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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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Insights+ EMA Marketing Authorization of New Drugs in June 2024
INSIGHTS+

Insights+: EMA Marketing Authorization of New Drugs in June 2024

Shots:   The EMA granted Positive Opinion to 4 Biologics and 3 New Chemical Entities in June 2024, leading to treatments for patients and advances in the healthcare industry  The major highlighted drugs were Merck’s Winrevair to treat Pulmonary Arterial Hypertension (PAH) and Roche’s PiaSky for Paroxysmal Nocturnal Haemoglobinuria (PNH)  PharmaShots has compiled a list of 5 drugs that…
July 23, 2024

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NEWS

Moderna’s mResvia (mRNA-1345) Gains the CHMP’s Positive Opinion to Prevent Lower Respiratory Tract Disease (LTRD) 

Shots:  The CHMP’s positive opinion of mRESVIA to prevent lower respiratory tract disease (LTRD) due to RSV infection based on the P-III (ConquerRSV) study in adults (n=37,000; ≥60yrs.)  Primary analysis (3.7mos. median follow-up) showed vaccine efficacy (VE) of 83.7%, published in the NEJM. Supplementary analysis (8.6mos. median follow-up) showed sustained VE of 63.3% against RSV-LRTD…
June 28, 2024

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MERCK
NEWS

Merck’s Winrevair (Sotatercept) Gains the CHMP’s Positive Opinion to Treat Pulmonary Arterial Hypertension (PAH) 

Shots:  The CHMP has granted positive opinion to Winrevair combined with other therapies to treat PAH. EC’s decision is anticipated in Q3’24, applicable across EU, Iceland, Liechtenstein & Norway  The opinion was based on the P-III (STELLAR) study evaluating the safety & efficacy of Winrevair (target dose 0.7mg/kg; n=163) or PBO (n=160) + stable background…
June 28, 2024

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Regeneron
NEWS

Regeneron’s Ordspono Gains the CHMP’s Positive Opinion to Treat r/r Follicular Lymphoma (FL) or Diffuse Large B-Cell Lymphoma (DLBCL) 

Shots:  The CHMP has granted a positive opinion for conditional marketing authorization of odronextamab (CD20xCD3 bispecific Ab) to treat r/r FL or r/r DLBCL post ≥2L of therapies, with the EC’s decision anticipated in the upcoming mos.  The opinion was based on the P-I (ELM-1) & pivotal P-II (ELM-2) studies, showing strong durable response rates…
June 28, 2024

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