Biologics
Pharmaceuticals

Mab Designs publishes selective IL-6 trans-signalling inhibitor C20 data

A Nature Portfolio journal has published peer-reviewed data showing C20 blocks IL-6 trans-signalling while leaving classic signalling intact.
A Nature Portfolio journal has published peer-reviewed data showing C20 blocks IL-6 trans-signalling while leaving classic signalling intact.
The Biotech Times Editorial Team  · 
Medical Devices
Digital Health
Biotech

Al Ghurair launches Trellis Health hospital group in Dubai

The UAE conglomerate has opened a 50-bed multi-speciality hospital in Umm Suqeim, with two further clinics planned by end-2026.
The UAE conglomerate has opened a 50-bed multi-speciality hospital in Umm Suqeim, with two further clinics planned by end-2026.
The Biotech Times Editorial Team  · 
Medical Devices
Biologics

Kuros Biosciences lifts 2026 guidance after 40% sales rise

The Swiss bone-graft company raised full-year revenue growth guidance to 36-40% after nine-month sales hit USD 141.8 million.
The Swiss bone-graft company raised full-year revenue growth guidance to 36-40% after nine-month sales hit USD 141.8 million.
The Biotech Times Editorial Team  · 
Pharmaceuticals
Regulatory Science

Orvida Pharma wins FDA RDEP entry for ontivatrep in Olmsted

Orvida Pharma's oral TRPV3 inhibitor ontivatrep has entered the FDA's RDEP process for Olmsted syndrome, with Phase 1b topline data due around year
Orvida Pharma's oral TRPV3 inhibitor ontivatrep has entered the FDA's RDEP process for Olmsted syndrome, with Phase 1b topline data due around year
The Biotech Times Editorial Team  · 
Pharmaceuticals
Genomics

Entrada reports Cohort 1 safety data for DMD exon-skipping drug

Entrada Therapeutics said ENTR-601-45 met safety and tolerability goals in Cohort 1 of its Phase 1/2 DMD trial, with Cohort 2 data
Entrada Therapeutics said ENTR-601-45 met safety and tolerability goals in Cohort 1 of its Phase 1/2 DMD trial, with Cohort 2 data
The Biotech Times Editorial Team  · 
Pharmaceuticals
Regulatory Science

Quoin Pharma gains EMA orphan status for QRX003 in skin disease

The EMA has granted QRX003 orphan drug designation for Peeling Skin Syndrome, adding 10 years of potential EU market exclusivity if approved.
The EMA has granted QRX003 orphan drug designation for Peeling Skin Syndrome, adding 10 years of potential EU market exclusivity if approved.
The Biotech Times Editorial Team  · 
Pharmaceuticals
Biologics

Elevar resubmits NDA for camrelizumab plus rivoceranib in HCC

Elevar Therapeutics resubmitted its FDA NDA for the camrelizumab plus rivoceranib combination in unresectable HCC, after receiving a CRL in July 2026.
Elevar Therapeutics resubmitted its FDA NDA for the camrelizumab plus rivoceranib combination in unresectable HCC, after receiving a CRL in July 2026.
The Biotech Times Editorial Team  · 
Pharmaceuticals
Regulatory Science

Belite Bio files tinlarebant MAAs in UK, Singapore and Switzerland

Belite Bio has submitted marketing authorisation applications for tinlarebant via the Access Consortium, seeking the first approved STGD1 treatment in three markets.
Belite Bio has submitted marketing authorisation applications for tinlarebant via the Access Consortium, seeking the first approved STGD1 treatment in three markets.
The Biotech Times Editorial Team  · 
Biologics
Pharmaceuticals

Invivyd initiates FLINTLOCK Phase 2 trial of VYD2311 in Long COVID

Invivyd and the SPEAR Study Group have dosed first patients in a 130-person placebo-controlled trial of its anti-spike monoclonal antibody VYD2311 for
Invivyd and the SPEAR Study Group have dosed first patients in a 130-person placebo-controlled trial of its anti-spike monoclonal antibody VYD2311 for
The Biotech Times Editorial Team  · 
Cell & Gene Therapy
Pharmaceuticals

Ocugen licenses OCU400 gene therapy to Roots Pharma for MENA

Ocugen has granted Roots Pharmaceutical exclusive MENA rights to its OCU400 retinitis pigmentosa gene therapy, with milestones worth up to $255 million.
Ocugen has granted Roots Pharmaceutical exclusive MENA rights to its OCU400 retinitis pigmentosa gene therapy, with milestones worth up to $255 million.
The Biotech Times Editorial Team  · 
Biologics
Pharmaceuticals

Kyowa Kirin publishes three-year real-world XLH data in JBMR

A 109-patient interim analysis compared burosumab with oral phosphate and vitamin D in adults with X-linked hypophosphatemia over three years.
A 109-patient interim analysis compared burosumab with oral phosphate and vitamin D in adults with X-linked hypophosphatemia over three years.
The Biotech Times Editorial Team  · 
Pharmaceuticals
Biologics

Parabilis Medicines starts dose-ranging FAP cohort for zolucatetide

Parabilis has opened a dedicated FAP cohort in its Phase 1/2 trial of zolucatetide after early data showed significant reductions in duodenal polyp burden.
Parabilis has opened a dedicated FAP cohort in its Phase 1/2 trial of zolucatetide after early data showed significant reductions in duodenal polyp burden.
The Biotech Times Editorial Team  · 
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