Pharmaceuticals

Biologics
Pharmaceuticals

Electra Therapeutics prices upsized $350m IPO on Nasdaq

The South San Francisco biotech will trade under "ETRA" after pricing 23.3 million shares at $15 each, with proceeds targeting its SIRP-targeting pipeline.
The South San Francisco biotech will trade under "ETRA" after pricing 23.3 million shares at $15 each, with proceeds targeting its SIRP-targeting pipeline.
Pharmaceuticals
Regulatory Science

MIRA Pharmaceuticals submits Ketamir-2 Phase 2a protocol for CIPN

MIRA's oral NMDA receptor modulator enters IRB review for a first-in-indication Phase 2a study in chemotherapy-induced peripheral neuropathy.
MIRA's oral NMDA receptor modulator enters IRB review for a first-in-indication Phase 2a study in chemotherapy-induced peripheral neuropathy.
Biologics
Pharmaceuticals

Novartis secukinumab gets positive CHMP opinion for PMR

The EMA's advisory committee has backed Cosentyx as the first IL-17A inhibitor for polymyalgia rheumatica in Europe, pending European Commission sign-off.
The EMA's advisory committee has backed Cosentyx as the first IL-17A inhibitor for polymyalgia rheumatica in Europe, pending European Commission sign-off.
Biologics
Pharmaceuticals
Regulatory Science

Novo Nordisk's Sogroya wins CHMP backing for idiopathic short stature

A positive EMA committee opinion positions somapacitan as the first growth hormone treatment recommended for ISS in the EU, pending European Commission sign-off.
A positive EMA committee opinion positions somapacitan as the first growth hormone treatment recommended for ISS in the EU, pending European Commission sign-off.
Biologics
Pharmaceuticals

Bavarian Nordic appoints Tarja Stenvall as CEO from October

The Danish vaccine company has named Sanofi and AstraZeneca veteran Tarja Stenvall as its new chief executive, effective 15 October 2026.
The Danish vaccine company has named Sanofi and AstraZeneca veteran Tarja Stenvall as its new chief executive, effective 15 October 2026.
Pharmaceuticals
Biologics

Teva presents Phase 3 data on once-monthly olanzapine LAI TEV-'749

Post hoc SOLARIS data show 56% stabilisation and 4% relapse rates; an FDA decision on TEV-'749 is expected in Q4 2026.
Post hoc SOLARIS data show 56% stabilisation and 4% relapse rates; an FDA decision on TEV-'749 is expected in Q4 2026.
Pharmaceuticals
Biologics
Regulatory Science

Zealand Pharma gets CHMP nod for glepaglutide in short bowel syndrome

The EMA's CHMP has recommended Zeydovio for short bowel syndrome, the first major European advance in the indication for over a decade.
The EMA's CHMP has recommended Zeydovio for short bowel syndrome, the first major European advance in the indication for over a decade.
Pharmaceuticals
Biologics

1ST Bio and SK Biopharma ink $314.8m Parkinson's licence for 1ST-104

The deal pairs 1STBIO's dual LRRK2/c-Abl inhibitor with SK Biopharmaceuticals' CNS development and commercialisation infrastructure.
The deal pairs 1STBIO's dual LRRK2/c-Abl inhibitor with SK Biopharmaceuticals' CNS development and commercialisation infrastructure.
Pharmaceuticals
Regulatory Science

Aquestive resubmits Anaphylm NDA after human factors and PK studies

Aquestive Therapeutics has refiled its FDA application for a needle-free sublingual epinephrine film after cutting pouch-opening time from 17 seconds to three.
Aquestive Therapeutics has refiled its FDA application for a needle-free sublingual epinephrine film after cutting pouch-opening time from 17 seconds to three.
Biologics
Pharmaceuticals

Lisata Therapeutics acquires Marea and raises $225m in concurrent PIPE

Lisata is pivoting to cardioendocrine disease after acquiring Marea Therapeutics in a stock deal backed by a $225m oversubscribed private placement.
Lisata is pivoting to cardioendocrine disease after acquiring Marea Therapeutics in a stock deal backed by a $225m oversubscribed private placement.
Biologics
Pharmaceuticals

Novo Nordisk wins CHMP nod for denecimig in haemophilia A

The EMA advisory committee recommended EU approval of FREHEMGO, a bispecific antibody offering monthly, fortnightly or weekly dosing in a pre-filled pen.
The EMA advisory committee recommended EU approval of FREHEMGO, a bispecific antibody offering monthly, fortnightly or weekly dosing in a pre-filled pen.
Biologics
Pharmaceuticals

Biogen publishes Phase 3 EMPAVELI paediatric data in CJASN

Adolescents with C3G or IC-MPGN achieved a 75% relative reduction in proteinuria on pegcetacoplan versus placebo in the VALIANT subgroup analysis.
Adolescents with C3G or IC-MPGN achieved a 75% relative reduction in proteinuria on pegcetacoplan versus placebo in the VALIANT subgroup analysis.
Diagnostics
Pharmaceuticals

Sol-Gel hits LPLV milestone in Phase 3 Gorlin syndrome trial

Sol-Gel Technologies has completed patient follow-up in its Phase 3 patidegib gel study, with top-line results expected in late November 2026.
Sol-Gel Technologies has completed patient follow-up in its Phase 3 patidegib gel study, with top-line results expected in late November 2026.
Cell & Gene Therapy
Pharmaceuticals
Regulatory Science
Biologics

Ultragenyx wins FDA approval for FAYUVI in Sanfilippo syndrome Type A

FAYUVI becomes the first approved treatment for MPS IIIA, backed by eight years of follow-up data showing significant cognitive benefit over natural history.
FAYUVI becomes the first approved treatment for MPS IIIA, backed by eight years of follow-up data showing significant cognitive benefit over natural history.
Pharmaceuticals
Medical Devices
Regulatory Science

RWS launches Tridion agentic platform for regulated content workflows

RWS has put its Tridion Agent and Tridion Connect tools into public preview, targeting regulated industries managing high-volume technical documentation.
RWS has put its Tridion Agent and Tridion Connect tools into public preview, targeting regulated industries managing high-volume technical documentation.
Pharmaceuticals
Biologics

Ascendis Pharma to regain TransCon rights in metabolic diseases

Ascendis Pharma will reclaim full rights to its TransCon platform in cardiometabolic indications after ending its Novo Nordisk collaboration.
Ascendis Pharma will reclaim full rights to its TransCon platform in cardiometabolic indications after ending its Novo Nordisk collaboration.
Pharmaceuticals
Biologics

Avacta reports clinical proof of mechanism for AVA6103 PDC in FOCUS-01

Avacta's next-generation pre|CISION peptide-drug conjugate showed a clean safety profile and matched preclinical PK predictions across three dose levels in solid
Avacta's next-generation pre|CISION peptide-drug conjugate showed a clean safety profile and matched preclinical PK predictions across three dose levels in solid
Medical Devices
Biologics
Pharmaceuticals

EIB and Angelini Ventures hit €48.5m deployed under €150m facility

The EIB-Angelini Ventures co-investment partnership has backed five European life sciences companies in under a year, with €100m expected deployed by early 2027.
The EIB-Angelini Ventures co-investment partnership has backed five European life sciences companies in under a year, with €100m expected deployed by early 2027.
Pharmaceuticals

Remedy Plan advances RPT1G to Cohort 2 in AML/MDS Phase 1 trial

The Gaithersburg biotech also secured a $30m Series A extension and won FDA IND acceptance for RPT1G in solid tumours.
The Gaithersburg biotech also secured a $30m Series A extension and won FDA IND acceptance for RPT1G in solid tumours.
Biologics
Pharmaceuticals

Roche's Lunsumio plus lenalidomide meets Phase III PFS endpoint in FL

Roche's CELESTIMO study showed mosunetuzumab plus lenalidomide significantly improved progression-free survival in relapsed or refractory follicular lymphoma.
Roche's CELESTIMO study showed mosunetuzumab plus lenalidomide significantly improved progression-free survival in relapsed or refractory follicular lymphoma.
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