NEWS

Apellis Pharmaceuticals and Sobi Report P-III (VALIANT) Trial Data of Empaveli for C3 Glomerulopathy (C3G) and Primary IC-MPGN

Shots: Apellis & Sobi have reported data from the open-label period of P-III (VALIANT) trial of Empaveli for the treatment of C3G & primary immune complex membranoproliferative glomerulonephritis (IC-MPGN); regulatory review is ongoing in the US & EU The P-III (VALIANT) trial assessed Empaveli (Q2W) vs PBO in C3G or primary IC-MPGN pts (≥12yrs., n=124)…

June 9, 2025

LEX Diagnostics Seeks 510(k) Clearance and CLIA Waiver Status for its VELO system to Deliver Highly Sensitive PCR Results

Shots: The US FDA has received 510(k) clearance & CLIA waiver application of VELO system for highly sensitive PCR results for respiratory pathogens LEX Diagnostics has completed US trials of the VELO system & Influenza/COVID assay during the 2024/2025 season & expects 510(k) clearance by late 2025 or early 2026, pending FDA review VELO system…

June 9, 2025

Aytu BioPharma Collaborates with Fabre-Kramer Pharmaceuticals to Commercialize Exxua (Gepirone) in the US for Major Depressive Disorder

Shots: Aytu has collaborated with Fabre-Kramer to commercialize Exxua in the US for treating major depressive disorder; launch is expected in Q4’25 As per the deal, Fabre-Kramer has received $3M upfront & is eligible to receive $3M within 45 days of the Exxua’s 1yr. commercial sale, increasing to $5M if net sales reach $35M as…

June 9, 2025

Samsung Bioepis Collaborates with NIPRO to Commercialize Biosimilar Candidates in Japan

Shots: Samsung Bioepis & NIPRO have entered into a license, development & commercialization agreement for various biosimilar candidates, incl. SB17, a biosimilar version of Stelara (ustekinumab) in Japan As per the deal, NIPRO will be responsible for commercialization of the biosimilar candidates in Japan, with Samsung Bioepis handling development, manufacturing & supply activities Ustekinumab is…

June 9, 2025

Italfarmaco Obtains the EC’s Conditional Approval for Duvyzat to Treat Duchenne Muscular Dystrophy (DMD)

Shots: The EC has granted conditional approval to Duvyzat (givinostat) for the treatment of ambulant DMD pts (≥6yrs.) on corticosteroids, regardless of underlying genetic mutation in all 30 EEA states Approval was based on the P-III (EPIDYS) study assessing Duvyzat (BID) vs PBO in ambulant DMD boys (n=179) on corticosteroid therapy Trial met its 1EP…

June 9, 2025

Arvinas and Pfizer Report the US FDA’s NDA Submission of Vepdegestrant for ESR1-Mutated Breast Cancer

Shots: FDA has received NDA of vepdegestrant (ARV-471) to treat pts with ESR1-mutated ER+/HER2- advanced or metastatic breast cancer previously treated with endocrine-based therapy NDA was backed by P-III (VERITAC-2) trial assessing ARV-471 alone vs fulvestrant in mentioned pts (n=624) previously treated with CDK4/6 inhibitor + endocrine therapy Trial showed improved PFS (1EP) by 43%…

June 9, 2025

Otsuka Pharmaceutical Reports Interim P-III (VISIONARY) Trial Data of Sibeprenlimab for Immunoglobulin A Nephropathy (IgAN)

Shots: Otsuka Pharmaceutical has reported interim P-III (VISIONARY) trial data evaluating sibeprenlimab (400mg, SC, Q4W) vs PBO in ~510 IgAN pts, who were on SoC therapy Trial showed a 51.2% reduction in 24hr. uPCR (1EP) at 9mos. (presented at ERA 2025) & will continue to assess kidney function (2EP) via eGFR over 24mos., with completion…

June 6, 2025

Formycon Receives the ANVISA Approval for Ranivisio (Biosimilar, Lucentis) Across Brazil

Shots: Brazil’s ANVISA has approved marketing authorization for Formycon’s Ranivisio (ranibizumab), a biosimilar to Lucentis; launch is anticipated in Q4’25 Formycon & Biomm have partnered to commercialize Ranivisio in Latin America, with approvals already granted in Peru, El Salvador, Honduras, and the Dominican Republic. Additional launches across Central and South America are planned through early…

June 6, 2025

Sydnexis’ SYD-101 Receives the EC’s Approval to Reduce Pediatric Myopia Progression

Shots: The EC has approved SYD-101 to slow pediatric myopia progression; NDA is under the US FDA’s review (PDUFA: Oct 23, 2025) Approval was based on P-III (STAR) trial evaluating SYD-101 to reduce pediatric myopia progression & risk of associated co-morbidities in pts (3-14yrs. at trial initiation), which met its 3yr. 1EP, with third-year data…

June 6, 2025

AstraZeneca’s Calquence Regimen Receives the EC’s Approval for 1L Chronic Lymphocytic Leukaemia (CLL)

Shots: The EC has approved Calquence (acalabrutinib) + venetoclax ± Gazyva for the treatment of adults with 1L CLL; regulatory review is ongoing in other regions Approval was based on the P-III (AMPLIFY) trial assessing Calquence regimen with or without Gazyva vs chemoimmunotherapy (fludarabine-cyclophosphamide-rituximab or bendamustine-rituximab) in treatment-naïve CLL pts without del(17p) or TP53 mutation Trial showed…

June 6, 2025

NEWS

Apellis Pharmaceuticals and Sobi Report P-III (VALIANT) Trial Data of Empaveli for C3 Glomerulopathy (C3G) and Primary IC-MPGN

LEX Diagnostics Seeks 510(k) Clearance and CLIA Waiver Status for its VELO system to Deliver Highly Sensitive PCR Results

Aytu BioPharma Collaborates with Fabre-Kramer Pharmaceuticals to Commercialize Exxua (Gepirone) in the US for Major Depressive Disorder

Samsung Bioepis Collaborates with NIPRO to Commercialize Biosimilar Candidates in Japan

Italfarmaco Obtains the EC’s Conditional Approval for Duvyzat to Treat Duchenne Muscular Dystrophy (DMD)

Arvinas and Pfizer Report the US FDA’s NDA Submission of Vepdegestrant for ESR1-Mutated Breast Cancer

Otsuka Pharmaceutical Reports Interim P-III (VISIONARY) Trial Data of Sibeprenlimab for Immunoglobulin A Nephropathy (IgAN)

Formycon Receives the ANVISA Approval for Ranivisio (Biosimilar, Lucentis) Across Brazil

Sydnexis’ SYD-101 Receives the EC’s Approval to Reduce Pediatric Myopia Progression

AstraZeneca’s Calquence Regimen Receives the EC’s Approval for 1L Chronic Lymphocytic Leukaemia (CLL)

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