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Decline of novel drug approvals means less business for cutting-edge CMOs

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

Drugs Manufacturing Contract Manufacturing FDA Approval

Provention finally gets FDA nod for type 1 diabetes drug teplizumab

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

Drugs FDA Approval Insulin Clinical Trials

Clinical Research Informer

Decline of novel drug approvals means less business for cutting-edge CMOs

Provention finally gets FDA nod for type 1 diabetes drug teplizumab

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