The ChEMBL-og

APRIL 16, 2024

71 out of the 882 newly added EMA drugs are only authorised by EMA, rather than from other regulatory bodies e.g. FDA. Zimmermann Lab Biotransformation data Dec 2023 (src_id = 69): 271 compounds have been tested for biotransformation in 68 bacterial species and 28 bacterial communities. University of Dundee: T. University of Dundee: T.

Clinical Trials 110

Clinical Trials FDA Cell Based Assays Packaging 110

Agency IQ

JANUARY 19, 2024

EMA’s 2023 new medicines report suggests return to pre-pandemic volume This week, the EMA released its 2023 New Medicines Highlights report, providing insights into the number of opinions provided and the types of products reviewed. The number of opinions issued by the EMA in 2023 fell in comparison to the previous two years.

Biosimilars 40

Biosimilars FDA Production Treatment 40

The Pharma Data

FEBRUARY 25, 2022

Pfizer is a leader in this vital healthcare segment with more than 14 years of global in-market experience, the first FDA approved biosimilar for the treatment of certain autoimmune conditions and nine approved biosimilars in the U.S. as early as July 2023 in accordance with the terms of its agreement with AbbVie.

Biosimilars 52

Biosimilars FDA FDA Approval Small Molecule 52

Agency IQ

NOVEMBER 3, 2023

BY CHELSEY MCINTYRE, PHARMD | OCT 30, 2023 10:57 PM CDT Background: What are microbiome-based therapies? The prebiotic may either feed the probiotic that it is packaged with, or it may feed another beneficial microbe that is intended to complement the activity of the probiotic. What is the microbiome itself?

Therapies 40

Therapies Science FDA Production 40

Agency IQ

OCTOBER 6, 2023

FDA fiscal year in review: New drug approvals in the wake of the pandemic and legislative reforms AgencyIQ analyzed CDER’s novel drug approvals in Fiscal Year 2023, identifying a recovery in approval numbers as the agency resumes a new normal following the pandemic. of all NME approvals this year.

FDA 52

FDA Biosimilars Science Production 52

Agency IQ

JUNE 2, 2023

BY ALEXANDER GAFFNEY, MS, RAC, LAURA DIANGELO, MPH MAY 30, 2023 9:39 PM CDT Regulatory background and context The FDA uses various controls, including labeling and warnings, to ensure that medical products are used appropriately and safely. OIRA eventually released the rule for release by the FDA (with changes) on May 10, 2023.

FDA 40

FDA FDA Approval Regulations Production 40

Drug & Device Law

DECEMBER 29, 2023

In 2023 there seemed to be an unusually large number of other decisions that are likely to have a substantial impact on what we or our clients do, but involve either different products, non-product claims, or both. In 2023, these include United States ex rel. 2023) (no medical monitoring in Delaware) ( here ); Brown v.

Testimonials 105

Testimonials FDA Drugs Vaccine 105