Shots:
NANOBIOTIX & Janssen have amended their 2023 collaboration to develop & commercialize JNJ-1900 (NBTXR3), adjusting the deal value from $2.7B to $2.6B
As per the revision, NANOBIOTIX will receive ~$1.77B in milestones related to cisplatin-ineligible HNSCC & inoperable stage 3 NSCLC, with ~$165M in milestones for China, South Korea, Singapore, & Thailand. J&J will cover…
Shots:
AstraZeneca to acquire EsoBiotec, which will operate as AstraZeneca’s subsidiary, while maintaining its operations in Belgium to advance cell therapy
As per the deal, AstraZeneca will acquire all outstanding equity of EsoBiotec on a cash & debt-free basis for ~$1B, incl. $425M upfront at closing & ~$575M in development & regulatory milestones; closing…
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The EC has approved Imfinzi monotx. for the treatment of LS-SCLC adults whose disease has not progressed after receiving Pt-based CRT; regulatory review underway in Japan & other regions
Approval was based on P-III (ADRIATIC) trial (n=730) assessing Imfinzi (1500mg, IV, Q4W) with or without Imjudo (75mg, IV, Q4W × 4 cycles) followed by…
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The US FDA has granted 510(k) clearance to Zipline Access Catheters to treat acute ischemic strokes
Zipline improves delivery of a large (070) & superbore (088) aspiration catheter to enhance trackability & simplify neuro-interventional procedures for faster as well as more efficient stroke treatment. Zipline also optimizes clot removal & improves success rates…
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Alteogen has granted AstraZeneca global rights of ALT-B4 to develop & commercialize SC formulations of multiple oncology assets, while Alteogen will be responsible for clinical & commercial supply of ALT-B4
As per the deal, Alteogen will receive an upfront, along with development, regulatory, & sales milestones, plus royalties on sale of commercialized products…
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Amgen has reported P-III (MINT) trial data on Uplizna vs PBO in adults (N=238) with AChR+ gMG (n=190) or MuSK+ gMG (n=48), followed for 52 & 28wks., respectively; sBLA under FDA’s priority review for IgG4-RD (PDUFA: Apr 3, 2025), with regulatory filings expected to end by H1’25
Pts received an initial loading dose…
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AbbVie has reported final analysis data from P-III (MIRASOL) trial assessing Elahere vs CT in FRα+ PROC pts (n= 453) who had previously received 1-3L of therapy
At 30.5mos. mFU, trial showed 37% improved PFS (mPFS: 5.59 vs 3.98mos.) & superior ORR (41.9% vs 15.9%), while mOS was 16.85 vs 13.34mos., with 32% reduced…
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Celltrion has launched SteQeyma (ustekinumab-stba) injection, a biosimilar to Stelara, for all indications of the reference products following the US FDA’s approval in Dec 2024
Approval was supported by various clinical evidence incl. P-III trial of SteQeyma vs Stelara for mod. to sev. plaque PsO, with 1EP as rate of change in the PASI for skin…
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The US FDA has granted 510(k) clearance to MONARCH QUEST, an AI-powered navigation tech for improved robotic-assisted bronchoscopy
MONARCH QUEST features a scope-in-sheath design & continuous vision, utilizing NVIDIA RTX platform to boost its computational power by 260% for enhanced accuracy. It also allows integration with GE HealthCare’s OEC 3D CBCT Imaging System to…
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Kemin Industries has launched Prosidium to improve biosecurity in animal feed and global food supply
Prosidium is based on peroxy acids, which disrupts pathogen cell membranes to reduce Salmonella risk & viral transmission in animal feed, while the residual acids offer continuous feed protection
Additionally, Prosidium’s ingredients are approved by various regulatory bodies incl.…

