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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, 2025
Selarsdi is an anti-IL-12/IL-23 mAb, with 4 approved presentations: 45mg/0.5mL & 90mg/mL…
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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…
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 solutions
As per the deal, VERAXA will initiate novel bsADC program targeting 2 cancer-related molecules, using OmniAb’s…
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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 US
The study showed dose-responsive improvements in insulin sensitivity & beta cell function at 12wks., sustained through 48wks., with 100% procedural success…
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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 US
The 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…
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P-Ib/II (TUPELO) trial (enrolment ongoing) assessed REC-4881 (4 or 8mg, QD) in FAP, with P-II evaluating efficacy via upper & lower endoscopy at Wk. 0, 13 (on-treatment), & 25 (off-treatment) in pts (≥55yrs.) with APC mutations
As of Mar 17, 2025, 4mg (n=6) showed a median 43% polyp burden decrease; 5/6 had reductions of…
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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 2025
Mometamax Single has shown favorable efficacy, with 80.5% resolution of clinical signs in dogs vs 19.6% with PBO
Mometamax Single is a single-dose in-clinic treatment for otitis…
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The US FDA has accepted NDA of oral Wegovy for chronic weight management & major adverse CV events risk reduction in adults with obesity or overweight & comorbidities (PDUFA: Q4’25)
Submission was based on the P-III (OASIS 4) trial assessing oral Wegovy (25mg; OD) vs PBO over 64wks. (incl. 12wk. dose escalation & 7wk.…