NEWS

Teva and Samsung Bioepis Launch Epysqli (Biosimilar, Soliris) in the US

Shots: Teva & Samsung Bioepis have launched Epysqli, a biosimilar version of Soliris (eculizumab) in the US to treat paroxysmal nocturnal hemoglobinuria (PNH), atypical hemolytic uremic syndrome (aHUS) & generalized myasthenia gravis(gMG) in AchR antibody-positive adults Epysqli was approved by the US FDA in Jul 2024 for PNH & aHUS, with a label expansion to gMG in…

April 8, 2025

The EC Approves AbbVie’s Rinvoq (Upadacitinib) to Treat Giant Cell Arteritis in Adults

Shots: The EC has approved Rinvoq (15mg; QD) to treat adults with giant cell arteritis (GCA) in 30 EEA states Approval was based on P-III (SELECT-GCA) trial assessing Rinvoq, where GCA pts (n=428) in first study period received either Rinvoq (7.5 or 15mg, QD) + 26wk. corticosteroid (CS) taper regimen or PBO + 52wk. CS taper regimen…

April 8, 2025

Rhythm Pharmaceuticals Reports Topline Data from P-III (TRANSCEND) Trial of Setmelanotide for Acquired Hypothalamic Obesity

Shots: The P-III (TRANSCEND) trial (N=120) assessed setmelanotide (n=81: 33 adults & 48 pediatric) vs PBO (n= 39) for acquired hypothalamic obesity in 49 adults & 71 pediatric pts; additional arm of 12 Japanese pts is ongoing, with topline data expected by Q1’26. FDA & EMA filings to be completed by Q3’25 Trial met its…

April 8, 2025

Teva Pharmaceuticals Reports the US FDA’s sBLA Acceptance of Ajovy (Fremanezumab) for Pediatric Episodic Migraine Prevention

Shots: The US FDA has accepted sBLA of Ajovy to prevent episodic migraine in children & adolescents (6-17yrs.; ≥45Kg) Submission was based on P-III (SPACE) trial assessing Ajovy (SC) vs PBO for 12wks. to treat episodic migraine in 237 pediatric pts, which showed improvements in reducing monthly migraine & headache days Ajovy (CGRP antagonist) is…

April 8, 2025

Johnson & Johnson Receives the EC’s Approval for Darzalex Regimen to Treat Newly Diagnosed Multiple Myeloma (NDMM)

Shots: The EC has approved Darzalex (SC) + bortezomib, lenalidomide & dexamethasone (D-VRd) to treat NDMM pts; sBLA under the US FDA’s review Approval was based on P-III (CEPHEUS) trial assessing D-VRd (n=197) vs VRd (n=198) in 395 ASCT-ineligible or deferred pts, in 13 countries across the EU, North & South America At 59mos. mFU, trial…

April 8, 2025

Intellia Therapeutics Reports the First Patient Dosing in P-III (MAGNITUDE-2) Trial of Nexiguran Ziclumeran for ATTRv-PN

Shots: Intellia has reported the first pts dosing in its P-III (MAGNITUDE-2) trial assessing nexiguran ziclumeran (nex-z) for hereditary ATTR amyloidosis with polyneuropathy (ATTRv-PN); BLA submission is expected in 2028 Trial will assess nex-z (55mg infusion) vs PBO in ~50 ATTRv-PN pts to evaluate modified neuropathy impairment score & change in serum TTR levels as…

April 7, 2025

Ethris Partners with Lonza to Develop Intranasal Spray-Dried mRNA Vaccines Against Respiratory Diseases

Shots: Ethris has entered into a collaboration agreement with Lonza to develop room-temperature stable, spray-dried formulations of mRNA-based vaccine candidates designed for mucosal delivery in pts with respiratory diseases As per the deal, Lonza will support Ethris’ vaccine candidates, which are based on Ethris’ stabilized non-immunogenic mRNA (SNIM RNA) & stabilized lipid nanoparticles (SNaP LNP)…

April 7, 2025

AliveDx Seeks the US FDA’s 510(k) Clearance for MosaiQ AiPlex Connective Tissue Diseases (CTDplus) Multiplex Microarray

Shots: The US FDA has received 510(k) application for MosaiQ AiPlex CTDplus multiplex microarray to improve & accelerate diagnosis of connective tissue diseases (CTDs) CTDplus diagnose CTDs using just 10μL of sample in one step, with its CTD microarray having 15 markers in each panel per pts—DFS70/LEDGF, CCP, dsDNA, Sm, Sm/RNP, U1RNP, Chromatin, Ribosomal P,…

April 7, 2025

Luye Pharma Launches Erzofri in the US for Schizophrenia and Schizoaffective Disorder

Shots: Luye Pharma has launched Erzofri extended-release injectable suspension in the US to treat adults with schizophrenia & as monotx. or adjunct therapy for adults with schizoaffective disorder Erzofri was approved by the US FDA based on a multiple-dose, parallel-group study evaluating its PK profile & relative bioavailability at steady state vs reference product, demonstrating…

April 7, 2025

Johnson & Johnson Reports P-IIIb (APEX) Trial Findings of Tremfya for Active Psoriatic Arthritis

Shots: J&J has reported P-IIIb (APEX) trial data assessing Tremfya vs PBO in biologic-naïve PsA pts with inadequate response to standard therapies for 24wks., followed by a 12wk. safety follow-up; eligible pts could enter a 2yr. extension phase prior to the final safety follow-up Trial met its 1EP of improved ACR20 response, showing reduced signs…

April 7, 2025

NEWS

Teva and Samsung Bioepis Launch Epysqli (Biosimilar, Soliris) in the US

The EC Approves AbbVie’s Rinvoq (Upadacitinib) to Treat Giant Cell Arteritis in Adults

Rhythm Pharmaceuticals Reports Topline Data from P-III (TRANSCEND) Trial of Setmelanotide for Acquired Hypothalamic Obesity

Teva Pharmaceuticals Reports the US FDA’s sBLA Acceptance of Ajovy (Fremanezumab) for Pediatric Episodic Migraine Prevention

Johnson & Johnson Receives the EC’s Approval for Darzalex Regimen to Treat Newly Diagnosed Multiple Myeloma (NDMM)

Intellia Therapeutics Reports the First Patient Dosing in P-III (MAGNITUDE-2) Trial of Nexiguran Ziclumeran for ATTRv-PN

Ethris Partners with Lonza to Develop Intranasal Spray-Dried mRNA Vaccines Against Respiratory Diseases

AliveDx Seeks the US FDA’s 510(k) Clearance for MosaiQ AiPlex Connective Tissue Diseases (CTDplus) Multiplex Microarray

Luye Pharma Launches Erzofri in the US for Schizophrenia and Schizoaffective Disorder

Johnson & Johnson Reports P-IIIb (APEX) Trial Findings of Tremfya for Active Psoriatic Arthritis

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