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THE GOOD
Approvals & Labels

Celltrion's Steqeyma (targeting IL-12 and IL-23; ustekinumab biosimilar, Janssen) lands FDA approval
Monoclonal antibody, ulcerative colitis, Crohn's disease, psoriasis, and psoriatic arthritis - Read more

Eli Lilly's Kisunla (targeting amyloid plaque) lands Chinese NMPA approval for early symptomatic Alzheimer's disease with amyloid plaques
Monoclonal antibody, Alzheimer’s disease - Read more

Xcovery's Ensacove (ALK tyrosine kinase inhibitor) lands FDA approval for ALK-positive, locally advanced or metastatic non-small-cell lung cancer.
Small molecule, lung cancer - Read more

Mesoblast's Ryoncil, an allogeneic mesenchymal stromal cell therapy, receives FDA approval for pediatric steroid-refractory acute graft-versus-host disease
Cell therapy, graft-versus-host-disease, allogeneic mesenchymal stromal cell therapy - Read more

THE GOOD
Business Development

Theranexus sells TX01 (novel approved medicine formulation) commercial rights “across key regions” (including the EU, UK, LATAM, and the Middle East) to Exeltis (part of Insud Pharma)
Novel approved medicine formulation, Gaucher disease, Niemann-Pick type C disease - Read more

insitro lands $25M milestone payment from Bristol myers Squibb as part of ALS drug discovery pact
Small molecule, amyotrophic lateral sclerosis, drug discovery, AI, ML - Read more

Merck & Co. buys global license to a preclinical small molecule (GLP-1 receptor agonist) obesity hopeful from China's Hansoh Pharma in deal worth up to $2B
Small molecule, obesity - Read more

THE GOOD
Clinical Trials

Hansa Biopharma's imlifidase (IgG cleaving enzyme) delivers positive Ph2 results in Guillain-Barré Syndrome patients
Enzyme, Guillain-Barré Syndrome - Read more

Aurion Biotech touts positive Ph1/2 topline data of AURN001, an allogeneic cell therapy, in treating corneal edema secondary to corneal endothelial dysfunction.
Cell therapy, corneal edema secondary to corneal endothelial dysfunction, allogeneic cell therapy - Read more

Cognition Therapeutics' CT1812 (sigma-2 receptor antagonist) showed strong therapeutic responses in Ph2 Lewy body dementia study
Small molecule, dementia with Lewy bodies - Read more

Corvus Pharmaceuticals reports positive interim Ph1 data for soquelitinib (ITK inhibitor) for moderate to severe atopic dermatitis
Small molecule, atopic dermatitis, eczema - Read more

Holoclara doses first patient in Ph1 trial of “roundworm-derived” small molecule HC002 targeting eosinophilic esophagitis
Small molecule, eosinophilic esophagitis - Read more

Sensorion touts safety profile of SENS-501 gene therapy in first two dosed Ph1/2 congenital deafness from OTOF mutations trial patients
Gene therapy, congenital deafness - Read more

Verastem Oncology’s avutometinib (RAF/MEK clamp), sotorasib (KRAS inhibitor), and defactinib (FAK inhibitor) combination in Ph1/2 trial for KRAS G12C mutant non-small cell lung cancer shows favorable tolerability and encouraging anti-tumor activity
Small molecule, lung cancer - Read more

ALK reports positive interim results from Ph1/2 trial their of sublingual peanut allergy immunotherapy tablet, showing safety and tolerability
Peanut tablet, peanut allergy - Read more

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⬇️ More Good News ⬇️

THE GOOD
Fundraises

Soleno Therapeutics $200M debt financing, secures funding for DCCR drug development for Prader-Willi syndrome treatment
Small molecule, Prader-Willi syndrome - Read more

General Proximity $8M Seed round, developing a proximity therapeutics platform to identify drug candidates for undruggable targets
Drug discovery, software - Read more [Paywall]

SandboxAQ $300M funding round, develops AI applications for drug discovery, chemistry, and medical devices
Drug discovery, AI, software - Read more

SiteOne Therapeutics $100M Series C, develops ion channel modulators for non-opioid pain treatments
Small molecule, sensory hyperexcitability disorder, pain - Read more

Tessera Therapeutics $50M investment from Bill & Melinda Gates Foundation, targeting development of in vivo sickle cell disease “Gene writing” program
Gene writing, sickle cell disease, gene editing, genetic medicine - Read more

Generate: Biomedicines’ undisclosed investment from Samsung, AI-powered discovery and design of novel therapeutic proteins
Protein therapeutics, oncology, immunology, infectious disease, AI - Read more

THE GOOD
Investments

U.S. International Development Finance Corporation, the African Development Bank, and the International Finance Corporation provide $45M to VaxSen to boost African vaccine production capacity and support local distribution networks
Vaccine, manufacturing, infectious disease - Read more

ACG launches Thailand's largest capsule manufacturing plant, capable of producing 20 billion hard gelatin capsules annually in Rayong
Manufacturing, capsules - Read more

THE GOOD
Lawsuits

Novartis, AbbVie, PhRMa score win as federal judge blocks West Virginia law requiring drugmakers to expand 340B discounted drug distribution to an “unlimited number of pharmacies”
340B drug pricing - Read more

THE GOOD
Mergers & Acquisitions

Cara Therapeutics and Tvardi Therapeutics announce all-stock merger, focusing on small molecules in treating fibrosis-driven diseases
Small molecule, fibrosis-driven disease, hepatocellular carcinoma, cancer - Read more

THE GOOD
Partnerships

BioAge Labs, Novartis, age-related disease drug discovery and research partnership using human longevity data and exercise insights
Small molecule, age-related disease, drug discovery, research - Read more

Novo Nordisk, Photys Therapeutics, partner to develop noval small molecule therapies for cardiometabolic diseases
Small molecule, cardiometabolic disease - Read more

Inceptor Bio, GRIT Bio, partner to develop IB-T101 CAR-T therapy targeting solid tumors using OUTLAST platform
Cell therapy, solid tumor, cancer, CAR-T - Read more

Guardant Health, Boehringer Ingelheim, partnering to develop liquid biopsy companion diagnostic for lung cancer drug zongertinib (HER2 tyrosine kinase inhibitor)
Companion diagnostic, liquid biopsy, lung cancer, blood test - Read more

THE GOOD
Product Launches

Dexcom launches AI-powered lifestyle advice feature for Stelo glucose sensor users
Medical device, diabetes - Read more

THE GOOD
Research

Neural stem cell transplants show promise in treating chronic spinal cord injuries, with improvements in motor function and pain demonstrated in academic Ph1 trial
Cell therapy, spinal cord injury, neural stem cell transplant - Read more

CDC and Moderna's experimental mRNA vaccine prevents death from avian flu strain; ferret strudy
mRNA vaccine, avian flu, bird flu, infectious disease - Read more

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THE BAD
Clinical Trials

CorestemChemon's ALS hopeful Neuronata-R fails to meet primary endpoint in Ph3 trial
Cell therapy, amyotrophic lateral sclerosis, mesenchymal stem cell therapy - Read more [Press release in Korean]

THE BAD
Earnings & Finances

AstraZeneca faces declining Chinese sales as hospitals, doctors avoid their drugs amid employee investigations, favoring local alternatives instead
Big pharma, public trust - Read more

THE BAD
Layoffs

Ring Therapeutics cuts nearly 50% of staff
Gene therapy, drug delivery, cancer, eye disease - Read more

THE BAD
Politics & Policy

US healthcare spending rose 7.5% to $4.9 trillion in 2023, representing 17.6% of US economy, per CMS report
Healthcare spending, healthcare costs, drug pricing - Read more

THE UGLY
Adverse Events

FDA adds black-box warning to Astellas' menopause drug Veozah (neurokinin 3 receptor antagonist) due to potential liver damage risks
Small molecule, menopause, liver damage - Read more

THE UGLY
Public Health

CDC confirms first severe H5N1 bird flu case in Louisiana resident who had contact with infected backyard birds
Bird flu, avian flu, H5N1, infectious disease - Read more [Paywall]

THE UGLY
Warnings Letters, Form 483s

FDA warns four companies for illegally selling and marketing unauthorized GLP-1 weight-loss drug
GLP-1, obesity, compounding, unauthorized sale - Read more

THE UGLY
Withdrawals & Recalls

Indian drugmakers Aurobindo, Glenmark, and Zydus all separately announce recalls related to various issues across multiple products (including impurities and labeling issues)
Small molecule, impurity, mislabelling - Read more

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