Pharmaceuticals

Pharmaceuticals

Chiesi wins Health Canada priority review for FILSUVEZ in EB

Health Canada has accepted Chiesi's birch triterpenes gel for priority review, potentially making it the first therapy approved for EB wounds in Canada.
Health Canada has accepted Chiesi's birch triterpenes gel for priority review, potentially making it the first therapy approved for EB wounds in Canada.
Pharmaceuticals

Imviva Biotech wins FDA IND clearance for dual-target allogeneic CAR-T

CTA313 targets CD19 and BCMA in a Phase 1b basket trial spanning lupus, progressive MS, and autoimmune encephalitis.
CTA313 targets CD19 and BCMA in a Phase 1b basket trial spanning lupus, progressive MS, and autoimmune encephalitis.
Pharmaceuticals

Kymera Therapeutics doses first participant in IRAK4 degrader trial

KT-485's Phase 1 first-in-human start triggers a $20m milestone payment from Sanofi under their IRAK4 degrader collaboration.
KT-485's Phase 1 first-in-human start triggers a $20m milestone payment from Sanofi under their IRAK4 degrader collaboration.
Pharmaceuticals

Sanofi halts MOBILIZE Phase 3 trial of riliprubart in refractory CIDP

An independent data monitoring committee found the study unlikely to demonstrate sufficient efficacy; no safety concerns were identified with riliprubart.
An independent data monitoring committee found the study unlikely to demonstrate sufficient efficacy; no safety concerns were identified with riliprubart.
Pharmaceuticals

Roche and Nurix strike $2.3bn BTK degrader deal for bexobrutideg

Roche will pay Nurix $700m upfront to co-develop and co-commercialise bexobrutideg across blood cancers, immunology and neurology.
Roche will pay Nurix $700m upfront to co-develop and co-commercialise bexobrutideg across blood cancers, immunology and neurology.
Pharmaceuticals

SERB Pharmaceuticals buys European and MENA rights to Idefirix for €115m

SERB Pharmaceuticals will acquire imlifidase's European and MENA commercialisation rights from Hansa Biopharma, targeting highly sensitised kidney transplant patients.
SERB Pharmaceuticals will acquire imlifidase's European and MENA commercialisation rights from Hansa Biopharma, targeting highly sensitised kidney transplant patients.
Pharmaceuticals

Survodutide Phase III data show 34% visceral and 63% liver fat cuts

Boehringer Ingelheim's glucagon/GLP-1 dual agonist met primary endpoints in two Phase III trials, with lean mass largely preserved, data published in NEJM
Boehringer Ingelheim's glucagon/GLP-1 dual agonist met primary endpoints in two Phase III trials, with lean mass largely preserved, data published in NEJM
Pharmaceuticals
Regulatory Science

GH Research publishes Phase 2a PPD data for inhaled GH001

All ten patients in GH Research's open-label trial achieved remission within two hours of a single inhaled dose of mebufotenin, the company reports.
All ten patients in GH Research's open-label trial achieved remission within two hours of a single inhaled dose of mebufotenin, the company reports.
Pharmaceuticals

BriaCell wins FDA clearance for Bria-BRES+ breast cancer IND

BriaCell Therapeutics can now initiate a Phase 1/2a study of its next-generation personalised cell immunotherapy in metastatic breast cancer.
BriaCell Therapeutics can now initiate a Phase 1/2a study of its next-generation personalised cell immunotherapy in metastatic breast cancer.
Pharmaceuticals
Biotech

Electra Therapeutics doses first patient in ipsoprubart T cell trial

Electra's SIRP-targeting monoclonal antibody enters a dedicated Phase 1 study in T cell malignancies, supported by a 100% tumour response rate in a
Electra's SIRP-targeting monoclonal antibody enters a dedicated Phase 1 study in T cell malignancies, supported by a 100% tumour response rate in a
Pharmaceuticals
Genomics

Madrigal Pharmaceuticals posts $311m Rezdiffra Q1 sales, up 127%

Madrigal's MASH therapy Rezdiffra has crossed blockbuster sales thresholds as the company expands its pipeline with a licensed siRNA targeting PNPLA3.
Madrigal's MASH therapy Rezdiffra has crossed blockbuster sales thresholds as the company expands its pipeline with a licensed siRNA targeting PNPLA3.
Pharmaceuticals
Biotech

Novo Nordisk raises 2026 guidance as Wegovy pill tops 2m prescriptions

Novo Nordisk lifted its full-year outlook after Wegovy pill surpassed two million prescriptions since its January launch, despite US pricing pressure denting adjusted
Novo Nordisk lifted its full-year outlook after Wegovy pill surpassed two million prescriptions since its January launch, despite US pricing pressure denting adjusted
Pharmaceuticals
Regulatory Science

Idorsia shareholders back all board proposals at 2026 AGM

Idorsia's 2026 AGM approved three new board members and reaffirmed Jean-Paul Clozel as chairman, with a CEO search ongoing.
Idorsia's 2026 AGM approved three new board members and reaffirmed Jean-Paul Clozel as chairman, with a CEO search ongoing.
Pharmaceuticals
Regulatory Science

Tonix Pharmaceuticals gains GPO coverage for TONMYA across 35m lives

The payer agreement covers roughly 20% of US commercial lives for TONMYA, the first new fibromyalgia treatment approved in more than 15 years.
The payer agreement covers roughly 20% of US commercial lives for TONMYA, the first new fibromyalgia treatment approved in more than 15 years.
Pharmaceuticals

Addex Therapeutics posts CHF 6.7m net loss as cash falls to CHF 1.6m

The Geneva-based allosteric modulator specialist ended 2025 with thinning cash reserves but two Phase 2 assets in hand after regaining rights to ADX71149.
The Geneva-based allosteric modulator specialist ended 2025 with thinning cash reserves but two Phase 2 assets in hand after regaining rights to ADX71149.
Pharmaceuticals
Genomics

Annovis Bio publishes Phase 2/3 buntanetap Alzheimer's data in Nature

Peer-reviewed results show buntanetap improved cognition in pTau217-positive early AD patients, with biomarker reductions suggesting potential disease-modifying activity.
Peer-reviewed results show buntanetap improved cognition in pTau217-positive early AD patients, with biomarker reductions suggesting potential disease-modifying activity.
Pharmaceuticals

Avalyn Pharma raises $300m in Nasdaq IPO for fibrosis drugs

The Boston-based clinical-stage biotech priced 16.7 million shares at $18 each to fund inhaled antifibrotic programmes targeting pulmonary fibrosis.
The Boston-based clinical-stage biotech priced 16.7 million shares at $18 each to fund inhaled antifibrotic programmes targeting pulmonary fibrosis.
Pharmaceuticals
Regulatory Science

Quoin Pharma maps multi-indication clinical push for QRX009 rapamycin

Quoin Pharmaceuticals is launching investigator-led trials in three rare skin diseases and targeting a first IND filing for QRX009 in Q3 2026.
Quoin Pharmaceuticals is launching investigator-led trials in three rare skin diseases and targeting a first IND filing for QRX009 in Q3 2026.
Pharmaceuticals

Crescent Biopharma posts Q1 2026 results with $189m cash runway

The Waltham-based oncology biotech reported a $23.3m net loss and outlined data readouts from its CR-001 bispecific and two ADC programmes beginning
The Waltham-based oncology biotech reported a $23.3m net loss and outlined data readouts from its CR-001 bispecific and two ADC programmes beginning
Pharmaceuticals
Regulatory Science

Cristcot to present CESSA corticosteroid data at DDW 2026

Cristcot will present Phase 3 ulcerative colitis trial data on covert steroid use at Digestive Disease Week in Chicago on 5 May.
Cristcot will present Phase 3 ulcerative colitis trial data on covert steroid use at Digestive Disease Week in Chicago on 5 May.
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