Shots: 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 a single implant & mimics physiological effects of fasting like improved insulin sensitivity, reduced fat mass, & improved metabolism without changing feeding routine in animals Ref ..read more

Shots: 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 expected in Q2 or Q3’25 Acquisition will integrate iCAD's AI-driven ProFound Breast Health Suite with RadNet's DeepHealth platform, expanding RadNet’s global reach through iCAD’s presence in over 1,500 provider sites across 50+ countries ..read more

Shots: 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, assessed rugonersen (ASO) vs natural history, which showed positive exploratory effects on multiple clinical measures & EEG delta power; data was presented at FAST’s Global Science Summit 2024 Ref: Oak Hill Bio | Image: Oak Hill Bio & ..read more

Shots: 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, safety, efficacy & immunogenicity Additionally, Biocon Biologics reached a settlement in Mar, 2024 with Bayer & Regeneron, allowing Canadian launch of Yesafili by Jul 1, 2025 Ref: Biocon Biologics ..read more

Shots: 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 as MA Holder in all regions    Leqembi is a humanized anti-soluble aggregated Aβ mAb that selectively binds to Aβ plaque components, reducing Aβ protofibrils & plaques in the ..read more

Shots: 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 Trio is a highly palatable, monthly chewable tablet that starts killing fleas within 4 hrs. & can be administered with or without food Ref: Zoetis | Image: Zoetis Rela ..read more

Shots: Cyprumed & Merck have entered into a non-exclusive license & option agreement to develop oral formulations of Merck’s peptides, leveraging Cyprumed’s innovative drug delivery tech  As per the deal, Merck has secured non-exclusive global rights to Cyprumed’s oral peptide delivery platform for an undisclosed number of targets, with an option to exclusively license it for individual targets & will be responsible for research, development, manufacturing, & commercialization efforts Cyprumed will receive ~$493M in upfront, development, regulatory, & sales milestones ..read more

Shots:      PharmaShots has compiled a list of US FDA-approved drugs in the month of March 2025       The US FDA has approved a total of 2 new drug including 2 new molecular entities leading to the treatment of patients and advances in the healthcare industry        The major highlighted drug was GSK’s Blujepa securing approval for treating Uncomplicated Urinary Tract Infections (uUTIs)      1. GSK Reports the US FDA’s Approval of Blujepa (Gepotidacin) to Treat Uncomplicated Urinary Tr ..read more

Shots: The US FDA has granted interchangeability designation to Yuflyma, a biosimilar version of Humira (adalimumab) Designation was backed by P-III interchangeability trial showing comparable PK, efficacy, safety, & immunogenicity in pts with mod. to sev. PsO receiving reference adalimumab (ADA) continuously or those who alternated between ADA & Yuflyma during Wk. 25-27; data was presented at EADV 2024 Yuflyma is a high-concentration (100mg/mL), citrate-free Humira formulation that is available in 20mg, 40mg, & 80mg doses for injection in a prefilled syringe or an autoinjector pen ..read more

Shots: The US FDA has granted conditional approval to initiate the second cohort of the early feasibility study (EFS) of the Aeson artificial heart in the US by H2’25, pending ethics committee approval & personnel training; launch expected by 2028 EFS is being conducted in 2 cohorts; first (n=3) was completed in Q3’21, leading to FDA-approved enhancements to Aeson. 2nd cohort will incl. 7 pts, with an interim report on the first 3, as CARMAT seeks the US FDA approval to use the updated version of Aeson in the study EFS will assess pts survival at 6mos. post-Aeson implant, or a success ..read more