Drug Development
It is unclear why an independent data safety monitoring board recommended the suspension of Pliant’s Phase IIb/III BEACON-IPF study in idiopathic pulmonary fibrosis.
FEATURED STORIES
Several companies—including JCR Pharmaceuticals, Denali Therapeutics and Regenxbio—have products in the pipeline that could improve treatment options for this rare disease.
Riding recent momentum in the Duchenne muscular dystrophy space, Capricor Therapeutics, Wave Life Sciences, Regenxbio and more aim to deliver the next wave of progress with near-term data and regulatory milestones.
The Japanese pharma had one asset rejected by the FDA and withdrew a regulatory application for another, but already this month the company has secured an approval for AstraZeneca-partnered Dato-DXd, to be marketed as Datroway.
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Kuro Oncology and partner Kyowa Kirin are on track for an NDA submission for ziftomenib in the second quarter of this year.
Robert F. Kennedy Jr.’s HHS nomination moves to a full Senate vote; Donald Trump’s tariff war sparks China-related concerns for biopharma; Pfizer, Merck and more announce Q4 and 2024 earnings; and the non-opioid painkiller space heats up as FDA approves Vertex’s Jounavx.
The Phase IIa results continue a surge of momentum in a treatment space that last week saw the approval of Vertex’s Journavx as the first novel mechanism for acute pain in decades.
The Massachusetts-based biotech plans to use the funds to push its candidates into mid-stage clinical trials in a space dominated by Vertex.
In a Phase IIb trial, GH001 elicited significant drops in treatment-resistant depression. The news comes less than two weeks after J&J secured FDA monotherapy approval for its esketamine nasal spray Spravato in the same indication.
APAC offers stability in an increasing challenging global geopolitical environment for clinical stage drug development.
Topline data on a combo including Pfizer’s kinase inhibitor Braftovi point to improved progression-free survival and pave the way for its full approval for the treatment of certain colorectal cancers, according to the company.
After the Phase II failure of its lead asset from Cerevel, AbbVie is resetting expectations and narrowing the clinical program to an adjunct approach—for now.
The greenlight for Journavx (suzetrigine), which comes on the heels of a $7.4 billion opioid settlement, could spark momentum in the fledgling non-opioid pain space.
CAR T–focused biotech Cargo Therapeutics surprised and disappointed analysts when it announced that it would discontinue a mid-stage trial of its lead program, firi-cel.