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NEWS

VectorY Therapeutics Collaborates with Shape Therapeutics to Develop Vectorized Antibodies for Neurodegenerative Diseases

Shots: VectorY has entered into an option & license deal with Shape to assess Shape’s SHP-DB1 (AAV capsid) for vectorized Abs payloads against 3 targets & may secure an exclusive license for their delivery if evaluation succeeds As per the deal, VectorY will handle development & commercialization of resulting therapies in exchange for an upfront…
September 18, 2025

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NEWS

Roche to Acquire 89bio for ~$3.5B, Strengthening its CVRM Portfolio

Shots: Roche has entered into a definitive merger agreement to acquire 89bio, incl. its lead asset pegozafermin (FGF21 analog) for metabolic dysfunction-associated steatohepatitis, expanding cardiovascular, renal, & metabolic disease portfolio   As per the deal, Roche will acquire 89bio for $14.5/share in an all-cash transaction totaling ~$2.4B, along with one non-tradeable CVR up to an…
September 18, 2025

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NEWS

Deciphera Pharmaceuticals Reports the EC’s Approval of Romvimza for Symptomatic Tenosynovial Giant Cell Tumor (TGCT)

Shots: The EC has approved Romvimza (vimseltinib) to treat symptomatic TGCT with physical function deterioration in adults for which surgery may lead to functional impairment or severe morbidity Approval was based on P-I/II trial as well as P-III (MOTION) trial, which evaluated Romvimza vs PBO in surgery-ineligible pts without prior anti-CSF1/CSF1R therapy (prior imatinib/nilotinib allowed)…
September 18, 2025

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Biocon Biologics Receives the FDA’s Approval & Provisional Interchangeability Designation for Aukelso and Bosaya (Biosimilars, Xgeva and Prolia)

Shots: The US FDA has approved & granted provisional interchangeability designation to Aukelso (70mg/mL, SC, single-dose vial) & Bosaya (60mg/mL, SC, PFS), biosimilar versions of Amgen’s Xgeva & Prolia (denosumab) Clinical data showed both biosimilars matched the reference product in quality, safety & efficacy, plus Bosaya was approved with Prolia’s REMS to inform about sev. hypocalcemia…
September 18, 2025

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Astrazeneca
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AstraZeneca Reports Interim P-III (TULIP-SC) Trial Data of Saphnelo for Systemic Lupus Erythematosus (SLE)

Shots: AstraZeneca has reported interim P-III (TULIP-SC) trial data assessing Saphnelo (anifrolumab; 120mg, SC, QW, accessorisedPFS) vs PBO in 367 pts (18-70yrs.) with mod. to sev. active, autoantibody-positive SLE while receiving SoC Interim analysis conducted after the first 220 pts reached Wk. 52, showed Saphnelo reduced disease activity (1EP), measured by BICLA at Wk. 52; data to be…
September 18, 2025

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Amber implants
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Amber Implants Reports the US FDA’s 510(k) Clearance of VCFix Spinal System for Treating Vertebral Compression Fractures

Shots: The US FDA has granted 510(k) clearance to VCFix Spinal System for thetreatment of vertebral compression fractures The company plans to launch a US pilot program in early 2026, expand physician access later that year, extend the EXPAND trial into the US, & pursue EU label expansion for stand-alone use & one-level fixation integration…
September 17, 2025

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NEWS

Alteogen’s Eyluxvi (Biosimilar, Eylea) Receives the EC’s Approval for Retinal Diseases

Shots: The EC has approved Eyluxvi (ALT-L9), a biosimilar version of Eylea (aflibercept), to treat wet AMD, visual impairment due to macular oedema secondary to branch/central retinal vein occlusion & visual impairment due to diabetic macular oedema & myopic choroidal neovascularisation Approval was based on P-III trials conducted across the EU, South Korea, & Japan,…
September 17, 2025

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NEWS

Johnson & Johnson MedTech Launches Shockwave Javelin Peripheral IVL Catheter in the EU

Shots: J&J has launched Shockwave Javelin peripheral IVL catheter in the EU to modify calcium & cross extremely narrowed vessels in pts with peripheral artery disease (PAD) Shockwave Javelin was studied in FORWARD PAD IDE trial that demonstrated similar safety & effectiveness compared to balloon-based Shockwave IVL catheters, regardless of the nature of calcified lesions…
September 17, 2025

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