Johnson & Johnson Reports P-III (Vivacity-MG3) Trial Data of Nipocalimab for Generalized Myasthenia Gravis

Shots: J&J has reported additional findings from P-III (Vivacity-MG3) trial & ongoing OLE assessing nipocalimab + SoC (30mg/kg, IV loading dose followed by 15mg/kg, Q2W) vs PBO in anti-AChR+, anti-MuSK+ & anti-LRP4+ adults (n=153) with gMG Trial showed a -4.9 QMG score improvement over 22 & 24wks. & pts were 4x more likely to sustain…

ByRidhi RastogiApril 10, 2025

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The US FDA Approves Biocon Biologics’ Jobevne (Biosimilar, Avastin)

Shots: The US FDA has approved Jobevne, a biosimilar version of Avastin (bevacizumab) for IV administration Approval was based on extensive data showing Jobevne is similar to Avastin in PK, safety, efficacy, structure, & function across clinical & analytical studies Jobevne (VEGF inhibitor) is marketed under the brand name Abevmy in the EU & Canada,…

ByRidhi RastogiApril 10, 2025

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KalVista Pharmaceuticals Partners with Kaken Pharmaceutical to Commercialize Sebetralstat in Japan

Shots: Kaken Pharmaceutical has entered into a licensing agreement with KalVista Pharmaceuticals to obtain commercialization rights of sebetralstat in Japan As per the deal, KalVista will receive $11M upfront & $13M in regulatory (expected in early 2026) & commercial milestones, along with Japan NHI price-based royalties, with royalty rate as sales % approximately in the…

ByRidhi RastogiApril 9, 2025

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Scientist.com Launches Clinical Labs Navigator to Improve Clinical Trial Operations

Shots: Scientist.com has launched Clinical Labs Navigator, an AI enabled platform to advance clinical trial services linked to sourcing, management, & execution Clinical Labs Navigator allows life sciences companies to collaborate efficiently with CROs by replacing legacy processes & offer a connected, compliant workflow with streamlined communication & greater transparency across clinical research lifecycle Platform optimizes…

ByRidhi RastogiApril 9, 2025

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Womed Collaborates with Kebomed Europe & Saesco Medical to Launch Womed Leaf in Europe

Shots: Womed has entered into licensing agreements with Kebomed Europe & Saesco Medical to distribute Womed Leaf, an intrauterine adhesion barrier film, across Europe As per the agreement, Kebomed will handle distribution across France, Germany, Sweden, Denmark, Norway, Finland, Austria & Switzerland, while Saesco Medical will oversee commercialization in Spain, Italy, Portugal, Belgium, the Netherlands…

ByRidhi RastogiApril 9, 2025

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Remegen Reports P-III Trial Data of Telitacicept for Generalized Myasthenia Gravis (gMG)

Shots: Remegen has reported P-III trial data assessing Telitacicept (RC18; 240mg; n=57) vs PBO (n=57) in 114 chinese gMG pts, with baseline MG-ADL score ≥6 & QMG score ≥8; trial incl. 24wk. double-blind phase followed by an open-label phase. BLA is under the NMPA’s review, with decision expected in Q2’25 Trial showed 98.1% vs 12% pts achieved…

ByRidhi RastogiApril 9, 2025

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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…

ByRidhi RastogiApril 9, 2025

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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…

ByRidhi RastogiApril 9, 2025

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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…

ByRidhi RastogiApril 8, 2025

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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…

ByRidhi RastogiApril 8, 2025

Ridhi Rastogi

Johnson & Johnson Reports P-III (Vivacity-MG3) Trial Data of Nipocalimab for Generalized Myasthenia Gravis

The US FDA Approves Biocon Biologics’ Jobevne (Biosimilar, Avastin)

KalVista Pharmaceuticals Partners with Kaken Pharmaceutical to Commercialize Sebetralstat in Japan

Scientist.com Launches Clinical Labs Navigator to Improve Clinical Trial Operations

Womed Collaborates with Kebomed Europe & Saesco Medical to Launch Womed Leaf in Europe

Remegen Reports P-III Trial Data of Telitacicept for Generalized Myasthenia Gravis (gMG)

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

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