Skip to content Skip to footer

NEWS

Intas & Coherus
Intas Pharmaceuticals Acquires Coherus BioSciences’ Udenyca Business (Biosimilar, Neulasta)
Shots: 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…
Pfizer New
Pfizer to Discontinue Danuglipron’s Development Program for Chronic Weight Management
Shots: 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…
Chromatin Bioscience & Astellas
Astellas Collaborates with Chromatin Bioscience to Develop Cell-Selective Synthetic Promoters
Shots: 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 &…
Innoblative
Innoblative Secures the US FDA’s IDE Approval of SIRA Electrosurgical Device for Breast Cancer Patients
Shots: 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…
Amgen
Amgen Reports P-III (DeLLphi-304) Trial Findings of Imdelltra for SCLC
Shots: 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…
OS Therapies
OS Therapies Reports Clinical Data of OST-HER2 for the Treatment of Unresected Osteosarcoma in Dogs
Shots: 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…