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…
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…
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,…
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…
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 &…
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…
Shots: The January Edition features RA Capital Management, a global multi-stage investment firm dedicated to healthcare and life sciences In 2024, RA Capital added 74 companies to its portfolio, investing approximately $8.5B across seven funding rounds, including private and common funding Welcome to the 2025 series of Know Your Investor, a meticulously crafted report highlighting…
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…
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…
Shots:The NMPA has granted sNDA approval of Orpathys to treat locally advanced or metastatic NSCLC with MET exon 14 skipping alterations, expanding its indication to include both treatment-naïve & experienced patients. Previous conditional approval is also converted to full approval
Approval was based on P-IIIb study, with preliminary data from the first line…
