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Avalyn Raises $175m To Fund Inhaled Versions Of Pulmonary Fibrosis Drugs

Financing Snapshot: Seattle biotech claims its targeted, inhalable versions of Esbriet and Ofev, both oral IPF drugs, may offer better tolerability and stronger efficacy than established products.

Financing Business Strategies

FDA Change In Bioequivalence Requirements Leads To Downgrade Of Accord’s Generic Tacrolimus

After agency tightened bioequivalence testing recommendations for tacrolimus products post approval, studies found Accord’s generic version of Prograf may deliver higher concentrations, leading agency to downgrade its therapeutic equivalence rating. No problems were found with five other tacrolimus ANDAs.

Generic Drugs Post Market Regulation & Studies

Sandoz Looks To Join EU Trastuzumab Party With CHMP Thumbs Up

Sandoz looks to be in line for an EU-wide approval for its trastuzumab biosimilar during 2023, with the backing of the EMA’s Committee for Medicinal Products for Human Use.

Biosimilars Drug Review

Lebrikizumab Among Nine Drugs To Get EMA Nod; PTC Faces Disappointment For Translarna

The European Medicines Agency has OKd nine new medicines for EU-wide approval, but recommended against renewing the conditional marketing authorization of two drugs. 

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