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Sandoz
NEWS

Sandoz Launches Pyzchiva Autoinjector (Biosimilar, Stelara) in the EU for Chronic Inflammatory Diseases

Shots: Sandoz has launched Pyzchiva autoinjectors, a biosimilar version of Stelara (ustekinumab) in EU to treat pts (≥6yrs.; ≥60kg) with plaque PsO, PsA, Crohn’s disease & pediatric plaque PsO; commercially available in Spain, with further expansion to continue In Sep 2023, Sandoz & Samsung Bioepis entered into a development & commercialization agreement, granting Sandoz rights to…
May 23, 2025

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Vigil Neuro
NEWS

Sanofi to Acquire Vigil Neuroscience for ~$470M

Shots: Sanofi has entered into an agreement to acquire Vigil Neuroscience incl. its asset VG-3927 (TREM2 agonist), strengthening its neurology pipeline; Vigil’s VGL101 program is not a part of the acquisition As per the deal, Sanofi will acquire Vigil for ~$470M, with shareholders receiving $8/share in cash & a non-transferable CVR of $2/share payable upon the…
May 22, 2025

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Astrazeneca
NEWS

AstraZeneca’s Tagrisso (Osimertinib) Secures Health Canada’s Conditional Approval to Treat Unresectable EGFR-Mutated NSCLC

Shots: Health Canada has granted conditional approval to Tagrisso for the treatment of pts with locally advanced, inoperable NSCLC with EGFR exon 19 deletions or exon 21 (L858R) substitution mutations, whose disease progressed on or following Pt-based CRT Approval was based on P-III (LAURA) study assessing Tagrisso (80mg, QD, PO) vs PBO among adults (n=216)…
May 22, 2025

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Genentech & Orionis
NEWS

Genentech Collaborates with Orionis to Identify and Develop Molecular Glue Therapies for Cancer Targets

Shots: Genentech has entered into a multi-year collaboration with Orionis to discover small-molecule monovalent glue drugs for novel & difficult oncology targets using Orionis’ Allo-Glue platform As per the deal, Orionis will receive $105M upfront & ~$2B in research, development, commercial, & sales milestones, with tiered royalties; Orionis will lead discovery & optimization, while Genentech…
May 22, 2025

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Celltrion
NEWS

Celltrion’s Yuflyma (Biosimilar, Humira) Receives the US FDA’s Interchangeability Designation for All Presentations

Shots: FDA has granted interchangeability designation to Yuflyma, a biosimilar version of Humira (adalimumab) for prefilled syringe (40mg) & autoinjectors (40 & 80mg) expanding on the prior designation for the 20mg & 80mg prefilled syringes Designation was based on P-III interchangeability trial showing comparable PK, efficacy, safety, & immunogenicity in pts with mod. to sev.…
May 22, 2025

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Crispr Therapeutics & SIRIUS
NEWS

CRISPR Therapeutics Enters a Multi-Target Collaboration with Sirius Therapeutics to Develop Novel siRNA Therapies

Shots: CRISPR & Sirius have partnered to co-develop & co-market SRSD107, with CRISPR having the option to nominate ~2 siRNA targets, fund related research, & retain opt-in rights for clinical development & marketing As per the deal, Sirius will receive $25M cash & $70M in equity upfront, with both companies jointly developing SRSD107 under a…
May 20, 2025

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Stryker
NEWS

The US FDA Grants 510(k) clearance to Stryker’s OptaBlate BVN System for Vertebrogenic Pain

Shots: The US FDA has granted 510(k) clearance to the OptaBlate BVN system for minimally invasive procedure designed to deliver long-lasting relief from vertebrogenic pain OptaBlate BVN achieves ≥1cm lesions in 7min. & features a steerable curved introducer, with microinfusion tech to minimize impedance & charring, plus 10-gauge access tools for precision OptaBlate BVN combines…
May 20, 2025

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