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THE GOOD
Approvals & Labels

FDA approves Novartis' Leqvio (inclisiran) as first-line PCSK9 monotherapy for hypercholesterolemia patients
Small molecule, cardiovascular, antisense oligonucleotide, hypercholesterolemia, PCSK9 inhibitor, LDL-C reduction - Read more

THE GOOD
Business Development & Partnerships

Sanofi, Arrowhead Pharmaceuticals partner on plozasiran China rights; $130M upfront plus $265M in milestones
Licensing deal, rare disease, RNAi therapeutic, metabolic disease, milestone payments, China - Read more

Lepu Biopharma, Excalipoint partner on two T-cell engagers in $857M deal with $10M upfront
Licensing deal, oncology, T-cell engager, milestone payments, global, equity investment - Read more

Chordia Therapeutics, Senju Pharmaceutical partner to repurpose GCN2 kinase inhibitor for eye disease treatments
Research collaboration, ophthalmology, small molecule, drug repurposing, R&D - Read more

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✅ More Good News ✅

THE GOOD
Clinical Trials

4DMT's Phase 2 gene therapy shows durability in diabetic macular edema, reducing need for eye injections
Gene therapy, ophthalmological, viral vector, diabetic macular edema, VEGF inhibition - Read more

Energenesis Biomedical's ENERGI-F705PD targeting alpha-synuclein shows positive Ph1 safety results for Parkinson's disease
Small molecule, neurological, Parkinson's disease, alpha-synuclein, ATP modulation, disease-modifying therapy - Read more

THE GOOD
Earnings & Finances

Moderna reports better-than-expected Spikevax sales despite 41% revenue drop and $825 million loss in Q2
mRNA vaccine, infectious disease, financial, revenue impact - Read more

Regeneron beats Q2 expectations despite FDA delays from Catalent manufacturing issues affecting Eylea HD applications
Monoclonal antibody, ophthalmology, regulatory, manufacturing, financial, strategic - Read more

THE GOOD
Fundraises

Oculis raises up to CHF 100M ($122.8M) loan facility for ophthalmic disease pipeline advancement
Ophthalmology, neurological, small molecule, clinical-stage, rare disease - Read more

THE GOOD
Lawsuits

Moderna wins UK patent appeal against Pfizer/BioNTech over COVID vaccine mRNA technology infringement
mRNA vaccine, infectious disease, regulatory, intellectual property, legal - Read more

THE GOOD
Politics & Policy

European pharma CEOs downplay impact of 15% US tariffs, citing domestic manufacturing capabilities
regulatory, operational, strategic, financial impact - Read more

THE GOOD
Regulatory

FDA's Makary seeks alignment between drug and biologics regulatory units after Prasad's departure
Gene therapy, rare disease, regulatory, organizational change, FDA alignment - Read more

FDA requires stronger safety labeling for opioids following review of long-term risks
Small molecule, pain management, regulatory, operational, drug safety - Read more

THE BAD
Approvals & Labels

FDA rejects Regeneron's odronextamab (CD20xCD3) for relapsed follicular lymphoma due to manufacturing issues
Antibody, cancer, bispecific antibody, lymphoma, manufacturing issues, follicular lymphoma - Read more

Regeneron faces Eylea delays and cancer drug rejection due to Novo Nordisk plant issues
Bispecific antibody, ophthalmology, oncology, manufacturing delays, regulatory, competitive - Read more

THE BAD
Clinical Trials

Spine BioPharma's TGF-β antagonist SB-01 misses Ph3 primary endpoint for chronic low back pain
Protein therapy, neurological, TGF-β antagonist, chronic low back pain, degenerative disc disease, intervertebral disc injection - Read more

THE UGLY
Politics & Policy

Trump administration imposes country-specific tariffs impacting Swiss drugmakers Roche and Novartis with 39% rate
Pharmaceutical manufacturing, trade policy, financial impact, regulatory - Read more

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

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