NEWS

argenx Reports the US FDA’s Approval of Vyvgart Hytrulo Prefilled Syringe for gMG and CIDP

Shots: The US FDA has approved Vyvgart Hytrulo (efgartigimod alfa & hyaluronidase-qvfc) prefilled syringe to treat AChR+ adults with generalized myasthenia gravis (gMG) & adults with chronic inflammatory demyelinating polyneuropathy (CIDP) Approval was based on studies showing bioequivalence to Vyvgart Hytrulo vial, with human factors validation confirming that pts with gMG or CIDP, or their caregivers,…

April 11, 2025

Johnson & Johnson Reveals P-III (ICONIC-LEAD) Trial Data of Icotrokinra for Plaque Psoriasis

Shots: J&J has reported subgroup analysis from P-III (ICONIC-LEAD) trial assessing icotrokinra (QD, PO; n=456) vs PBO (n=228) in 684 adolescents & adults with mod. to sev. plaque PsO At Wk. 16, 84.1% adolescent achieved IGA 0/1 vs 27.3%, & 70.5% vs 13.6% reached PASI 90. By Wk. 24, 86.4% achieved IGA 0/1, 88.6% reached PASI…

April 11, 2025

Bayer’s Vitrakvi Receives the US FDA’s Full Approval for NTRK Fusion-Positive Solid Tumors

Shots: The US FDA has granted full approval to Vitrakvi for adults & pediatrics with NTRK fusion-positive metastatic or inoperable solid tumors, who had disease progression on prior therapy or lacked alternative therapy options Approval was based on 3 trials: LOXO-TRK-14001, SCOUT, & NAVIGATE, evaluating Vitrakvi in 339 adult & pediatric pts. Key EPs were…

April 11, 2025

Makana Therapeutics Collaborates with Tonix Pharmaceuticals for TNX-1500

Shots: Makana Therapeutics has collaborated with Tonix Pharmaceuticals for TNX-1500 (anti-CD40L mAb) to reduce rejection of Makana’s genetically engineered (GE) pig organs in xenotransplantation Preclinical R&D collaboration may extend across Makana’s kidney, heart, & islet cell transplant programs, with an aim to support the US FDA’s IND submission for compassionate use in xenotransplantation pts Makana’s…

April 10, 2025

Oculis Completes Patient Enrollment in P-III (DIAMOND-1 & DIAMOND-2) Trials of OCS-01 for Diabetic Macular Edema

Shots: Oculis has completed pts enrollment in both P-III (DIAMOND-1 & DIAMOND-2) trials of OCS-01 in diabetic macular edema pts; trials to support NDA submission The trials will evaluate the efficacy & safety of OCS-01 in over 800 pts with DME across 119 sites in the US & other countries for 52wks.; topline data is…

April 10, 2025

Merit Medical Reports the US Launch of Ventrax Delivery System

Shots: Merit Medical has launched its Ventrax delivery system in the US Ventrax is designed to streamline retrograde aortic access by guiding ablation catheters into the left ventricle, helping in procedures that are used to treat ventricular tachycardia Ventrax Delivery System features a 95cm sheath for targeted access, an ultralow-profile sheath-to-dilator transition for smooth insertion,…

April 10, 2025

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

NEWS

argenx Reports the US FDA’s Approval of Vyvgart Hytrulo Prefilled Syringe for gMG and CIDP

Johnson & Johnson Reveals P-III (ICONIC-LEAD) Trial Data of Icotrokinra for Plaque Psoriasis

Bayer’s Vitrakvi Receives the US FDA’s Full Approval for NTRK Fusion-Positive Solid Tumors

Makana Therapeutics Collaborates with Tonix Pharmaceuticals for TNX-1500

Oculis Completes Patient Enrollment in P-III (DIAMOND-1 & DIAMOND-2) Trials of OCS-01 for Diabetic Macular Edema

Merit Medical Reports the US Launch of Ventrax Delivery System

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

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