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Amgen s interchangeable Soliris biosimilar Bkemv approved by FDA for rare blood disorders

Amgen s interchangeable Soliris biosimilar Bkemv approved by FDA for rare blood disorders
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Samsung Bioepis gets Korean approval for Soliris biosimilar

Samsung Bioepis, a biosimilar developer under Samsung Group, said Monday that the company's rare blood disease treatment, Epysqli, has won marketing authorization from South Korea's medicine authorities. Epysqli, a biosimilar close to AstraZeneca's Soliris (eculizumab), is a treatment for patients with paroxysmal nocturnal hemoglobinuria (PNH), a rare disease where red blood cells prematurely break apa.

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JPM24: Amgen CEO hopes to take a bite of competitive obesity market with unique approach

JPM24: Amgen CEO hopes to take a bite of competitive obesity market with unique approach
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Novartis Nabs FDA Nod for Rare Disease Drug Rival to AstraZeneca Meds

FDA approval of Novartis’s Fabhalta makes the drug the first approved oral therapy for rare blood disorder paroxysmal nocturnal hemoglobinuria. With clinical data showing superiority versus two infused AstraZeneca drugs, Novartis’s pill is well-positioned to take market share from those blockbuster products.

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Pipeline Report 2023: Game on for blockbusters, novel MOAs and more

The industry awaits a number of readouts and approvals for drugs that address market gaps and enrich treatment landscapes with huge sales potential to boot.

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