Deals, Development and Manufacturing

A request has been made to the CHMP by the executive director of EMA to provide guidance on how to avoid the presence of nitrosamine impurities in human medicines.

Procarta Biosystems has received an award from CARB-X, potentially worth $9.2 million, for the development of antibiotic precision medicines.

The merger creates a combined organization with a leading position in the eClinical market.

Colorcon Ventures looks to fund promising startups in drug manufacturing, delivery, and supply chain.

The acquisition will enhance Lundbeck’s brain disease therapy portfolio as well as its antibody process and development capabilities.

The acquisition gives PPF a 19.2% stake in Autolus and provides a pipeline of cell therapy product candidates.

The companies aim to integrate glucose sensing with insulin delivery technologies to help change the way diabetes is managed.

The venture will focus on single-use and modular systems designed to develop novel biotherapeutics.

BioCity has invested in Maxwellia, a company based at Alderley Park in the United Kingdom that is driving industry movement towards self-care therapeutics.

BIA has signed a memorandum of understanding with AstraZeneca and the Wuxi International Life-science Innovation Campus (I-Campus) to boost access for UK SMEs in China.

TrakCel and McKesson have formed a collaboration that is aimed at accelerating commercialization of cell and gene therapies by leveraging services to enable a more efficient development pathway.

The companies will develop and commercialize a Phase III cell therapy candidate for treating chronic low back pain in a deal worth potentially $1 billion.

Passage Bio has licensed a sixth gene therapy development program under its partnership with the University of Pennsylvania for the clinical development of a potential treatment for a nerve disorder.

Bayer will use ProBioGen’s GlymaxX technology to maximize the potency of its antibody drug candidate in development for oncological indications.

The new antibody, Citryll’s CIT-013, could offer new treatment options for various human diseases including lupus, vasculitis, pulmonary fibrosis, and organ damage due to sepsis.

Roche has extended its offering period for the purchase of Spark to provide US and UK regulatory authorities with additional time to complete their review of the acquisition.

Vertex will use the acquisition to develop cell-based treatments for type 1 diabetes.

Valo Therapeutics has acquired a technology from Helsinki University that is expected to broaden its approach and expand the capability of its cancer vaccines platform, PeptiCRAd.

PCI has divulged that it is making significant investment at its site near Dublin, Ireland to strengthen its position globally and to ensure pharmaceutical supply is uninterrupted for its customers after Brexit.

The partnership will provide cost effective biologics for the world market.

The joint venture, named BacThera, will operate out of headquarters in Basel, Switzerland and will serve pre-clinical to Phase II projects, with the ability to expand to Phase III and commercial manufacturing in the future.

A global agreement with Polpharma Biologics gives Sandoz commercialization rights to a proposed biosimilar natalizumab for relapsing-remitting multiple sclerosis.

Velabs Therapeutics announced it has deepened its cooperation with Chiome Biosciences to incorporate functional antibody screening as a result of a successful feasibility study.

BioCity has revealed it will be investing in Kinomica, an early-stage precision medicine biotech company that was spun out of Barts Cancer Institute, Queen Mary University of London.

Alvotech and Prestige Biopharma, have announced the formation of a new contract manufacturing partnership for the commercial production of a biosimilar.

A collaboration between Insilico Biotechnology and IFAT aims to develop a manufacturing, planning, and control system for the production of monoclonal antibodies.

The transaction will reach completion during the fourth quarter of 2019.

LBB Specialties and Meggle Excipients & Technology will work to distribute excipient products to companies in the American pharmaceutical and nutraceutical industries.

The partners will collaborate to identify the bioactive components in hydrolysates, which have long been used as additives in cell culture media and feed formulation in the biopharma industry.

The transaction is part of Bristol-Myers Squibb’s proposed acquisition of Celgene.