Pharmaceutical Technology Editors

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.

In a partnership with Thermo Fisher Scientific Pharma Services, Pacira added a manufacturing suite in Swindon, UK, that doubles the company’s capacity by mirroring the company’s facility in San Diego, CA.

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.

The strategic partnership is expected to bring a new source of supply to providers, alleviating in particular the two-year shortage of metoprolol injection.

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

The final part of the European Falsified Medicines Directive (EU FMD) is to come into force on Feb. 9, 2019, which means that all medicines within the European Union will need to comply with the safety features as laid out by the delegated regulation.

Nine award winners from the 2019 edition of Pharmapack Europe, covering innovations across drug delivery, packaging, and materials and components, have been announced by the event organizers.

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.

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