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THE GOOD
Approvals & Labels

FDA approves Johnson & Johnson's Darzalex Faspro (daratumumab) for high-risk smoldering multiple myeloma following Ph3 trial
Antibody, cancer, monoclonal antibody, multiple myeloma, CD38 target, smoldering myeloma - Read more

Johnson & Johnson's Caplyta (lumateperone) wins FDA approval for major depressive disorder treatment
Small molecule, neurological, major depressive disorder, schizophrenia, bipolar disorder, atypical antipsychotic - Read more

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✅ More Good News ✅

THE GOOD
Clinical Trials

Eli Lilly's amylin agonist (eloralintide) advances to Ph3 obesity trials after achieving 20% weight loss in Ph2
Protein therapy, metabolic, amylin agonist, obesity, weight loss - Read more

Heidelberg Pharma reports promising Ph2 results for HDP-101 (pamlectabart tismanitin) in relapsed or refractory multiple myeloma
Antibody, cancer, antibody-drug conjugate, multiple myeloma, BCMA target - Read more

UroGen reports 77.8% response rate for UGN-103 (mitomycin) in Ph3 trial for recurrent bladder cancer
Small molecule, cancer, intravesical therapy, non-muscle invasive bladder cancer, mitomycin - Read more

ProKidney presents Ph2 results for rilparencel autologous cell therapy in advanced chronic kidney disease with diabetes
Cell therapy, chronic kidney disease, autologous cell therapy, diabetic nephrology, kidney function preservation - Read more

Bayer's Kerendia (finerenone) shows Ph3 success in chronic kidney disease associated with type 1 diabetes
Small molecule, metabolic, mineralocorticoid receptor antagonist, chronic kidney disease, type 1 diabetes - Read more

Viking Therapeutics presents Ph2 data showing VK2735 dual GLP-1/GIP agonist improves prediabetes and metabolic syndrome
Small molecule, metabolic, dual agonist, obesity, GLP-1 receptor, prediabetes - Read more

Vera Therapeutics' atacicept shows positive Ph3 results for IgA nephropathy with 42% proteinuria reduction
Protein therapy, autoimmune, BAFF/APRIL inhibitor, IgA nephropathy, proteinuria - Read more

Noema Pharma reports positive Ph2a results for cendifensine in menopausal vasomotor symptoms including hot flashes
Small molecule, women's health, monoamine modulator, menopause, vasomotor symptoms - Read more

THE GOOD
Company Launches

Renasant Bio launches with $54.5M seed funding to develop ADPKD small molecule treatments
Small molecule, rare disease, strategic, major transaction - Read more

Accipiter Biosciences launches with $12.7M Seed, developing de novo protein therapies for complex diseases
Protein design, de novo biologics, immunology, oncology, platform technology, preclinical - Read more

THE GOOD
Earnings & Finances

AstraZeneca CEO says Trump drug pricing deal won't impact $80B 2030 revenue target
Antibody-drug conjugate, oncology, strategic, revenue impact - Read more

AstraZeneca quarterly revenue surpasses $15B milestone, boosting confidence in $80B 2030 target
Oncology, financial, revenue impact, strategic - Read more

THE GOOD
Fundraises

Forbion closes €200M ($229.9M) BioEconomy Fund I, investing in sustainable biotechnologies
Venture capital, biotechnology, sustainability, platform technology - Read more

arcoris bio raises $6.3M Seed, biomarker detection platform for digital pathology
Biomarker discovery, in vitro diagnostics, platform technology, research tools - Read more

Halozyme raises $1.3B convertible notes, biotech platform enabling drug delivery
Platform technology, enzyme delivery, clinical-stage - Read more

Benitec Biopharma raises $100M public offering, gene therapy development via ddRNAi platform
Gene therapy, ddRNAi platform, clinical-stage, platform technology - Read more

THE GOOD
Investments

Cencora allocates $1B over five years to expand US drug distribution with new facilities
Drug distribution, operational, major transaction, supply chain - Read more

THE GOOD
Mergers & Acquisitions

Axsome acquires AstraZeneca epilepsy candidate AXS-17 through Baergic Bio acquisition (Avenue Therapeutics subsidiary), up to $83M potential
Acquisition, neurological, small molecule, milestone payments - Read more

AstraZeneca acquires obesity startup SixPeaks Bio for $170M, targeting muscle-preserving weight loss drugs
Small molecule, obesity, strategic, major transaction - Read more

Novo Nordisk raises Metsera bid again after Pfizer matches $10B offer in obesity drug acquisition battle
Small molecule, obesity, strategic, major transaction - Read more

THE GOOD
Politics & Policy

Eli Lilly, Novo Nordisk strike White House deal offering GLP-1 drugs at $350 monthly via TrumpRx platform
GLP-1 agonist, metabolic disease, strategic, major transaction - Read more

China lifts export ban on Illumina effective November 10 amid US-China trade truce
Diagnostics, strategic, operational, regulatory - Read more

THE GOOD
Regulatory

FDA awards priority review vouchers to Novo Nordisk's Wegovy, Vertex Pharmaceuticals' Casgevy, four other approved drugs
Gene therapy, rare disease, regulatory, strategic, competitive - Read more

THE BAD
Clinical Trials

UroGen returns Agenus anti-CTLA-4 drug zalifrelimab after disappointing phase 1 bladder cancer data
Licensing deal, oncology, antibody, milestone payments - Read more

Moderna's Ph3 norovirus vaccine (mRNA-1403) trial extends to 2025-2026 season after insufficient case accrual
Vaccine, infectious disease, mRNA vaccine, norovirus, phase 3 trial - Read more

AstraZeneca discontinues AZD2693 antisense oligonucleotide for metabolic dysfunction-associated steatohepatitis after disappointing Ph2 results
Antisense oligonucleotide, metabolic, MASH, antibody-drug conjugate, acute myeloid leukemia, KRAS inhibitor - Read more

THE BAD
Earnings & Finances

Moderna reports 45% revenue decline, cuts 2025 forecast but shares rise on cost-cutting progress
mRNA vaccine, infectious disease, cost reduction, operational - Read more

THE BAD
Lawsuits

Healthcare groups sue to nullify RFK's reconstituted vaccine advisory panel recommendations
Vaccine, infectious disease, regulatory, operational - Read more

THE BAD
Lawsuits

Bavarian Nordic's $38.61 per share private equity buyout fails with only 60% shareholder support
Vaccine, infectious disease, strategic, major transaction - Read more

THE BAD
Regulatory

FDA cancer chief Pazdur declines CDER director role after Tidmarsh's sudden resignation
Oncology, regulatory, operational, strategic - Read more

THE BAD
Strategic Plans

Cullinan Therapeutics discontinues two oncology programs CLN-619 and CLN-617 amid autoimmune pivot strategy
Monoclonal antibody, oncology, strategic, cost reduction - Read more

THE UGLY
No Ugly News Today!

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