NEWS

Johnson & Johnson Receives the EC’s Approval for SC Rybrevant to Treat Advanced EGFR-Mutated NSCLC

Shots: The EC has approved label extension to SC Rybrevant (Q1W x 4wks, then Q2W) + Lazcluze for 1L advanced NSCLC harboring EGFRm exon 19 del/ exon 21 L858R substitution & as monotx. for NSCLC pts with EGFRm exon 20 insertions unresponsive to Pt-based CT Approval was backed by P-III (PALOMA-3) trial, evaluating non-inferiority of…

April 9, 2025

BMS Reports the US FDA’s Approval of Opdivo + Yervoy as a 1L Treatment of MSI-H/dMMR Metastatic Colorectal Cancer (mCRC)

Shots: The US FDA has approved Opdivo + Yervoy for 1L treatment of MSI-H/dMMR unresectable mCRC pts (≥12yrs.) based on P-III (CheckMate-8HW) study assessing Opdivo + Yervoy vs Opdivo alone or CT in 839 pts (Approved before PDUFA: Jun 23, 2025) Regimen vs Opdivo monotx. showed 38% PFS (mPFS: not reached (NR) vs 39.3mos) in…

April 9, 2025

J&J MedTech Reports First Patient Enrollment in FORWARD CAD trial of Shockwave Javelin Coronary IVL Catheter

Shots: Shockwave Medical (J&J MedTech’s company) has initiated the pivotal FORWARD CAD IDE trial with first pts enrolled, evaluating safety & efficacy of the Shockwave Javelin coronary IVL catheter to treat calcified, hard-to-cross de novo coronary artery lesions prior to stenting Trial will evaluate the coronary IVL catheter in ~158 pts with mod. to…

April 8, 2025

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

NEWS

Johnson & Johnson Receives the EC’s Approval for SC Rybrevant to Treat Advanced EGFR-Mutated NSCLC

BMS Reports the US FDA’s Approval of Opdivo + Yervoy as a 1L Treatment of MSI-H/dMMR Metastatic Colorectal Cancer (mCRC)

J&J MedTech Reports First Patient Enrollment in FORWARD CAD trial of Shockwave Javelin Coronary IVL Catheter

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

Contact US

FOLLOW US