All articles by Swagath Bandhakavi
Swagath Bandhakavi
Hikma Pharmaceuticals to invest $1bn to boost US medicine production
The investment aims to expand its capacity to develop and produce generic medicines essential for the US healthcare system.
KalVista and Pendopharm to collaborate on HAE candidate sebetralstat in Canada
Sebetralstat is an investigational oral plasma kallikrein inhibitor being developed as an on-demand treatment for hereditary angioedema.
Alvotech-led study finds AVT23 biosimilar matches Xolair’s therapeutic effects
The study found AVT23 therapeutically equivalent and similarly safe as the reference biologic for treating chronic spontaneous urticaria.
Amarin signs licensing deal with Recordati for VAZKEPA in Europe
Recordati will lead marketing and distribution across the covered European markets, allowing Amarin to simplify its global structure and lower regional commercial costs.
TEVA’s Phase 4 study confirms long-term efficacy of Ajovy in migraine management
The PEARL study data confirmed the achievement of both primary and secondary objectives, highlighting sustained effectiveness and strong adherence to fremanezumab treatment.
Sanofi and Regeneron’s Dupixent gains FDA approval for bullous pemphigoid
The FDA’s approval comes after results from the ADEPT Phase 2/3 study, which evaluated Dupixent’s safety and effectiveness in comparison to a placebo for adults with moderate-to-severe bullous pemphigoid.
Health Canada greenlights Novartis’ Kisqali for early-stage breast cancer treatment
The approval is for adults with early-stage breast cancer characterised by hormone receptor positivity and human epidermal growth factor receptor 2 negativity, who are at a high risk of recurrence.
AbbVie’s atogepant achieves primary endpoint in Phase 3 migraine trial
The study assessed the efficacy of atogepant, administered once daily, in comparison to different doses of topiramate for adults experiencing at least four migraine days per month.
Ferrer’s FNP-223 granted fast track status by FDA for progressive supranuclear palsy
Currently, FNP-223 is in a Phase 2 trial evaluating its safety, efficacy, and pharmacokinetics in adults with potential PSP-Richardson syndrome.
Supernus to expand CNS portfolio with Sage Therapeutics acquisition
The acquisition allows Supernus to add ZURZUVAE, an FDA-approved oral treatment for postpartum depression, to its product lineup.