Shots:
The US FDA has approved Valtoco for short-term treatment of acute repetitive seizures (seizure clusters) in pts (≥2yrs.) with epilepsy
Approval was based on P-I/IIa trial assessing safety & PK of Valtoco, which showed favorable safety & efficacy with easy administration in pts who had episodes of frequent seizures; data was presented at CNS…
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The IIT P-II (IPAX-Linz) trial assessed TLX101 (IV) in 8 glioblastoma pts with recurrent tumors & PET-confirmed amino acid uptake, who received adaptive dosing with ~4GBq before & ~2GBq after, 2L EBRT; 5/8 had MGMT-unmethylated tumors
Trial showed mOS of 12.4mos. or 32.2mos. from initial diagnosis, complementing P-I (IPAX-1) trial results of 13mos. & 23mos.,…
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Vivani Medical & Okava Pharmaceuticals have expanded their 2019 collaboration to develop OKV-119 for cardiometabolic conditions in dogs, which initially focused on cats
Financial terms of the expanded agreement remain undisclosed but incl. future milestones & royalty payments to Vivani
OKV-119 (GLP-1 receptor agonists) uses Vivani’s NanoPortal tech for steady drug delivery over time from…
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RadNet has entered into a definitive merger agreement to acquire iCAD in an all-stock transaction, through which iCAD will become a wholly owned subsidiary of RadNet
As per the deal, iCAD stockholders will receive 0.0677 RadNet shares/ iCAD share, representing transaction value of ~$103M, or ~$3.61/share (~98% premium) on a fully diluted basis; closing…
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Oak Hill Bio has entered into an exclusive license agreement with Roche to obtain global rights of rugonersen (RO7248824) for the treatment of angelman syndrome
Oak Hill to initiate a pivotal P-III trial of rugonersen for angelman syndrome in early 2026, pending regulatory review of the final trial protocol
TANGELO study led by Roche,…
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Biocon Biologics & Regeneron have entered into a settlement & license agreement, allowing the US launch of Yesafili, an interchangeable biosimilar version of Eylea (aflibercept) by H2’26
Yesafili’s FDA approval was supported by analytical, nonclinical & clinical data incl. P-III (INSIGHT) trial assessing Yesafili vs Eylea in DME pts, confirming its similarity in PK,…
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The EC has approved Leqembi for the treatment of early Alzheimer’s disease in all 30 EEA states
Eisai handles global development & regulatory filings for Leqembi, co-commercializing & co-promoting it with Biogen while retaining final decision-making authority. Eisai co-promotes Leqembi with Biogen in the EU (excl. Nordics) & with BioArctic in the Nordic countries, distributing it…
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The US FDA has approved label expansion of Simparica Trio to protect dogs against Dipylidium caninum (flea tapeworm) infections by killing Ctenocephalides felis vector fleas
Simparica Trio (sarolaner, moxidectin, & pyrantel) is a parasiticide that protects dogs against heartworm disease, 6 tick species (incl. Lyme-transmitting deer ticks), fleas, roundworms, hookworms, & flea tapeworms
Simparica…

