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Takeda
NEWS

Takeda Reports the EC’s Approval of Adzynma to Treat Congenital Thrombotic Thrombocytopenic Purpura (cTTP) 

Shots:    The EC has approved Adzynma (recombinant ADAMTS13) to treat ADAMTS13 deficiency in cTTP adults & children. Adzynma is also being assessed under P-IIb study for immune-mediated thrombotic thrombocytopenic purpura (iTTP)  Approval was based on the P-III study assessing Adzynma to treat cTTP, published in the NEJM, with patients receiving Adzynma (40IU/kg, IV, weekly) or…
August 7, 2024

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New Drug Designations - June 2024
INSIGHTS+

New Drug Designations – June 2024

Shots:   PharmaShots' designation report provides a concise overview of several drugs and their designations by the FDA, NMPA and EMA. This month’s report includes designations allotted to 7 small molecules, 5 biologics, 8 cell & gene therapies, 2 recombinant fusion protein, and 3 devices   This month, ChromaDex’s Nicotinamide Riboside Chloride received US FDA’s ODD &…
July 30, 2024

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Bio-Thera New
NEWS

 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

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Astellas
NEWS

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

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NEWS

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

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Ipsen
NEWS

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

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Ipsen
NEWS

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

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NEWS

Junshi Biosciences Reports the CHMP’s Positive Opinion of Loqtorzi (Toripalimab) Across Two Indications 

Shots:    The CHMP has granted positive opinion to 1L Loqtorzi with cisplatin & gemcitabine for recurrent, metastatic NPC as well as with cisplatin & paclitaxel for unresectable advanced, recurrent or metastatic ESCC; valid across the EU plus Iceland & Norway  The opinions for NPC & ESCC were supported by P-III (JUPITER-02 & JUPITER-06) trials, respectively;…
July 26, 2024

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Johnson& Johnson
NEWS

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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