Pharmaceuticals

Pharmaceuticals
Regulatory Science

Teva ecopipam shows durable tic reduction in Tourette trial

New data presented at MDS 2026 show ecopipam cut tic severity by 45.6% at 18 months, with no new safety signals in an ongoing
New data presented at MDS 2026 show ecopipam cut tic severity by 45.6% at 18 months, with no new safety signals in an ongoing
Biologics
Pharmaceuticals

Leads Biolabs' opamtistomig wins Japan orphan status for EP-NEC

The PD-L1/4-1BB bispecific antibody has now secured orphan drug designation in Japan, the US, and Europe, as its China NDA enters technical
The PD-L1/4-1BB bispecific antibody has now secured orphan drug designation in Japan, the US, and Europe, as its China NDA enters technical
Pharmaceuticals
Genomics

Cullinan files NDA for zipalertinib in first-line EGFR ex20ins NSCLC

Cullinan Therapeutics has begun an FDA RTOR submission for zipalertinib plus chemotherapy in first-line EGFR exon 20 insertion NSCLC, backed by Phase 3 data.
Cullinan Therapeutics has begun an FDA RTOR submission for zipalertinib plus chemotherapy in first-line EGFR exon 20 insertion NSCLC, backed by Phase 3 data.
Medical Devices
Diagnostics
Pharmaceuticals

IBA to distribute ARTMS QIS cyclotron technology for theranostics

IBA will offer ARTMS's solid-target QUANTM Irradiation System to cyclotron customers worldwide, supporting local radiometal production for theranostics.
IBA will offer ARTMS's solid-target QUANTM Irradiation System to cyclotron customers worldwide, supporting local radiometal production for theranostics.
Pharmaceuticals
Biologics

Amplio Pharma Phase 1b data back NovoBioJect methotrexate booster

The Amsterdam biotech reported a 38% rise in active methotrexate inside immune cells, supporting a €10m Series A and a Phase 2a trial in 2027.
The Amsterdam biotech reported a 38% rise in active methotrexate inside immune cells, supporting a €10m Series A and a Phase 2a trial in 2027.
Pharmaceuticals
Digital Health

Discovery Vitality adds doctor-led GLP-1 pathway to weight programme

Discovery Vitality has expanded its HealthyWeight programme to include clinician-assessed access to anti-obesity medicines alongside structured lifestyle support.
Discovery Vitality has expanded its HealthyWeight programme to include clinician-assessed access to anti-obesity medicines alongside structured lifestyle support.
Pharmaceuticals
Biologics

Survodutide hits 13.1% weight loss in Phase III obesity-T2D trial

Boehringer Ingelheim's glucagon/GLP-1 dual agonist met both co-primary endpoints in SYNCHRONIZE-2, with full results published simultaneously in the New England
Boehringer Ingelheim's glucagon/GLP-1 dual agonist met both co-primary endpoints in SYNCHRONIZE-2, with full results published simultaneously in the New England
Biologics
Pharmaceuticals

Regeneron's ubamatamab hits 73% response rate in LGSOC trial

Phase 1/2 data from 11 heavily pre-treated patients showed a 73% objective response rate and 11-month median progression-free survival.
Phase 1/2 data from 11 heavily pre-treated patients showed a 73% objective response rate and 11-month median progression-free survival.
Pharmaceuticals
Biologics

Roche giredestrant cuts progression risk 44% in breast cancer trial

Phase III evERA data published in NEJM show giredestrant plus everolimus nearly halved disease progression risk in ER-positive advanced breast cancer.
Phase III evERA data published in NEJM show giredestrant plus everolimus nearly halved disease progression risk in ER-positive advanced breast cancer.
Biologics
Pharmaceuticals

Sanofi and Regeneron expand immunology alliance with $8bn deal

Four next-generation long-acting antibodies targeting IL-13, IL-4 and IL-4Rα join the partnership that produced Dupixent, with Regeneron receiving $1bn upfront.
Four next-generation long-acting antibodies targeting IL-13, IL-4 and IL-4Rα join the partnership that produced Dupixent, with Regeneron receiving $1bn upfront.
Pharmaceuticals
Biologics

Boehringer's survodutide hits Phase III endpoints in obesity plus T2D

SYNCHRONIZE-2 showed 13.1% average weight loss versus 3.1% on placebo after 76 weeks, with significant glycaemic improvements published in the NEJM.
SYNCHRONIZE-2 showed 13.1% average weight loss versus 3.1% on placebo after 76 weeks, with significant glycaemic improvements published in the NEJM.
Pharmaceuticals
Regulatory Science

PolyPid's D-PLEX100 MAA validated by EMA for SSI prevention

The EMA has accepted PolyPid's marketing authorisation application for D-PLEX100, which also faces an FDA PDUFA date of 28 November 2026.
The EMA has accepted PolyPid's marketing authorisation application for D-PLEX100, which also faces an FDA PDUFA date of 28 November 2026.
Biologics
Pharmaceuticals

Connect Biopharma: rademikibart cuts COPD failure rate 81% in Ph2

Connect Biopharma's IL-4Rα antibody rademikibart met its primary endpoint in a Phase 2 COPD trial, eliminating hospital return visits versus placebo.
Connect Biopharma's IL-4Rα antibody rademikibart met its primary endpoint in a Phase 2 COPD trial, eliminating hospital return visits versus placebo.
Pharmaceuticals
Biologics

Novo Nordisk CagriSema data shows brain, organ and bone effects

New EASD 2026 data show CagriSema modifies brain food-cue responses and reduces ectopic fat, with bone health maintained during weight loss.
New EASD 2026 data show CagriSema modifies brain food-cue responses and reduces ectopic fat, with bone health maintained during weight loss.
Pharmaceuticals
Biologics

Highlight Therapeutics: BO-112 meets Phase 2b BCC endpoint

Highlight Therapeutics' intralesional BO-112 met its primary visual and pathological response endpoint in 61% of basal cell carcinoma patients.
Highlight Therapeutics' intralesional BO-112 met its primary visual and pathological response endpoint in 61% of basal cell carcinoma patients.
Biologics
Pharmaceuticals

Egle Therapeutics: EGL-003 Phase 1 shows clean safety, Treg lift

Egle's IL-2 agonist EGL-003 was well tolerated across four dose cohorts and produced selective Treg expansion, supporting a Q4 2026 atopic dermatitis
Egle's IL-2 agonist EGL-003 was well tolerated across four dose cohorts and produced selective Treg expansion, supporting a Q4 2026 atopic dermatitis
Pharmaceuticals
Biologics

Novo Nordisk licenses Hengrui's oral GLP-1/GIP agonist for $2.6bn

Novo Nordisk will pay $300m upfront for global rights to HRS-1596, a once-weekly oral dual GLP-1/GIP agonist nearing Phase 1 trials.
Novo Nordisk will pay $300m upfront for global rights to HRS-1596, a once-weekly oral dual GLP-1/GIP agonist nearing Phase 1 trials.
Biologics
Pharmaceuticals

Tectonic Therapeutic reports clean Phase 1a data for HHT drug

TX2100 cleared all six dose cohorts without serious adverse events; FDA Fast Track status and a Phase 1b trial in HHT patients are set for
TX2100 cleared all six dose cohorts without serious adverse events; FDA Fast Track status and a Phase 1b trial in HHT patients are set for
Biologics
Pharmaceuticals

Knight Therapeutics signs Latin America deal for Kyowa Kirin's Poteligeo

Knight Therapeutics will seek regulatory approval and commercialise mogamulizumab across Brazil, Mexico, Colombia and Argentina under an exclusive distribution pact.
Knight Therapeutics will seek regulatory approval and commercialise mogamulizumab across Brazil, Mexico, Colombia and Argentina under an exclusive distribution pact.
Pharmaceuticals
Biologics

Roche fenebrutinib NDA accepted by FDA for RMS and PPMS

Roche's oral BTK inhibitor fenebrutinib has received priority review acceptance for both relapsing and primary progressive MS, a first for the class.
Roche's oral BTK inhibitor fenebrutinib has received priority review acceptance for both relapsing and primary progressive MS, a first for the class.
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