Pharmaceutical Technology Editors

FDA approved Ryplazim (plasminogen, human-tmvh) for the treatment of plasminogen deficiency type 1.

FDA has granted Janssen breakthrough therapy designation for teclistamab, an investigational bispecific antibody under development for treating relapsed or refractory multiple myeloma.

FDA has granted accelerated approval to Biogen for Aduhelm (aducanumab), a new mAb treatment for Alzheimer’ disease.

Well-defined studies are crucial to effective process development

Hovione has re-joined iBET to increase its R&D programs in novel and high potential pharmaceutical technologies and to combine expertise for industrial innovation in new therapeutic fields.

Through the acquisition, Aceto can now offer its customers support throughout the drug development process and access to North American manufacturing for APIs and advanced intermediates.

The added capabilities include clinical-scale sachet and blister packaging for clinical trial pharmaceuticals and a relationship with a European Union Qualified Person for its CTS offerings.

Aptamer Group and PinotBio have formed a strategic collaboration aimed at the development of new drug conjugates for targeted drug delivery.

Eight companies representing the pharmaceutical supply chain have joined a newly founded non-profit membership association, Alliance to Zero, aimed at facilitating the transition of the pharma sector to comply with net-zero emissions.

The Optima Group is expanding production capacities in Germany to meet with high demand for packaging and filling solutions.

The acquisition of Advanz Pharma by Nordic Capital has now completed, in a deal worth $846 million.

Samsung Biologics and KAHR Medical have signed a strategic development and manufacturing agreement for a cancer immunotherapy drug candidate.

Celltrion Healthcare has revealed positive one-year results from a Phase III trial comparing biosimilar adalimumab, Yuflyma, with the reference adalimumab in patients with rheumatoid arthritis.

GoSilico’s software for digital twins of downstream biopharmaceutical processes will be integrated into Cytiva.

Currently, PNI offers a Genetic Medicine Toolkit, including its GenVoy LNP delivery platform and NanoAssemblr microfluidic-based nanoparticle manufacturing platform, for the development of genetic medicines.

Through the acquisition, Avantor will have access to RIM’s Changzhou, China, facility, making it Avantor’s first single-use production plant in the AMEA region.

The companies are expanding their collaboration to extend the drug substance manufacturing of Moderna’s COVID-19 vaccine with the addition of a new manufacturing line at Lonza’s Geleen, Netherlands, site.

Moderna has initiated a rolling submission process with FDA for a biologics license application for its mRNA COVID-19 vaccine for individuals 18 years of age and older.

The acquisition gives PerkinElmer access to Nexcelom Bioscience’s complementary cell counting and analysis capabilities and enhances its QA/QC capabilities.

Colorcon’s new suite will provide clients with capabilities to develop prototype tablets or capsule dosage forms when API quantity is limited or the API potency requires a higher level of protection.

PPD has opened its new multipurpose clinical research laboratory in Suzhou, China, which offers bioanalytical, biomarker, and vaccine sciences services for China and the global market.

The new design improves system performance, reliability, and stability, while an update to the software provides a better user experience, reduces user-instrument interaction, and allows for more robust data analysis.

Expected to be completed by 2022, the new addition is part of the Samsung Biologics’ long-term strategy to become a fully integrated global biopharmaceutical company.

FDA has issued an emergency use authorization for sotrovimab, an investigational monoclonal antibody therapy, for the treatment of mild-to-moderate COVID-19.

EMA has provided further advice to healthcare professionals on blood clots and low blood platelets occurring after vaccination with Vaxzevria (formerly the COVID-19 Vaccine AstraZeneca).

EMA has recommended EU marketing authorization for Bylvay (odevixibat) as a treatment of progressive familial intrahepatic cholestasis (PFIC).

The Discovery Labs has signed a foundational lease with the University of Pennsylvania Gene Therapy Program to build a new life sciences cluster in King of Prussia, Pa.

Moderna and Aldevron have expanded their existing collaboration to support Moderna’s COVID-19 vaccine program as well as additional clinical programs in Moderna’s pipeline.

Biogen and Ginkgo Bioworks have partnered to develop a next-generation AAV production platform to accelerate Biogen’s gene therapy drug development efforts.

Codagenix and Univercells have partnered on a research collaboration to pursue an undisclosed, high-priority human vaccine target.