Pharmaceutical Technology

JANUARY 30, 2023

The FDA approved fewer innovative drugs, New Molecular Entities (NMEs), in 2022 than it did in 2021: only 42 drugs compared to 59 drugs. This is due to generally more stringent criteria on approvals in the wake of the Aduhelm scandal. However, non-NME and biosimilar approvals increased in 2022.

Drugs 130

Drugs Manufacturing Contract Manufacturing FDA Approval 130

pharmaphorum

NOVEMBER 18, 2022

At its second attempt, Provention Bio has secured FDA approval for teplizumab, as a treatment to delay late-stage type 1 diabetes (T1D) in at-risk individuals – becoming the first disease-modifying therapy for these patients. It is now in line for a $35 million equity investment by Sanofi following FDA approval.

Drugs 52

Drugs FDA Approval Insulin Clinical Trials 52

Roots Analysis

JANUARY 14, 2024

Given the ongoing scientific advancements and the rise of FDA-approved biologics, the pharmaceutical industry seems to be approaching the era of biologics. Expression Systems for Biologics The processes associated with the manufacturing of biopharmaceuticals are complex and require highly sterile and aseptic conditions.

Contract Manufacturing 40

Contract Manufacturing Protein Manufacturing Production 40