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Vivani Medical & Okava

Vivani Medical & Okava Pharmaceuticals Extend Collaboration to Develop OKV-119 for Canine Cardiometabolic Diseases

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…

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iCAD

RadNet to Acquire iCAD for ~$103M

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…

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Biocon Biologics

Biocon Biologics and Regeneron Settle over Yesafili’s (Biosimilar, Eylea) US Launch

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,…

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Eisai, Biogen and BioArctic

Eisai, Biogen and BioArctic Report the EC’s Approval of Leqembi (lecanemab) for Early Alzheimer’s Disease

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…

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Zoetis

The US FDA Approves Zoetis’ Simparica Trio to Prevent Flea Tapeworm Infections in Dogs

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…

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Merck & Cyprumed

Merck Signs a ~$493M Deal with Cyprumed to Develop Oral Peptide Therapeutics

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…

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Celltrion

Celltrion’s Yuflyma (Biosimilar, Humira) Receives the US FDA’s Interchangeability Designation

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…

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Carmat

The US FDA Grants Conditional Approval to Initiate Second Cohort of the EFS Study of CARMAT’s Aeson Artificial Heart

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…

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