BioPharm International Editors

Pathios Therapeutics and Sygnature Discovery have signed a strategic and innovative partnership agreement aimed at accelerating Pathios’ drug discovery and development programs.

The multi-year agreement will give Novartis access to AbCellera’s expertise and state-of-the-art antibody discovery technology for up to ten clinically-relevant disease targets.

The companies will use a $4.4-million grant from the National Institute of Allergy and Infectious Diseases to discover sustainable alternatives to shark squalene to use as vaccine adjuvants.

GS1, a global supply-chain standards organization, launched a new messaging standard in collaboration with GS1 US to help meet the requirements of the US Drug Supply Chain Security Act (DSCSA) for salable returns of serialized prescription drugs.

C-Bridge Capital will form a new biopharmaceutical company, AffaMed Therapeutics, which will collaborate with Samsung Bioepis to accelerate clinical development and registration of Samsung Bioepis’ next-generation biosimilars in China.

Caron’s Wally CO2 incubators for laboratories are now available for purchase in the European Union.

The company will expand its global R&D footprint at its facility in Billerica, MA, with a $70-million investment.

The companies will jointly develop and commercialize an investigational bifunctional fusion protein immunotherapy currently in clinical development for cancer treatment.

Supply chain players are eligible to participate in FDA’s pilot program to develop an electronic system for tracking drug products.

PDA survey and conference discussion will generate information to guidance on technology transfer.

The companies will develop a software-connected pipetting system for improved reproducibility and traceability in life-science laboratories.

The US District Court for the Western District of Pennsylvania entered into a consent decree of permanent injunction against Ranier’s Rx Laboratory Inc., a compounding facility.

Researchers used magnesium particles as tiny motors to deliver an oral vaccine against the bacterial pathogen Staphylococcus aureus.

A study funded by the National Institutes of Health has created a virtual library expected to expand the availability of “make-on-demand” molecules for drug discovery.

PCI Pharma Services expanded capacity of its commercial packaging site in Illinois.

The agency recommended six medicines for approval at its January 2019 meeting, including treatments for lung cancer, HIV-1, and autoimmune disorders.

The US Pharmacopeial Convention’s new plan will include new and revised quality standards and activities to support the development of new generic drugs.

In a deal potentially worth up to $460 million, Genentech and Xencor will develop and commercialize novel cytokine therapeutics.

The company will open its first European manufacturing facility in Castlebar, Ireland.

A solid lipid excipient from ABITEC is designed for multiple dosing forms.

Company launches new services dedicated to emerging biotech and biopharma companies.

TrakCel and WindMIL Therapeutics have formed a partnership to build a custom-configured cellular supply chain tracking and orchestration platform.

Sphere Fluidics has closed its latest investment round in which it raised US$2 million (approximately £1.5 million).

The acquisition will boost Hitachi Chemical’s presence in the European regenerative medicines market.

Janssen and MeiraGTx will collaborate on the development and commercialization of gene therapies for treating inherited retinal diseases.

Formulatrix’s FLO i8 and Flow Axial Seal Tip liquid handlers offer automated transferring.

In a statement, FDA Commissioner Scott Gottlieb announced the agency’s plans to publish guidance to promote the development of complex generic drugs.

SGS announces expansion of cell bank and bulk harvest testing services.

CDMO leader Marc Funk will succeed Ridinger as CEO of Lonza.

Parker Bioscience Filtration added a cleanroom at its site in Birtley, UK for manufacturing single-use assemblies and sensors used in biopharmaceutical processing.