Clinical
New ACC/AHA dyslipidemia treatment guidelines say prescribers should consider LDL cholesterol-lowering drugs’ costs, but Amgen and Esperion note the work they’ve done to ensure access to their products.
The guidelines give specific guidance about LDL cholesterol goals, recommending Esperion’s bempedoic acid and PCSK9 inhibitors from Amgen and Regeneron on top of statins in many cases, but evidence review concluded before Repatha’s primary prevention data.
Teva’s R&D chief Eric Hughes discusses the company’s long-acting injectable olanzapine program, how it could address adherence challenges in schizophrenia, and why the therapy forms a key pillar of the firm’s growing injectables franchise.
Positive results from a randomized study in healthy volunteers mark a key milestone for Alvotech’s proposed Entyvio rivals AVT80 and AVT16.
The European Commission’s proposal does not envisage a single centralized medtech agency, but instead sets out a targeted redistribution of tasks that could strengthen the existing framework. Professor Tom Melvin told Medtech Insight how.
Industry associations support the commission’s MDR/IVDR revision simplification objective and aim to increase Europe’s competitiveness, but MedTech Europe also sees further room for improvement.
Sponsors of higher risk device and diagnostic investigations are being invited to participate in a pilot that aims to reduce regulatory burden.
To develop bispecific, dual-payload antibody-drug conjugates, Phrontline Biopharma’s strategy is to tune the activity of each payload to a similar level and engineer both toxins to fit within a branched linker, its CEO tells Scrip in an interview.
Clinical evaluation and standards expert Danielle Giroud celebrates progress on the document and looks at what it means internationally and for the EU.
In this detailed overview, Generics Bulletin dives into which biosimilar sponsors are currently known to be working towards filings for biosimilars to Keytruda (pembrolizumab), which had sales of around $30bn last year.
Orexo believes its data further demonstrates the ability of the AmorphOX powder-based intranasal formulation technology to develop formulations for large molecules.
As gene therapy advances and regulations tighten, biopharma companies face growing pressure to design diagnostic assays that are both flexible and future ready. Strategic early investment in assay development can prevent costly delays and rework as therapies progress toward approval.