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Eisai, Biogen and BioArctic
NEWS

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…
April 16, 2025

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Zoetis
NEWS

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…
April 16, 2025

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Merck & Cyprumed
NEWS

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…
April 15, 2025

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Celltrion
NEWS

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…
April 15, 2025

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Carmat
NEWS

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…
April 15, 2025

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Bruno Vision Care
NEWS

Bruno Vision Care’s Deseyne Contact Lens Secures the US FDA’s Approval for Dry Eye Disease

Shots: The US FDA has approved Deseyne (vifilcon C) daily disposable contact lens with FusionTechnology; commercially available in Q4’25 Deseyne lenses integrates 2 patented innovations: vifilcon C hydrogel material & FusionTechnology, to gradually release embedded Lachryceuticals (incl. amino acids, vitamins, & polysaccharides), ensuring sustained bioavailability & long-lasting eye comfort FusionTechnology combines hyaluronic acid & tamarind…
April 15, 2025

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Cue Biopharma & Boehringer Ingelheim
NEWS

Cue Biopharma Collaborates with Boehringer Ingelheim to Develop B cell-Targeting Bispecifics for Autoimmune and Inflammatory Diseases

Shots: BI & Cue Biopharma have entered into a multi-year strategic research & license agreement to develop & commercialize CUE-501 for autoimmune diseases, with the potential to expand into other B cell-targeting bispecifics using Cue’s Immuno-STAT platform As per the deal, Cue Biopharma will receive a $12M upfront & ~$345M in research, development, & commercial…
April 15, 2025

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Intas & Coherus
NEWS

Intas Pharmaceuticals Acquires Coherus BioSciences’ Udenyca Business (Biosimilar, Neulasta)

Shots: Intas has acquired Coherus’ Udenyca business (incl. prefilled syringe, autoinjector & on-body injector), a biosimilar version of Amgen’s Neulasta (pegfilgrastim) via 2024 asset purchase agreement; Accord BioPharma (Intas’ US specialty division) will handle Udenyca’s US business As per the deal, Coherus received $483.4M upfront in cash, incl. $118.4M for Udenyca inventory, with an additional…
April 15, 2025

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