Pharmaceutical Technology Editors

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.

CMA has launched an anti-competition investigation into AstraZeneca’s $39-billion acquisition of Alexion Pharmaceuticals.

MilliporeSigma has launched SAFC, a high-purity synthetic cholesterol product, nine months ahead of schedule to meet the lipid demands for COVID-19 messenger RNA therapeutics.

ISPE’s latest guide ISPE Good Practice Guide: Knowledge Management in the Pharmaceutical Industry focuses on how knowledge management allows for a more effective pharmaceutical quality system.

In the study, which enrolled 3700 US participants ages 12 to less than 18 years, no cases of COVID-19 were found in participants who had received two doses of the Moderna COVID-19 vaccine.

The new line can fill prefilled syringes, cartridges, and vials using ready-to-use components.

Evonik has introduced the EUDRACAP, a portfolio of easy-to-handle capsules to fast-track speed to market for oral drug products in the early development stage.

Almac Sciences is investing in the expansion of its continuous flow chemistry equipment as an additional project to its previously announced £5-million (US$7-million) laboratory expansion.

The final guidance document provides recommendations for regulatory, quality, nonclinical, and clinical considerations for bispecific antibody development programs.

The guidance addresses implementation of amendments made by the FDA Reauthorization Act of 2017.

The agency’s human medicines committee concluded sotrovimab can be used to treat COVID-19 in adults and adolescents who do not require supplemental oxygen therapy and are at risk for severe COVID-19.

Samsung Biologics plans to support the production of hundreds of millions of doses of Moderna’s vaccine to supply to markets outside of the United States beginning in the third quarter of 2021.

The Committee for Medicinal Products for Human Use of the European Medicines Agency presented a positive opinion of bluebird bio’s SKYSONA (elivaldogene autotemcel, Lenti-D), a one-time gene therapy for the treatment of early cerebral adrenoleukodystrophy, an X-linked metabolic disorder.

Developing and manufacturing a therapy in a regulated environment demands careful adherence to quality practices.

The agency is authorizing extending the time undiluted, thawed vaccine vials can be stored in the refrigerator to one month.

The guidance provides a framework for the management of postapproval chemistry, manufacturing, and controls changes.

The guidance document gives recommendations to support biopharmaceutics classification of drug substances and the Biopharmaceutics Classification System-based waiver of the in-vivo bioequivalence study requirement for drugs.

Pfizer and BioNTech have entered into a new agreement with the European Commission to supply 900 million doses of Comirnaty to the European Union with an option to request up to 900 million additional doses.

Under the terms of the agreement, Thermo Fisher will construct and operate a 44,000-ft2 cell therapy development, manufacturing, and collaboration center on UCSF's Mission Bay campus.

USP worked with a patient advocacy group and a purchasing organization to create a predictive model for improving supply chain resilience for critical pediatric oncology drugs.

Bristol Myers Squibb has entered into a definitive agreement with Agenus for a global exclusive license to Agenus’ proprietary bispecific antibody program, AGEN1777, that blocks TIGIT and a second undisclosed target.