Quality/GMPs

In an opinion article, FDA leaders commit to applying “the best science” to approval decisions.

Imfinzi has been granted approval in the EU for the treatment of adults with extensive-stage small cell lung cancer.

As public confidence in the drug development process waivers, leading vaccine developers promise to adhere to scientific and regulatory principles.

The companies have entered into a strategic partnership for the CMC development and manufacturing of Ansun’s biologics pipeline.

The agency sent a warning letter after an inspection of the company’s Sangareddy District, India found inadequate cleaning procedures.

The increased use of single-use bags in biologic manufacturing poses the risk of pinholes and other defects that cannot currently be tested for.

As technology matures, inefficiencies and process limitations in downstream process chromatography are improved.

Processes, people, and tools are necessary to comply with the pharmacopoeia and approved drug product registrations.

Current and newer biologic modalities pose increasingly complex challenges to the detection and characterization of protein aggregates.

Regulators strive to review flood of advanced treatments while also vetting COVID-19 vaccines.

FDA issued an emergency use authorization for COVID-19 convalescent plasma treatments following a report on NIH concerns about insufficient studies and data.

BioMarin received the complete response letter for valoctocogene roxaparvovec, its gene therapy intended for treating severe hemophilia A.

EC finalizes agreement to purchase millions of doses of AstraZeneca's COVID-19 vaccine.

The UK's MHRA will resume on-site risk based GxP inspections from September 2020.

A new FDA guidance provides answers to such questions about when the agency will seek to visit a site during the COVID-19 pandemic and how it will respond when a needed inspection cannot be conducted safely.

The agency provides recommendations for development and labeling of drugs to treat male patients with breast cancer.

The company has launched its biosimilar rituximab, Ritucad, for the Indian market.

The committee has given a positive opinion on the biosimilar bevacizumab for several cancer indications.

The companies received approval from the EC for Zercepac (HLX02), a biosimilar referencing Roche’s originator biologic, Herceptin (trastuzumab).

The White House initiative to encourage production of essential medicines in the United States calls on FDA to set the parameters for and implement main aspects of the program.

The companies have agreements to supply its mRNA-based COVID-19 vaccine to Japan and Canada, pending regulatory approvals in those countries.

The company is working to ensure broad global access to its COVID-19 vaccine candidate, following approval from regulators.

Sanofi and GlaxoSmithKline have been selected to supply the US government and the European Union with millions of doses of their COVID-19 vaccine candidate.

The therapy, indicated for a rare form of B-cell non-Hodgkin’s lymphoma, was developed by Kite, a Gilead company, which will manufacture the therapy at its facility in El Segundo, CA.

As biopharma companies and research institutes advance the development of COVID-19 vaccines, policy makers and health officials are debating strategies for ensuring fair and equitable distribution of anticipated preventives.

This article presents the results of a survey conducted to gain insight on the impact of the COVID-19 pandemic on biomanufacturing operations.

Process modeling offers an opportunity to troubleshoot for and anticipate difficult aspects of a bioprocess.

Technologies in use and on the horizon could change aseptic processing in ways that seemed inconceivable years ago but approaches to aseptic process validation still need to move beyond their 1970s roots.

Efforts are already underway to harmonize standards and regulatory approaches for testing of raw and ancillary materials, but continuous improvement is required.

Efforts by regulators seek common approaches to clinical research and biopharmaceutical production needed to wipe out the coronavirus pandemic globally.