Biologics
Diagnostics

Telix wins FDA alignment to open ProstACT Global Phase 3 in US

Telix Pharmaceuticals secured FDA agreement on protocol and statistics for Part 2 of its lutetium-177 rosopatamab Phase 3 trial in metastatic prostate cancer.
Telix Pharmaceuticals secured FDA agreement on protocol and statistics for Part 2 of its lutetium-177 rosopatamab Phase 3 trial in metastatic prostate cancer.
The Biotech Times Editorial Team  · 
Biologics

Ipsen to acquire Memo Therapeutics for up to EUR 700m

Ipsen is buying Swiss biotech Memo Therapeutics to gain potravitug, a Phase II monoclonal antibody targeting BK polyomavirus in kidney transplant recipients.
Ipsen is buying Swiss biotech Memo Therapeutics to gain potravitug, a Phase II monoclonal antibody targeting BK polyomavirus in kidney transplant recipients.
The Biotech Times Editorial Team  · 

JenaValve presents LVAD and pacemaker data for Trilogy TAVR system

New York Valves 2026 featured two late-breaking Trilogy datasets, including early outcomes in LVAD patients with aortic regurgitation showing 7.3% one-year mortality.
New York Valves 2026 featured two late-breaking Trilogy datasets, including early outcomes in LVAD patients with aortic regurgitation showing 7.3% one-year mortality.
The Biotech Times Editorial Team  · 
Biologics

Nicox partner Kowa files NDA for NCX 470 glaucoma eye drop

Kowa's US NDA submission for the nitric oxide-donating bimatoprost drop triggers a €3m milestone and targets FDA approval by mid-2027.
Kowa's US NDA submission for the nitric oxide-donating bimatoprost drop triggers a €3m milestone and targets FDA approval by mid-2027.
The Biotech Times Editorial Team  · 
Biologics

Truveta study finds 16% of adalimumab biosimilar switchers revert

Real-world data from 67,594 US patients shows biosimilar adoption peaked after formulary changes, but switch-back rates highlight gaps in patient support.
Real-world data from 67,594 US patients shows biosimilar adoption peaked after formulary changes, but switch-back rates highlight gaps in patient support.
The Biotech Times Editorial Team  · 
Proteomics
Diagnostics

Seer wins EPO patent ruling and secures ITC probe into Nanomics

Seer has defended a key European proteomics patent and launched a US trade investigation targeting Nanomics' competing Proteonano products.
Seer has defended a key European proteomics patent and launched a US trade investigation targeting Nanomics' competing Proteonano products.
The Biotech Times Editorial Team  · 
Biologics
Regulatory Science

Novartis wins EC approval for Itvisma in broader SMA population

The European Commission has approved Itvisma as the first gene replacement therapy for SMA patients aged two and older, including teens and adults.
The European Commission has approved Itvisma as the first gene replacement therapy for SMA patients aged two and older, including teens and adults.
The Biotech Times Editorial Team  · 
Biologics
Regulatory Science

PolarityBio files BLA for SkinTE in diabetic foot ulcers

PolarityBio has submitted a BLA to the FDA for SkinTE, an autologous skin therapy backed by RMAT and Breakthrough Therapy designations.
PolarityBio has submitted a BLA to the FDA for SkinTE, an autologous skin therapy backed by RMAT and Breakthrough Therapy designations.
The Biotech Times Editorial Team  · 
Digital Health

Startup Coalition and DSIT launch Pitch in Whitehall competition

UK startups have until 24 July to apply for a government proof-of-concept contract under the Green Compute challenge.
UK startups have until 24 July to apply for a government proof-of-concept contract under the Green Compute challenge.
The Biotech Times Editorial Team  · 
Biologics
Regulatory Science

Roche's Enspryng wins FDA Priority Review for thyroid eye disease

The FDA has accepted Roche's sBLA for satralizumab in TED, with a decision expected by 15 October 2026 based on Phase 3 SatraGO data.
The FDA has accepted Roche's sBLA for satralizumab in TED, with a decision expected by 15 October 2026 based on Phase 3 SatraGO data.
The Biotech Times Editorial Team  · 
Diagnostics
Genomics
Regulatory Science

Mdxhealth GPS-ProMPT study published in European Urology Oncology

The peer-reviewed Oxford study of 409 men over six years underpins the GPS-ProtecT randomised controlled trial of mdxhealth's 17-gene prostate assay.
The peer-reviewed Oxford study of 409 men over six years underpins the GPS-ProtecT randomised controlled trial of mdxhealth's 17-gene prostate assay.
The Biotech Times Editorial Team  · 
Biologics

Candel Therapeutics opens Phase 3 AURORA trial for CAN-2409 in NSCLC

Candel has activated the first site in its 150-site pivotal AURORA trial, testing viral immunotherapy aglatimagene against docetaxel in ICI-refractory lung cancer.
Candel has activated the first site in its 150-site pivotal AURORA trial, testing viral immunotherapy aglatimagene against docetaxel in ICI-refractory lung cancer.
The Biotech Times Editorial Team  · 
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