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THE GOOD
Approvals & Labels

BeiGene's Tevimbra (PD-1 inhibitor) approved by FDA for first-line treatment of esophageal squamous cell carcinoma
Monoclonal antibody, esophageal cancer - Read more

AstraZeneca's Imfinzi (targeting PD-L1) with tremelimumab (targeting CTLA-4) approved in India for treating unresectable hepatocellular carcinoma, a liver cancer
Monoclonal antibody, hepatocellular cancer, commercialization - Read more

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THE GOOD
Business Development

Avecho Biotechnology out-licenses CBD insomnia treatment Australian rights to Sandoz for $3M upfront, potential $16M milestones, plus royalties
Small molecule, insomnia, cannabinoid - Read more

THE GOOD
Clinical Trials

Researchers at Massachusetts Eye and Ear developed CALEC stem cell therapy, showing 90% success in restoring previously irreversible corneal damage in Ph1/2 trial
Cell therapy, stem cell-derived therapy, corneal damage - Read more

CalciMedica showcases Ph2 data for Auxora (CRAC channel inhibitor) in acute kidney injury
Small molecule, acute kidney injury - Read more

Laekna's LAE120 (USP1 inhibitor) receives FDA IND approval for advanced solid tumors, showing efficacy and synergy with PARP inhibitors
Antibody, solid tumor, cancer - Read more

THE GOOD
Company Launches

Former Cerebral CEO launches AdvocateMH, a new venture connecting patients to mental health resources
Virtual health, digital health, mental health - Read more

THE GOOD
Fundraises

Sofinnova Partners €1.2B ($1.3B) VC funding to support 50-60 new healthcare and sustainability companies
Venture capital, biotech investing, life science investment, healthcare investment - Read more

Osivax $10.7M Series B, developing vaccines for broad protection against mutating respiratory viruses
Vaccine, Influenza, respiratory infection - Read more

Garuda Therapeutics $50M Series A-1, developing off-the-shelf blood stem cell therapies for various blood disorders
Cell therapy, stem cell-derived therapy, cancer, allogeneic cell therapy, platform technology - Read more

Flosonics Medical $5.5M USD venture debt, expanding reach of FloPatch medical device for life sciences
Medical device, ultrasound - Read more

Akari Therapeutics $7.6M private placement, developing bi-functional ADCs for cancer treatment and seeking licensing partners
Bi-functional antibody-drug conjugate (ADC), cancer, solid tumor - Read more

Aadi Bioscience $100M PIPE financing, precision oncology biotech going after mTor-drive cancers
Small molecule, nanoparticle, solid tumor, cancer - Read more

BioXcel Therapeutics $14M registered direct offering, utilizing AI to develop treatments for neurological diseases
Small molecule, Alzheimer's disease, agitation associated with Alzheimer's disease, AI, neuroscience - Read more

Tenaya Therapeutics $52.5M public offering, gene therapy for cardiac conditions
Gene therapy, hypertrophic cardiomyopathy, arrhythmogenic right ventricular cardiomyopathy, adeno-associated virus (AAV) - Read more

Zelluna NOK 20,227,065.30 ($1.85M) private placement, developing allogeneic TCR-NK cells for cancer treatment
Cell therapy, solid tumor, cancer, TCR-NK cell therapy - Read more

THE GOOD
Lawsuits

Gilead allocates $200 million for potential settlement of government investigation following HIV drug speaker program
Human immunodeficiency virus (HIV), speaker program suit - Read more

THE GOOD
Mergers & Acquisition

Acelyrin rejects Concentra's $3.00/share acquisition bid, proceeding with Alumis merger despite dramatic post-IPO value decline
Monoclonal antibody, thyroid eye disease, small molecule, plaque psoriasis - Read more

Repligen acquires 908 Devices' bioprocessing analytics portfolio, gaining four desktop devices for real-time process monitoring and control
Bioprocessing, equipment/instrumentation, analytical platform - Read more

THE GOOD
Partnerships

Evotec, Bristol Myers Squibb advancing neuroscience collaboration with $20M payment for neurodegeneration program development
Drug development, neuroscience, neurodegenerative disease, small molecule, milestone - Read more

Cadrenal Therapeutics, Abbott collaboration to support pivotal trial of tecarfarin in HeartMate 3 LVAD patients
Small molecule, cardiovascular disease, clinical development - Read more

SLAM Bio, IFLI, strategic partnership to accelerate development of novel blood cancer treatments, particularly for follicular lymphoma
Bispecific antibody, antibody-drug conjugate (ADC), follicular lymphoma, cancer, drug development, platform technology, myeloid leukemia, myelodysplastic syndrome, lymphoma - Read more

THE GOOD
Politics & Policy

Pfizer CEO says company can quickly reshore production to existing US plants if Trump imposes tariffs
Domestic manufacturing, tariffs - Read more

THE GOOD
Research

Gene therapy successfully prevents death and restored growth in mice and calf with maple syrup urine disease
Gene therapy, maple syrup urine disease - Read more

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THE BAD
Clinical Trials

PepGen pauses PGN-EDO51 (exon-skipping therapy) Ph2 trial in the UK in Duchenne muscular dystrophy following magnesium deficiency concerns and FDA hold to US arm of the same trial
Antisense oligonucleotide, Duchenne muscular dystrophy (DMD) - Read more

THE BAD
Lawsuits

Genevant and Arbutus sue Moderna for patent infringement on lipid nanoparticle technology used in vaccines across 30 countries
Vaccine, mRNA, lipid nanoparticle (LNP), patent suit - Read more

THE BAD
Layoffs

Cytiva to lay off 85 employees at Massachusetts facility
Equipment/Instrumentation, bioprocessing, biomanufacturing - Read more

Atara Biotherapeutics cuts workforce by 50% (again)
Cell therapy, cancer, T cell therapy, CAR-T, allogeneic cell therapy, autoimmune disease - Read more

THE BAD
Marketing

FDA reprimands Edenbridge Pharmaceuticals for falsely claiming its multiple myeloma drug Hemady outperforms generics
Small molecule, multiple myeloma, cancer, drug marketing, generic - Read more [Paywall]

THE BAD
Mergers & Acquisition

23andMe Special Committee rejects CEO Anne Wojcicki's $0.41 per share acquisition proposal, an 84% decrease from a previous joint offer
Genetic screening - Read more

THE BAD
Strategic Plans

Asceneuron terminates Phase II trial of Alzheimer's drug ASN5 after raising $100 million in funding
Peptide, Alzheimer's disease - Read more

THE UGLY
Politics & Policy

30 FDA facilities across 23 states are amongst 748 federal sites whose leases were terminated as part of massive DOGE-spearheded cuts
Food & Drug Administration (FDA), site closure - Read more

China bans Illumina DNA sequencer imports in retaliation to Trump's expanded tariffs on Chinese goods
Next generation sequencing (NGS), tariffs - Read more

THE UGLY
Withdrawals & Recalls

Glenmark recalls 1.48M bottles of generic ADHD drug atomoxetine due to potential carcinogen contamination.
Small molecule, attention deficit hyperactivity disorder (ADHD), contaminant - Read more

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

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