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THE GOOD
Business Development & Partnerships

Pi Health partners with Filamon to conduct Phase 1/2 trial of anti-inflammatory cancer drug kesonotide in Australia
Clinical trial services, oncology, anti-inflammatory, AI/ML, CRO partnership - Read more

Alchem Laboratories, Applied Pharmaceutical Innovation partner to strengthen antimicrobial supply chains and advance essential medicines production
Strategic alliance, antimicrobial, manufacturing agreement, essential medicines, supply chain - Read more

Biocytogen, Merck KGaA partnership for antibody-conjugated LNP delivery systems; fees and royalties included
Licensing deal, antibody technology, drug delivery, R&D collaboration, nucleic acid therapeutics - Read more

Release Therapeutics, HUG/UNIGE: exclusive license for MVX-ONCO cancer immunotherapy with option to reacquire rights
Licensing deal, oncology, cell therapy, immunotherapy, R&D - Read more

Oxford and EIT partner on £118M ($158.6M) AI-driven vaccine research program targeting antibiotic-resistant infections
Research collaboration, infectious disease, AI/ML, vaccine development, antimicrobial resistance - Read more

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✅ More Good News ✅

THE GOOD
Clinical Trials

AlzeCure's Ph2 trial shows TRPV1 antagonist ACD440 reduces neuropathic pain by 50% with proof-of-mechanism
Small molecule, neurological, TRPV1 antagonist, neuropathic pain, topical therapy, erythromelalgia - Read more

Nebraska Medicine initiates first-in-human Ph1 trial of allogeneic CAR T-cells targeting CD19 for multiple sclerosis
Cell therapy, autoimmune, CAR-T, multiple sclerosis, allogeneic, CD19 target - Read more

MindMed publishes positive Ph2b data for LSD therapy in generalized anxiety disorder, advances to Ph3
Small molecule, neurological, psychedelic medicine, generalized anxiety disorder, depression, LSD - Read more [Paywall]

Immunovant's batoclimab shows six-month remission in Ph2 Graves' disease trial targeting FcRn pathway
Antibody, autoimmune, monoclonal antibody, Graves' disease, FcRn inhibitor, thyroid - Read more

AL-S Pharma's AP-101 targeting SOD1 shows positive Ph2 results for amyotrophic lateral sclerosis treatment
Antibody, neurological, monoclonal antibody, amyotrophic lateral sclerosis, SOD1 target, disease-modifying - Read more

Ashvattha's Ph2 migaldendranib shows 80% reduction in anti-VEGF injections for diabetic macular edema and age-related macular degeneration
Small molecule, metabolic, ophthalmology, diabetic macular edema, age-related macular degeneration, VEGF inhibitor - Read more

CAGE Bio's CGB-500 meets primary endpoints in Ph2b trial for atopic dermatitis with favorable safety profile
Small molecule, dermatological, ionic liquid-based therapy, atopic dermatitis, skin disease, immune-mediated - Read more

THE GOOD
Fundraises

Enveda Biosciences raises $150M Series D for immune and obesity drug discovery
Drug discovery, atopic dermatitis, AI-driven, platform-enabled, immunology, obesity - Read more

Atlas Venture raises $400M Opportunity Fund, supporting existing biotech startups amid funding challenges
Venture capital, biotech investment, portfolio funding, early-stage investing, drug development - Read more

Ketryx raises $39M Series B for AI-powered compliance platform in life sciences
AI/ML platform, compliance platform, life sciences, software platform, regulatory technology - Read more

Revalia Bio raises $14.5M seed funding, testing therapies on revived human organs
Drug development, platform technology, services, CRO, preclinical, human organ testing - Read more

MRM Health raises $64M Series B to advance microbiome therapeutics for inflammatory diseases
Microbiome, inflammatory disease, clinical-stage, IBD, immune-oncology - Read more

Mercy BioAnalytics raises $59M Series B for early cancer detection liquid biopsy platform
Cancer, liquid biopsy, diagnostics, early detection, platform technology, ovarian cancer - Read more

Sunflower Therapeutics receives $2.36M SBIR grant, developing automated protein manufacturing platform
Protein manufacturing, platform technology, services, CDMO, bioprocessing - Read more

Lactiga wins NIH grant for breastmilk-derived antibody development targeting inflammatory bowel disease
Autoimmune, antibody, inflammatory bowel disease, mucosal immunity, platform technology, preclinical - Read more

Rapafusyn Pharmaceuticals raises $44M Series A, advancing non-degrading molecular glue therapeutics platform
Platform technology, molecular glue, small molecule, drug discovery, non-degrading, preclinical - Read more

THE GOOD
Lawsuits

Judge orders Trump administration to restore Harvard's $2.2 billion research funding after illegal freeze
Research funding, multiple diseases, regulatory, legal, operational - Read more

THE GOOD
Marketing

ImmunoPrecise rebrands as MindWalk to highlight AI focus after $12M subsidiary sale
AI drug discovery, artificial intelligence, strategic, operational, rebranding - Read more

THE GOOD
Product Launches

Illumina launches Protein Prep assay measuring 9,500 proteins to enhance drug discovery and diagnostics
Proteomics, diagnostic tool, strategic, technology platform - Read more

Quest Diagnostics launches pharmacogenomic testing service to guide personalized medication decisions across multiple specialties
Pharmacogenomic testing, precision medicine, diagnostic services, strategic, healthcare technology - Read more

THE GOOD
Regulatory

FDA establishes new pathway for ultra-rare disease drugs, accepting single-arm trials as sufficient evidence
Rare disease, regulatory, strategic, operational - Read more

FDA releases (heavily redacted) CRLs in transparency effort, “promptly after they are issued to sponsors”
Psychedelic therapy, PTSD, regulatory, drug rejection, gene therapy, rare disease - Read more

THE BAD
Approvals & Labels

FDA delays Agios Pharmaceuticals' Pyrukynd thalassemia approval decision to December amid liver safety concerns, sending shares down 16%
Small molecule, rare disease, regulatory, operational - Read more

THE BAD
Clinical Trials

Sanofi's anti-OX40L antibody amlitelimab meets Ph3 endpoints in atopic dermatitis but falls short of Dupixent efficacy
Antibody, autoimmune, monoclonal antibody, atopic dermatitis, OX40L target, dermatology - Read more

THE BAD
Layoffs

AC Immune lays off 30% of staff, extends cash runway to 2027 while focusing on clinical Alzheimer's programs
Active immunotherapy, neurological, cost reduction, strategic, operational - Read more

THE BAD
Regulatory

FDA's Vinay Prasad requires controlled trials for vaccine co-administration claims, affecting Pfizer and other manufacturers
mRNA vaccine, infectious disease, regulatory, operational - Read more

THE UGLY
Politics & Policy

RFK Jr. faces Senate criticism over CDC vaccine committee shake-up and anti-pharma rhetoric
mRNA vaccines, infectious disease, misinformation, regulatory, public health - Read more

Medical and public health organizations demand RFK Jr.'s resignation amid CDC turmoil and staffing exodus
Public health policy, government leadership, regulatory, organizational, institutional crisis - Read more

Kennedy expands CDC's vaccine advisory committee with seven new members amid controversy
mRNA vaccine, infectious disease, regulatory, operational - Read more

THE UGLY
Regulatory

Amneal Pharmaceuticals receives FDA warning letter for failing to fix particulate contamination issues in antibacterial drugs
Generic antibacterial, manufacturing quality, regulatory warning, operational - Read more

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

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