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Gilead (2)
NEWS

Gilead Receives CHMP’s Positive Opinion of Seladelpar to Treat Primary Biliary Cholangitis (PBC)  

   Shots:    The CHMP has recommended Seladelpar + ursodeoxycholic acid (UDCA) to treat PBC in those with inadequate response or as monotx. in those intolerants to UDCA. The EC’s decision is expected in Q1’25   Opinion was based on a P-III (RESPONSE) study assessing seladelpar (10mg, QD, oral) vs PBO in PBC patients (n=193). It showed…
December 13, 2024

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Galderma
NEWS

Galderma’s Nemluvio (Nemolizumab) Receives Positive CHMP Opinion to Treat Prurigo Nodularis (PN) and Atopic Dermatitis 

   Shots:    The CHMP's recommendation of Nemluvio (SC) for mod. to sev. atopic dermatitis (≥12yrs.) & prurigo nodularis in eligible ones for systemic therapy was based on P-III ARCADIA & OLYMPIA studies, respectively. Reviews are ongoing in Australia, Singapore, Switzerland, Canada, Brazil & South Korea, with more filings underway   ARCADIA 1 & 2 studies assessed…
December 13, 2024

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Geron
NEWS

Geron Receives Positive CHMP Opinion for Rytelo (Imetelstat) to Treat Transfusion-Dependent Anemia due to Lower-Risk MDS 

Shots:    The CHMP has recommended Rytelo to treat TD anemia in adults with very low, low, or intermediate risk non-del(5q) MDS, unresponsive or ineligible for erythropoietin-based therapy, with the EC’s decision expected in the coming months  Opinion was based on P-III (IMerge) study of Rytelo vs PBO that showed reduced need for RBC transfusions within…
December 13, 2024

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NEWS

CSL Behring’s Andembry (Garadacimab) Receives Positive CHMP Opinion to Treat Hereditary Angioedema (HAE) 

     Shots:     The CHMP has recommended Andembry as a prophylactic treatment of HAE in patients (≥12 yrs.), with the EC’s decision anticipated in Q1’25, based on P-III (VANGUARD) trial & ongoing OLE study  The P-III study (full results published in The Lancet) of Andembry vs PBO met its 1EP, showing attack-free status in 62% while…
December 13, 2024

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MERCK
NEWS

 Merck Reports the CHMP’s Positive Opinion of Welireg (Belzutifan) for Von Hippel-Lindau (VHL) Disease-Associated Tumors and Previously Treated Renal Cell Carcinoma 

Shots:     The CHMP has recommended conditional approval of Welireg for VHL-related localized RCC, CNS hemangioblastomas or pNET unsuitable for localized procedures and advanced ccRCC post PD-1/PD-L1 inhibitors or VEGF therapies progression. EC’s decision is anticipated in Q1’25  Opinion for VHL-related tumors was based on LITESPARK-004 study (n=61), showing ORR of 49% (all PRs), with 56%…
December 13, 2024

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New Drug Designations - October 2024
INSIGHTS+

New Drug Designations – October 2024

Shots:   PharmaShots' designation report provides a concise overview of the latest drug designations by major regulatory authorities, including the FDA, NMPA, and EMA   The October 2024 report covers designations granted to 33 drugs and 2 devices, encompassing 14 small molecules, 4 biologics, 8 cell and gene therapies, and 2 medical devices.  Significant trends this month…
November 26, 2024

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Pfizer New
NEWS

Pfizer Reports the EC’s Approval of Hympavzi (Marstacimab) to Treat Hemophilia A/B without Inhibitors in Adults and Adolescents

  Shots:    The EC has approved Hympavzi (QW, SC) as a prophylactic treatment to prevent bleeding episodes in patients (≥12yrs., at least 35kg) with hemophilia A & B, without FVIII & FIX inhibitors, respectively. It is valid across the EU plus Iceland, Liechtenstein & Norway  Approval was based on pivotal P-III (BASIS) study of Hympavzi…
November 20, 2024

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Abbvie
NEWS

AbbVie’s Elahere (Mirvetuximab Soravtansine) Receives the EC’s Approval to Treat Platinum-Resistant Ovarian Cancer 

    Shots:    The EC has approved Elahere to treat FRα+, Pt-resistant high grade serous epithelial ovarian, fallopian tube, or primary peritoneal cancer after 1-3 prior treatments, valid across whole EU plus Iceland, Liechtenstein, Norway & Northern Ireland  Approval was based on P-III (MIRASOL) trial assessing Elahere vs investigator's choice of CT (weekly paclitaxel, pegylated liposomal…
November 18, 2024

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BMS
NEWS

BMS’ Augtyro (Repotrectinib) Gains the CHMP’s Positive Opinion to Treat Advanced ROS1+ NSCLC and NTRK+ Solid Tumors 

Shots:     The CHMP has granted positive opinion to repotrectinib for treating ROS1+ advanced NSCLC in adults and NTRK+ advanced solid tumors in patients (≥12yrs.), with the EC’s decision anticipated in Jan 2025  Opinion was based on P-I/II (TRIDENT-1 & CARE) trials, with TRIDENT-1 assessing repotrectinib in advanced solid tumors (NSCLC and tumors with ROS1 &…
November 15, 2024

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NEWS

InflaRx’s Gohibic (Vilobelimab) Gains the CHMP’s Positive Opinion for the Treatment of ARDS 

    Shots:    The CHMP has recommended Gohibic (under exceptional circumstances) to treat SARS-CoV-2-induced acute respiratory distress syndrome (ARDS) adults on systemic corticosteroids (SoC) & IMV (with/without ECMO), with the decision anticipated within 67days (Q1’24)  Opinion was backed by P-III (PANAMO) study of Gohibic vs PBO among invasively mechanically ventilated COVID-19 patients in ICU, showing improvement…
November 15, 2024

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