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THE GOOD
Approvals & Labels

Novo Nordisk's oral Wegovy (semaglutide), a GLP-1 receptor agonist for weight management in obesity, awaits FDA approval by Q4 based on Ph3 trial results
GLP-1, obesity, oral formulation, drug approval process - Read more

Element Science's Jewel wearable cardioverter defibrillator system receives FDA approval for patients with elevated risk of sudden cardiac arrest
Medical device, wearable device, defibrillator - Read more

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THE GOOD
Clinical Trials

Topas Therapeutics reports promising results from Ph1 trial of nanoparticle tolerance induction therapy for celiac disease
Peptide, nanoparticle, celiac disease - Read more

Unity Bio's UBX1325 (targeting Bcl-xL) shows non-inferiority to aflibercept at 36 weeks in Ph2b ASPIRE trial for diabetic macular edema, potentially offering alternative to anti-VEGF therapy
Small molecule, diabetic macular edema - Read more

Sylentis reports positive Ph2a trial results for SYL1801 (NRARP receptor inhibitor), an siRNA eye drop therapy for neovascular Age-Related Macular Degeneration, showing improved visual acuity
siRNA, Age-Related Macular Degeneration (AMD) - Read more

Immutep's eftilagimod alfa (MHC class II agonist) with Keytruda shows 17.6-month survival in Ph2b trial for head and neck cancer patients with low PD-L1 expression
Fusion protein, monoclonal antibody, head & neck cancer - Read more

Johnson & Johnson's Tremfya (guselkumab), an IL-23 inhibitor, shows strong Ph3 results for ulcerative colitis with fully subcutaneous dosing option
Monoclonal antibody, ulcerative colitis, drug formulation - Read more

EsoBiotec to present preclinical data on ENaBL-T vector for in-vivo CAR-T therapies targeting BCMA in multiple myeloma
Cell therapy, CAR-T, in-vivo cell therapy, nanobody, lentiviral vector (LVV) - Read more

Genocury Biotech's in vivo CD19 CAR-T therapy achieved complete remission in relapsed/refractory diffuse large B-cell lymphoma without lymphodepletion
Cell therapy, B cell lymphoma, cancer, CAR-T, in-vivo cell therapy - Read more

Aldeyra Therapeutics' reproxalap (0.25% ophthalmic solution) meets primary endpoint in Ph3 trial for dry eye disease, demonstrating superior symptom relief versus vehicle
Small molecule, dry eye disease - Read more

THE GOOD
Fundraises

Deerfield Management raises $600M Healthcare Innovations Fund to invest in therapeutics, care delivery technologies, and AI
Venture capital, machine learning, AI, biotech investing, healthcare investing - Read more

Inventiva receives €116M ($132M) second tranche of structured financing for MASH drug development
Small molecule, metabolic dysfunction-associated steatohepatitis (MASH) - Read more

AMPLY Discovery $1.75M Seed, UK-based AI drug discovery startup advancing gene-silencing therapies
Drug discovery, AI, cancer - Read more

Dawn Health raises €11.5M ($13M), develops medical software and digital therapeutics to support patient care
Virtual healthcare - Read more

HistoIndex raises SGD9M ($7.0M), expanding operations and R&D for stain-free tissue imaging solutions with AI-based fibrosis analysis
Imaging, fibrosis-driven disease - Read more

THE GOOD
Investments

European Commission pledges €500M ($568M) in research funding to attract scientists amid US funding cuts under Trump administration
Biotech ecosystem, public-private partnership, federal funding, federal research funding - Read more

THE GOOD
Lawsuits

States' attorneys general sue over HHS restructuring, claiming cuts to staff and programs harm public health
US Department of Health & Human Services (HHS), federal funding, public funding, public funding suit - Read more

THE GOOD
Mergers & Acquisitions

CellBio Scientific acquires BioChain, enhancing its capabilities in providing human-relevant cellular models for drug discovery and research
Biospecimen management, cell culturing, equipment/instrumentation - Read more

THE GOOD
Patient Access

Telethon Foundation charity takes ownership of Europe-approved ultra-rare disease gene therapy amid industry financial struggles
Gene therapy, adenosine deaminase-deficient severe combined immunodeficiency, non-profit - Read more [Paywall]

THE GOOD
Product Launches

Iambic Therapeutics upgrades Enchant AI platform to better predict clinical success of early-stage drugs with limited data
Drug development, AI, drug design - Read more

THE GOOD
Research

Molecular profiling helps 46% of endometrial cancer patients avoid unnecessary radiotherapy while ensuring targeted care for high-risk cases
Personalized medicine, endometrial cancer, radiotherapy, molecular profiling - Read more

Man who injected himself with venom 856 times helps scientists develop broad-spectrum antivenom effective against 19 deadly snake species
Antivenom, snake bite - Read more

THE GOOD
Strategic Plans

BioNTech prepares for 2025 cancer drug filing while diversifying supply chain beyond China-based manufacturing for HER2-targeted therapy BNT323
CDMO (Contract Development & Manufacturing Organization), supply chain, manufacturing partnership, antibody-drug conjugate (ADC), endometrial cancer, geopolitics - Read more

BioNTech expects no immediate impact on its COVID vaccine from RFK Jr.'s proposed changes to vaccine approval standards
Vaccine, COVID-19, drug approval process - Read more [Paywall]

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THE BAD
Approvals & Labels

ImmunityBio received FDA “refusal to file” letter for ANKTIVA plus BCG sBLA for non-muscle invasive bladder cancer with papillary disease, despite prior “unambiguous guidance“
Interleukin, bladder cancer - Read more

Capricor Therapeutics' shares fall 15% after FDA announces plans to convene expert panel review for deramiocel for Duchenne muscular dystrophy
Cell therapy, Duchenne muscular dystrophy (DMD), allogeneic cell therapy - Read more

THE BAD
Clinical Trials

Johnson & Johnson's gene therapy botaretigene sparoparvovec flops in Ph3 trial, missing primary endpoint in X-linked retinitis pigmentosa
Gene therapy, retinitis pigmentosa, adeno-associated virus (AAV) - Read more

PTC Therapeutics' oral Huntington's disease drug PTC518 (votoplam) reduced HTT protein in Ph2 PIVOT-HD trial, but showed lower efficacy than previously reported
Small molecule, Huntington's disease - Read more

THE BAD
Layoffs

Unity Biotechnology, once valued at $700 million, lays off all employees amid financial crisis and explores strategic alternatives
Small molecule, diabetic macular edema - Read more

Bristol Myers Squibb cutting 516 more jobs in Lawrenceville, NJ, bringing total layoffs to 806 this year
Big pharma layoffs - Read more

Mammoth Biosciences cuts 24 jobs during strategic restructuring, CEO confirms
CRISPR, gene-editing - Read more

THE BAD
Market Reports

US prescription drug spending grew 11.4% to $487 billion in 2024, driven by obesity and cancer medications
Drug Pricing, cancer, obesity - Read more

THE BAD
Politics & Policy

Scientists criticize NIH's $500 million investment in outdated whole killed virus technology for developing universal flu vaccine
National Institute of Health (NIH), influenza, vaccine, drug development, platform technology - Read more [Paywall]

THE BAD
Strategic Plans

Recursion Pharmaceuticals shelves three mid-stage drug programs to reduce costs and focus on areas of greatest impact
Small molecule, pipeline strategy, AI, Clostridioides difficile (C. diff) infection, cerebral cavernous malformation, neurofibromatosis type II - Read more

THE UGLY
Lawsuits

Johnson & Johnson moves to discredit expert witness in talc lawsuits after bankruptcy strategy failures
Talc, cancer - Read more

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

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