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THE GOOD
Approvals & Labels

FDA approves Ionis Pharmaceuticals' Dawnzera (donidalorsen), targeting HAE protein, for hereditary angioedema prevention in Ph3 milestone
Antisense oligonucleotide, rare disease, hereditary angioedema, genetic disorder, preventive therapy - Read more

THE GOOD
Business Development & Partnerships

ANGLE and Myriad Genetics partner to develop blood-based cancer testing using Parsortix technology for liquid biopsies
Research collaboration, oncology, diagnostics, liquid biopsy, precision medicine - Read more

CCRM Nordic invests in Precision BioAnalytics to enhance ATMP development services across Nordic region
Venture partnership, ATMP, cell therapy, R&D, commercialization, strategic investment - Read more

Bio-Thera, STADA partner on Actemra and Simponi biosimilars; Bio-Thera to receive up to €136M ($159M) plus royalties
Licensing deal, biosimilar, commercialization, milestone payments, royalties - Read more

Elix, KYORIN Pharmaceutical partner on AI drug discovery platform Elix Discovery to accelerate compound identification
AI/ML, drug discovery, licensing deal, R&D - Read more

Friends of Cancer Research partners with MMS to enhance interpretation of overall survival data in oncology trials
Small molecule, cancer, clinical trial design, overall survival, regulatory strategy, drug development - Read more

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✅ More Good News ✅

THE GOOD
Clinical Trials

Dynavax's Z-1018 shingles vaccine matches Shingrix with better tolerability in Ph1/2 trial results
Vaccine, infectious disease, recombinant subunit vaccine, shingles, CpG adjuvant, elderly population - Read more

AbbVie's Ph3 trial shows Rinvoq (upadacitinib) delivers strong results for alopecia areata, regulatory submission planned
Small molecule, autoimmune, JAK inhibitor, alopecia areata, hair loss, immunology - Read more

Nicox's NCX 470 nitric oxide eye drop hits Ph3 goals for open-angle glaucoma, US filing planned
Small molecule, ophthalmological, nitric oxide donor, glaucoma, intraocular pressure, open-angle glaucoma - Read more

THE GOOD
Earnings & Finances

Sarepta exchanges $700 million debt due in 2027, issuing new notes and shares to strengthen finances
Gene therapy, rare disease, financial, debt restructuring, strategic - Read more

THE GOOD
Fundraises

Kromatid raises $8M Series C, genomic structural analysis for cell and gene therapy
Genomic analysis, platform technology, services, cell therapy, gene therapy - Read more

Calidi Biotherapeutics raises $6M public offering for targeted genetic medicine delivery
Oncology, targeted therapies, genetic medicines, clinical-stage, platform technology - Read more

Immuneering raises $25M private placement for clinical-stage cancer drug development
Oncology, clinical-stage, pancreatic cancer, small molecule, drug development - Read more

Invivyd announces public offering to fund VYD2311 clinical program and respiratory virus research
Infectious disease, antibody, clinical-stage, COVID-19, RSV - Read more

THE GOOD
Investments

Johnson & Johnson commits $2 billion for new facility at FUJIFILM site in North Carolina
Manufacturing expansion, strategic, major transaction, investment, operational - Read more

THE GOOD
Mergers & Acquisitions

Gilead's Kite Pharma acquires Interius BioTherapeutics for $350M, gaining in vivo CAR-T platform to hopefully expand portfolio beyond existing Gilead ex-vivo CAR-T therapies
in vivo CAR-T, oncology, strategic acquisition, major transaction - Read more

THE GOOD
Regulatory

FDA accelerates Stealth Bio's elamipretide review for Barth syndrome, targets decision by September
Protein therapy, rare disease, peptide, Barth syndrome, mitochondrial disorder, pediatric indication - Read more

THE BAD
Clinical Trials

Krystal discontinues Ph1/2 trial of KB707 herpes-based gene therapy for advanced skin cancer after FDA rejection
Gene therapy, cancer, oncolytic virus, melanoma, herpes virus vector, immunotherapy combination - Read more

THE BAD
Lawsuits

Enanta Pharmaceuticals sues Pfizer in EU court over COVID-19 drug patent infringement
Small molecule, infectious disease, legal, patent infringement, COVID-19 - Read more

THE BAD
Politics & Policy

Trump sets 15% tariff on EU branded drugs, exempts generics starting September 1st
Generic drugs, branded pharmaceuticals, trade policy, tariffs, regulatory, financial - Read more

THE UGLY
No Ugly News Today!

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