The collaboration will connect ChemoMetec’s XcytoMatic 30 cell counter with Roche’s Cedex Bio Analyzer and establish a joint go-to-market strategy for the combined bioprocess monitoring solution.

The EU Health Technology Assessment Regulation now requires eligible oncology medicines and advanced therapies to undergo a single European clinical assessment, increasing the importance of early evidence planning alongside EMA regulatory development.

The acquisition would add a clinical-stage KCNT1 inhibitor for a rare genetic epilepsy with no FDA-approved treatments, while Actio’s remaining programmes will be transferred into a separate privately held company.

The completed transaction combines Kashiv’s biologics R&D and manufacturing capabilities with Amneal’s commercial infrastructure, giving the company end-to-end control across biosimilar development, production and commercialisation.

The next-generation sequencing companion diagnostic identifies BRAF V600E and V600K variants, helping clinicians determine which melanoma patients may be eligible for FDA-approved BRAF or BRAF/MEK targeted therapies.

The transaction would give Sobi full ownership of a specialist commercialisation platform spanning seven Latin American markets, building on its $105 million investment in Pint Pharma in 2025.

The partnership gives Sobi potential global commercial and development rights to the first-in-class anti-KIR3DL2 antibody while funding Innate’s Phase III programme in cutaneous T-cell lymphoma.

The long-term manufacturing agreement covers 55 oncology and non-oncology products across three Gland Pharma sites, with commercial revenue expected to begin in 2029.

The proposed acquisition gives Wise Equity control of a specialist oral solid-dose manufacturer with established capabilities in effervescent, soluble, orally disintegrating and sublingual formulations.

The draft guidance could reduce reliance on animal studies for some oncology products while increasing the importance of analytical characterisation and weight-of-evidence approaches during development.

Healthcare organisations and technology developers face an expanding mix of state laws, sector-specific FDA expectations and federal policy initiatives rather than a single nationwide AI regulatory framework.

Recent legal and regulatory developments could influence how innovative medicines are protected in Europe by changing the interaction between regulatory exclusivity, patent rights and generic market entry.

The biomarker-selected regimen adds an AKT inhibitor to abiraterone and prednisone for adults with newly diagnosed metastatic disease whose tumours show PTEN deficiency.

The approval adds another US biosimilar option for rituximab-treated conditions, including non-Hodgkin lymphoma and chronic lymphocytic leukaemia, although commercial availability and pricing have not yet been confirmed.

Pathos AI licenses first-in-class bispecific ADC JSKN016 from Alphamab Oncology in deal worth up to $4.8 billion

The all-stock transaction combines complementary central nervous system portfolios spanning neuroscience and addiction medicine, creating a larger commercial-stage company with a broader product portfolio and pipeline.

The orexin receptor agonist provides adults with a treatment that targets the underlying loss of orexin signalling rather than managing individual symptoms separately.

The approval introduces the first messenger RNA influenza vaccine into the US market, expanding vaccine technology options for seasonal influenza prevention in older adults.

The engineered oncolytic viral therapy, used with nivolumab, provides a new treatment option for adults with unresectable cutaneous melanoma that has progressed despite prior PD-1-based immunotherapy.

The proposed acquisition would add Xycota’s preclinical CNS pipeline and exosome-based delivery platform to NexTel Medical, including lead programme XYCO-01 for frontotemporal dementia.