NEWS

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…

April 10, 2025

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,…

April 10, 2025

AstraZeneca and Daiichi Sankyo Receive the EC’s Approval for Datroway to Treat HR+/HER2- Breast Cancer

Shots: The EC has approved Datroway to treat unresectable or metastatic HR+/HER2- (IHC 0, IHC 1+ or IHC 2+/ISH-) breast cancer in pts who have received endocrine therapy & ≥1L of CT in the advanced setting Approval was based on global P-III (TROPION Breast01) trial, assessing Datroway (6mg/kg; IV, Q21D) vs single agent CT (eribulin,…

April 10, 2025

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…

April 9, 2025

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…

April 9, 2025

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…

April 9, 2025

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…

April 9, 2025

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

NEWS

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

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

AstraZeneca and Daiichi Sankyo Receive the EC’s Approval for Datroway to Treat HR+/HER2- Breast Cancer

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

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