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Top biosimilar news of the Apr 2025

Key Biosimilars Events of April 2025  

Shots:        Biosimilars are developed to be highly similar versions of approved biologics in terms of safety, purity, and potency         Biosimilars are expected to be a cost-effective alternative to the high-priced branded biologics, offering significant and much-needed cost savings to both payers and patients         Henlius Collaborates with Sandoz for the Commercialization of HLX13. Our team at PharmaShots…

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Roche

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…

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How Healthcare Teaching Shapes Future Medical Practices

Teaching in healthcare involves guiding future professionals in how they think through problems, interact with colleagues, and make informed decisions during clinical work. If you’re involved in clinical training, your ability to teach effectively can influence how future clinicians treat patients and how confidently they move through high-pressure environments. Courses focused on teaching methodologies help…

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Eli Lilly and Alchemab Therapeutics

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 &…

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Immutep

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 +…

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Vanda Pharmaceuticals

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…

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Hlth

2025 | HLTH Europe: 16-19 June | Amsterdam

HLTH Europe is the continent’s #1 healthcare innovation event. Following an enormously successful first event in 2024 and the exponential growth of HLTH in the US, this landmark event is where global expertise meets local insight to address Europe's unique healthcare challenges and opportunities. Don’t miss out on this opportunity to connect with like-minded individuals…

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