KIF1A

MARCH 9, 2024

This spring we’ve been quite fortunate to be joined by 6 Master’s students from Columbia University, who have been contributing to our creation of community resources as part of their Seminar in Biotechnology Course. Researchers have used a variety of cellular tests to model HSPs in iPSC models.

Laboratories 111

Laboratories Science Research Disease 111

Agency IQ

OCTOBER 27, 2023

Upcoming Webinar Hosted by Xtalks Webinar/Seminar ( OPEN) Xtalks 11/6/2023 11/6/2023 What is the evidence for high-risk medical devices in the field of cardiovascular disease and diabetes?

Regulations 40

Regulations Pharmaceuticals Production Packaging 40

Agency IQ

MARCH 29, 2024

regulatory framework Webinar/ Seminar ( OPEN ) EMA 4/17/2024 4/17/2024 CEP 2.0: regulatory framework Webinar/ Seminar ( OPEN ) EMA 4/17/2024 4/17/2024 CEP 2.0: regulatory framework Webinar/ Seminar ( OPEN ) EMA 4/17/2024 4/17/2024 CEP 2.0: regulatory framework Webinar/ Seminar ( OPEN ) EMA 4/17/2024 4/17/2024 CEP 2.0:

Regulations 40

Regulations Production Clinical Trials Pharmaceuticals 40

Agency IQ

MARCH 1, 2024

9 – Advertising for medical devices and in vitro diagnostic medical devices Webinar/ Seminar ( OPEN ) Czech State Institute for Drug Control (NISZP) 3/25/2024 3/25/2024 Clinical Trials Information System Webinar: Last Year of Transition Webinar/ Seminar ( OPEN ) EMA 3/25/2024 3/25/2024 Next steps for clinical research in the U.K.

Regulations 40

Regulations Biosimilars Clinical Trials Production 40

Agency IQ

JULY 8, 2024

Positive August 2024 Eurneffy (epinephrine) Ars Pharmaceuticals Irl Limited Positive August 2024 MResvia (Respiratory Syncytial Virus mRNA vaccine) Moderna Biotech Spain S.L.

Regulations 40

Regulations Pharmaceuticals Production Vaccine 40

Agency IQ

OCTOBER 6, 2023

As such, it doesn’t review things like vaccines, blood products or gene therapies – those products are instead reviewed by CBER. CDER is the FDA office in charge of reviewing pharmaceuticals and therapeutic biologics. As AgencyIQ has previously discussed , developing biosimilars is an expensive process.

FDA 52

FDA Biosimilars Science Drugs 52

Agency IQ

OCTOBER 20, 2023

A January 2022 Seminars in Arthritis and Rheumatism publication noted that a “generic [drug] may only cost $1 million to $4 million and take two years to develop vs $100 million to $250 million and seven to eight years for a biosimilar.”

Science 40

Science Biosimilars FDA Production 40