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Intas has acquired Coherus’ Udenyca business (incl. prefilled syringe, autoinjector & on-body injector), a biosimilar version of Amgen’s Neulasta (pegfilgrastim) via 2024 asset purchase agreement; Accord BioPharma (Intas’ US specialty division) will handle Udenyca’s US business
As per the deal, Coherus received $483.4M upfront in cash, incl. $118.4M for Udenyca inventory, with an additional…
NEWS
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Pfizer has discontinued the development of danuglipron (PF-06882961) as a potential therapy for chronic weight management
Danuglipron was evaluated in 2 P-I trials (NCT06567327 & NCT06568731), meeting key PK objectives & confirming formulation & dose with potential for strong efficacy & tolerability in P-III. However, a case of drug-induced liver injury & recent regulatory input led…
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Astellas has entered into a collaboration agreement with Chromatin Bioscience to design cell-selective synthetic promoters
As per the agreement, Chromatin will utilize its chromatinLENS platform to develop cell-selective synthetic promoters for Astellas’ target profile, allowing precise & durable gene expression in specific cells
chromatinLENS platform identifies gene regulatory elements from the dark genome &…
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The EC has granted full approval to Columvi + GemOx for ASCT-ineligible r/r DLBCL pts based on P-III (STARGLO) trial assessing the regimen vs MabThera/Rituxan + GemOx in previously treated DLBCL pts
At 11.3mos. mFU (primary analysis), trial showed improved OS, a 41% reduction in death risk, with a 63% improvement in PFS. At…
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The US FDA has granted IDE approval to initiate US feasibility study of SIRA radiofrequency ablation (RFA) electrosurgical device for pts undergoing breast-conservation surgery (BCS)
SIRA device is a single-use applicator designed to deliver circumferential RFA to the post-lumpectomy cavity during breast-conserving surgery to provide consistent ablation depth & increased confidence in margin treatment…
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Amgen has reported P-III (DeLLphi-304) trial data evaluating Imdelltra (tarlatamab-dlle) vs SoC CT (topotecan globally excl. Japan; lurbinectedin in the US, Canada, Australia, Singapore, Korea; & amrubicin in Japan) in SCLC pts who progressed on or after single line of Pt-based CT
In the interim analysis, trial met its 1EP, with superior OS; full…
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The US FDA has approved Opdivo + Yervoy as 1L therapy to treat inoperable or advanced HCC adults
Approval was based on P-III (CheckMate-9DW) trial assessing Opdivo (1mg/kg, Q3W) + Yervoy (3mg/kg, Q3W), followed by Opdivo alone (480mg, Q4W) vs lenvatinib/sorafenib in 668 pts with advanced HCC who had not received prior systemic therapy.…
Health Canada Approves AstraZeneca’s Imfinzi to Treat Limited-Stage Small Cell Lung Cancer (LS-SCLC)
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Health Canada has approved Imfinzi monotx. for the treatment of LS-SCLC adults whose disease has not progressed after receiving Pt-based CRT
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 Imfinzi (for ~24mos.) vs PBO
Study showed reduced risk…
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OS Therapies has reported data from 2 studies assessing OST-HER2 with palliative radiation to prevent or delay amputation in dogs with unresected appendicular osteosarcoma
Unpublished data showed tumor arrest, delayed metastases, & >500-day survival in 5/15 dogs while data published Molecular Therapy, showed early immune response from the 1st dose, with short-term survivors with…
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Elixir has reported European MDR CE Mark approval & commercial launch of LithiX Hertz Contact (HC) Intravascular Lithotripsy (IVL) System in EU to improve calcium & percutaneous coronary intervention treatment
LithiX is a transcatheter device that uses low-profile metal hemispheres on a semi-compliant balloon to apply HC Stress, creating deep & wide fractures while…

