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THE GOOD
Approvals & Labels

CHMP recommends AstraZeneca's Koselugo, a MEK inhibitor, for adult neurofibromatosis type 1 plexiform neurofibromas in EU
Small molecule, neurological, MEK inhibitor, neurofibromatosis type 1, genetic condition, tumor reduction - Read more

European Commission approves Servier's VORANIGO as first targeted therapy for Grade 2 IDH-mutant glioma in EU
Small molecule, cancer, IDH inhibitor, glioma, CNS tumor, brain cancer - Read more

Torii Pharmaceutical receives japanese approval for YCANTH (cantharidin) to treat molluscum contagiosum
Small molecule, infectious disease, topical therapy, molluscum contagiosum, pediatric indication, regulatory approval - Read more

THE GOOD
Business Development & Partnerships

Angelini, Sovargen partner on preclinical neurological compound SVG1051; potential $550M+ deal with milestones
Licensing deal, neurological, antisense oligonucleotide, milestone payments, global - Read more

AstraZeneca, SOPHiA Genetics expand collaboration to develop NGS assay for detecting PTEN mutations in cancer patients
Research collaboration, oncology, diagnostics, AI/ML, biomarker testing, R&D - Read more

Starpharma, Genentech partner on DEP cancer drug delivery technology for $5.5M upfront, potential $564M in milestones
Licensing deal, oncology, drug delivery technology, milestone payments, royalties, co-development - Read more

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THE GOOD
Clinical Trials

Roche's giredestrant meets Ph3 endpoints for ER-positive metastatic breast cancer targeting estrogen receptor degradation
Small molecule, cancer, oral SERD, breast cancer, estrogen receptor, ESR1 mutations - Read more

Ionis Pharmaceuticals' zilganersen shows Ph3 success in Alexander disease, plans FDA filing for rare neurological condition
Antisense oligonucleotide, neurological, rare disease, Alexander disease, orphan drug, gene-targeted therapy - Read more

MBX's weekly PTH drug canvuparatide achieves primary endpoints in Ph2 trial for hypoparathyroidism
Peptide therapy, endocrine disease, long-acting prodrug, hypoparathyroidism, parathyroid hormone, rare disease - Read more

IMUNON's IL-12 immunotherapy IMNN-001 shows 13-month survival extension in Ph2 ovarian cancer trial
Gene therapy, cancer, DNA-based immunotherapy, ovarian cancer, interleukin-12, tumor microenvironment - Read more

Johnson & Johnson's seltorexant shows comparable efficacy to quetiapine XR in Ph3 trial for major depressive disorder with insomnia
Small molecule, neurological, orexin receptor antagonist, major depressive disorder, insomnia, dual indication - Read more

Ipsen's Ph2 IPN10200 shows longer-lasting effect for glabellar lines, advances to Ph3 trials
Protein therapy, neurological, neurotoxin, aesthetic medicine, glabellar lines, long-acting formulation - Read more

THE GOOD
Earnings & Finances

MapLight files for IPO on Nasdaq to advance neuropsychiatric drugs for Alzheimer's and schizophrenia
Neurological, Alzheimer disease, schizophrenia, small molecule, clinical-stage, CNS disorders - Read more

THE GOOD
Fundraises

Until raises $58M Series A, developing organ cryopreservation for transplant patients
Organ transplantation, cryopreservation, platform technology, medical devices, preclinical - Read more

Mondego Bio raises Series A funding for PTPN2 inhibitors in immuno-oncology
Oncology, small molecule, cancer, immunotherapy, protein inhibitor - Read more

Plus Therapeutics receives $1.9M CPRIT grant payment for CNS cancer radiotherapeutics development
Central nervous system, oncology, radiotherapeutics, clinical-stage, platform technology - Read more

Avenzo Therapeutics raises $60M Series B to advance pipeline of next-generation oncology therapies
Oncology, clinical-stage, drug discovery, pipeline development - Read more

Ensoma raises $53M financing for HSC engineering and Phase 1/2 trial in X-CGD
Gene therapy, hematopoietic stem cell, in vivo, rare disease, clinical-stage, platform technology - Read more

Jasper Therapeutics raises $30M public offering for briquilimab development in mast cell diseases
Antibody, autoimmune, clinical-stage, mast cell diseases, KIT targeting - Read more

THE GOOD
Mergers & Acquisitions

Pfizer acquires Metsera for $4.9B to revive obesity drug ambitions after abandoning previous candidates
Small molecule, metabolic disease, strategic, major transaction, obesity - Read more

THE GOOD
Regulatory

European Commission releases new variations guidelines to streamline drug lifecycle management and marketing authorization updates
Regulatory, operational, strategic, competitive - Read more

THE GOOD
Strategic Plans

Novartis CEO explores U.S. drug price cuts amid Trump's push for most favored nation pricing policy
Drug pricing, strategic, policy, financial impact, competitive - Read more

Roche unveils strategy to become top-3 obesity player by 2030, backed by $4.3B in acquisitions
GLP-1/GIP receptor agonist, obesity, strategic, financial, competitive - Read more

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THE BAD
Approvals & Labels

FDA extends review for Sanofi's tolebrutinib BTK inhibitor to December for non-relapsing secondary progressive multiple sclerosis
Small molecule, neurological, Bruton's tyrosine kinase (BTK) inhibitor, multiple sclerosis, secondary progressive multiple sclerosis (nrSPMS), liver safety - Read more

THE BAD
Politics & Policy

Bristol Myers plans US-level pricing for schizophrenia drug Cobenfy in UK, challenging NHS cost controls
Small molecule, neurological, pricing strategy, regulatory, competitive - Read more

THE UGLY
Politics & Policy

Trump claims Tylenol during pregnancy may cause autism; announces research funding and treatment approval
Acetaminophen, neurological, regulatory, misinformation, public health - Read more

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

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