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THE GOOD
Approvals & Labels

FDA approves Exelixis' cabozantinib (tyrosine kinase inhibitor) for previously treated, unresectable neuroendocrine tumors in adults and children 12+
Small molecule, neuroendocrine tumor - Read more

Neurim Pharmaceuticals receives EC approval for Slenyto (prolonged-release melatonin) to treat insomnia in children with ADHD
Small molecule, insomnia, attention deficit hyperactivity disorder (ADHD), drug formulation - Read more

Merck & Co. scores EC approval for Capvaxive (21-valent pneumococcal conjugate vaccine) for adults, preventing invasive pneumococcal disease and pneumonia
Vaccine, pneumococcal disease, pneumonia - Read more

Newronika received CE Mark approval for AlphaDBS, a closed-loop deep brain stimulation device that automatically adjusts therapy for Parkinson's disease
Medical device, Parkinson's disease, deep-brain stimulation - Read more

THE GOOD
Business Development

Bayer in-licenses PRMT5 inhibitor from China's Puhe BioPharma to target MTAP-deleted tumors
Small molecule, cancer - Read more

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THE GOOD
Clinical Trials

Wave Life Sciences' WVE-N531 (exon-skipping oligonucleotide, targeting dystrophin) delivers promising Ph2 trial results in DMD
Antisense oligonucleotide, Duchenne muscular dystrophy (DMD) - Read more

Leap Therapeutics touts positive Ph2 restuls for sirexatamab (anti-DKK1), combined with bevacizumab (targeting VEGF-A) and chemotherapy for microsatellite stable colorectal cancer
Monoclonal antibody, colorectal cancer, combo therapy - Read more

Johnson & Johnson's Rybrevant (targeting EGFR, MET) and Lazcluze (targeting EGFR) combo shows 25% reduced death risk versus AstraZeneca's Tagrisso (targeting EFGR) in EGFR-mutated non-small-cell lung cancer Ph3 trial
Bispecific antibody, small molecule, lung cancer, combo therapy - Read more

Acrivon Therapeutics reports positive Ph2b interim data for prexasertib (CHK1/2 inhibitor) in endometrial cancer; simultaneously announced deprioritization of ovarian and bladder cancer ambitions due to “increased competition and a smaller market opportunity“
Small molecule, endometrial cancer - Read more

Genelux and Newsoara report positive Ph1b/2 data for Olvi-Vec oncolytic virus therapy in platinum-relapsed or refractory small cell lung cancer patients
Oncolytic virus, lung cancer - Read more

THE GOOD
Company Launches

Munich startup Differential Bio raises €2M to revolutionize biomanufacturing with AI-powered Virtual Scale-up Platform
Biomanufacturing, laboratory automation, automated manufacturing, AI - Read more

THE GOOD
Fundraises

Epicrispr Biotechnologies $68M Series B, developing epigenetic editing therapy for rare muscle disease
Gene-editing, CRISPR, facioscapulohumeral muscular dystrophy, Epigenetic editor- Read more

Humacyte $50M public offering, developing bioengineered human tissues for vascular trauma and other pipeline candidates
Acellular tissue-engineered vessel, vascular trauma - Read more

Tribune Therapeutics €37M ($39.9M) Seed and Series A, biotech developing anti-fibrotic therapies for diseases like IPF
Protein, fibrosis-driven disease, pulmonary fibrosis - Read more

Hubble Therapeutics $7.3M Series A, developing gene therapies for pediatric blindness, advancing HUB-101 to clinical trials
Gene therapy, Leber Congenital Amaurosis Type 16 , snowflake vitreoretinal degeneration, adeno-associated virus (AAV) - Read more

Supira Medical $120M Series E, developing next-gen percutaneous ventricular assist device for high-risk procedures
Medical device, cardiogenic shock, percutaneous ventricular assist device - Read more

Genelux $10.5M underwritten offering, developing immuno-oncology therapies with proceeds funding Olvi-Vec clinical development
Oncolytic virus, ovarian cancer, lung cancer - Read more

Tenon Medical $2.5M Registered Direct Offering, medical devices for sacroiliac joint disorders with proceeds for working capital
Medical device, sacroiliac join disorders - Read more

TCP Analytical (investment amount not disclosed), received investment from Audax Strategical Capital for M&A and growth initiatives in specialty chemicals, reagents, and consumables across industries including life sciences
Reagents - Read more

THE GOOD
Investments

Singota Solutions opens third European facility in Balerna, Switzerland, adding GDP compliant pharmaceutical storage and logistics services
CDMO (Contract Development & Manufacturing Organization), new facility, sterile manufacturing, supply chain - Read more

THE GOOD
Partnerships

Charles River Laboratories, Valo Health discover lupus drug candidate using AI-driven Logica platform, combining preclinical capabilities with computational analysis
Small molecule, drug discovery, AI, lupus erythematosus - Read more

THE GOOD
Research

NIH scientists develop eye drops with shortened PEDF protein that prevented vision loss in mice with retinitis pigmentosa
Protein, retinitis pigmentosa, eye drops - Read more

Study explores tick feeding mechanisms, suggesting potential mRNA vaccine to combat tick-transmitted Lyme disease
mRNA, Vaccine, Lyme disease - Read more [Paywall]

AI tool by Altis Labs outperforms conventional methods in predicting cancer survival, aiding drugmakers with better trial design
AI, data analysis, clinical trial design, breast cancer, colorectal cancer - Read more [Paywall]

THE GOOD
Strategic Plans

Actinium Pharmaceuticals holds investor event at Trump's Mar-a-Lago, joining health companies visiting the resort
Radiopharm, cancer, leukemia, lobbying - Read more [Paywall]

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THE BAD
Layoffs

ElevateBio cuts 17% of staff, refocusing on BaseCamp manufacturing and Life Edit gene editing technologies
Cell therapy, gene therapy, CDMO (Contract Development & Manufacturing Organization), cell therapy manufacturing, gene therapy manufacturing, gene-editing - Read more

THE BAD
Marketing

FDA calls out Taiho Oncology for misleading claims about Lytgobi (targeting FGFR) efficacy data on healthcare provider website
Drug marketing, drug marketing violations - Read more

THE BAD
Politics & Policy

CDC retracts $11.4 billion in pandemic funding as HHS shifts focus from COVID-19 to chronic diseases under Trump's health priorities
Centers for Disease Control and Prevention (CDC), COVID-19, pandemic preparedness, Research & Development, healthcare equity - Read more

THE BAD
Strategic Plans

Ascletis shifts focus from antiviral, oncology and liver programs to obesity, cutting funding for hepatitis, HIV and RSV treatments
Metabolic disease, GLP-1, obesity, hepatitis B, human immunodeficiency virus (HIV), respiratory syncytial virus (RSV) - Read more

ImmuneOnco stops development of CD47 bispecific and anti-CD24 antibody to focus resources on more promising candidates
Bispecific antibody, cancer, solid tumor - Read more

THE UGLY
Politics & Policy

Survey reveals 94% of pharma companies fear Trump's EU tariffs would increase costs and hinder drug development
Tariffs, drug pricing, drug access - Read more

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

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