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The Good News

THE GOOD
Approvals & Labels

FDA approves Otsuka's Simtriyo (centanafadine), first norepinephrine-dopamine-serotonin reuptake inhibitor for attention-deficit hyperactivity disorder
Small molecule, neurological, ADHD, norepinephrine dopamine serotonin reuptake inhibitor, non-stimulant therapy - Read more

Minoryx Therapeutics, Neuraxpharm Group's Nezglyal (leriglitazone) receives positive CHMP opinion for cerebral adrenoleukodystrophy following Ph2/3 results
Small molecule, neurological, PPAR-gamma agonist, cerebral adrenoleukodystrophy, pediatric, rare disease - Read more

Outlook Therapeutics wins FDA approval for Lytenava (bevacizumab-vikg) targeting wet age-related macular degeneration
Antibody, ophthalmology, monoclonal antibody, wet age-related macular degeneration, anti-VEGF, bevacizumab - Read more

MannKind Corporation's Furoscix ReadyFlow (furosemide) wins FDA approval for edema in heart failure or chronic kidney disease
Small molecule, cardiovascular, diuretic, heart failure, chronic kidney disease, edema - Read more

FDA approves Kenvue's Tylenol with Naproxen (acetaminophen/naproxen sodium) fixed-dose combination for over-the-counter pain relief
Small molecule, pain, combination therapy, acetaminophen, NSAID, over-the-counter - Read more

Gilead Sciences' Trodelvy plus Keytruda receives CHMP positive opinion for first-line PD-L1-positive metastatic TNBC
Antibody-drug conjugate, oncology, regulatory, competitive - Read more

NewAmsterdam Pharma, Menarini Group receive positive CHMP opinion for obicetrapib cholesterol-lowering therapies in Europe
Small molecule, cardiovascular, regulatory, strategic - Read more

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More Good News

THE GOOD
Business Development & Partnerships

Idorsia, Jamjoom Pharmaceuticals partner to commercialize QUVIVIQ for insomnia in Saudi Arabia and the Levant
Commercialization, small molecule, neurological, royalties, licensing deal - Read more

Almirall, Certest Biotec collaborate to discover and develop novel rare dermatology treatments using mRNA and LNP platform
Research collaboration, licensing deal, rare disease, dermatology, mRNA, lipid nanoparticle platform - Read more

Pfizer Japan, Eisai enter co-promotion agreement for Nartique migraine treatment in Japan
Co-promotion agreement, neurology, small molecule, commercialization - Read more

THE GOOD
Clinical Trials

AstraZeneca's (sonesitatug vedotin) meets Ph3 overall survival endpoint in Claudin 18.2-positive advanced gastric cancer
Antibody-drug conjugate, cancer, gastric cancer, Claudin 18.2, ADC - Read more

Faron Pharmaceuticals' bexmarilimab (anti-Clever-1) shows encouraging Ph1/2 overall survival data in higher-risk myelodysplastic syndrome
Antibody, cancer, monoclonal antibody, myelodysplastic syndrome, anti-Clever-1, combination therapy - Read more

THE GOOD
Earnings & Finances

AstraZeneca reaffirms $80B revenue target despite eplontersen trial failure and mixed pipeline results
Antisense oligonucleotide, cardiovascular, oncology, financial - Read more

THE GOOD
Investments

Novogene Europe expands single-cell RNA sequencing capability at Cambridge Omics Centre for UK researchers
Single-cell sequencing, oncology, immunology, neuroscience, operational - Read more

THE GOOD
Mergers & Acquisitions

Argenx acquires Forte Biosciences for $2.2B, gaining phase 2-stage vitiligo and celiac disease drug FB102
Monoclonal antibody, autoimmune, major transaction, strategic - Read more

THE GOOD
Product Launches

Labcorp launches DTC Genetic Health Panel analyzing 163 genes to assess risk for 100+ hereditary conditions
Genetic testing, multi-disease, direct-to-consumer, operational - Read more

Biointron launches RushData, an AI-driven antibody discovery platform featuring 1-day CHO expression technology
Monoclonal antibody, AI-driven discovery, operational, competitive - Read more

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The Bad News

THE BAD
Clinical Trials

Kite Pharma's Yescarta (axi-cel) Ph3 analysis uncovers genetic risk signatures for CAR-T toxicity in lymphoma patients
Cell therapy, cancer, CAR-T, lymphoma, cytokine release syndrome, STXBP2 - Read more

AstraZeneca discontinues Ph1/Ph2 tilatamig samrotecan (EGFR-cMET TOP1i ADC) and AZD4360 (CLDN18.2 TOP1i ADC) due to poor performance
Antibody-drug conjugate, cancer, EGFR, solid tumors, non-small cell lung cancer, pancreatic cancer - Read more

AstraZeneca's Ultomiris (ravulizumab) fails Ph3 primary endpoint in haematopoietic stem cell transplant-associated thrombotic microangiopathy
Antibody, rare disease, complement inhibitor, thrombotic microangiopathy, Ultomiris, ravulizumab - Read more

THE BAD
Layoffs

Amgen lays off 40 employees amid Tavneos regulatory scrutiny and pipeline setbacks
Small molecule, rare disease, operational, cost reduction - Read more

THE BAD
Regulatory

FDA advisory panel votes down emideltide, approves epitalon and semax for bulk compounding list
Peptide therapeutics, wellness/fitness, regulatory, competitive - Read more

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

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