The Dutch firm’s US filing for its first-in-class PI3K inhibitor has been accepted under priority review, bringing the asset closer to becoming the first disease-modifying option for a rare, genetic disorder.
Pharming Group N.V.’s new drug application for leniolisib in activated phosphoinositide 3-kinase δ syndrome has been accepted by the US Food and Drug Administration under a priority review, meaning the candidate could enter a vacant market early next year.
The NDA was filed in July for patients aged 12 or older and the FDA has set a user fee date of 29 March 2023. The submission contains data from...
All eyes are on the upcoming readout of BPL-003 for treatment-resistant depression.
The information flow in the months before the approval of GSK’s Nucala in COPD provides an interesting case study, and brings to mind the cautionary tale of Alnylam’s Onpattro.
But the French major is still keen on early-stage M&A.
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.
The information flow in the months before the approval of GSK’s Nucala in COPD provides an interesting case study, and brings to mind the cautionary tale of Alnylam’s Onpattro.
The company highlighted the KLK2-targeting agent’s safety at ASCO but it may have to rely on combinations to make pasritamig competitive.
The drugmaker presented oral abstracts at the meeting for Libtayo in adjuvant cutaneous squamous-cell carcinoma and linvoseltamab in multiple myeloma.
