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…

ByRidhi RastogiApril 10, 20250Comments

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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,…

ByRidhi RastogiApril 10, 20250Comments

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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, 20250Comments

News

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, 20250Comments

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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,…

ByDipanshu DixitApril 10, 20250Comments

MAGAZINE

PharmaShots Magazine-April-2025 Edition

Emerging technologies holds a promising foothold in redefining the aspects of preventative, diagnostic, therapeutic, and patient care in the healthcare landscape. 3D Bioprinting offers innovative approach to addressing unmet healthcare needs with efficacious precision medicine in life-threatening conditions and developing therapies and medical devices that mimic complex human physiology. In April, PharmaShots Magazine is exploring…

ByAditya SinghApril 10, 20250Comments

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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, 20250Comments

News

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, 20250Comments

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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, 20250Comments

News

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, 20250Comments

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

PharmaShots Magazine-April-2025 Edition

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)

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