NEWS

Innovent and Ask Biopharma Receives China’s NMPA Approval for Limertinib to Treat Non-Small Cell Lung Cancer

Shots: NMPA approved limertinib (oral EGFRm TKI) to treat LA/M EGFR T790M-mutated NSCLC in adults, based P-IIb trial assessing limertinib in (n=301) NSCLC patients This study showed 68.8% ORR, 92.4% DCR, plus 11mos. mPFS with 11.1mos. mDoR. It also showed ORR & mPFS of 65.9% & 10.6mos., respectively in patients with assessable CNS lesions…

January 17, 2025

Sutter Health Collaborates with GE HealthCare to Enhance Patient Care Through AI-Powered Imaging for Physicians and Clinicians

Shots: Sutter Health and GE HealthCare signed a 7yrs. strategic collaboration agreement (Care Alliance), to enhance access to imaging services for patient and clinician experiences in California. This will enable faster appointments, quicker imaging results, and more consistent care Sutter Health's key initiatives include a fast technology program to deploy advanced AI imaging tools…

January 17, 2025

Mainstay Medical Reports Data from RESTORE Trial of ReActiv8 Implantable Device to Treat Chronic Low Back Pain

Shots: The RESTORE trial assessed the ReActiv8 Restorative Neurostimulation therapy (n=99) vs SoC (n=104) for 1yr. to treat intractable chronic low back pain in patients (N=203) The data showed a mean improvement in ODI score (1EP; -19.7 ± 1.4 vs -2.9 ± 1.4), back pain measured by 11-pts. NRS (2EPs; -3.6 ± 0.2 vs…

January 16, 2025

Silexion Therapeutics Reports Preclinical Data for SIL-204 in Combination with 1L Chemotherapies for Pancreatic Cancer

Shots: Silexion reported preclinical data of SIL-204 (siRNA agent) + 5-fluorouracil + irinotecan & SIL-204 + gemcitabine combinations in KRAS G12D mutated human pancreatic tumor cell lines The data demonstrated a reduction in cancer cell confluence in contrast to 1L CT agents alone, where SIL-204 + 5-fluorouracil + irinotecan achieved reduction after 3 days…

January 16, 2025

Formycon and Fresenius Kabi Report the MHRA’s Approval of Otulfi (Biosimilar, Stelara)

Shots: The UK’s MHRA has approved Otulfi (SC & IV), biosimilar of J&J’s Stelara (ustekinumab), to treat mod. to sev. active Crohn's disease, ulcerative colitis, plaque psoriasis as well as active psoriatic arthritis & is set to enter UK market as per a confidential settlement b/w the companies and J&J. It is approved across the US,…

January 16, 2025

Innovent’s IBI343 Secures the NMPA’s Breakthrough Therapy Designation for Advanced Pancreatic Cancer

Shots: The NMPA has granted BTD to IBI343 alone for treating CLDN18.2+ advanced pancreatic ductal adenocarcinoma (PDAC) progressed post 1L of systematic therapy Designation was based on the ongoing P-I trial of IBI343 (6mg/kg, Q3W) in CLDN18.2+ advanced PDAC patients (n=43) treated with at least 1L of therapy (5% received 2L+ of therapy) across…

January 16, 2025

Eli Lilly Receives the US FDA’s Approval for Omvoh (Mirikizumab-mrkz) to Treat Crohn’s Disease (CD)

Shots: Approval was based on a P-III (VIVID-1) trial assessing Omvoh vs PBO in mod. to sev. CD patients, unresponsive/intolerable to corticosteroids, BRMs &/or biologics, post its approval for UC in Dec 2023. Regulatory submissions are filed globally, incl. Japan & the EU, with other submissions underway Study showed 53% vs 36% clinical remission &…

January 16, 2025

NEXTBIOMEDICAL Secures the US FDA’s IDE Approval of Nexsphere-F to Use it in Genicular Artery Embolization (GAE) for Knee Osteoarthritis

Shots: The US FDA has granted IDE approval to initiate RESORB clinical evaluation of Nexsphere-F for knee osteoarthritis. It is CE-MDD approved for arthritis embolization & has shown superior efficacy in various musculoskeletal embolization cases across Asia & the EU RESORB study will evaluate the efficacy of Nexsphere-F to ease pain & improve mobility…

January 16, 2025

J.P. Morgan Special: Dealmaker of the Year 2024 (Part 02)

Shots: In this second installment of Dealmaker 2024, PharmaShots presents an insightful guide to the top M&A deals ranked by deal value This report highlights Novo Nordisk’s remarkable achievements, including 24 collaborations spanning acquisitions, company formations, contract services, development and commercialization agreements, facility purchases, licensing options, and platform/product purchases. Collectively, these deals amount to…

January 15, 2025

REGENXBIO Join Forces with Nippon Shinyaku to Develop and Commercialize RGX-121 and RGX-111 for Mucopolysaccharidosis (MPS)

Shots: REGENXBIO & Nippon have partnered to develop RGX-121 (Hunter syndrome; FDA’s accelerated approval expected in late 2025, with ongoing rolling BLA filing) & RGX-111 (P-I/II study for Hurler syndrome) in the US & Asia. The closing is expected in Q1’25 REGENXBIO will get $110M upfront, ~$700M milestones ($40M development & regulatory + $660M…

January 15, 2025

NEWS

Innovent and Ask Biopharma Receives China’s NMPA Approval for Limertinib to Treat Non-Small Cell Lung Cancer

Sutter Health Collaborates with GE HealthCare to Enhance Patient Care Through AI-Powered Imaging for Physicians and Clinicians

Mainstay Medical Reports Data from RESTORE Trial of ReActiv8 Implantable Device to Treat Chronic Low Back Pain

Silexion Therapeutics Reports Preclinical Data for SIL-204 in Combination with 1L Chemotherapies for Pancreatic Cancer

Formycon and Fresenius Kabi Report the MHRA’s Approval of Otulfi (Biosimilar, Stelara)

Innovent’s IBI343 Secures the NMPA’s Breakthrough Therapy Designation for Advanced Pancreatic Cancer

Eli Lilly Receives the US FDA’s Approval for Omvoh (Mirikizumab-mrkz) to Treat Crohn’s Disease (CD)

NEXTBIOMEDICAL Secures the US FDA’s IDE Approval of Nexsphere-F to Use it in Genicular Artery Embolization (GAE) for Knee Osteoarthritis

J.P. Morgan Special: Dealmaker of the Year 2024 (Part 02)

REGENXBIO Join Forces with Nippon Shinyaku to Develop and Commercialize RGX-121 and RGX-111 for Mucopolysaccharidosis (MPS)

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