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Daiichi Sankyo
NEWS

Daiichi Sankyo Reports the EMA’s MAA Acceptance of Enhertu + Perjeta to Treat HER2 Positive Metastatic Breast Cancer

Shots: The EMA has validated the Type II Variation MAA for Enhertu (trastuzumab deruxtecan) in combination with pertuzumab for the 1L treatment of patients with HER2+ positive unresectable or metastatic breast cancer. MAA was supported by P-III (DESTINY-Breast09) trial data on Enhertu (5.4mg/kg) ± Perjeta vs taxane, trastuzumab & Perjeta (THP) in HER2+ metastatic breast cancer…
January 19, 2026

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Telix Pharmaceuticals
NEWS

Telix Reports First US Patient Dosing in the P-III Trial of Illuccix and Gozellix, for the Diagnosis of Prostate Cancer

Shots: The company has reported dosing of the first patient in the US  P-III (BiPASS) trial evaluating its PSMA-PET imaging agents, Illuccix and Gozellix, for use in the initial diagnosis of prostate cancer BiPASSa P-III study enrolling 250 pts in the US and Australia to support marketing authorization of 68Ga-PSMA-PET in the pre-biopsy setting Building…
January 19, 2026

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NEWS

J&J Reports P-III Trial Outcomes Showing Tecvayli Monotherapy Extends PFS and OS in R/R Multiple Myeloma

Shots: J&J has reported positive topline Phase III (MajesTEC-9) results demonstrating that Tecvayli (teclistamab) monotx. significantly outperformed SoC in r/r multiple myeloma The study included patients with 1–3 prior therapies, all previously treated with anti-CD38 antibodies and lenalidomide. Most patients were refractory to anti-CD38 mAbs (85%), lenalidomide (79%), and their last therapy (>90%). Tecvayli achieved…
January 15, 2026

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NEWS

Lupin Receive the CHMP Positive Opinion for Ranluspec (Biosimilar, Lucentis) 

Shots:  The CHMP has recommended marketing authorization for Lupin’s Ranluspec, in both vial and PFS forms, a biosimilar version of Lucentis (ranibizumab)  Opinion was supported by analytical similarity data and a global P-III trial (n=600 pts) in neovascular AMD across the US, EU, Russia, and India  Under the agreement, Lupin’s biosimilar ranibizumab will be marketed by Sandoz across the EU (excluding Germany),…
December 17, 2025

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NEWS

LIB Therapeutics Receives the FDA Approval for Lerochol (Lerodalcibep-liga) for Adults with Elevated LDL Cholesterol 

Shots:  The US FDA has approved Lerochol as an LDL-C lowering therapy for adults with hypercholesterolemia, including HeFH; US launch as a PFS is expected in spring 2026, with an autoinjector later in 2026, while EMA approval is anticipated in Jun 2026 alongside additional global regulatory filings   Approval was supported by the global P-III (LIBerate) trial, enrolling over 2,900 CVD patients and without…
December 12, 2025

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NEWS

Innoviva Specialty Therapeutics Receives the FDA Approval for Nuzolvence (Zoliflodacin) for Uncomplicated Urogenital Gonorrhea 

Shots:  The US FDA has approved Nuzolvence for the treatment of uncomplicated urogenital gonorrhea in pts (age ≥12yrs.; Wt.≥35 kg), with US commercialization planned for the H2’26  Approval was based on a pivotal P-III multinational trial (n=930) evaluating a single 3g oral dose of Nuzolvence vs ceftriaxone (500 mg IM) + azithromycin (1 g oral) for uncomplicated urogenital gonorrhea, which demonstrated non-inferiority, comparable tolerability…
December 12, 2025

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Chronic Dermatologic Care: Baldo Scassellati Sforzolini from Galderma in Conversation with PharmaShots
VIEWPOINTS

Chronic Dermatologic Care: Baldo Scassellati Sforzolini from Galderma in Conversation with PharmaShots

Shots:  Recently, the groundbreaking results from Galderma’s Phase III OLYMPIA 1 trial were published in JAMA Dermatology. The study evaluated nemolizumab in patients with moderate-to-severe active prurigo nodularis  The trial met all primary and secondary endpoints, with results aligning with those from the OLYMPIA 2 trial, reinforcing nemolizumab’s potential in achieving sustained improvements in the…
May 26, 2025

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VIEWPOINTS_Andrew Menzies-Gow1_2024
VIEWPOINTS

AstraZeneca at ACR 2023: Andrew Menzies-Gow Highlights Data from the MANDARA Study

Shots:  Andrew Menzies-Gow, in a stimulating conversation with PharmaShots, shares the insights from the Phase III MANDARA study that evaluates Fasenra (benralizumab) vs. mepolizumab for patients with relapsing or refractory EGPA  Five out of the 18 abstracts presented by AstraZeneca at ACR were from the MANDARA study. Apart from the positive endpoints of the MANDARA…
February 6, 2024

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