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Teva and Alvotech
Teva and Alvotech’s Selarsdi (Biosimilar, Stelara) Receives the US FDA’s Interchangeability Designation
Shots:The US FDA has granted interchangeable designation to Selarsdi, a biosimilar version of Stelara (ustekinumab) for all indications incl. treatment of adult & pediatric PsA & plaque PsO as well as Crohn’s disease, & ulcerative colitis, effective as of Apr 30, 2025Selarsdi is an anti-IL-12/IL-23 mAb, with 4 approved presentations: 45mg/0.5mL & 90mg/mL…
Takeda at AASLD 2024: Chinwe Ukomadu in a Riveting Dialogue Exchange with PharmaShots
Takeda at AASLD 2024: Chinwe Ukomadu in a Riveting Dialogue Exchange with PharmaShots
Shots:  AATD-associated liver disease is a progressive genetic disorder with no approved therapy, and liver transplantation remains the only option for patients with end-stage disease. Fazirsiran is an investigational RNAi therapy designed to treat AATD-associated liver disease by lowering the production of Z-AAT. PharmaShots welcomes Dr. Chinwe Ukomadu, Head of the Gastrointestinal and Inflammation Therapeutic…
VERAXA Biotech & OmniAb
VERAXA Biotech Collaborates with OmniAb to Develop Novel Bispecific Antibody Drug Conjugate for Solid Tumors
Shots:VERAXA Biotech has entered into a co-discovery alliance with OmniAb to develop novel bispecific antibody drug conjugate (bsADC) targeting solid tumors using the former’s ADC linker tech & conjugation expertise & OmniAb’s suite of transgenic antibody discovery solutionsAs per the deal, VERAXA will initiate novel bsADC program targeting 2 cancer-related molecules, using OmniAb’s…
Endogenex
Endogenex Reports REGENT-1 Australian Clinical Study Data of ReCET System for Type 2 Diabetic Duodenopathy
Shots:Endogenex has reported REGENT-1 Australian study data of ReCET System for the treatment of inflamed & dysfunctional tissue associated with type 2 diabetic (T2D) duodenopathy; REGENT-1 is also being conducted in the USThe study showed dose-responsive improvements in insulin sensitivity & beta cell function at 12wks., sustained through 48wks., with 100% procedural success…
Vanotech
Chengdu Origen and Vanotech Report the First Patient Dosing in P-I (VAN-2401) Trial of KH658 for Wet Age-related Macular Degeneration
Shots:Chengdu Origen & Vanotech has reported the first pts dosing in Vanotech-led P-I (VAN-2401) trial assessing KH658 for wet age-related macular degeneration (wet AMD) in the USThe P-I trial will assess safety, tolerability, & efficacy of single suprachoroidal KH658 gene therapy in ~9 previously treated wet AMD pts that are responsive to anti-VEGF therapy…
Merck Animal Health
Merck Animal Health’s Mometamax Single Receives the US FDA’s Approval to Treat Dogs with Otitis Externa
Shots:The US FDA has approved Mometamax Single (gentamicin, posaconazole, & mometasone furoate otic suspension) to treat otitis externa in dogs; commercially available by the summer of 2025Mometamax Single has shown favorable efficacy, with 80.5% resolution of clinical signs in dogs vs 19.6% with PBOMometamax Single is a single-dose in-clinic treatment for otitis…