Chiesi, USA
NEWS
The Italian pharma will gain access to Gossamer Bio’s candidate seralutinib, which reached its primary endpoint in a Phase II pulmonary arterial hypertension trial in 2022 and started a Phase III study last year.
Chiesi Global Rare Diseases gained access to the Filsuvez topical gel in January 2023, when it bought Amryt Pharma. Tuesday’s approval comes nearly two years after an initial rejection by the regulator.
Elfabrio’s label contains a boxed warning for hypersensitivity reactions, such as anaphylaxis, and recommends that medical support measures should be on standby when administering the treatment.
Italian biopharma Chiesi Farmaceutici SpA announced Sunday it was acquiring rare disease-focused Amryt Pharma in a deal that could reach up to $1.48 billion in value.
Fabry disease treatment is going to get new updates as Protalix and Chiesi are seeking approval. This can be a game-changer in the market. Here’s more about it.
The U.S. FDA approved Chiesi Global Rare Diseases’ Ferriprox for treatment of transfusional iron overload caused by sickle cell disease (SCD) or other anemias in adults and children ages three years and older. This approval expands the use of the drug for patients with SCD or other anemias.
The companies indicated they are studying the CRL to determine the best way to understand the problems and what course of action they might take.
The U.S. Food and Drug Administration’s schedule for April has several PDUFA dates scattered across the rest of the month. Here’s a look.
Boston is getting a new tenant focused on rare diseases. Italian pharma company Chiesi Farmaceutici S.p.A is launching a U.S.-based subsidiary Chiesi Global Rare Diseases with a focus on advancing research and new product development for rare and ultra-rare diseases.
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