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THE GOOD
Approvals & Labels

BridgeBio’s Attruby (transthyretin stabilizer) nabs FDA approval in transthyretin amyloid cardiomyopathy
Small molecule, transthyretin amyloid cardiomyopathy - Read more

Merck & Co.’s Welireg (HIF inhibitor) nabs China NMPA approval for von Hippel-Lindau (VHL) disease with certain solid tumors
Small molecule, von Hippel-Lindau disease, cancer - Read more

Zenyaku Kogyo, Chugai Pharmaceutical land Japan MHLW label expansion for Rituxan (anti-CD20) in treating chronic idiopathic thrombocytopenic purpura
Monoclonal antibody, chronic idiopathic thrombocytopenic purpura - Read more

GSK’s Arexvy scores expanded RSV vaccination label by Japan’s MHLW to adults aged 50-59 (original approval for adults over aged 60)
Vaccine, respiratory syncytial virus - Read more

StemCyte’s Regenecyte BLA approved by FDA, in combo with appropriate prep regimen for hematopoietic and immunologic reconstitution in certain patients
Cell therapy, donor hematopoietic progenitor cell transplantation, allogeneic hematopoietic stem cell - Read more

THE GOOD
Business Development

Vilya in-licenses peptide structure prediction framework from University of Washington
Peptide, drug discovery, machine learning - Read more

Otsuka Pharmaceutical lands exclusive global licensing rights to Ionis Pharmaceuticals’ ulefnersen (targeting RNA-binding protein fused in sarcoma/translocated in liposarcoma), potential ALS treatment
Antisense oligonucleotide, amyotrophic lateral sclerosis (ALS) - Read more

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⬇️ More Good News ⬇️

THE GOOD
Clinical Trials

Gan & Lee Pharmaceuticals touts positive Ph2b data for GZR18 (GLP-1 receptor agonist)
GLP-1, obesity - Read more [Press release in Chinese]

Lumos Pharma showcases new Ph2 data analyses for LUM-201 (growth hormone secretagogue) in pediatric growth hormone deficiency
Small molecule, pediatric growth hormone deficiency - Read more

Roche’s Vabysmo (VEGF, Ang-2 targeting) builds expanded label case with Ph3b/4 data in polypoidal choroidal vasculopathy
Bispecific antibody, polypoidal choroidal vasculopathy, neovascular AMD - Read more

THE GOOD
Fundraises

OncoVerity undisclosed Series A extension, proceeds to fund Ph2 for cusatuzumab (anti-CD70) in acute myeloid leukemia
Monoclonal antibody, acute myeloid leukemia, cancer, bioinformatics - Read more 

THE GOOD
Patient Access

Baxter releases first batch of IV solutions post-hurricane from North Cove, NC facility
IV solutions, manufacturing, supply chain - Read more

Sanofi makes suggestions to US’s 340B system with “Innovate Credit System”
340B drug pricing program, drug pricing - Read more

THE GOOD
Politics & Policy

US’s PREVAIL Act, related to drug patent challenges, narrowly moved forward to Senate floor vote
Drug patent, drug pricing - Read more

THE GOOD
Product Development

Nabla Bio posts technical paper on AI-enabled protein design tech
Drug design, biologics, AI, de novo - Read more

Illumina previews updated tumor profiling research assay
Genomic testing, cancer, research & development - Read more

THE GOOD
Research

Washington University researcher publish immune checkpoint inhibitor-releasing probiotic yeast as potential gut tumor drug delivery method
Drug delivery, solid tumor, cancer - Read more

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THE BAD
Company Shutdown

Seelos Therapeutics files for bankruptcy
Small molecule, amyotrophic lateral sclerosis, post-traumatic stress disorder - Read more

THE BAD
Lawsuits

Johnson & Johnson’s talc saga continues as UK lawsuits may be ramping up
Talc, cancer - Read more

THE BAD
Layoffs

Lexicon Therapeutics shutters commercial division and 60% of staff due to Zynquista approval package “deficiencies” per FDA
Small molecule, type 1 diabetes, insulin therapy adjunct - Read more

THE BAD
Mergers & Acquisitions

Halozyme Therapeutics withdraws Evotec acquisition proposal after getting the silent treatment
Drug delivery tech platform, drug discovery - Read more

THE BAD
Regulatory

FDA still undecided on tirzepatide “shortage”, much to continued delight of compounding pharmacies
GLP-1, obesity, drug compounding - Read more

THE BAD
Public Health

Florida’s surgeon general goes against the research on fluoride
Water fluoridation, oral health - Read more [Paywall]

THE BAD
Strategic Plans

AstraZeneca drops AZD4041 (orexin receptor type 1 agonist) Ph2 trial
Small molecule, opioid use disorder - Read more

THE UGLY
Clinical Trials

Neurogene reports death in high-dose cohort of Rett syndrome gene therapy NGN-401, likely due to AAV over-exposure
Gene therapy, Rett syndrome, AAV - Read more

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

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