Pharmaceutical Technology Editors

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.

As part of its support for novel nicotine replacement therapies, the agency published guidance on the development of these products.

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.

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.

The acquisition would strengthen Charles River’s contract research capabilities.

In a deal worth $530 million, the companies will develop and commercialize an anti-epileptic drug candidate in Europe.

The “hands-on” seminar will be held June 12–13, 2019 and will feature educational sessions and demonstrations in the company’s process laboratory.

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.

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

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

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

The approval expands use of the drug, Egaten (triclabendazole), which has been by the WHO since 2005 for treating liver fluke infestation.

The approval expands the indications for Sprycel (dasatinib) in Europe.

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

The Society of Plastics Engineers (SPE) Extrusion Division will host the SPE Minitec-PLUS polyethylene terephthalate (PET)/polylactic acid (PLA) Extrusion, a two-day event at the Polymers Center in Charlotte, NC, on May 1–2, 2019.

CatSci has announced an expansion of its offering to include end-to-end services with an additional focus on lead optimization.

Big data technology company, Aigenpulse, has been granted with International Organization for Standardization (ISO) 9001:2015 and ISO 27001:2013 certification.

Sharp has invested US$650,000 into enhancing its Interactive Response Technology (IRT) solution.

Zogenix has submitted an NDA to the US Food and Drug Administration and an MAA to the European Medicines Agency for FINTEPLA.

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.