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Roche
NEWS

Roche Launches Elecsys PRO-C3 Test for Liver Fibrosis Severity Assessment

Shots: Roche has launched its Elecsys PRO-C3 test, developed with Nordic Bioscience to evaluate the severity of liver fibrosis in pts showing signs of metabolic dysfunction–associated steatotic liver disease  Elecsys PRO-C3 test requires a single assay & in combination with ADAPT formula (incl. PRO-C3 levels, platelet count, age, & diabetes status) provides clear assessment of…
May 6, 2025

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Eli Lilly and Alchemab Therapeutics
NEWS

Eli Lilly Enters a ~$415M Licensing Agreement with Alchemab Therapeutics for ATLX-1282 to Treat Amyotrophic Lateral Sclerosis (ALS)

Shots: Eli Lilly has entered into a licensing agreement with Alchemab for ATLX-1282 to treat ALS & other neurodegenerative conditions As per the deal, Alchemab will receive ~$415M, incl. an upfront payment, potential discovery, development, & commercial payments, as well as royalties, plus will handle early P-I trial activities, with Lilly leading further development &…
May 6, 2025

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Immutep
NEWS

Immutep Reports P-IIb (KEYNOTE-C34/ TACTI-003) Trial Data of Eftilagimod Alfa + Keytruda for Head and Neck Squamous Cell Carcinoma (HNSCC)

Shots: Immutep has reported Cohort B data from P-IIb (KEYNOTE-C34/ TACTI-003) trial, with Cohort B assessing eftilagimod alfa + Keytruda as a 1L treatment of recurrent/metastatic HNSCC pts with PD-L1 expression (CPS <1) As of Mar 31, 2025, trial showed improved mOS of 17.6mos. in evaluable pts (n=31) compared to historical mOS of cetuximab +…
May 6, 2025

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Vanda Pharmaceuticals
NEWS

Vanda Pharmaceuticals Reports the US FDA’s NDA Acceptance of Bysanti (Milsaperidone) for Acute Bipolar I Disorder & Schizophrenia

Shots: The US FDA has accepted NDA of Bysanti, an active metabolite of iloperidone to treat acute bipolar I disorder & schizophrenia (PDUFA: Feb 21, 2026). If approved, Bysanti may receive 5yrs. of data exclusivity, with pending patents extending into the 2040s NDA is backed by various iloperidone trials, incl. 2 in acute schizophrenia, 1…
May 6, 2025

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Teva and Alvotech
NEWS

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, 2025 Selarsdi is an anti-IL-12/IL-23 mAb, with 4 approved presentations: 45mg/0.5mL & 90mg/mL…
May 6, 2025

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VERAXA Biotech & OmniAb
NEWS

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 solutions As per the deal, VERAXA will initiate novel bsADC program targeting 2 cancer-related molecules, using OmniAb’s…
May 5, 2025

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Endogenex
NEWS

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 US The study showed dose-responsive improvements in insulin sensitivity & beta cell function at 12wks., sustained through 48wks., with 100% procedural success…
May 5, 2025

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Vanotech
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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 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…
May 5, 2025

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