
Roche, Hanmi Pharm partner on weight loss drug HM17321, $190M upfront, up to $2.3B deal | Gif: NetflixKContent on Giphy
All the top Biotech & Pharma news in one daily newsletter.
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✅ The Good News ✅
THE GOOD
Approvals & Labels
Roche, Eli Lilly win FDA clearance for Elecsys pTau217 blood test targeting phosphorylated Tau 217 in Alzheimer's disease
Diagnostic test, neurological, Alzheimer's disease, pTau217 biomarker, amyloid pathology - Read more
European Commission approves Acadia Pharmaceuticals' DAYBU (trofinetide) for Rett syndrome neurobehavioral symptoms following Ph3 success
Small molecule, neurological, Rett syndrome, neurodevelopmental disorder, trofinetide - Read more
Takeda's Orzeyful (oveporexton) approved in Japan for narcolepsy type 1, first OX2R agonist targeting orexin deficiency
Small molecule, neurological, orexin receptor agonist, narcolepsy type 1, orexin deficiency, first-in-class - Read more
Bayer's Hyrnuo (sevabertinib) wins Japan MHLW approval for HER2-mutant non-small cell lung cancer based on Ph1/Ph2 data
Small molecule, cancer, tyrosine kinase inhibitor, non-small cell lung cancer, HER2 - Read more
GC Biopharma's Hunterase receives India and Taiwan approval for Hunter syndrome (mucopolysaccharidosis type II)
Protein therapy, rare disease, enzyme replacement therapy, Hunter syndrome, lysosomal storage disorder, blood-brain barrier - Read more
Johnson & Johnson's Tecvayli (teclistamab) plus daratumumab wins EC approval for relapsed/refractory multiple myeloma
Antibody, cancer, bispecific antibody, multiple myeloma, BCMA target, combination therapy - Read more
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• Audience segmentation (how tailored marketing content can more effectively engage a focused bioprocess customer segment) and
• Cold calling (the technical underpinning and strategies + mindset to win at it)
Join us August 26th - register for free here!
✅ More Good News ✅
THE GOOD
Business Development & Partnerships
TME Pharma narrows brain cancer drug NOX-A12 licensing search to two final partners
Licensing deal, oncology, small molecule, neurological, milestone payments - Read more
Roche, Hanmi Pharm partner on weight loss drug HM17321, $190M upfront, up to $2.3B deal
Licensing deal, obesity, small molecule, milestone payments, royalties - Read more
Mankind Pharma licenses insulin degludec and degludec+aspart combo from Chongqing Chenan Biopharmaceutical for India
Licensing deal, diabetes, biologics, commercialization, injectable therapies - Read more
THE GOOD
Earnings & Finances
Lundbeck reports 16% sales growth in H1 2026, driven by Vyepti and Rexulti gains
Small molecule, neurological, revenue impact, competitive - Read more
THE GOOD
Fundraises
Jupiter Neurosciences prices $2.0M registered direct offering, CNS and neuroinflammation focus
Neurological, clinical-stage, central nervous system, neuroinflammation - Read more
THE GOOD
Investments
Novotech opens Tokyo office to expand Japan presence and support biopharma clinical trials globally
CRO services, oncology, rare disease, operational, strategic - Read more
THE GOOD
Regulatory
Spruce Biosciences advances toward Q4 FDA filing for ultra-rare Sanfilippo syndrome drug after successful manufacturing talks
Enzyme replacement therapy, rare disease, regulatory, strategic - Read more
MHRA publishes position paper clarifying regulatory pathway for microbiome-based medicinal products in UK
Microbiome-based therapy, infectious disease, regulatory, operational - Read more
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❌ The Bad News ❌
THE BAD
Layoffs
Cellares downsizes workforce after losing major pharmaceutical manufacturing customer, CEO confirms restructuring plans
Cell therapy manufacturing, autoimmune, operational, cost reduction - Read more
THE BAD
Politics & Policy
Kennedy challenges CDC vaccine recommendation categories, seeks stakeholder input following Trump's MMR breakup order
Vaccine, infectious disease, regulatory, operational - Read more
THE BAD
Regulatory
REGENXBIO shares drop 22% after FDA clinical hold on RGX-121 Hunter syndrome gene therapy delays resubmission
Gene therapy, rare disease, regulatory, financial - Read more
You’re all caught up on the latest Pharma & Biotech News!
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