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Bio-Thera New
 Bio-Thera Reports the EMA’s Approval of Avzivi (Biosimilar, Avastin) for Treating Multiple Indications 
Shots:    The EMA has granted approval to the company’s Avzivi (bevacizumab), a biosimilar version of Avastin. Sandoz is responsible for marketing the drug across the EU  The license and commercialization agreement b/w Bio-Thera and Sandoz was signed in Sep 2021, under which Bio-Thera had the development and manufacturing rights while Sandoz secured the commercialization…
July 30, 2024
Astellas
Astellas Reports the CHMP’s Positive Opinion of Zolbetuximab to Treat Gastric and Gastroesophageal Junction Cancer 
  Shots:    The CHMP has granted positive opinion to zolbetuximab + CT, with the decision anticipated in Oct 2024 & applicable across the whole EU plus Iceland, Liechtenstein & Norway. Other worldwide regulatory applications are under review  Opinion was supported by 2 P-III studies assessing zolbetuximab plus mFOLFOX6 [SPOTLIGHT (n=565)] & CAPOX [GLOW (n=507)] vs PBO…
July 29, 2024
Novaliq’s Vevizye (Ciclosporin) gains the CHMP’s Positive Opinion to Prevent Moderate to Severe Dry Eye Disease (DED) 
Shots:   The CHMP has granted a positive opinion to Vevizye in moderate to severe dry eye disease adults treated with tear substitutes based on (ESSENCE-1 & ESSENCE-2) trials involving >1500 patients  Vevizye showed improved ocular surface health, with a reduction in corneal fluorescein staining at D15 (~71.6% responded within 4wks.); additional benefits were observed at…
July 29, 2024
Ipsen
Ipsen’s Kayfanda (Odevixibat) Gains the CHMP’s Positive Opinion to Treat Cholestatic Pruritus in Alagille Syndrome (ALGS) 
        Shots:    The CHMP’s positive opinion of Kayfanda to treat cholestatic pruritus in ALGS individuals (≥6mos.) was based on P-III (ASSERT) study. EC’s decision is anticipated in Q3’24  The P-III (ASSERT) study assessed the safety & efficacy of Kayfanda (120µg/kg/day) vs PBO for 24wks.to relieve itch in ALGS patients (n=52; 0-17yrs.) across North America, EU,…
July 27, 2024
Ipsen
Ipsen’s Iqirvo (Elafibranor) Gains the CHMP’s Positive Opinion for Treating Primary Biliary Cholangitis (PBC) 
Shots:    The CHMP’s positive opinion of Iqirvo (PPAR agonist) + ursodeoxycholic acid (UDCA) for PBC adults having inadequate UDCA response or Iqirvo alone for UDCA intolerant patients was based on P-III (ELATIVE) study. EC’s decision is anticipated in Q3’24. The company has submitted Iqirvo for PBC to the MHRA    The P-III (ELATIVE) study assessed Iqirvo…
July 26, 2024
Formycon and Fresenius Kabi
Fresenius Kabi and Formycon Report the CHMP’s Positive Opinion of FYB202 (Biosimilar, Stelara) 
Shots:    The CHMP has granted a positive opinion to Fresenius & Formycon’s FYB202, a biosimilar version of Stelara (ustekinumab), with the decision anticipated during Q4’24  The opinion was supported by non-clinical & clinical studies plus manufacturing data, depicting similar effectiveness, safety & PK profile of FYB202 vs Stelara among moderate to severe psoriasis vulgaris (plaque psoriasis)…
July 26, 2024
Johnson& Johnson
Johnson & Johnson’s Yuvanci (macitentan and tadalafil) Receives the CHMP’s Positive Opinion for Treating Pulmonary Arterial Hypertension (PAH) 
Shots:    The CHMP has granted positive opinion to Yuvanci [macitentan (10mg) + tadalafil (40mg)] as a substitution therapy of PAH adults, based on P-III (A DUE) study  The P-III (A DUE) trial assessed Yuvanci STCT vs macitentan (10mg) & tadalafil (40mg) alone in PAH patients (n=187). Subjects with PVR ≥240 dyn×s/cm5 randomly received M/T STCT…
July 26, 2024
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