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From AI-powered discovery to next-generation biologics and gene editing, 2025 was a blockbuster year for life sciences dealmaking. Pharma and biotech companies signed multibillion-dollar partnerships and acquisitions to accelerate innovation across oncology, cardiometabolic diseases, neurology, and rare disorders.
Platform technologies dominated the deal landscape, with big pharma securing access to cutting-edge modalities from bispecific…
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Roche has received the CE Mark approval for its Elecsys Apolipoprotein E4 biomarker test, an in-vitro diagnostic immunoassay to identify the presence of the ApoE4 gene variant in the bloodstream
The assay was evaluated in a study of 607 subjects with cognitive complaints or objective memory impairment of unknown aetiology, where Elecsys ApoE4 assay showed…
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The P-II trial assessed 5 doses of petrelintide (SC, QW) vs PBO for 42wks. in 493 overweight or obese pts (mean BMI of 37 kg/m²) with weight-related comorbidities
Trial met its 1EP, with Q4W dose-escalated injections delivering significant weight loss across 5 arms after 28wks. & sustaining ~10.7% vs 1.7% mean reduction through Wk.…
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Roche has reported P-III (FENhance 1) trial results in RMS pts, randomized to either fenebrutinib (PO, BID) with PBO-matched to teriflunomide or teriflunomide (PO, QD) with PBO matched to fenebrutinib
Trial met its 1EP, reducing ARR by 51% over ≥96wks., consistent with the P-III (FENhance 2) study showing 59% reduction, while 2EPs showed significant…
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The US FDA has accepted Roche’s NDA for giredestrant in combination with everolimus to treat adults with ER-positive, HER2-negative, ESR1-mutated locally advanced or metastatic breast cancer following recurrence or progression on prior endocrine-based therapy
NDA acceptance is based on P-III (evERA) study data showing giredestrant + everolimus reduced the risk of disease progression or…
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The EC has approved STADA & Bio-Thera’s Gotenfia (BAT2506; 50mg/0.5mL & 100mg/mL PFS), a biosimilar version of Simponi (golimumab), in all 30 EEA states, with launch preparations ongoing
Approval was based on extensive analytical, non-clinical & clinical data demonstrating biosimilarity of BAT2506 to Simponi
In May 2024 deal, STADA obtained exclusive commercial rights to Gotenfia…
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Labcorp has launched the Elecsys pTau-181 test to measure phosphorylated Tau 181 protein to help rule out Alzheimer’s-related amyloid pathology in individuals (≥55yrs.)
The test delivers a 97.9% negative predictive value to help rule out Alzheimer’s pathology in symptomatic pts & offers a less invasive, more accessible alternative to brain scans or lumbar punctures…
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2025 pharma M&A was defined by fewer but more transformational deals, with companies prioritizing commercial-stage assets, late-stage pipelines, and platform technologies capable of reshaping long-term growth and strengthening core therapeutic franchises
The year’s momentum was led by three standout transactions, J&J’s $14.6B acquisition of Intra-Cellular Therapies, Novartis’ $12B deal for Avidity Biosciences, and Merck’s…
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Roche reported positive topline results from the P-II (CT388-103) study evaluating CT-388, an investigational dual GLP-1/GIP receptor agonist, for the treatment of obesity
Once-weekly CT-388 (SC) achieved a statistically significant PBO-adjusted weight loss of 22.5% (p<0.001; efficacy estimand) at 48 wks. at the highest dose (24 mg), with no weight-loss plateau observed; 54% of…
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MediLink has entered into an additional collaboration & exclusive licensing agreement with Roche for the development & commercialization of YL201 (B7H3 ADC) across numerous solid tumor types
Under the deal, Roche will obtain an exclusive license to develop, manufacture, & commercialize YL201 worldwide, excl. Mainland China, Hong Kong SAR, & Macau SAR
In return,…

