The main goal of the Phase IIb study wasn't met with statistically significant results, but there is still some good news On Dec. 18, 2024, Roche shared results from a Phase IIb study (PADOVA) where prasinezumab, an investigational monoclonal antibody (mAb), did not meet the study’s primary
Novo Nordisk will establish a modular, adaptable production facility in Odense, Denmark Novo Nordisk announced a $1.2 billion production plant in Odense, Denmark, on Dec. 16, 2024. The facility will house present and future hemophilia treatment products. In a press release, Novo Nordisk said this investment is its first
Lilly will invest $3 billion in its newly purchased Wisconsin manufacturing site, and Amgen will invest $1 billion in North Carolina. Companies Amgen of Holly Springs, North Carolina, and Eli Lilly and Company (Lilly) of Kenosha County, Wisconsin, have each declared intentions to increase production capacity. Amgen has announced a
The new system for reporting medication shortages by holders of market authorizations is now active With the launch of its primary functions, the European Shortages Monitoring Platform (ESMP) was announced by the European Medicines Agency (EMA) on November 28, 2024. With the help of ESMP, MAHs can regularly report shortages
Eladocagene exuparvovec-tneq (Kebilidi) is the first FDA-approved gene therapy for AADC deficiency The FDA has approved eladocagene exuparvovec-tneq (Kebilidi, PTC Therapeutics), a gene therapy using an adeno-associated virus vector, for the treatment of both adult and pediatric patients with aromatic L-amino acid decarboxylase (AADC) deficiency. Kebilidi is the first gene
Eisai Europe and Biogen received encouraging feedback for monoclonal antibody therapy for early Alzheimer's disease in adults The Committee for Medicinal Products for Human Use (CHMP) at the European Medicines Agency (EMA) has given a positive opinion to Eisai Europe and Biogen regarding the use of the amyloid-beta
Oblenio Bio is granted the only right to license LBL-051, a novel CD19xBCMAxCD3 tri-specific T-cell engager antibody, from Leads Biolabs. On November 7, 2024, Aditum Bio and Leads Biolabs announced the formation of a new company, Oblenio Bio, in conjunction with an exclusive option and license agreement to develop LBL-051,
The company is spending $76 million to make its St. Louis, Missouri, factory able to make more ADCs. MilliporeSigma, the US and Canada Life Science division of Merck KGaA, Darmstadt, Germany, shared on Oct. 29, 2024, that it will invest $76 million to enhance manufacturing capabilities for antibody-drug conjugates (ADCs)
REGiMMUNE/Kiji TX, a company that specializes in regulatory T cells, will be formed from this merger On October 18, 2024, REGiMMUNE and Kiji Therapeutics shared their plans to merge, forming a new specialty company called REGiMMUNE/Kiji TX. This company will focus on developing drugs that target regulatory T
This new center intends to speed up R&D, cut expenses, and find new candidate cures faster BioDuro-Sundia, a contract research, development, and manufacturing organization (CRDMO) based in Irvine, California, made the announcement on October 2, 2024 that it has established its new Compound Management Center in the Shanghai
Thermo Fisher Scientific launched its Accelerator Drug Development in 2024 after expanding R&D, production, and testing locations in Cincinnati, Ohio, and Bend, Oregon On October 7, 2024, Thermo Fisher Scientific shared exciting news about the launch of the Accelerator Drug Development. This initiative offers comprehensive contract development and
SGD Pharma will exhibit its siliconized molded glass vials at CPHI Milan as part of its sustainable offerings SGD Pharma, a worldwide supplier of pharmaceutical glass packaging solutions, shared on Oct. 1, 2024, that it will showcase a new variety of products and services at CPHI Milan in Milan, Italy,