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Quick note: I’ll be OOO starting today ‘til end of week, so TLDR Biotech will be on a few day break. Back to your regularly scheduled news compilations on Monday!

THE GOOD
Approvals & Labels

AstraZeneca's Calquence (BTK inhibitor) plus bendamustine and rituximab receives European Commission approval for first-line mantle cell lymphoma, based on Ph3 ECHO trial
Monoclonal antibody, small molecule, combo therapy, lymphoma, cancer - Read more

THE GOOD
Business Development

Eli Lilly licenses Alchemab Therapeutics's ALS therapy ATLX-1282 for up to $415M, targeting UNC5C protein in neurodegenerative diseases
Antibody, amyotrophic lateral sclerosis (ALS/Lou Gehrig's disease) - Read more

Twist Bioscience spins out DNA data storage technology as Atlas Data Storage, an independent company, retaining minority ownership and future royalties
Corporate spin-out, DNA data storage - Read more

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THE GOOD
Clinical Trials

Actuate Therapeutics' elraglusib, targeting GSK-3β, achieved significant results in Ph2 trial for metastatic pancreatic ductal adenocarcinoma with gemcitabine/nab-paclitaxel combination
Small molecule, pancreatic cancer - Read more

Atara Biotherapeutics' Ebvallo, an EBV-specific T-cell therapy, resumes Ph3 ALLELE trial for Epstein-Barr virus-associated post-transplant lymphoproliferative disease after FDA lifts clinical hold
Cell therapy, T cell therapy, allogeneic cell therapy, Epstein-Barr virus positive post-transplant lymphoproliferative disease - Read more

OSE Immunotherapeutics reports Lusvertikimab, an anti-IL-7 receptor antibody, maintained remission in >90% of ulcerative colitis responders during Ph2 extension study
Monoclonal antibody, ulcerative colitis - Read more

Innovent Biologic's efdamrofusp alfa (IBI302), targeting VEGFR and CR1, shows competitive Ph2 results in neovascular age-related macular degeneration patients over one year
Bispecific fusion protein, wet age-related macular degeneration (wet AMD) - Read more

THE GOOD
Earnings & Finances

Vertex Pharmaceuticals Q1 earnings missed expectations, but strong Journavx launch with 25,000 prescriptions and promising coverage progress is encouraging analysts
Big pharma earnings, small molecule, pain, non-opioid pain - Read more

THE GOOD
Fundraises

Nuevocor $45M Series B, Singapore biotech developing treatments for cardiomyopathies, funding Phase 1/2 trial of NVC-001
Gene therapy, dilated cardiomyopathy, mechanobiology - Read more

Ousia Pharma raises undisclosed Seed round to develop once-weekly obesity treatment using peptide-drug conjugates
Peptide drug conjugate, obesity - Read more

Alphabiome $8M Seed, developing AI technology that extracts genetic biomarkers from microbial DNA for precision medicine
Biomarkers, AI, drug discovery - Read more

Khondrion receives €5M ($5.7M) Innovation Credit to fund Phase 3 trial of sonlicromanol for mitochondrial disease
Small molecule, primary mitochondrial disease - Read more

Hilo $42M Series B, blood pressure intelligence platform expanding markets and product innovation using funds.
Medical device, blood pressure monitoring - Read more

PAQ Therapeutics $39M Series B, pivoted to cancer-focused PROTAC approach from autophagy technology
Protein degrader, cancer, pipeline strategy - Read more [Paywall]

NewLimit $130M Series B, developing epigenetic drugs to extend healthy lifespan using AI and genomics
Longevity medicine, AI, drug discovery, drug development, epigenome - Read more

Trailhead Biosystems $20M funding to advance iPSC differentiation technology for drug discovery and regenerative medicine
Induced pluripotent stem cell (IPSC/iPS cell), platform technology, stem cell-derived therapy, bioinformatics - Read more

Intelligence Ventures launches $1M fund, writing $50k checks to seed-stage AI-powered healthcare startups in US and Canada
Venture capital, healthcare investing, AI - Read more

Seqera $26M Series B, building software-first platform for bioinformatics and life science R&D
Software, AI, bioinformatics, Research & Development - Read more

Atlas Data Storage $155M Seed, building end-to-end DNA data storage technology for high-density, durable storage solutions
DNA data storage - Read more

THE GOOD
Investments

AstraZeneca opens $300 million CAR-T cell therapy factory in Maryland as part of $3.5 billion US investment
Domestic manufacturing, manufacturing, new facility, cell therapy manufacturing, cell therapy, CAR-T, cancer, lymphoma, leukemia, cancer cachexia - Read more

Bristol Myers Squibb pledges $40B for US R&D and manufacturing, expanding radiopharmaceutical production and AI despite recent cost-cutting plans
Domestic manufacturing, tariffs - Read more

THE GOOD
Lawsuits

Incyte and Novartis settle Jakafi royalty dispute right before May 5 trial date, ending lawsuit over 2009 agreement
Royalty, royalty suit, small molecule, myelofibrosis, polycythemia vera, graft versus host disease (GvHD) - Read more

THE GOOD
Mergers & Acquisitions

Castle Biosciences acquires gastrointestinal health company Previse, adding Esopredict test for Barrett's esophagus to its diagnostic portfolio
Esophageal cancer, biomarker, diagnostics - Read more

Carlyle and SK Capital have received all regulatory approvals for acquiring bluebird bio, with merger expected following tender offer completion
Gene therapy, sickle cell disease, beta thalassemia - Read more

THE GOOD
Partnerships

Formosa Pharmaceuticals, Almac Discovery, global licensing agreement for ALM-401, a bispecific antibody-drug conjugate targeting aggressive solid tumor
Bispecific antibody-drug conjugate, cancer, solid tumor, drug development, clinical development - Read more

THE GOOD
Politics & Policy

Trump orders FDA to streamline drug factory regulations, increase foreign inspections, and reduce building timeframes from 5-10 years
Food & Drug Administration (FDA), Domestic manufacturing - Read more

Trump administration and bipartisan lawmakers propose linking US drug prices to lower costs in other developed countries
Drug Pricing - Read more [Paywall]

THE GOOD
Regulatory

SEC expected to abandon investigation into Illumina's $8 billion acquisition of cancer test developer Grail
Next-generation sequencing (NGS) - Read more [Paywall]

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THE BAD
Clinical Trials

Vertex Pharmaceuticals temporarily pauses Ph1/2 trial of VX-522, a Moderna-partnered mRNA therapy for cystic fibrosis, due to tolerability issues
mRNA, cystic fibrosis - Read more

THE BAD
Earnings & Finances

Vertex Pharmaceuticals misses Q1 estimates as CF drug Trikafta's sales rise 2% to $2.53 billion, below expectations
Big pharma earnings, small molecule, cystic fibrosis - Read more

THE BAD
Layoffs

NIH cuts 250 more jobs, including 50 at National Cancer Institute, as part of Trump administration's downsizing efforts
National Institute of Health (NIH), public agency layoffs - Read more

Mersana lays off 55% of staff, narrows focus to Emi-Le, its B7-H4 ADC for breast cancer, to extend cash runway
ADC Manufacturing, breast cancer - Read more

Biomea Fusion cuts 35% of staff, consolidates facilities in cost-saving move to extend cash runway into Q4 2025
Small molecule, obesity, diabetes, metabolic disease - Read more

THE BAD
Market Reports

VC funding dropped 20% in Q1 2025, with $6.5 billion raised across 162 deals, mostly in later-stage companies
Venture capital, biotech ecosystem - Read more

THE BAD
Politics & Policy

Bristol Myers Squibb CEO criticizes Trump administration's tariff plans and health reforms as threats to American health and economy
Domestic manufacturing, tariffs, Big pharma strategy - Read more

THE BAD
Regulatory

FDA names COVID restriction critic Vinay Prasad as new CBER director, adding uncertainty to biotech sector
Food & Drug Administration (FDA), Center for Biologics Evaluation and Research (CBER) - Read more

THE UGLY
Public Health

Trump policies disrupt NIH Clinical Center trials, causing staffing cuts, patient reduction, and delayed research
National Institute of Health (NIH), clinical trial-focused - Read more [Paywall]

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

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