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THE GOOD
Approvals & Labels

Novartis' Vanrafia (endothelin A receptor antagonist) lands FDA accelerated approval in IgA nephropathy
Small molecule, IgA nephropathy - Read more

Amgen's Uplizna (anti-CD19) lands FDA approval for IgG4-related disease
Monoclonal antibody, IgG4-related disease - Read more

THE GOOD
Business Development

PharmaMar out-licenses lurbinectedin (guanine targeting) to Merck KGaA for small cell lung cancer in Japan for €22 million upfront
Small molecule, lung cancer - Read more

Sangamo out-licenses STAC-BBB neurotropic AAV capsid to Eli Lilly for blood-brain genomic medicine delivery to treat CNS diseases
Gene therapy, adeno-associated virus (AAV), drug delivery, blood-brain barrier - Read more

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THE GOOD
Clinical Trials

Roche touts positive Ph1b/2a data for trontinemab, a Brainshuttle-enhanced gantenerumab (targeting amyloid-beta) in Alzheimer's disease
Bispecific antibody, Alzheimer's disease - Read more

Atamyo Therapeutics showcases promising Ph1b/2b dose-finding data for ATA-100 gene therapy ing limb-girdle muscular dystrophy Type 2I/R9
Gene therapy, Limb-Girdle Muscular Dystrophy Type R9, adeno-associated virus (AAV) - Read more

THE GOOD
Fundraises

Neurona Therapeutics $102M fundraise, advancing NRTX-1001 cell therapy for drug-resistant epilepsy
Cell therapy, mesial temporal lobe epilepsy, stem cell-derived therapy - Read more

MoonLake Immunotherapeutics secures up to $500M non-dilutive financing to support future launch of nanobody (anti-IL17) for inflammatory skin diseases.
Nanobody, hidradenitis suppurativa, palmoplantar pustulosis, axial spondyloarthritis, psoriatic arthritis - Read more

OSR Holdings $80M equity purchase agreement with White Lion GBM Innovation Fund for glioblastoma therapy advancement
Vaccine, monoclonal antibody, combo therapy, glioblastoma - Read more

GRI Bio $5.0M public offering, developing NKT cell modulators for inflammatory, fibrotic, and autoimmune diseases
Small molecule, pulmonary fibrosis, lupus erythematosus - Read more

Sylvan receives investment from Novo Holdings, expanding fungal biotechnology solutions and production capacity
Fungal biotechnology - Read more

UniteLabs €2.77M ($3.05M) pre-seed funding, lab automation platform connecting instruments for data collection and AI integration
Laboratory automation, AI - Read more

Sunshine Biopharma $2.46M registered direct offering, developing and commercializing diverse range of medicines
Small molecule, mRNA, lipid nanoparticle (LNP), COVID-19, recombinant human granulocyte colony-stimulating factor, liver cancer - Read more

Northernmost $1.9M Seed, developing NoMo Kidney Pump to modernize organ preservation for transplantation
Medical device, organ transport - Read more

vopemed raises CAD$2.29M ($1.61M) in pre-seed funding for AI-powered surgical image clarification technology
Medical device, surgical vision, AI - Read more

THE GOOD
Investments

Boehringer Ingelheim invests $31M into new Swiss ADC facility run by subsidiary NBE Therapeutics
Antibody-drug conjugate (ADC), new facility, Research & Development - Read more

THE GOOD
Mergers & Acquisitions

Brookfield to acquire Antylia Scientific, major laboratory equipment supplier with 200,000 products, for $1.4B
Equipment/Instrumentation, private equity acquisition - Read more

Eliquent Life Sciences to acquire Truliant Consulting, pharmacovigilance capabilities & product lifecycle support
Consulting - Read more

THE GOOD
Partnerships

Parse Biosciences, SCRUM partnership to distribute single cell sequencing solutions throughout Japan
Single cell analysis, distribution partnership, equipment/instrumentation - Read more

Wacker Biotech, RNAV8 Bio collab to develop and manufacture advanced mRNA therapeutics
CDMO (Contract Development & Manufacturing Organization), mRNA, mRNA manufacturing, manufacturing partnership - Read more

Edity Therapeutics, Aurigene Oncology to co-develop novel cell therapy for solid tumors
Cell therapy, cancer, solid tumor, drug delivery, drug development - Read more

LIfT BioSciences, GOLB stem cells sourcing partnership for experimental neutrophil-based cancer cell therapy
Cell therapy, hematopoietic stem cell, allogeneic cell therapy - Read more

Akiram Therapeutics, TetraKit Technologies PRE-CISE collaboration developing targeted alpha-therapeutics using CD44v6 antibody platform and radiolabeling chemistry
Radiopharm, drug development, antibody - Read more

Plex Research, Ginkgo Bioworks partner to use AI and transcriptomic datasets for drug repurposing and therapeutic discovery
Drug discovery, AI, transcriptomics - Read more

THE GOOD
Research

Study shows shingles vaccine Zostavax reduced dementia risk by 20% in Welsh adults over seven years
Vaccine, shingles, dementia - Read more

Sunshine Biopharma's mRNA therapy delivers promising results against liver cancer in mouse studies
mRNA, lipid nanoparticle (LNP), hepatocellular carcinoma - Read more

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THE BAD
Approvals & Labels

Aldeyra's dry eye disease drug reproxalap (RASP modulator) rejected by FDA again, demanding additional efficacy studies
Small molecule, dry eye disease - Read more

FDA missed review deadline for Novavax's 2024-2025 COVID-19 vaccine formulation, despite company responding to all information requests
Vaccine, COVID-19 - Read more

THE BAD
Clinical Trials

BeiGene discontinues ociperlimab (anti-TIGIT receptor) after Ph3 trial stumble in non-small cell lung cancer
Monoclonal antibody, lung cancer - Read more

Roche halts three trials of Sarepta Therapeutics-developed Elevidys DMD gene therapy after a 16-year-old's death from liver failure.
Gene therapy, Duchenne muscular dystrophy (DMD), adeno-associated virus (AAV) - Read more

THE BAD
Company Shutdown

Biotech firm Pure Protein closes after losing major contracts, entire research team laid off without notice
Peptide, reagents - Read more

THE BAD
Layoffs

Roche cuts 108 jobs at Santa Clara's Molecular Systems division amid biotech industry layoffs (Gilead layoffs covered in yesterday’s TLDR Biotech newsletter)
Big pharma layoffs - Read more

THE BAD
Market Reports

PIPE financing for biopharma dramatically decreased in Q1 2025, with only 9 deals raising $1.3B versus 34 deals totaling $4.9B last year
PIPE Funding - Read more [Paywall]

THE BAD
Regulatory

FDA inspection of drug facilities could decline further due to HHS cutting 3,500 FDA positions, despite promises to protect inspection staff
Food & Drug Administration (FDA), facility inspection - Read more

FDA reorganizing into five shared services offices, cutting layers and mushing together expertise, amid broader HHS staff reductions
Food & Drug Administration (FDA) - Read more

THE BAD
Strategic Plans

Cyclacel Pharmaceuticals discontinues fadraciclib (targeting CDK2, CDK9) to focus on plogosertib (targeting Plk1) while reducing costs amid financial struggles
Small molecule, cancer, pipeline strategy, solid tumor, leukemia - Read more

THE UGLY
Politics & Policy

Princeton and Harvard face federal funding cuts, following similar actions against Columbia and UPenn, threatening vital research programs
Federal research funding - Read more

NIH must cut $2.6 billion in contracts following Trump administration order, compounding recent leadership and staff losses
National Institute of Health (NIH), federal research funding - Read more [Paywall]

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

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