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(Sorry for the late edition today - rolling in slow from the Long Weekend!)

THE GOOD
Approvals & Labels

Sanofi and Regeneron's Dupixent (dupilumab) approved by FDA for chronic spontaneous urticaria in patients 12+ unresponsive to antihistamines after Ph3 trials
Monoclonal antibody, chronic spontaneous urticaria - Read more

FDA approves reduced monitoring for Bristol Myers Squibb's Camzyos (mavacamten), a cardiac myosin inhibitor for symptomatic obstructive hypertrophic cardiomyopathy, expanding patient eligibility
Small molecule, hypertrophic cardiomyopathy - Read more

Akeso's Eiroqi (ebdarokimab), an IL-12/IL-23 monoclonal antibody, approved by NMPA for moderate to severe plaque psoriasis in adults
Monoclonal antibody, plaque psoriasis - Read more

Medtronic receives FDA approval for pairing Simplera Sync continuous glucose monitor with MiniMed 780G insulin pump for diabetes management.
Medical countermeasures, diabetes, insulin, insulin pump, insulin delivery - Read more

Novo Nordisk submitted oral semaglutide to FDA for obesity approval following successful Ph3 trial showing 15% weight loss after 64 weeks
GLP-1, drug approval process, obesity, oral formulation - Read more

THE GOOD
Business Development

VelaVigo licenses bispecific antibody VBS-102 to Ollin for $440M, retaining Greater China rights
Bispecific antibody, undisclosed indications - Read more

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✅ More Good News ✅

THE GOOD
Clinical Trials

Ferring presests Ph3 trial data showing ADSTILADRIN (nadofaragene firadenovec-vncg) effective for high-risk bladder cancer with 75% complete response in Japanese patients
Gene therapy, bladder cancer, adenovirus - Read more

Gilead's Trodelvy (Trop-2 ADC) plus Merck & Co.'s Keytruda improved progression-free survival in Ph3 trial for newly diagnosed triple-negative breast cancer patients
Antibody-drug conjugate (ADC), monoclonal antibody, breast cancer - Read more

AstraZeneca and Daiichi Sankyo's Enhertu (trastuzumab deruxtecan) plus Roche's Perjeta (pertuzumab) shows PFS benefits in Ph3 trial for HER2-positive metastatic breast cancer
Antibody-drug conjugate (ADC), monoclonal antibody, breast cancer - Read more

HuidaGene tests first CRISPR therapy in brain for MECP2 duplication syndrome and Duchenne muscular dystrophy, showing promising early results
CRISPR, gene-editing, MECP2 du­pli­ca­tion syn­drome - Read more

THE GOOD
Company Launches

Alis Biosciences launches fund to unlock trapped capital from public biotech companies with depressed valuations
Venture capital, public markets, trapped capital - Read more

THE GOOD
Fundraises

Aptevo Therapeutics $2.0M registered direct offering, developing bispecific immunotherapies for cancer treatment with proceeds for clinical development.
Bispecific antibody, cancer, myeloid leukemia, solid tumor - Read more

Invivyd $30M loan facility with Silicon Valley Bank for developing VYD2311, a monoclonal antibody for COVID-19 protection
Monoclonal antibody, COVID-19 - Read more

PhotoPharmics $6M Series B extension, pioneering light-based neurodegenerative disease therapies including Parkinson's.
Photodynamic therapy, Parkinson's disease, neurodegenerative disease - Read more

THE GOOD
Investments

EuBiologics leads Korea's $356 million government project to develop domestic mRNA vaccines for future pandemics.
Public-private partnership, mRNA, domestic manufacturing, COVID-19, pandemic preparedness - Read more

THE GOOD
Lawsuits

Alvogen appeals court ruling blocking its generic version of Bausch Health's IBS drug Xifaxan until at least 2028
Small molecule, antibiotic, generic, generic suit, infectious disease - Read more

THE GOOD
Mergers & Acquisitions

Voiant acquires Voxeleron to accelerate AI-driven ophthalmic image analysis for eye disease treatment innovation
AI, imaging, software - Read more

THE GOOD
Partnerships

Fibrolamellar Cancer Foundation, Dialectic Therapeutics, partnering to fund production of DT2216 drug for fibrolamellar cancer clinical trial
Small molecule, fibrolamellar, liver cancer, supply contract - Read more

Onco-Innovations, Dalton Pharma, partner for custom isotope synthesis of PNKP inhibitor technology advancing cancer treatment research
Radiopharm, isotope manufacturing, nanoparticle, colorectal cancer, manufacturing partnership - Read more

Ono Pharmaceutical, Jorna Therapeutics, partnership using AI-guided RNA editing platform for novel drug discovery and development
RNA Editing, protein, AI, drug discovery - Read more

DAAN Biotherapeutics, GC Cell, exclusive licensing of tumor antigen-specific antibody for CAR-T and CAR-NK cell therapies development
Cell therapy, CAR-T, CAR-NK (natural killer) cell, drug development, cancer, solid tumor - Read more

THE GOOD
Product Launches

CSL Behring launches ANDEMBRY, a once-monthly injectable anti-FXIIa monoclonal antibody for HAE attack prevention in Japan
Monoclonal antibody, hereditary angioedema - Read more

THE GOOD
Regulatory

FDA Commissioner Makary plans new pathway for rare disease drug approvals based on plausible mechanisms rather than randomized trials.
Rare disease, drug approval process, regulatory guidance - Read more

THE GOOD
Research

Study shows AI chatbot Therabot effectively reduced depression, anxiety, and eating disorder symptoms, with high patient engagement.
Read more

THE BAD
Approvals & Labels

FDA issues complete response letter for Regeneron's Eylea HD (aflibercept, targeting VEGF), rejecting extended dosing intervals beyond 16 weeks
Fusion protein, wet age-related macular degeneration (wet AMD), macular edema following retinal vein occlusion, diabetic macular edema, diabetic retinopathy, drug formulation, long-acting formulation - Read more

THE BAD
Lawsuits

ToolGen sues Vertex in UK for patent infringement, claiming its CRISPR RNP technology was used in Vertex's gene therapy CASGEVY
Gene therapy, patent suit, CRISPR, sickle cell disease, beta thalassemia - Read more

THE BAD
Layoffs

Tempest Therapeutics lays off 80% of staff following strategic alternatives announcement, retaining key employees as consultants
Small molecule, cancer - Read more

THE BAD
Politics & Policy

NIH ends funding for Pluri Biotech's radiation exposure cell therapy PLX-R18, citing possible budget cuts after years of support
Cell therapy, acute radiation syndrome, placental stromal cells, federal research funding - Read more

THE UGLY
Politics & Policy

FDA layoffs gut user fee negotiation teams, disrupting critical staff and functions necessary for industry-regulator partnerships
Drug user fee program, drug approval process - Read more

White House website Covid.gov now promotes lab leak theory, replacing health guidance with Trump imagery and conspiracy claims.
COVID-19, lab leak theory - Read more [Paywall]

NIH reportedly halts awarding new grants to elite universities amid Trump administration's funding freeze, impacting at least six institutions
Federal funding, federal research funding, National Institute of Health (NIH) - Read more [Paywall]

NIH bans grants to universities with DEI programs or Israel boycotts, threatening to revoke funding
Federal funding, federal research funding, National Institute of Health (NIH), DEI - Read more [Paywall]

Post-Brexit red tape and costs prevent NHS cancer patients from accessing life-saving drugs and trials, leaked report finds
Brexit, drug access, healthcare access, cancer - Read more

THE UGLY
Withdrawals & Recalls

Amneal recalls ropivacaine anesthetic due to potential plastic fiber contamination that could cause serious side effects.
Small molecule, contaminant, injectables - Read more

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

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