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The Good News

THE GOOD
Approvals & Labels

Incyte wins MHLW approval for Minjuvi (tafasitamab) plus lenalidomide in relapsed or refractory diffuse large B-cell lymphoma
Antibody, cancer, monoclonal antibody, diffuse large B-cell lymphoma, combination therapy, CD19 - Read more

Zenyaku Kogyo, Chugai Pharmaceutical's Rituxan (rituximab) approved in Japan for adult-onset frequently relapsing or steroid-dependent nephrotic syndrome
Antibody, autoimmune, monoclonal antibody, nephrotic syndrome, CD20, rituximab - Read more

Chugai Pharmaceutical's Avastin (bevacizumab) receives world-first approval for neurofibromatosis type 2 based on Ph2 data
Antibody, neurological, monoclonal antibody, neurofibromatosis type 2, VEGF, bevacizumab - Read more

Shionogi's Xocova (ensitrelvir fumaric acid) receives Japan supplemental approval for pediatric coronavirus disease 2019 patients aged 6 and older based on Ph3 data
Small molecule, infectious disease, antiviral, COVID-19, pediatric population, protease inhibitor - Read more

Teijin Pharma, Merz Therapeutics win MHLW approval for Xeomin (incobotulinumtoxinA) in cervical dystonia and blepharospasm following Ph3 trials
Protein therapy, neurological, botulinum toxin, cervical dystonia, blepharospasm, acetylcholine inhibition - Read more

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More Good News

THE GOOD
Business Development & Partnerships

Denali Therapeutics sells FDA priority review voucher for $195M to fund neurodegenerative pipeline
Priority review voucher, rare disease, neurological, neurodegenerative, non-dilutive capital - Read more

Sanofi, Pangaea Data partner on AI platform to detect underdiagnosed genetic disease AATD
AI/ML, rare disease, diagnostics, data analytics - Read more

Insilico Medicine, SK Biopharmaceuticals partner on neuroimmune AI drug discovery, $18M upfront, $2.5B+ milestones
Research collaboration, AI/ML, neurological, milestone payments, royalties - Read more

Eli Lilly, BioArctic partner on neurodegenerative disease using BrainTransporter technology, $30M upfront, $800M deal
Research collaboration, neurological, drug delivery, antibody, milestone payments, royalties - Read more

Voro Therapeutics, Alloy Therapeutics collaborate to advance next-generation masked T-cell engager cancer immunotherapies
Research collaboration, oncology, antibody, drug discovery, immunotherapy - Read more

Boltz, Takeda partner on AI drug discovery, deploying biomolecular models for molecular structure prediction and drug design
Research collaboration, AI/ML, drug discovery, small molecule, R&D - Read more

K2 Therapeutics, Antengene ink twin T-cell engager license deals worth ~$2B
Licensing deal, oncology, bispecific antibody, milestone payments, equity investment - Read more

Monash University, Brigham and Women's Hospital renew sleep and circadian medicine research partnership
Research collaboration, sleep medicine, digital health, wearable devices, chronic disease, clinical trials - Read more

Greenstone Biosciences, Intel Corp. collaborate to accelerate AI-enabled drug discovery using iPSC biobank and edge computing
Research collaboration, AI/ML, drug discovery, cell therapy, R&D - Read more

THE GOOD
Clinical Trials

Definium Therapeutics' DT120 ODT (lysergic acid diethylamide) meets all Ph3 endpoints for major depressive disorder
Small molecule, neurological, psychedelic, major depressive disorder, LSD, serotonin - Read more

Merck & Co.'s (tulisokibart) anti-TL1A antibody meets Ph3 primary endpoint in moderately to severely active ulcerative colitis
Antibody, autoimmune, monoclonal antibody, ulcerative colitis, TL1A target - Read more

uniQure's AMT-260 shows up to 100% seizure reduction in Ph1/2a refractory mesial temporal lobe epilepsy trial
Gene therapy, neurological, epilepsy, mesial temporal lobe epilepsy, Huntington's disease, AAV vector - Read more

THE GOOD
Company Launches

Bionyra launches with $165M Series A to advance next-generation immune disease biologics targeting IBD and atopic dermatitis
Autoimmune, biologics, monoclonal antibody, bispecific antibody, inflammatory bowel disease, clinical-stage - Read more

Houdini Bio launches with £1.5M ($1.98M) funding, using AI to overcome gene therapy cellular silencing barriers
Gene therapy, rare disease, investment, platform technology - Read more

THE GOOD
Fundraises

Memento Medicines raises $93M Series A, advancing bispecific antibody MMT-205 for retinal disorders
Ophthalmology, bispecific antibody, retinal disease, preclinical - Read more

Nura Bio raises $73.8M Series B to advance ALS-targeting SARM1 inhibitor programs
Neurological, small molecule, ALS, clinical-stage - Read more

Scribe Therapeutics awarded $25M+ from CIRM to advance CRISPR-based cardiometabolic gene editing therapies
CRISPR, gene therapy, cardiovascular, rare disease, preclinical, platform technology - Read more

COUR Pharma raises $50M Series B, advancing type 1 diabetes nanoparticle immunotherapy
Autoimmune, nanoparticle technology, type 1 diabetes, immunotherapy, clinical-stage - Read more

Syntax Bio expands Series A to $14.4M, programming new cell therapies
Synthetic biology, cell therapy, CRISPR, stem cell, platform technology - Read more

THE GOOD
Mergers & Acquisitions

AbbVie acquires Apogee Therapeutics for $10.9B to bolster immunology portfolio and challenge Dupixent
Monoclonal antibody, autoimmune, strategic, major transaction - Read more

THE GOOD
Regulatory

FDA advisory panel unanimously backs Moderna's (mRNA-1010) mRNA influenza vaccine for adults aged 50 and older
Vaccine, infectious disease, mRNA vaccine, influenza, FDA advisory committee - Read more

REGENXBIO to resubmit Hunter syndrome gene therapy application in Q3 after FDA reversal
Gene therapy, rare disease, regulatory, accelerated approval - Read more

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The Bad News

THE BAD
Politics & Policy

US probes Germany's drug pricing policies over unfair pharmaceutical R&D cost burden on America
Drug pricing, pharmaceutical R&D, regulatory, financial - Read more

THE BAD
Regulatory

Pfizer complaint leads PMCPA to reprimand Alnylam over off-label Amvuttra promotion at cardiology congress
RNAi therapy, cardiovascular, rare disease, regulatory, competitive - Read more

👹 The Ugly News 👹

THE UGLY
No Ugly News Today!

You’re all caught up on the latest Pharma & Biotech News!

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