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THE GOOD
Approvals & Labels

AVEROA receives UK MHRA approval for XOANACYL (ferric citrate) targeting iron deficiency and elevated phosphorus in chronic kidney disease
Small molecule, metabolic, chronic kidney disease, iron deficiency, phosphate binder, ferric citrate - Read more

Meitheal Pharmaceuticals receives FDA approval for CONTEPO (fosfomycin) targeting complicated urinary tract infections including acute pyelonephritis
Small molecule, infectious disease, antibiotic, complicated urinary tract infections, fosfomycin, antimicrobial resistance - Read more

Compass Pathways accelerates COMP360 commercial timeline for treatment-resistant depression following positive FDA meeting
Small molecule, neurological, psilocybin, treatment-resistant depression, psychedelic therapy - Read more [Paywall]

THE GOOD
Business Development & Partnerships

Prelude Therapeutics, Incyte option agreement on JAK2V617F inhibitors, $60M upfront, $910M potential
Exclusive option agreement, oncology, small molecule, milestone payments, equity investment - Read more

Blackstone Life Sciences signs royalty deal with Merck & Co., pays $700M upfront in exchange for portion of sacituzumab tirumotecan future sales
Royalty investment, oncology, antibody-drug conjugate, milestone payments - Read more

Boehringer Ingelheim, CDR-Life expand partnership with immune reset candidate CDR111 license for $570M
Licensing deal, autoimmune, antibody, milestone payments - Read more

AmacaThera, Pacira sign exclusive licensing agreement for AMT-143 anaesthetic, $5M upfront, $230M total
Licensing deal, pain management, small molecule, milestone payments - Read more

Basilea receives $30M milestone payment from Pfizer for strong Cresemba antifungal sales in Europe
Small molecule, infectious disease, financial, milestone payment - Read more

Merck & Co. assumes full rights for MK-8690 program from Dr. Falk Pharma $150M upfront + undisclosed biobucks
Licensing deal, monoclonal antibody, autoimmune, milestone payments - Read more

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✅ More Good News ✅

THE GOOD
Clinical Trials

Santhera reports positive long-term Ph4 data for AGAMREE (vamorolone) in Duchenne muscular dystrophy patients
Small molecule, neurological, Duchenne muscular dystrophy, vamorolone, corticosteroid alternative - Read more

Spinogenix reports positive Ph2a results for SPG302 in amyotrophic lateral sclerosis showing slower functional decline
Small molecule, neurological, amyotrophic lateral sclerosis, synapse restoration, regenerative therapy - Read more

Hengrui Pharma, Kailera Therapeutics report positive Ph3 data for HRS9531 dual GLP-1/GIP agonist in obesity treatment
Protein therapy, metabolic, dual GLP-1/GIP receptor agonist, obesity, weight management - Read more

THE GOOD
Company Launches

CRISPR pioneer Jennifer Doudna co-founds Azalea Therapeutics, launching with $82M to develop in vivo CAR-T therapies using genome editing delivery technology
CAR-T, oncology, strategic, major transaction - Read more

Neok Bio debuts with $75M Series A to advance bispecific antibody-drug conjugates targeting dual cancer markers
Antibody-drug conjugate, oncology, strategic, major transaction - Read more

THE GOOD
Mergers & Acquisitions

Novo Nordisk raises Metsera buyout bid to $10B, beating Pfizer's revised $8.1B offer
Biotech acquisition, strategic, major transaction, competitive, financial - Read more

THE GOOD
Politics & Policy

Eli Lilly, Novo Nordisk negotiate $149 monthly obesity drug pricing with Trump administration for federal coverage
GLP-1 agonist, obesity, strategic, major transaction, cost reduction - Read more

THE BAD
Approvals & Labels

FDA rejects Alvotech, Teva’s Simponi biosimilar application due to Iceland manufacturing plant inspection deficiencies
Monoclonal antibody, autoimmune, regulatory, operational, financial - Read more

THE BAD
Clinical Trials

Harmony halts ZYN002 (cannabidiol) gel development for 22q11.2 deletion syndrome following Ph3 fragile X syndrome failure
Small molecule, neurological, cannabidiol, Fragile X syndrome, 22q11.2 deletion syndrome, genetic disorders - Read more

THE BAD
Company Shutdown

Arena BioWorks shuts down after 2 years, cites adverse biotech conditions despite $500M backing
Cell therapy, oncology, operational, major transaction - Read more

THE BAD
Earnings & Finances

Pfizer's Prevnar, Abrysvo, Comirnaty vaccines decline in Q3 amid challenging US immunization market
Vaccine, infectious disease, financial, revenue impact - Read more

Vertex shares drop 4% as new pain drug Journavx misses estimates despite CF growth
Gene therapy, rare disease, financial, operational - Read more

THE BAD
Strategic Plans

Pfizer cuts 11 pipeline programs including Seagen assets, BioNTech vaccine, and MASH treatments
Bispecific antibody, oncology, strategic, cost reduction, operational - Read more

Nuvation cancels head-to-head brain cancer drug trial against Servier's Voranigo following FDA discussions
Small molecule, oncology, strategic, regulatory - Read more

THE UGLY
Regulatory

Teva recalls 500,000+ blood pressure drug bottles over potential cancer-causing impurity levels
Small molecule, cardiovascular, operational, regulatory - Read more

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

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