Shots:The US FDA received BLA, plus a request for a priority review of apitegromab to improve motor function in pts with SMA who are on SMN-targeted therapy. The EMA’s MAA to be filed in Q1’25
The BLA was supported by the P-III (SAPPHIRE) & P-II (TOPAZ) trial, where SAPPHIRE met its 1EP of…
Shots:The FDA has approved Journavx (50mg; BID) to treat moderate-to-severe acute pain in adults
JOURNAVX is an oral, non-opioid pain signal inhibitor that selectively targets NaV1.8 relative to other NaV channels
The company is also testing suzetrigine for peripheral neuropathic pain (PNP), with ongoing P-III trial for diabetic neuropathy and plans for…
Shots:The EC has approved Blincyto monotherapy as a part of consolidation therapy to treat 1L philadelphia chromosome-negative CD19+ B-ALL adults based on P-III (E1910) trial
Blincyto + CT showed improved OS with 4.5yrs. median follow up vs CT alone, whereas 5-yrs. mFU demonstrated 82.4% vs 62.5% OS in 112 pts
The trial was led by…
Shots:The US FDA has granted 510(k) clearance to Prolift Pivot expandable spacer system, expanding Life Spine’s Micro Invasive tech portfolio
The system provides full articulation for precise spinal fusion, while reducing tissue disruption & nerve retraction, allowing surgeons to restore patient alignment with superior control & efficiency. It also features OSSEO-LOC surface tech that promotes osseointegration & long-term…
Shots:The P-III (INAVO120) trial evaluated Itovebi + Ibrance + fulvestrant vs matching PBO in PIK3CA-mutated, HR+/HER2-, endocrine-resistant, 1L LA/M breast cancer pts (n=325); ongoing regulatory review in EU & other regions
Study met its 2EP of significant OS demonstrating 57% reduction in risk of disease worsening or death (mPFS: 15 vs 7.3mos.; HR=0.43).…
Shots:Pet Honesty launched Urinary Tract Health, a supplement to promote cats' urinary health, expanding its feline wellness product portfolio
Urinary Tract Health chews contain cranberry, glucosamine, & probiotics to support normal urinary function, gut health & maintain urine pH
This is a dual-texture cat supplement to increase palatability in cats, plus provide…
Shots:The EMA has accepted MAA of Anktiva + Bacillus Calmette-Guérin (BCG) to treat BCG-unresponsive NMIBC with CIS, & with/without papillary tumors, based on an ongoing QUILT 3.032 study. Application covers 27 EU countries, plus Iceland, Norway & Liechtenstein, with submission also made to the UK's MHRA
As of the data cut-off on Jul…
Shots:Lantheus will acquire Evergreen Theragnostics for $250M upfront plus ~$752.5M development & sales milestones related to Octevy & other assets in an all-cash transaction, with closing anticipated in H2’25 pending regulatory approvals
The acquisition will add Evergreen’s Octevy (registrational-stage PET imaging agent for somatostatin receptor +ve NETs in adults & pediatrics) complementing Lantheus'…
Shots:Zimmer Biomet has agreed to acquire Paragon 28 for $13.00/share in cash with an equity value of ~$1.1B & enterprise value of ~$1.2B. Closing is expected in H1’25
As per the terms, shareholders will also get a non-tradeable CVR of $1/share on achieving revenue milestones, which is payable from $0 to $1 (calculated linearly)…
Shots:The US FDA has granted 510(k) clearance to Adaptive Nomogram algorithm in the Aurora Xi Plasmapheresis System to improve plasma collection efficiency
Clearance was based on a trial of Adaptive Nomogram in Aurora Xi Software Version 2.0 vs the existing Optimized Nomogram involving >52,400 procedures that met its 1EP, depicting increased plasma volume…
