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All the top Biotech & Pharma news in one daily newsletter.

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The Good News

THE GOOD
Approvals & Labels

CSL's Privigen (human immunoglobulin) receives European approval for measles pre- and post-exposure prophylaxis
Protein therapy, infectious disease, immunoglobulin, measles, passive immunization, immunocompromised patients - Read more

THE GOOD
Business Development & Partnerships

Cencora, Gilead Sciences expand partnership to grow CAR-T therapy access across U.S. treatment centers
Distribution agreement, oncology, cell therapy, CAR-T, commercialization - Read more

Alnylam Pharmaceuticals, Inceptive Nucleics partner on AI-driven siRNA drug discovery, $30M upfront, up to $2B total
Research collaboration, AI/ML, drug discovery, siRNA, milestone payments - Read more

Mineralys Therapeutics pays Tanabe Pharma $200M upfront to eliminate lorundrostat royalties ahead of FDA decision
Licensing deal, small molecule, cardiovascular, milestone payments, royalties - Read more

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More Good News

THE GOOD
Clinical Trials

Innovent Biologics' (arcotatug tavatecan) hits Ph3 win in CLDN18.2-positive gastric or gastroesophageal junction adenocarcinoma
Antibody-drug conjugate, cancer, gastric cancer, CLDN18.2, exatecan payload - Read more

THE GOOD
Fundraises

Ona Therapeutics raises $86.6M Series B to advance lead ADC into clinical studies
Oncology, antibody-drug conjugate, breast cancer, colorectal cancer, platform technology, clinical-stage - Read more

Parabilis plans up to $476M IPO, advancing peptide drug zolucatetide for desmoid tumors
Peptide therapeutics, oncology, rare disease, small molecule, clinical-stage - Read more

Haga Bioscience raises $2.3M Seed funding, advancing spatial RNA biomarker discovery and clinical translation
Spatial biology, biomarker discovery, RNA diagnostics, oncology, preclinical - Read more

Jade Biosciences prices $150M public offering to fund autoimmune disease clinical trials
Clinical-stage, autoimmune, biotechnology - Read more

Celcuity prices upsized $500M convertible notes offering, solid tumor targeted therapies
Clinical-stage, oncology, solid tumors, targeted therapy - Read more

THE GOOD
Lawsuits

Axsome Therapeutics settles all Sunosi patent litigation, blocking generic competition until 2040
Small molecule, narcolepsy, competitive, strategic - Read more

THE GOOD
Regulatory

FDA accepts Absentia Labs' AI liver injury prediction model into ISTAND qualification program
Small molecule, hepatology, AI drug development, regulatory - Read more

FDA issues draft guidance to help developers leverage existing science for gene therapy submissions
Gene therapy, rare disease, regulatory, operational - Read more

FDA Acting Chief Diamantas meets rare disease groups to restore confidence after Makary's turbulent tenure
Rare disease, regulatory, operational, strategic - Read more

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The Bad News

THE BAD
Politics & Policy

Eli Lilly, Boehringer Ingelheim pull back €2B+ ($2.33B) Germany investments over healthcare spending cuts
GLP-1, metabolic disease, financial, operational, competitive - Read more

THE BAD
Regulatory

FDA issues untitled letter to QOL Medical over misleading Sucraid promotional emails with eye-catching graphics
Oral enzyme replacement therapy, rare disease, regulatory, operational - Read more

👹 The Ugly News 👹

THE UGLY
Clinical Trials

ADC Therapeutics' Zynlonta (loncastuximab tesirine) Ph3 trial reveals 27 deaths, raising safety concerns in diffuse large B cell lymphoma
Antibody-drug conjugate, cancer, diffuse large B cell lymphoma, anti-CD19, rituximab combination, lymphoma - Read more

THE UGLY
Regulatory

FDA issues warning letter to Medline Industries over recurring bacterial contamination at multiple drug facilities
Manufacturing quality, drug safety, operational, financial - Read more

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

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