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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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Bruno Vision Care

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…

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Cue Biopharma & Boehringer Ingelheim

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…

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Intas & Coherus

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…

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Pfizer New

Pfizer to Discontinue Danuglipron’s Development Program for Chronic Weight Management

Shots: Pfizer has discontinued the development of danuglipron (PF-06882961) as a potential therapy for chronic weight management Danuglipron was evaluated in 2 P-I trials (NCT06567327 & NCT06568731), meeting key PK objectives & confirming formulation & dose with potential for strong efficacy & tolerability in P-III. However, a case of drug-induced liver injury & recent regulatory input led…

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Chromatin Bioscience & Astellas

Astellas Collaborates with Chromatin Bioscience to Develop Cell-Selective Synthetic Promoters

Shots: Astellas has entered into a collaboration agreement with Chromatin Bioscience to design cell-selective synthetic promoters As per the agreement, Chromatin will utilize its chromatinLENS platform to develop cell-selective synthetic promoters for Astellas’ target profile, allowing precise & durable gene expression in specific cells chromatinLENS platform identifies gene regulatory elements from the dark genome &…

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