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THE GOOD
Approvals & Labels

MHRA approves EURneffy, first nasal epinephrine spray for anaphylaxis treatment in UK patients 30kg+
Small molecule, autoimmune, nasal spray delivery, anaphylaxis, emergency treatment, epinephrine - Read more

Merck KGaA's Ezmekly (mirdametinib) gains EU approval for neurofibromatosis type 1 plexiform neurofibromas following Ph2b success
Small molecule, neurological, MEK inhibitor, neurofibromatosis type 1, rare disease, pediatric indication - Read more

THE GOOD
Business Development & Partnerships

Eisai adopts Elix's AI drug discovery platform to accelerate development through multi-model technology trained from 16 pharma companies
Research collaboration, AI/ML, drug discovery, small molecule, R&D - Read more

CorestemChemon, ATG Lifetech partner on transcriptome/organoid preclinical services for global pharma clients
Strategic partnership, preclinical services, co-development, transcriptome analytics, organoid technology, global - Read more

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THE GOOD
Clinical Trials

Telomir shares surge as preclinical data shows Telomir-1 enzyme inhibitor reverses epigenetic silencing in prostate cancer
Small molecule, cancer, enzyme inhibitor, epigenetic therapy, STAT1 target, prostate cancer - Read more

Cloudbreak's CBT-004 Demonstrates Positive Ph2 Results for Vascularized Pinguecula in Ocular Surface Disease Trial
Small molecule, ophthalmological, ophthalmic solution, ocular surface disease, pinguecula - Read more

THE GOOD
Investments

Bain Capital and Botanic break ground on multi-tenant biomanufacturing facility in Massachusetts
Biomanufacturing, strategic, operational, investment - Read more

THE GOOD
Politics & Policy

J&J and Novartis prepare for Trump's pharmaceutical tariff threat while emphasizing US investments
Regulatory, pharmaceutical manufacturing, strategic, financial impact, tariff policy - Read more

THE GOOD
Regulatory

FDA panel urges removal of warning labels on hormone therapy for menopausal women
Hormone replacement therapy, women's health, regulatory, patient access - Read more

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THE BAD
Approvals & Labels

FDA rejects Roche's Columvi (CD20xCD3) for second-line diffuse large B-cell lymphoma, citing insufficient US data
Antibody, cancer, bispecific antibody, diffuse large B-cell lymphoma, CD20xCD3, combination therapy - Read more

FDA rejects Genentech's Columvi (glofitamab) sBLA for second-line DLBCL; drug remains approved for third-line treatment
Antibody, cancer, combination therapy, diffuse large B-cell lymphoma, hematological malignancy, regulatory update - Read more

FDA panel rejects GSK's Blenrep for multiple myeloma, citing safety concerns over efficacy benefits
Antibody-drug conjugate, oncology, regulatory, competitive - Read more

FDA panel rejects Otsuka's brexpiprazole for PTSD, voting 10-1 against efficacy evidence
Small molecule, neurological, PTSD, regulatory, efficacy data - Read more

THE BAD
Clinical Trials

BMS's Reblozyl fails Ph3 trial for myelofibrosis, missing primary endpoint for red blood cell transfusion independence
Protein therapy, cancer, erythropoiesis stimulating agent, myelofibrosis, anemia, transfusion independence - Read more

Viatris' Ph3 study of pimecrolimus (MR-139) calcineurin inhibitor fails primary endpoint in blepharitis treatment
Small molecule, ophthalmological, topical therapy, blepharitis, calcineurin inhibitor - Read more

THE BAD
Investments

Moderna cancels planned mRNA plant in Japan amid business uncertainty, while maintaining research facility
mRNA vaccine, infectious disease, strategic, operational, financial - Read more

THE BAD
Layoffs

Flagship's Sail Biomedicines cuts 36 jobs, refocuses on immunology programs and in vivo CAR-T pipeline
CAR-T, immunology, operational, strategic restructuring - Read more

THE UGLY
Clinical Trials

Sarepta reports patient death in Ph1 trial of SRP-9004 gene therapy for limb-girdle muscular dystrophy
Gene therapy, neuromuscular, muscular dystrophy, safety concerns, patient death - Read more

THE UGLY
Regulatory

FDA requests Sarepta halt gene therapy shipments over safety concerns; company refuses for younger patients
Gene therapy, rare disease, regulatory, safety concerns - Read more

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

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