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. 📣

THE GOOD
Approvals & Labels

FDA approves Boehringer Ingelheim's jascayd (nerandomilast) PDE4 inhibitor for idiopathic pulmonary fibrosis following Ph3 success
Small molecule, respiratory disease, PDE4 inhibitor, idiopathic pulmonary fibrosis, FDA approval - Read more

FDA approves Johnson & Johnson's SIMPONI (golimumab) TNF-alpha inhibitor for pediatric ulcerative colitis treatment
Antibody, autoimmune, monoclonal antibody, ulcerative colitis, TNF inhibitor, pediatric population - Read more

IceCure Medical's ProSense cryoablation device wins FDA approval for early-stage breast cancer treatment
Medical device, cancer, cryoablation, breast cancer, early-stage treatment, elderly patients - Read more

Zydus Lifesciences receives FDA approval for generic Deflazacort oral suspension treating Duchenne muscular dystrophy patients.
Small molecule, neurological, corticosteroid, Duchenne muscular dystrophy, anti-inflammatory - Read more

Cosmo Pharmaceuticals receives South Korean approval for Winlevi androgen-receptor inhibitor cream treating acne vulgaris in patients 12+
Small molecule, dermatological, topical therapy, acne vulgaris, androgen receptor antagonist - Read more

Lexeo says FDA open to accelerated approval of LX2006 gene therapy for Friedreich's ataxia
Gene therapy, neurological, adeno-associated virus, Friedreich's ataxia, cardiomyopathy, accelerated approval - Read more

THE GOOD
Business Development & Partnerships

MEDSIR, Ataraxis AI collaborate on AI-powered breast cancer treatment prediction platform
Research collaboration, oncology, AI/ML, drug discovery - Read more

OXB buys viral vector facility from National Resilience for $4.5M, expanding US manufacturing capabilities
Acquisition, manufacturing, gene therapy, US expansion - Read more

MOLCURE, Boehringer Ingelheim partner on AI-driven antibody drug discovery for multiple targets
Research collaboration, antibody, AI/ML, oncology, autoimmune, infectious disease - Read more

Kazia Therapeutics, QIMR Berghofer collaborate on first-in-class PD-L1 protein degrader NDL2
Licensing deal, oncology, protein degrader, immunotherapy - Read more

PRESENTED BY YOU?
Get the attention of 2200+ 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]

✅ More Good News ✅

THE GOOD
Clinical Trials

AstraZeneca's baxdrostat hits Ph3 win targeting aldosterone synthase for treatment-resistant hypertension, advancing regulatory filings
Small molecule, cardiovascular, aldosterone synthase inhibitor, treatment-resistant hypertension, phase 3 trial - Read more

BlueRock Therapeutics reports positive 36-month Ph1 results for bemdaneprocel cell therapy in Parkinson's disease
Cell therapy, neurological, stem cell therapy, Parkinson's disease, dopamine restoration - Read more

RIBOMIC reports positive Ph2 results for umedaptanib pegol anti-FGF2 aptamer in achondroplasia, plans Ph3 trial
Protein therapy, genetic disorder, aptamer, achondroplasia, FGF2 target, pediatric - Read more

Johnson & Johnson's icotrokinra meets Ph2b endpoints in ulcerative colitis, targeting IL-23 pathway ahead of Ph3 trials
Small molecule, autoimmune, IL-23 inhibitor, ulcerative colitis, inflammatory bowel disease, Phase III - Read more

Johnson & Johnson's tremfya shows sustained Ph3 results through 48 weeks in ulcerative colitis treatment
Monoclonal antibody, autoimmune, IL-23 inhibitor, ulcerative colitis, subcutaneous delivery - Read more

Herantis reports positive Ph1b results for HER-096 CDNF therapy in Parkinson's disease, advancing to Ph2
Protein therapy, neurological, Parkinson's disease, subcutaneous injection, blood-brain barrier crossing - Read more

Adicet Bio reports positive Ph1 ADI-001 gamma delta T cell therapy data for lupus nephritis and systemic lupus erythematosus
Cell therapy, autoimmune, gamma delta T cell therapy, lupus nephritis, systemic lupus erythematosus, allogeneic therapy - Read more

Arcus Biosciences reports casdatifan HIF-2a inhibitor shows 35% response rate in Ph1 clear cell renal cell carcinoma
Small molecule, cancer, HIF-2α inhibitor, clear cell renal cell carcinoma, autoimmune - Read more

MaaT Pharma's MaaT033 microbiome therapy clears second safety review in Ph2b allogeneic stem cell transplant trial
Microbiome therapy, cancer, hematopoietic stem cell transplantation, oncology, immune modulation - Read more

THE GOOD
Company Launches

Soufflé Therapeutics launches with $200M Series A + big pharma partners to advance targeted siRNA medicines
siRNA, platform technology, rare disease, metabolism, preclinical - Read more

GEMMABio spins out Rare Therapeutics to develop gene therapies for ultra-orphan lysosomal storage disorders
Gene therapy, rare disease, strategic, operational - Read more

GLD, Heligenics launch Altagenics for muscle-wasting treatments using GigaAssay platform
Research collaboration, rare disease, drug discovery, AI/ML - Read more

THE GOOD
Fundraises

Kernal Bio receives $48M government funding for in vivo mRNA CAR-T development
mRNA platform, cell therapy, autoimmune, oncology, clinical-stage - Read more

MapLight seeks $227M IPO for neuropsychiatric drug development portfolio
Neurological, small molecule, clinical-stage, Alzheimer disease - Read more

DemeRx raises $1.7M SBIR grant, neuroplastogen candidate for alcohol use disorder
Neurological, clinical-stage, small molecule, alcohol use disorder - Read more

Peer AI raises $12.1M funding for AI-powered drug regulatory documentation platform
AI/ML platform, regulatory affairs, software platform, services - Read more

Celaid Therapeutics raises $7.2M Series B for ex vivo hematopoietic stem cell therapy
Cell therapy, hematopoietic stem cell, platform technology, clinical-stage - Read more

TORL raises $96M Series C, CLDN6-targeted ADC for platinum-resistant ovarian cancer
Oncology, antibody-drug conjugate, clinical-stage, ovarian cancer - Read more

AeroRx raises $21M Series A for nebulised COPD treatment Phase IIb study
Respiratory disease, small molecule, clinical-stage, drug delivery - Read more

Affinia Therapeutics raises $40M Series C for AAV gene therapies development
Gene therapy, cardiovascular, neurological, AI/ML platform, clinical-stage - Read more

Jade Biosciences raises $135M PIPE, autoimmune disease therapies development
Autoimmune, clinical-stage - Read more

THE GOOD
Lawsuits

Gilead settles biktarvy patent disputes with three generics, extending US exclusivity until 2036
Small molecule, infectious disease, strategic, patent settlement, revenue protection - Read more

THE GOOD
Product Launches

Benchling launches AI command centre integrating agents and predictive models for drug discovery acceleration
AI platform, multi-therapeutic, strategic, operational - Read more

THE GOOD
Regulatory

Eli Lilly hires former FDA vaccine chief Peter Marks as SVP molecule discovery, infectious disease head
Infectious disease, vaccine, gene therapy, regulatory, drug discovery - Read more

THE BAD
Lawsuits

Novo Nordisk loses Medicare price cuts appeal, extending pharma's legal defeats against IRA
Insulin, diabetes, regulatory, financial, competitive - Read more

THE BAD
Market Reports

Report finds most U.S. life sciences firms holding investment plans despite Trump’s pharma tariffs, while Big Pharma boosts U.S. spending
Tariffs, policy impact, strategic, financial, investment - Read more

THE UGLY
Lawsuits

J&J ordered to pay record $966M in baby powder mesothelioma lawsuit, plans immediate appeal
Consumer product, oncology, legal liability, financial impact, regulatory risk - 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! ♻️

And lastly - connect with me on LinkedIn!

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