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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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Johnson& Johnson
NEWS

Johnson & Johnson’s Rybrevant Plus Lazcluze Receives the CHMP’s Positive Opinion as a 1L Treatment of EGFR-Mutated NSCLC

  Shots:      The CHMP has recommended Rybrevant + Lazcluze as a 1L treatment of NSCLC with EGFR exon 19 deletions or exon 21 L858R substitution mutations and approval of Type II extension of indication for amivantamab  Opinion was based on the P-III (MARIPOSA) study assessing Rybrevant + Lazcluze vs osimertinib & Lazcluze in NSCLC patients…
November 15, 2024

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Alvotech & Advanz Pharma
NEWS

Alvotech and Advanz Pharma Reports the EMA’s MAA Acceptance of AVT05 (Biosimilar, Simponi) 

Shots:  The EMA has accepted the MAA of AVT05, biosimilar version of J&J's Simponi & Simponi Aria (golimumab), for the treatment of several chronic inflammatory diseases, with the decision expected in Q4’25  Alvotech, in Apr 2024, reported top-line data from a confirmatory trial of AVT05 vs Simponi in patients with moderate to severe rheumatoid arthritis,…
November 4, 2024

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NEWS

Serum Institute of India Reports the CHMP’s Positive Opinion of Siiltibcy as a Diagnostic Aid for Mycobacterium Tuberculosis Infection 

Shots:    The CHMP has recommended Siiltibcy (0.5μg/mL rdESAT-6 & rCFP-10) to diagnose Mycobacterium tuberculosis infection in individuals (age: ≥28 days), valid in the EU plus Norway, Iceland & Liechtenstein. Separate MAA will be submitted to the UK MHRA   Siiltibcy’s sensitivity & specificity was assessed in comparison with QuantiFERON TB Gold In-Tube test (QFT, in-vitro test)…
October 30, 2024

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