NEWS

Daiichi Sankyo and AstraZeneca Report the EC’s Approval of Enhertu for HER2 Low/Ultralow Metastatic Breast Cancer (MBC)

Shots: The EC has approved Enhertu monotx. for inoperable HR+, HER2-low/ultralow MBC whose disease progressed on & are ineligible for endocrine therapy, based on the P-III (DESTINY-Breast06) trial; regulatory review is ongoing in Japan & other regions Trial (N=866) assessed Enhertu (5.4mg/kg) vs CT in HER2-low (n=713) & ultralow (n=153) pts, showing 38% PFS in CT-naïve…

April 4, 2025

Eli Lilly Enters a ~$1.4B Licensing Agreement with Sangamo Therapeutics for its STAC-BBB Capsid

Shots: Sangamo has granted Eli Lilly global exclusive license of STAC-BBB for one initial CNS target, with an option to add up to 4 more targets upon payment of additional license fees, allowing IV delivery of Lilly’s genomic medicines for CNS diseases As per the deal, Lilly will handle R&D, regulatory activities, manufacturing, & global…

April 4, 2025

Amgen’s Uplizna Receives the US FDA’s Approval for Immunoglobulin G4-related Disease (IgG4-RD)

Shots: The US FDA has approved Uplizna to treat adults with IgG4-RD; regulatory filings for gMG are underway, with completion expected in H1’25 Approval was based on P-III (MITIGATE) trial assessing Uplizna (n=68) vs PBO (n=67) in IgG4-RD adults, which incl. an optional 3yr. OLE & up to 2yrs. of safety follow-up after Uplinza discontinuation Trial…

April 4, 2025

BridgeBio Oncology Therapeutics Reports the First Patient Dosing in P-I (KONQUER-101) Trial of BBO-11818 for Advanced Solid Tumors

Shots: BBOT has reported first pts dosing in its P-I (KONQUER-101) trial assessing BBO-11818 for advanced solid tumors, with trial enrolling pts globally In cellular assays, BBO-11818 showed pERK inhibition in selected KRAS G12D & G12V-mutant cell lines at lower concentrations, while reducing viability in KRAS G12D/G12V/G12C mutant cells & exhibiting >500-fold selectivity for KRAS…

April 3, 2025

Accord Healthcare Reports the CHMP’s Positive Opinion on Osvyrti and Jubereq (Biosimilar, Prolia & Xgeva)

Shots: The CHMP has recommended Osvyrti & Jubereq, biosimilar versions of Amgen’s Prolia & Xgeva (denosumab); launch expected post patent expiry of reference products in Nov 2025 Osvyrti (60mg pre-filled syringe) is indicated to treat osteoporosis in postmenopausal women & men at increased risk of fractures. It also used to treat bone loss in pts…

April 3, 2025

Siemens to Acquire Dotmatics for $5.1B, Strengthening its Position in Life Science Market

Shots: Siemens has entered into an agreement to acquire Dotmatics for $5.1B from Insight Partners, strengthening its position in the life science market Acquisition will integrate Siemens' manufacturing, industrial simulation, & AI expertise with Dotmatics' complementary offerings, creating an AI-powered product lifecycle management (PLM) portfolio as part of Siemens Xcelerator for seamless R&D-to-manufacturing connectivity Siemens will…

April 3, 2025

The US FDA Grants 510(k) Clearance to Medivis’ Spine Navigation Platform

Shots: The US FDA has granted 510(k) clearance to Spine Navigation platform; commercially launched in the US, making it available nationwide to hospitals & ambulatory surgical centers Spine Navigation integrates AI-driven surgical intelligence, real-time insights, & advanced imaging with lightweight AR hardware allowing surgeons ergonomic freedom using hand tracking & voice control in neuro &…

April 3, 2025

SineuGene Therapeutics Reports the US FDA’s IND Clearance of SNUG01 for Amyotrophic Lateral Sclerosis

Shots: The US FDA has granted IND clearance to SNUG01 for ALS SNUG01 will be evaluated in a P-I/IIa dose-escalation & expansion trial to assess its safety, tolerability, & preliminary efficacy in ALS adults; SineuGene to partner with academics & institutions to lead clinical development of SNUG01 SNUG01, a TRIM72-targeted gene therapy, counteracts ALS through…

April 3, 2025

Novartis’ Vanrafia (Atrasentan) Receives the US FDA’s Accelerated Approval for Primary IgA Nephropathy (IgAN)

Shots: The US FDA has granted accelerated approval to Vanrafia for proteinuria reduction in adults with primary IgAN at risk of rapid disease progression based on the ongoing P-III (ALIGN) trial, with no requirement for REMS program; traditional approval will be supported by eGFR results expected in 2026 Trial assessed atrasentan (0.75mg, PO, QD) +…

April 3, 2025

Sanofi Licenses an Undisclosed Nurix Therapeutics’ Drug Program for Autoimmune Diseases

Shots: Sanofi has licensed an undisclosed Nurix program targeting a previously undruggable transcription factor for autoimmune diseases under their Dec 2019 deal As per the deal, Nurix used its DEL-AI platform to develop E3 ligase-targeting degraders, with Sanofi having rights to license them. Nurix can co-develop & co-promote up to 2 US products, sharing US…

April 3, 2025

NEWS

Daiichi Sankyo and AstraZeneca Report the EC’s Approval of Enhertu for HER2 Low/Ultralow Metastatic Breast Cancer (MBC)

Eli Lilly Enters a ~$1.4B Licensing Agreement with Sangamo Therapeutics for its STAC-BBB Capsid

Amgen’s Uplizna Receives the US FDA’s Approval for Immunoglobulin G4-related Disease (IgG4-RD)

BridgeBio Oncology Therapeutics Reports the First Patient Dosing in P-I (KONQUER-101) Trial of BBO-11818 for Advanced Solid Tumors

Accord Healthcare Reports the CHMP’s Positive Opinion on Osvyrti and Jubereq (Biosimilar, Prolia & Xgeva)

Siemens to Acquire Dotmatics for $5.1B, Strengthening its Position in Life Science Market

The US FDA Grants 510(k) Clearance to Medivis’ Spine Navigation Platform

SineuGene Therapeutics Reports the US FDA’s IND Clearance of SNUG01 for Amyotrophic Lateral Sclerosis

Novartis’ Vanrafia (Atrasentan) Receives the US FDA’s Accelerated Approval for Primary IgA Nephropathy (IgAN)

Sanofi Licenses an Undisclosed Nurix Therapeutics’ Drug Program for Autoimmune Diseases

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