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

🤒 I was out sick yesterday so you get an Extra Big newsletter today to make up for it.

Want to understand how these updates are formatted? Check-out the FAQ.

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

Looking to reach an audience of 1000+ biotech and pharma professionals? Let’s chat. 👍

THE GOOD
Approvals & Labels

Novocure’s tumour-targeting fields therapy nabs FDA approval in lung cancer
Medical device, lung cancer, alternative electric fields therapy - Read more

AbbVie’s Parkinson’s combo med Vyalev scores FDA approval
Small molecule, Parkinson’s disease - Read more

Avadel Pharmaceuticals’ Lumryz lands FDA approval for ages 7 and up
Small molecule, cataplexy, narcolepsy - Read more

AstraZeneca, Ionis Pharmaceuticals’ Wainzua approved by UK’s MHRA
Antisense oligonucleotide, polyneuropathy associated with hereditary transthyretin amyloidosis - Read more

Sanofi’s Flublok flu vaccine label expansion ok’d by FDA, pregnant individuals
Vaccine, influenza - Read more

THE GOOD
Business Development

Exscientia scores $15M milestone payment from Sanofi
Small molecule, drug discovery, AI - Read more

Novartis buys exclusive, worldwide license to Baiyu Pharmaceutical’s anti-tumor asset for $70M upfront, $1.1B biobucks
Small molecule, cancer - Read more

Viatris buys ex-US, ex-Europe rights to Inpefa from Lexicon Pharmaceuticals for $25M upfront, $200M biobucks
Small molecule, heart failure, type 2 diabetes - Read more

RevOpsis lands $1.8M SBIR grant
Tri-specific biologic, retinal vascular disease - Read more

Synedgen receives up to $119M BARDA contract to develop radiation syndrome countermeasure MIIST305
Glycomedicine, gastrointestinal acute radiation syndrome, medical countermeasure - Read more

Orasis Pharmaceuticals sells Qlosi’s Korea commercialization rights to Optus Pharmaceuticals
Small molecule, presbyopia - Read more

THE GOOD
Clinical Trials

Akeso Biopharma touts positive cadonilimab Ph3 data in cervical cancer
Bispecific antibody, cervical cancer - Read more

Beacon Therapeutics’ AGTC-501 delivers positive 24 month data in Ph2
Gene therapy, X-linked retinitis pigmentosa - Read more

Innovent Biologics ulcerative colitis candidate picankibart hits Ph2 primary endpoint
Monoclonal antibody, ulcerative colitis - Read more

Wave Life Sciences posts promising in-human data for RNA-editing therapeutic approach
RNA editing, alpha-1 antitrypsin deficiency - Read more

GSK, ViiV Healthcare showcases 99% effectiveness of HIV prevention med Apretude
Small molecule, human immunodeficiency viruses, HIV infection prevention - Read more

Athos Therapeutics posts positive Ph1 data for “AI-generated” ATH-063 in inflammatory bowel disease
Small molecule, inflammatory bowel disease, AI - Read more

Neurogastrx posts positive Ph2 data in GLP-1 side effect combatting small molecule
Small molecule, obesity med side effects, GLP-1 - Read more

HUTCHMED’s postive lung cancer Ph2 data utilizing Tagrisso + Orpathys combo
Small molecule, lung cancer - Read more

Noema Pharma’s Tourette syndrome hopeful notches Ph2a primary and secondary endpoints wins
Small molecule, Tourette’s syndrome - Read more

Thryv Therapeutics’ touts positive results for small molecule LQT-1213 in rare genetic heart condition proof-of-concept clinical study
Small molecule, congenital Long QT Syndrome - Read more

Bavarian Nordic’s mpox vaccine performs equally well in adolescents as in adults
Vaccine, mpox (monkeypox) - Read more

Merck & Co.’s Capvaxive delivers positive Ph3 results in patients with chronic conditions that put them at increased pneumococcal disease risk
Vaccine, pneumococcal disease - Read more

Aura Biosciences touts positive Ph1 data for bladder cancer hopeful bel-sar + light activation
Viruslike drug conjugate, bladder cancer - Read more

PRESENTED BY YOU?
Get 1000+ sets of biotech/pharma eyeballs on your product or service 👀

Looking to promote your biotech/pharma/life science-focused product or service to a captivated audience of industry professionals?

Consider sponsoring TLDR Biotech - your sponsored feature would go right here!

Want to take the next step (or just learn more)? Just reply to this email or message me on LinkedIn.

⬇️ More Good News ⬇️

THE GOOD
Fundraises

KdT Ventures $100M fourth fund
Venture capital, biotech investing - Read more

Treeline Biosciences $421M financing
Cancer - Read more [Paywall]

Capricor Therapeutics $75M public offering
Cell therapy, Duchenne’s muscular dystrophy, heart disease - Read more

Sunbird Bio $14M raise
Diagnostics, blood test, Alzheimer’s disease, Parkinson’s disease - Read more

Minze Health $5.3M raise
Digital health, urology - Read more

Alchemy $31M Seed raise
Pharmacy infrastructure - Read more

Orano Med raises €300M ($326M) from Sanofi
Radiopharma, neuroendocrine tumors, cancer - Read more

Monument Therapeutics £1M ($1.3M) investment from Forster Foundation
Small molecule, schizophrenia - Read more

TenNor Therapeutics $41M Series E
Small molecule, bacterial infections, metabolic disease - Read more

Terray Therapeutics $120M Series B
Small molecule, drug development, AI - Read more

THE GOOD
Healthcare Equity

Sanofi earmarks $18M towards three historically Black medical schools in bid to increase clinical trial diversity
Clinical trial diversity - Read more

THE GOOD
Investments

OmniaBio CDMO opens up commercial-scale CGT manufacturing site in Canada
Cell & gene therapy, CDMO, contract manufacturing - Read more

SpectronRx showcases upcoming Belgian-based radiolabeling plant, Q1 2025 expected start
Radiopharma, manufacturing - Read more

THE GOOD
Lawsuits

Exelixis comes out on top in Cabometyx patent scuffle against MSN Laboratories
Small molecule, kidney cancer, liver cancer, thyroid cancer - Read more

Amicus Therapeutics, Teva Pharmaceuticals settle Galafold generic disagreement
Small molecule, Fabry disease, generic - Read more

THE GOOD
Partnerships

ExpreS2ion, Serum Institute of India partner on development, manufacturing of novel malaria vaccine
Vaccine, malaria, drug development - Read more

Matica Bio, Mongoose Bio partner on TCR-T cell therapy drug development
TCR-T cell therapy, cancer, drug development, CDMO - Read more

Mila Partners, Ability Biologics partner on AI-powered antibody drug discovery
Antibody, drug discovery, AI - Read more

Clairo, PathAI partner on streamlining gastrointestinal clinical trials
Clinical trials, pathology, endoscopy - Read more

Eterna Therapeutics, Factor Bioscience iPSC-derived cell therapy drug development pact
Cell therapy, cancer, rare disease, autoimmune, induced pluripotent stem cells - Read more

THE GOOD
Politics & Policy

Biosecure Act has unlikely detractor in prominent US House China critic
Biosecure Act - Read more [Paywall]

THE GOOD
Regulatory

FDA unveils rare disease innovation hub
Rare diseases, drug development - Read more

FDA finalizes trio of guidance documents (generics, cancer trials, neonatal drug development)
Regulatory guidance - Read more [Paywall]

THE GOOD
Strategic Plans

Teva Pharmaceuticals adopts “biotech mindset” as it ventures into pushing new assets
Small molecule, neuroscience, immunology - Read more

Scilex Holdings considers spinning-out Scilex Pharma division
Small molecule, postherpetic neuralgia, migraine - Read more

Merck KGaA open to more manufacturing-focused M&A
Drug manufacturing - Read more [Paywall]

ENJOYING THESE NEWSLETTERS?
Support TLDR Biotech🧬🦠🔬 

I’m offering this newsletter for free so it can get out to as many people as possible.

If you’re getting value out of these daily compilations, please consider a paid subscription (only $5/month) to support my continued work on this project.*

*Best of all, it’s a work-related news source that you can likely expense. 😉 

THE BAD
Approvals & Labels

Intercept Pharmaceuticals’ (Alfasigma) Ocaliva FDA decision faces delay, approval path uncertain after overwhelmingly negative adcom
Small molecule, primary biliary cholangitis - Read more

Amgen’s Lumakras also faces FDA decision delay
Small molecule, colorectal cancer - Read more

Biogen, Eisai’s Leqembi gets rejected by Australia’s TGA
Monoclonal antibody, Alzheimer’s disease - Read more

THE BAD
Business Development

Sanofi attempts to quell strike movement by assuring that consumer health division will remain “anchored” in France
Consumer health - Read more 

THE BAD
Clinical Trials

Kezar Life Sciences terminates Ph2b lupus trial with zetomipzomib
Small molecule, lupus nephritis - Read more

Novavax COVID/flu and standalone flu vaccines hit with FDA hold after serious adverse event
Vaccine, COVID-19, influenza - Read more

THE BAD
Lawsuits

US District Judge rules against Novartis in Entresto generic spat with MSN Pharmaceuticals
Small molecule, heart failure, generic - Read more

THE BAD
Layoffs

Sage Therapeutics look to cut total workforce by 1/3rd (R&D by half) as part of “regroup”
Small molecule, Huntington’s disease - Read more

THE BAD
Mergers & Acquisitions

Despite potentially precarious position, Kezar Life Sciences rejects buyout offer from Concentra Biosciences
Small molecule, autoimmune hepatitis - Read more

THE BAD
Partnerships

Takeda waves goodbye to Wave Life Sciences Parkinson’s drug development collab
Antisense oligonucleotide, Huntington’s disease - Read more

THE UGLY
Withdrawals & Recalls

Bankrupt Cue Health’s COVID-19 tests hit with FDA Class II recall
At-home test, COVID-19 - 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. 📝

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

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