Drug Development
The FDA’s proposal to offer 50% off application fees for drugs with early-stage trials conducted in the U.S. is unlikely to achieve the intended result. What biotechs really want is speed.
FEATURED STORIES
Foundation models will change the way we study the natural, applied and clinical sciences, but only under certain conditions, and not in the way that some AI leaders claim.
While some drugmakers continue to walk the alpha-synuclein antibody path, others like AC Immune opt for new approaches that could bring the first-ever disease-modifying therapy for Parkinson’s disease.
Zanvastro, an antisense oligonucleotide therapy, represents the first independent neurology launch for Ionis Pharmaceuticals, which intends to leverage the foothold for more approvals in rare neurodegenerative diseases, including Angelman syndrome.
Subscribe to ClinicaSpace
Clinical trial results, research news, the latest in cancer and cell and gene therapy, in your inbox every Monday
THE LATEST
Mosliciguat, being developed by the Roivant Sciences subsidiary Pulmovant, ‘significantly exceeded expectations’ in reducing pulmonary vascular resistance, according to analysts, and is progressing to a late-stage study.
While Novartis’ antibody-oligonucleotide conjugate failed to significantly improve hand function in patients with myotonic dystrophy type 1, the asset nevertheless showed signs of clinical activity in secondary and exploratory measures.
The failure of Novartis’ pelacarsen to translate its Lp(a)-lowering effects to clinical benefits “marks a meaningful setback” for other companies taking a similar approach to cardiovascular risk, analysts say—including Eli Lilly and Amgen.
Belgium and the Netherlands have built some of Europe’s strongest life sciences ecosystems, powered by leading research institutions and a growing pool of experienced biotech talent. While early-stage funding remains scarce and investment is often fragmented across regions, investors see national biotech initiatives and broader EU support as catalysts for future growth.
AbbVie’s etentamig has a relatively cleaner safety profile and an administration schedule that could give it an edge over other BCMA-targeting multiple myeloma therapies on the market, according to BMO Capital Markets.
The data, which come from a subgroup in an earlier trial that Truist Securities called “the most relevant” to Revolution Medicines’ ongoing Phase 3 test in RAS mutant NSCLC, showed a 42% overall response rate and overall survival of 16 months.
New Phase 3 data show that Summit Therapeutics and Akeso’s PD-1/VEGF therapy improved overall survival in patients with a type of lung cancer as compared to Merck’s Keytruda but the results will need to be replicated in non-Chinese patients.
The success of apazunersen in a Phase 3 trial for Angelman syndrome was a key driver of Ultragenyx’s value, according to William Blair, and the asset’s failure robs the biotech of any meaningful near-term milestones.
In this episode of Denatured, you’ll hear from Christina Takke, managing partner at V-Bio Ventures and Mariette van der Velden-Roesink, founding partner at Curie Capital. We explore why the Benelux region remains scientifically strong, but investment fragmented, and what it will take to turn it into a more unified biotech investment corridor.
The biologics license application follows months of public speculation—and regulatory reversals—for uniQure’s AMT-130. If accepted by the FDA for priority review, approval could come in the second quarter of 2027.