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

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 1900+ biotech and pharma professionals? Let’s chat. 👍

THE GOOD
Approvals & Labels

Johnson & Johnson's Balversa (erdafitinib), an FGFR kinase inhibitor, receives NICE endorsement for FGFR3-altered urothelial cancer following Ph3 trial success
Small molecule, bladder cancer - Read more

Belief BioMed and Takeda's dalnacogene ponparvovec, targeting coagulation factor IX, approved by China’s NMPA for hemophilia B based on Ph3 trial data
Gene therapy, hemophilia B, adeno-associated virus (AAV) - Read more

argenx's VYVGART Hytrulo prefilled syringe approved by FDA for self-injection in anti-AChR antibody positive generalized myasthenia gravis and chronic inflammatory demyelinating polyneuropathy
Monoclonal antibody fragment, drug formulation, myasthenia gravis, chronic inflammatory demyelinating polyneuropathy (CIDP) - Read more

Bayer received full FDA approval for VITRAKVI (larotrectinib), a TRK inhibitor for NTRK gene fusion-positive solid tumors with no satisfactory treatment alternatives
Small molecule, solid tumor, cancer - Read more

Dexcom G7 15 Day Continuous Glucose Monitoring System receives FDA clearance, offering 15.5-day wear and improved accuracy for adults with diabetes
Diabetes, continuous glucose monitoring, medical device - Read more

THE GOOD
Business Development

Pfizer sells five-building San Diego campus to BioMed Realty for $255 million in major life science real estate deal
Facility sale, big pharma strategy - Read more

PRESENTED BY TLDR BIOTECH
What would you do with 7k+ meticulously tagged biotech & pharma data points?
Free gene-editing data set below!

Over the past year, TLDR Biotech has been collecting and categorizing industry news across approvals, clinical trials, fundraises, partnerships, M&A, politics & policy, and much much more.

Each data point is tagged by drug modality, disease indication, tech area, and even more specific categories. For example:

🔍 Need to track all small molecule fundraises across oncology?

📈 Want a curated list of recent cell therapy clinical trials updates (both the successes and failures)?

💡 Looking for trends in Alzheimer's and Parkinson's disease partnerships?

Here’s a free set of data - gene-editing stories over the last 4 months.

We’re leveraging this resource to build tailored reports and curated insights for select clients—and now you can get full access.

Ready to get access or have questions? Check out our landing page.

✅ More Good News ✅

THE GOOD
Clinical Trials

Alterity Therapeutics' ATH434 shows 48% decreased progression in Ph2 trial for Multiple system atrophy, reducing iron signals in affected brain regions
Small molecule, multiple system atrophy - Read more

Amgen's Uplizna (anti-CD19 antibody) shows sustained and improved efficacy through one year for generalized myasthenia gravis patients, comparable to rival treatments
Monoclonal antibody, myasthenia gravis - Read more

Palatin's melanocortin agonist shows positive Ph2b BREAKOUT trial results for diabetic kidney disease, with 71% of patients showing improved kidney function
Peptide, hormone, diabetic kidney disease - Read more

Protagonist Therapeutics' icotrokinra, an IL-23 receptor blocker, showed 84.1% of adolescents achieved clear/almost clear skin in Ph3 trial for plaque psoriasis
Peptide, plaque psoriasis - Read more

TauRx's oral tablet HMTM (tau aggregation inhibitor) shows potential to slow Alzheimer's progression by targeting tau protein pathology over 18 months, Ph3 study analysis
Small molecule, Alzheimer's disease - Read more

THE GOOD
Company Launches

TVM Capital Life Science and Cellestia Biotech invest $34M to launch Anciata Therapeutics, developing IPX-2017 small molecule for autoimmune disorders
Small molecule, autoimmune disease - Read more

THE GOOD
Fundraises

Imbria Pharmaceuticals $57.5M Series B, developing ninerafaxstat (pFOX inhibitor) for non-obstructive hypertrophic cardiomyopathy and cardiometabolic diseases
Small molecule, hypertrophic cardiomyopathy - Read more

Procaps Group $130M equity investment, comprehensive debt restructuring to restore financial health and rebuild growth
Generic, over-the-counter, CDMO (Contract Development & Manufacturing Organization) - Read more

Auxilium Health $1.5M Pre-Seed, developing biomaterials for skin tissue regeneration and infection management
Tissue regeneration, tissue Biomaterials - Read more

Cingulate $3M grant, developing once-daily anxiety treatment CTx-2103 (buspirone) using proprietary PTR delivery platform
Small molecule, anxiety disorder - Read more

Suoyuan Biotechnologies RMB 235M ($32M) Series B, advancing iPSC-derived cell therapies for regenerative medicine and tumor immunity
Cell therapy, induced pluripotent stem cell (IPSC/iPS cell), stem cell-derived therapy, inflammatory disease, cancer - Read more (Press release in Chinese)

THE GOOD
Investments

Novartis announces $23B investment to expand US manufacturing and R&D facilities amid potential Trump tariffs
Domestic manufacturing, new facility, big pharma strategy - Read more

THE GOOD
Lawsuits

US court allows Sun Pharma to launch alopecia drug Leqselvi (JAK inhibitor), overturning Incyte's patent injunction
Patent suit, small molecule, alopecia areata - Read more

THE GOOD
Mergers & Acquisitions

Onconetix and Ocuvex Therapeutics sign letter of intent for potential merger, combining oncology and ophthalmic therapeutic portfolios
Small molecule, open-angle glaucoma (OAG), ocular hypertension, post-operative inflammation and pain following ocular surgery, glaucoma - Read more

THE GOOD
Partnerships

Flatiron Health, Massive Bio, partnering to use Massive Bio's database for identifying and recruiting clinical trial participants in oncology
Clinical trial enrolment, AI - Read more

Cellares, University of Wisconsin School of Medicine and Public Health, collaborating to automate manufacturing of CRISPR-edited GD2 CAR-T therapy
Cell therapy, cell therapy manufacturing, CAR-T, CRISPR, cancer, automated manufacturing - Read more

THE GOOD
Product Launches

eXoZymes launches BioClick, an enzyme engineering platform for precise chemical reactions, funded by $300K NIH grant
Enzyme, enzyme engineering, click chemistry - Read more

Quest Diagnostics launches blood test predicting amyloid plaques in Alzheimer's patients with 87% accuracy
Blood test, Alzheimer's disease, diagnostics - Read more

THE GOOD
Regulatory

FDA reverses telework ban after staff departures threaten essential functions like drug approvals
Food & Drug Administration (FDA), public agency layoffs, remote working - Read more

FDA will phase out required animal testing for drugs, recognizing more effective human-relevant methods exist
Non-animal models, monoclonal antibody, small molecule, drug approval process, drug development, animal testing - Read more

THE GOOD
Research

Study shows GLP-1 or combined GLP-1/GIP obesity drugs can minimize lean muscle loss during weight loss with expert supervision
GLP-1, obesity, lean mass preservation - Read more

Orexo and Abera report positive results for powder-based intranasal influenza vaccine using AmorphOX technology; rat studies
Inhaled therapy, vaccine, drug delivery, influenza - Read more

Atalanta's RNA therapy ATL-201 reduced seizures by 84% in mice with rare epilepsy, advancing toward clinical trials
siRNA, epilepsy - Read more

PRESENTED BY YOU?
Get the attention of 1900+ Biotech & Pharma Professionals 🤩

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
Clinical Trials

Alzheon's Alzheimer's drug valiltramiprosate failed Ph3 trial, showing no significant improvement over placebo for APOE4 patients with early Alzheimer's disease
Small molecule, Alzheimer's disease - Read more

THE BAD
Earnings & Finances

Charles River Labs stock plunges 28% as FDA announces plans to phase out animal testing requirements for drugs approvals, threatening business model
Non-animal models, monoclonal antibody, small molecule, drug approval process, drug development, animal testing - Read more

THE BAD
Layoffs

Opthea cuts 65% of staff after Phase III trial failures of sozinibercept for AMD treatment showed no benefits
Fusion protein, age-related macular degeneration (AMD) - Read more

Pfizer laying off 56 employees in R&D restructuring
Big pharma layoffs - Read more

THE BAD
Market Reports

Survey reveals newer psychiatric drugs struggle to gain HCP recognition, with 76% of mindshare going to older medicines
Psychiatry, physician opinions, drug marketing - Read more

THE BAD
Strategic Plans

Tempest Therapeutics funding snag, seeks partner to fund Phase III trial for liver cancer hopeful amezalpat (PPAR⍺ antagonist) amid capital challenges
Small molecule, liver cancer - Read more

Keros adopts poison pill defense after investor pressure, initiates strategic review including potential sale
Poison pill, monoclonal antibody, fusion protein, pulmonary arterial hypertension (PAH), myelodysplastic syndrome, myelofibrosis - Read more

THE UGLY
Politics & Policy

CDC lacks an Acting Director despite website and memos claiming Monarez still leads the agency
Centers for Disease Control and Prevention (CDC) - Read more

Public health group demands Kennedy's resignation, citing scientific disregard and harmful health policies
US Department of Health & Human Services (HHS) - Read more [Paywall]

CDC shutters small alcohol program, leaving states uncertain about funding and support for prevention efforts
Centers for Disease Control and Prevention (CDC), alcohol use disorder - Read more [Paywall]

THE UGLY
Public Health

RFK Jr. promotes measles vaccination while questioning other vaccines' safety and downplaying the threat of a growing measles outbreak
Vaccine, vaccine hesitancy - Read more [Paywall]

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