing partner, launched its new Cell and Gene Therapy Centre good manufacturing practice (GMP) facility on Oct.
Salipro Biotech and Icosagen have entered a multi-target collaboration to discover and characterize monoclonal antibodies. Sweden-based Salipro Biotech and Estonia-based Icosagen, a contract research, development, and manufacturing organization, announced on Oct. 10, 2023 that they have entered into a multi-target antibody research agreement to advance drug discovery programs. The companies
The companies will co-promote GSK’s shingles vaccine, Shingrix, to healthcare professionals and points of vaccination in China. Global biopharma company, GSK, has entered an exclusive strategic partnership with Chongqing Zhifei Biological Products Co. (Zhifei)—a fully-integrated biotechnology company—to co-promote GSK’s shingles vaccine, Shingrix, to healthcare professionals and
Roche will gain exclusive worldwide rights to develop, manufacture, and commercialize Ionis’ investigational RNA-based therapeutic candidates for Alzheimer's and Huntington's disease. Roche has entered into an agreement with Ionis Pharmaceuticals for two undisclosed early stage programs for RNA-targeting investigational therapeutics for treating Alzheimer's disease
The Janssen Pharmaceutical Companies of Johnson & Johnson have requested an extension to the indication application of its fully-human, bispecific antibody treatment, Rybrevant (amivantamab). The submission was announced in an Oct. 6, 2023 company press release. In the Type II extension request, submitted to the European Medicines Agency (EMA), Janssen
The program will improve access to adeno-associated virus gene therapy vectors. On Oct. 10, 2023, the National Institute for Innovation in Manufacturing Biopharmaceuticals (NIIMBL) announced the launch of the Viral Vectors NIIMBL-led program. The program will be focused on developing available, economically viable manufacturing processes and analytical platforms for adeno-associated
Spinning off Sandoz allows Novartis to focus on the areas of cardiovascular, immunology, renal and metabolic, and oncology. On Oct 4, 2023, Novartis announced it has completed its plan to spin-off Sandoz, its generics and biosimilars business, into an independent company. The spin-off took place through a dividend-in-kind distribution to
Orakl Oncology has raised funds to develop its precision oncology platform and accelerate drug development. Orakl Oncology—a precision oncology start-up spun out of the Gustave Roussy Institute in France—has fundraised €3 million (US$3.2 million) to develop its techbio platform, which enables the identification of relevant targets
East Rutherford, NJ – October 2, 2023 – Cambrex today announced the completion of its $38 million capacity expansion at its small molecule active pharmaceutical ingredient (API) manufacturing facility in High Point, North Carolina. This expansion doubles the facility’s manufacturing capacity, with new state-of-the-art analytical and chemical development laboratories, two new
Eli Lilly and Company has received a complete response letter from FDA for its anti-dermatitis biologic therapeutic, lebrikizumab. Eli Lilly and Company (Lilly) announced on Oct. 2, 2023 that it received a complete response letter (CRL) from FDA for the biologics license application (BLA) for lebrikizumab, a candidate for treating
The commission’s membership will help facilitate reach and impact for standards harmonization. The US Pharmacopeia (USP) announced on Oct. 5, 2023, that the Indian Pharmacopoeia Commission (IPC) is now a member of the Pharmacopoeial Discussion Group (PDG). The PDG was established by the European Pharmacopoeia Commission (Ph. Eur.), Japanese