This website uses cookies

Read our Privacy policy and Terms of use for more information.

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

Have any feedback? I’d love to hear you from - connect with me on LinkedIn. 📣

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

PRESENTED BY SCIENCE 2 SALES & HAPATUNE

Ready to supercharge your marketing AND sales workflows into biopharma?

You won’t want to miss this webinar, where Kimo (Hapatune) and Anis (Science 2 Sales) get into the nitty-gritty of both:

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

PRESENTED BY YOU?
Get the attention of 3000+ Biotech & Pharma Professionals 🤩

Gif: mostexpensivest on Giphy

Do you offer a biotech/pharma-focused product or service?

Or looking to get investor/analyst interest on your budding start-up?

Considering sponsoring TLDR Biotech to get in-front of an engaged audience of biotech & pharma-focused professionals.

Just reply to this email* or message me on LinkedIn to learn more.

*If you’re reading this on the web version, email [email protected]

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!

TLDR Biotech wants to hear from you! 📣

Have comments/questions/complaints about this newsletter?
Send me an email - I want your brutally honest feedback. 📝

If you find the content useful and think a colleague would too, please share TLDR Biotech with them! ♻️

Thanks for reading! -Anis

Disclaimer: Content, news, research, tools, and mention of stock or tradeable securities are for educational and illustrative purposes only and do not imply a recommendation or solicitation to buy or sell a particular security or to engage in any particular investment strategy. Read the full terms & conditions here