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Valitacell and Solentim, have announced a collaboration aimed at the acceleration of discovery and development of biologic drugs and advanced cell therapies.

A multi-partner collaboration has been announced, which will target the acceleration of the development of automated microfluidic systems for rapid and high-throughput gene editing in mammalian cell lines.

In a statement, FDA Commissioner Scott Gottlieb laid out the case for the safety and effectiveness of generic drugs compared to brand drugs.

Mustang intends to combine an oncolytic virus with an interleukin-13 Rα2-(IL13Rα2)-specific chimeric antigen receptor to potentially enhance efficacy in treating glioblastoma multiforme.

Teva will apply Insilico’s technology for predictive biomanufacturing to create more efficient biomanufacturing processes.

The Swiss Agency for Therapeutic Products has begun entering GMP compliance information in the European Union’s EudraGMDP database.

India’s Bharat Biotech is set to acquire GlaxoSmithKline’s Chiron Behring Vaccines, a World Health Organization-prequalified global manufacturer of rabies vaccines.

The USP Quality Institute’s third fellow in its Fellowship in Quality Medical Products program will study the role of poor-quality medicines in fostering antimicrobial resistance.

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.

FDA came away with the largest boost in its annual budget in a decade as part of the final spending package approved by Congress this week.

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.