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The company will invest an additional $60 million to expand its manufacturing facility in Durham County, NC.

The agency clarified the process for development programs for regenerative medicine therapies.

Ireland’s National Institute for Bioprocessing Research and Training received funding from the Science Foundation Ireland’s Technology Innovation Development Award program for monoclonal antibody research.

Catalent adds position of president and chief operating officer to lead sales and quality efforts.

The partnership will expand Lonza’s offering of hematopoietic cell lines.

The two countries have been included in the mutual recognition agreement between the EU and US for GMP inspections.

The guidance explains the process of applying for competitive generic therapy designation.

A taskforce evaluated the advantage of using Big Data in the evaluation of the benefits versus risks of medications.

The drug is approved in the United States specifically for treating acquired thrombotic thrombocytopenic purpura, a rare blood-clotting disorder.

The partners will collaborate on the development and commercialization of a B-cell maturation antigen-targeting immunotherapeutic for treating multiple myeloma.

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.