Regulatory Oversight and Compliance

The Impact of COVID-19 on Biologics Regulations

May 15, 2021

Industry experts discuss how FDA’s response to COVID-19 and related pandemic-related guidance documents may impact the biologics industry long term.

FDA Inspection “Roadmap” Acknowledges Continued Delays and Challenges Ahead

May 12, 2021

FDA expects to conduct only a small portion of scheduled facility visits in 2021 due to continued limitations on travel imposed by the COVID-19 pandemic.

FDA OKs Pfizer-BioNTech Vaccine for Adolescents

May 11, 2021

Adolescents are now eligible for the Pfizer-BioNTech COVID-29 vaccine under expanded EUA.

Pfizer and BioNTech Initiate Rolling Submission of Biologics License Application for Their COVID-19 Vaccine

May 10, 2021

Pfizer and BioNTech have initiated a rolling submission of a biologics license application to FDA for the approval of their COVID-19 vaccine in individuals 16 years of age and older.

Hospira Recalls Sterile Water for Injection

May 10, 2021

The company is recalling lot DN9185 of Sterile Water for Injection, USP, 100 mL Single Dose Glass Fliptop Vial because of visible particulates.

FDA on Inspections During and After Pandemic

May 10, 2021

The agency released a report that outlines inspectional activities conducted during the COVID-19 pandemic and discusses plans for future inspection operations.

EC approves GSK’s Benlysta for Adults with Active Lupus Nephritis

May 07, 2021

The EC’s approval of GSK’s Benlysta (belimumab) marks the first and only biologic approved for both systemic lupus erythematosus and lupus nephritis.

EC Approves Additional Indication for Roche’s Tecentriq in Lung Cancer Treatment

May 07, 2021

The European Commission has approved an additional indication for Roche’s Tecentriq (atezolizumab) as a first-line monotherapy treatment for metastatic non-small cell lung cancer.

Sandoz Begins Late-Stage Clinical Development for Biosimilar Aflibercept

May 07, 2021

Sandoz will soon begin enrolling patients with neovascular age-related macular degeneration in a Phase III study with its proposed biosimilar to aflibercept.

Accelerated Assessment of Comirnaty in Young People Commences

May 07, 2021

The European Medicines Agency has announced the commencement of an evaluation for the extension of use of Comirnaty, Pfizer/BioNTech’s COVID-19 vaccine, to include young people aged 12 to 15 years.