Disease

Pharmaceuticals
Regulatory Science

Filana Therapeutics clears FDA hold on simufilam for TSC epilepsy

The NASDAQ-listed biotech can now progress its Phase 2a proof-of-concept study after the FDA lifted a clinical hold on its simufilam IND.
The NASDAQ-listed biotech can now progress its Phase 2a proof-of-concept study after the FDA lifted a clinical hold on its simufilam IND.
Pharmaceuticals
Regulatory Science

Ophirex BRAVIO trial misses endpoints but signals krait benefit

Phase 2 data published in PLOS NTD show varespladib cut krait patients' ventilation time by half, despite missing both primary endpoints.
Phase 2 data published in PLOS NTD show varespladib cut krait patients' ventilation time by half, despite missing both primary endpoints.
Pharmaceuticals
Regulatory Science

Quoin Pharma wins FDA Fast Track for QRX003 in Peeling Skin Syndrome

Quoin Pharmaceuticals secured the first-ever Fast Track Designation for a Peeling Skin Syndrome therapy, with a Phase 2/3 trial set to start by
Quoin Pharmaceuticals secured the first-ever Fast Track Designation for a Peeling Skin Syndrome therapy, with a Phase 2/3 trial set to start by
Pharmaceuticals
Biologics

Zealand Pharma starts Phase 3 ZUPREME programme for petrelintide

The Copenhagen biotech and Roche partner have initiated three placebo-controlled trials enrolling around 7,000 participants across obesity sub-populations.
The Copenhagen biotech and Roche partner have initiated three placebo-controlled trials enrolling around 7,000 participants across obesity sub-populations.
Medical Devices
Diagnostics

Fakih IVF marks UAE 15th anniversary with free IVF initiative

The Dubai fertility group will provide 15 complimentary IVF cycles to families facing financial barriers, timed to the UAE's Year of the Family.
The Dubai fertility group will provide 15 complimentary IVF cycles to families facing financial barriers, timed to the UAE's Year of the Family.
Pharmaceuticals
Biologics

Roche enicepatide hits both Phase II endpoints in T2D and obesity

Roche's once-weekly dual GLP-1/GIP agonist enicepatide achieved 2.65% HbA1c reduction and 15.5% weight loss at 48 weeks, with Phase
Roche's once-weekly dual GLP-1/GIP agonist enicepatide achieved 2.65% HbA1c reduction and 15.5% weight loss at 48 weeks, with Phase
Pharmaceuticals
Diagnostics

Avalyn publishes Phase 1 data showing AP02's lung-targeted delivery

Peer-reviewed Phase 1 results confirm nebulised nintedanib achieved 26-fold higher lung exposure than the oral dose, with no serious adverse events.
Peer-reviewed Phase 1 results confirm nebulised nintedanib achieved 26-fold higher lung exposure than the oral dose, with no serious adverse events.
Pharmaceuticals
Regulatory Science

HMNC Brain Health names Doebler CEO ahead of Phase 3 push

The Munich neuroscience company promotes its Chief Business Officer to lead Ketabon and Nelivabon into late-stage development following a $50m Series B close.
The Munich neuroscience company promotes its Chief Business Officer to lead Ketabon and Nelivabon into late-stage development following a $50m Series B close.
Pharmaceuticals
Biologics

J&J wins EC approval for icotrokinra in plaque psoriasis

Johnson & Johnson's icotrokinra becomes the first targeted oral peptide to block the IL-23 receptor, approved for moderate-to-severe plaque psoriasis in Europe.
Johnson & Johnson's icotrokinra becomes the first targeted oral peptide to block the IL-23 receptor, approved for moderate-to-severe plaque psoriasis in Europe.
Biologics
Medical Devices

Roche wins EC approval for Susvimo refillable eye implant in nAMD

The European Commission has approved Roche's Susvimo, a continuous-delivery ranibizumab implant requiring as few as two treatments per year for neovascular AMD.
The European Commission has approved Roche's Susvimo, a continuous-delivery ranibizumab implant requiring as few as two treatments per year for neovascular AMD.
Pharmaceuticals
Biologics

NewAmsterdam and Menarini win EC approval for obicetrapib

The European Commission has approved obicetrapib as both a monotherapy and fixed-dose combination, marking the CETP inhibitor's first regulatory clearance worldwide.
The European Commission has approved obicetrapib as both a monotherapy and fixed-dose combination, marking the CETP inhibitor's first regulatory clearance worldwide.
Pharmaceuticals
Biologics

Novo Nordisk CagriSema beats tirzepatide on weight loss in Phase 3

CagriSema at 1.0 mg/1.0 mg achieved 12.4% weight loss versus 9.1% for tirzepatide 5 mg in adults with type 2
CagriSema at 1.0 mg/1.0 mg achieved 12.4% weight loss versus 9.1% for tirzepatide 5 mg in adults with type 2
Cell & Gene Therapy
Biologics
Pharmaceuticals

Vironexis VNX-101 achieves MRD-negative responses in R/R ALL

All three antibody-naïve relapsed/refractory ALL patients in SENTRY-CD19 achieved durable MRD-negative complete responses after a single VNX-101 infusion.
All three antibody-naïve relapsed/refractory ALL patients in SENTRY-CD19 achieved durable MRD-negative complete responses after a single VNX-101 infusion.
Pharmaceuticals
Biologics

CDT Equity and QIMA to test tapinarof combos in psoriasis

CDT Equity is partnering with dermatology CRO QIMA Life Sciences to evaluate novel tapinarof combinations in psoriasis and vitiligo using human patient skin tissue.
CDT Equity is partnering with dermatology CRO QIMA Life Sciences to evaluate novel tapinarof combinations in psoriasis and vitiligo using human patient skin tissue.
Biologics
Pharmaceuticals

Cue Biopharma: CUE-221 beats placebo and omalizumab in CSU trial

CUE-221 met both primary and key secondary endpoints in a 145-patient Phase 2 study, with the 4 mg/kg dose outperforming omalizumab 12
CUE-221 met both primary and key secondary endpoints in a 145-patient Phase 2 study, with the 4 mg/kg dose outperforming omalizumab 12
Cell & Gene Therapy
Pharmaceuticals

Longeveron HLHS stem cell trial misses primary endpoint

ELPIS II did not meet its RVEF primary endpoint at 12 months, but exploratory data showed fewer cardiovascular events in treated infants.
ELPIS II did not meet its RVEF primary endpoint at 12 months, but exploratory data showed fewer cardiovascular events in treated infants.
Pharmaceuticals
Regulatory Science

Teva study shows HCPs favour AUSTEDO attributes for older TD patients

A discrete choice experiment involving 489 clinicians found somnolence risk and symptom improvement are the top priorities when selecting a VMAT2 inhibitor for tardive
A discrete choice experiment involving 489 clinicians found somnolence risk and symptom improvement are the top priorities when selecting a VMAT2 inhibitor for tardive
Pharmaceuticals
Diagnostics
Bioinformatics

Roche opens Boston CVRM hub at Harvard campus as part of $50bn US push

Roche and Genentech have opened a 95,000 sq m Innovation Center in Allston, Boston, housing up to 500 staff focused on cardiovascular, renal and
Roche and Genentech have opened a 95,000 sq m Innovation Center in Allston, Boston, housing up to 500 staff focused on cardiovascular, renal and
Pharmaceuticals
Genomics

Telomir Pharmaceuticals publishes preclinical AMD data for Telomir-Zn

A peer-reviewed zebrafish study shows Telomir-Zn restored visual function and retinal structure, extending the drug's biology beyond its lead oncology programme.
A peer-reviewed zebrafish study shows Telomir-Zn restored visual function and retinal structure, extending the drug's biology beyond its lead oncology programme.
Pharmaceuticals
Biologics

Teva's UZEDY shows lower ER visits and cost savings in real-world data

New observational data presented at Psych Congress show UZEDY outperformed rival long-acting injectables on treatment continuity and cut monthly healthcare costs by over
New observational data presented at Psych Congress show UZEDY outperformed rival long-acting injectables on treatment continuity and cut monthly healthcare costs by over
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