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…
NEWS
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…
Shots:The P-III (COMPETE) trial assessed ITM-11 (7.5 GBq + nephroprotective amino acid, Q3M × max. 4 cycles) vs everolimus (10mg for ~30mos. or until disease progression) in patients (n=309) with inoperable, progressive, SSTR+ gr 1/2 GEP-NETs. The US FDA’s NDA submission is expected in 2025
The study met its 1EP of improved PFS,…
Shots:The EMA accepted depemokimab’s MAA as an add-on maintenance therapy for inadequately controlled asthma pts (≥12yrs.) with type 2 inflammation marked by blood eosinophil count as well as CRSwNP, based on P-III (SWIFT & ANCHOR) trials, respectively. NDA is also accepted by the NMPA & MHLW
SWIFT-1 (n=382) & SWIFT-2 (n=380) studies assessed…
Shots:The P-III (EMBARK: N=126) study was carried out in 2 parts, with P1 involving ambulatory DMD boys (n=63; 4-7yrs.) to receive Elevidys (1.33x10^14 vg/kg) vs PBO while P2 involved crossing over of the patients (5-9yrs.); 59 crossed over to Elevidys post 52wks.
Parts 1 (post 2yrs.) & 2 (post 1yr.) depicted improved NSAA…
Shots:The US FDA has granted 510(k) clearance to ClearPoint Navigation Software 3.0 that will introduce intraoperative CT workflow, expanding its use from MRI. The company is planning to initiate limited market release in Q1’25 & full release in H2’25
Navigation Software 3.0 is compatible with intraoperative CT & Conebeam CT imaging, enabling precision neurosurgery in facilities…
Shots:The US FDA’s approval of Enhertu for HR+, HER2 low/ultralow MBC, progressed on endocrine therapies, was based on P-III (DESTINY-Breast06) study compared to CT shared at ASCO 2024 & published in The NEJM. AZ will pay $175M for this milestone
Study depicted PFS of 36%, mPFS of 13.2 vs 8.1mos., cORR of 62.6%…
