Vyepti revenues rise by nearly 70% in the first quarter.
CEO Paul Stoffels exits early to be succeeded by Henry Gosebruch, who will now consider ‘all options’ for the Belgian firm as it tries to claw back investor confidence.
The therapy has been developed for GM1 and GM2 gangliosidoses and Niemann-Pick disease type C.
The presentation and publication of the Phase IIIb study showing greater efficacy for Zepbound over Wegovy come at a time when competition has been heating up between the two obesity medications.
Vaccine and accelerated approvals are expected to face greater scrutiny under new CBER leader Vinay Prasad, but he has promised “no light switch change” to policy, giving some reassurance to companies whose share prices have been battered.
Pipeline Watch is a weekly snapshot of selected late-stage clinical trial events and approvals announced by pharmaceutical and biotech companies at medical and industry conferences, in financial and company presentations, and in company releases and statements.
Seven years after acquiring it, Viatris will seek approval of a meloxicam formulation for acute pain backed by data from two Phase III studies in post-surgical pain settings.
The Phase I results are the best to date among ANGPTL3-targeting candidates in the pipeline, but analysts will wait for further updates before predicting a likely winner.
Houman Ashrafian tells delegates at Swiss Biotech Day that ‘literally only two things matter in our industry – target credentialing and differentiated pharmacology. The rest is execution.’
Phase IIa data for ANGPTL4-targeted antibody shows reduced triglycerides and remnant cholesterol, which Marea asserts indicates potential to protect against cardiovascular outcomes.
Already dominating in later lines of breast cancer treatment, Enhertu could now displace both chemotherapy combinations and Roche’s Kadcyla in early-stage HER2-positive patients.
Australian firm's combo of eftilagimod and Keytruda shows 17.6-month median overall survival in first-line HNSCC patients with low PD-L1, raising hopes for potential accelerated approval.
Aptose’s tuspetinib triplet shows early mutation-agnostic promise in new data from Phase I/II program for frontline acute myeloid leukemia.
Despite the ability to initiate clinical trials quickly and having strong manufacturing capacity, Chinese companies are facing multiple challenges in the obesity space.
The biotech hopes a third time will be the charm after two FDA complete responses, with plans to position its eye drop as offering quicker onset of action.
The pharma company is helping to validate the biotech’s model by developing a novel amyotrophic lateral sclerosis candidate, based on its novel approach that ‘turns drug discovery on its head’.
Pipeline Watch is a weekly snapshot of selected late-stage clinical trial events and approvals announced by pharmaceutical and biotech companies at medical and industry conferences, in financial and company presentations, and in company releases and statements.
PTC said its updated Phase II data for PTC 518 met the primary endpoint of Huntingtin’s protein reduction, but analysts said there isn’t clear correlation with clinical benefit.
Genmab will submit an sBLA for Epkinly in R/R follicular lymphoma in H1 2025, backed by positive Phase III data.
Chief medical officer Eliav Barr discussed Merck’s investment in new therapeutic areas and business development in an interview with Scrip.