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Rare disease
UniQure Eyes Phase 3 for Huntington’s Gene Therapy Despite Makary’s Apparent Criticism
Days after FDA Commissioner Marty Makary appeared to malign uniQure’s AMT-130 in an interview with
CNBC
, the agency confirmed to the biotech that a sham surgery–controlled study is needed before submitting the gene therapy for approval.
March 2, 2026
·
3 min read
·
Heather McKenzie
Press Releases
Light-Activated Ruvidar and Interferon Demonstrate Enhanced Efficacy
Theralase(R) Demonstrates Additive Anti-Cancer Effect in Bladder Cancer In-Vitro Model when Light-Activated Ruvidar(R) is Combined with Interferon
March 2, 2026
·
6 min read
Events
Register: Aligning With the FDA on a Regulatory Pathway To Avoid Decision Day Surprises
Join us for this critical discussion on how regulators and biotech companies can bridge the expectation gap during the regulatory review process to ensure novel therapies reach patients in a timely manner—because patients don’t have time to wait.
March 2, 2026
Press Releases
Defence Therapeutics to Showcase Accum Platform at Key International Industry Events in March
March 2, 2026
·
4 min read
Press Releases
KangaBio Announces FDA IND Clearance for KGX105, AACR Acceptance of KGX101 Clinical Data Abstract, and Completion of Over $15 Million in Pre-A+ Financing
March 2, 2026
·
1 min read
Press Releases
Model Medicines to Highlight Two IND-Track Assets, Record-Setting AI Platform at BIO Investment & Growth Summit 2026
Company to spotlight its two lead drug candidates, MDL-001, a novel direct-acting antiviral targeting RdRp-Thumb 1, and MDL-4102, a novel transcriptional regulator targeting BRD4, both advancing toward IND.
March 2, 2026
·
1 min read
Manufacturing
Novo Commits $506M To Repurpose Irish Plant for Oral Wegovy Production
As Novo Nordisk continues to lose ground in the obesity market to rival Eli Lilly, the Danish company has started construction projects to establish the ex-Alkermes plant as a hub for supplying oral GLP-1 products to global markets.
March 2, 2026
·
2 min read
·
Nick Paul Taylor
Rare disease
Aardvark Tanks After Pausing Prader-Willi Study on ‘Surprise’ Safety Signals
Aardvark Therapeutics is down 54% since Friday after the biotech said it detected “reversible cardiac observations” in a healthy volunteer study of its drug to treat extreme hunger in patients with the rare genetic disease.
March 2, 2026
·
2 min read
·
Tristan Manalac
Press Releases
Lucent Diagnostics and Life Line Screening Partner to Bring Advanced Blood-Based Diagnostics to Communities Nationwide
March 2, 2026
·
4 min read
Press Releases
Orca Bio to Present Clinical Data on Its Pipeline of High-Precision Cell Therapies at the 52nd Annual Meeting of the EBMT
March 2, 2026
·
4 min read
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