Agency IQ

DECEMBER 1, 2023

Start Date End Date Event Event Type Organization 12/01/2023 12/01/2023 BIVDA Environmental Working Party Webinar/Seminar ( CLOSED ) British In Vitro Diagnostics Association (BIVDA) 12/04/2023 12/04/2023 HMA/EMA Big Data Stakeholder Forum 2023 Webinar/Seminar ( OPEN ) European Medicines Agency (EMA) / Heads of Medicines Agencies (HMA) 12/04/2023 12/04/2023 (..)

Regulations 40

Regulations Clinical Trials Production Biosimilars 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

AUGUST 2, 2024

Positive August 2024 Eurneffy (epinephrine) Ars Pharmaceuticals Irl Limited Positive August 2024 MResvia (Respiratory Syncytial Virus mRNA vaccine) Moderna Biotech Spain S.L. Positive August 2024 Balversa (erdafitinib) Janssen-Cilag International N.V.

Regulations 40

Regulations Clinical Trials Production International 40

KIF1A

MAY 4, 2024

Currently, Wenxu is part of Cornish Lab at Columbia University, working on theranostic cells and synthetic biology of yeast vaccine. In undergraduate research at Reinhard Lab, he researched HIV nanomedicine and influence of nanoplastic on GI-tract (which was published on ACS Nano).

Science 116

Science Medical Schools RNA Research 116

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 Compliance 40

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.

Laboratories 111

Laboratories Science Research Disease 111

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

The Pharma Data

MAY 14, 2021

But, here’s the bottom line: Instead of taking decades to learn the proper sequencing of these intrinsic strength moves… or having to pay for one expensive seminar, workshop and package of personal training sessions after another to finally “get it”… you can…. Anyway, I could go on and on.

Packaging 52

Packaging Production Vaccine International 52

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 Production 52

The Pharma Data

MAY 13, 2021

It’s like having a private seminar in the luxury of your own home! “Muscle Imbalances Revealed should be in every personal trainer’s and fitness professional’s DVD library. Not only is this a great compilation of information, it is easily accessible in the webinar format. They download fast and you can take notes on the power point handouts.

Production 52

Production Treatment Vaccine Research 52

The Pharma Data

MAY 15, 2021

At an unconventional strength seminar I tracked down a bear of a man known as “The Crazy Russian”… who exposed me to weird “mental tricks” to elevating your strength simply by changing the way you THINK about how your muscles move your body…. I knew I needed to take my research “off-grid”, and…. …on And guess what I discovered?

Production 52

Production Packaging Doctors Science 52