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…
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…
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…
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…
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…
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…
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…
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 &…
Shots:
The EC has granted full approval to Columvi + GemOx for ASCT-ineligible r/r DLBCL pts based on P-III (STARGLO) trial assessing the regimen vs MabThera/Rituxan + GemOx in previously treated DLBCL pts
At 11.3mos. mFU (primary analysis), trial showed improved OS, a 41% reduction in death risk, with a 63% improvement in PFS. At…

