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THE GOOD
Approvals & Labels

Roche, Genetech's TNKase (tissue plasminogen activator) lands FDA approval for acute ischemic stroke
Enzyme, ischemic stroke, heart attack - Read more

Krystal Biotech receives positive CHMP opinion for Vyjuvek (beremagene geperpavec-svdt) for treating dystrophic epidermolysis bullosa patients with COL7A1 mutations
Gene therapy, dystrophic epidermolysis bullosa, herpes simplex virus (HSV) - Read more

PRESENTED BY TLDR BIOTECH
Chinese Biotech Ecosystem - what do you want to know?

It's a unique time to be attending a Chinese biotech conference - the BIOSECURE Act, the current US political climate, and pharma's increasing interest in licensing China-originating assets should make for an interesting event.

From my attendance, I'll be putting together a report on the Chinese biotech space for TLDR Biotech - but this is where I need your help:

What questions do you have about this unique ecosystem? What do you want to know?

I'll try my best to answer these questions in this report - send me your questions in an email to [email protected] (if you’re received this newsletter in an email, just hit reply!).

Or even better - if you/your company is attending, let me know! Would be great to meet at the event.

⬇️ More Good News ⬇️

THE GOOD
Business Development

Novartis in-licenses Kyorin Pharmaceutical's KRP-M223 (MRGPRX2 antagonist) for $55M upfront, potentially $777M total
Small molecule, chronic spontaneous urticaria - Read more

AbbVie jumps into the obesity foray, paying Gubra $350M upfront (+ up to $1.9B in biobucks) for once-weekly obesity hopeful GUB014295 (amylin, calcitonin receptor agonist)
Amylin analogues, obesity - Read more

THE GOOD
Clinical Trials

Protagonist Therapeutics and Takeda's injectable rusfertide (hepcidin peptide mimetic) delivers Ph3 success, targeting excess red blood cells in polycythemia vera patients
Peptide mimetic, polycythemia vera, cancer - Read more

Roche's injectable Xolair (anti-IgE) outperforms oral competitor in Ph3 trial for multiple food allergies
Monoclonal antibody, food allergy - Read more

Celldex Therapeutics’ barzolvolimab (KIT inhibitor) delivers positive Ph2 data in chronic urticaria
Monoclonal antibody, chronic urticaria - Read more

Daiichi Sankyo and AstraZeneca's Enhertu (HER2-directed ADC) touts superior survival in Ph3 trial versus Eli Lilly's VEGFR2 inhibitor Cyramza in second-line HER2+ gastric cancer
Antibody-drug conjugate (ADC), gastric cancer - Read more

Voyager Therapeutics' showcases promising Ph1 data for VY7523 (anti-tau) in Alzheimer's disease
Monoclonal antibody, Alzheimer's disease - Read more

THE GOOD
Company Launches

Callio Therapeutics launches with $187M Series A, developing multi-payload antibody-drug conjugates to improve cancer therapy
Antibody-drug conjugate (ADC), cancer - Read more

THE GOOD
Fundraises

Nuvation Bio $250M non-dilutive financing, funding future commercialization efforts of taletrectinib (targeting ROS1) if approved
Small molecule, lung cancer - Read more

Myosin Therapeutics $3M second seed round, developing novel therapies for cancer and neurological disorders using molecular nanomotor-targeting compounds
Small molecule, glioblastoma, cancer - Read more

Pulnovo Medical $100M Series C, develoing medical devices for pulmonary hypertension and heart failure
Medical device, pulmonary hypertension, heart failure - Read more

Biocomposites undisclosed investment from Novo Holdings and TA Associates investment, medical devices company expanding operations and R&D
Biocomposites, medical device - Read more

SimCare AI $2M Seed raise, utilizing AI patient personas to train clinical skills
Clinical skills, clinical training, AI - Read more

Faks raises €6M ($6.47M) to centralize and streamline digital services for pharmacies.
Software, pharmacy operations - Read more

THE GOOD
Market Reports

GSK's higher-priced COPD inhalers justified, according to ICER, due to advantages over generics
Small molecule, chronic obstructive pulmonary disease (COPD), generic - Read more

THE GOOD
Mergers & Acquisition

Blackstone acquires 60% stake in Japanese CRO CMIC
CRO (Contract Research Organization), private equity investment - Read more (Paywall)

Boston Scientific acquires SoniVie for $540M, entering renal denervation market
Medical device, renal denervation, hypertension - Read more

THE GOOD
Partnerships

Proteotype Diagnostics, Five Alarm Bio collaborate to study biomarkers for cellular senescence to advance anti-aging treatments
Diagnostics, biomarker, research & development - Read more

Novo Nordisk, Gensaic partner to development cardiometabolic therapies using AI-enabled FORGE technology
Protein, drug discovery, drug development, platform technology, cardiometabolic disease, drug delivery - Read more

THE GOOD
Product Launches

IN8bio unveils INB-600, a gamma-delta T cell platform for cancer and autoimmune diseases with improved efficacy
Cell therapy, platform technology, cancer, autoimmune disease, gamma-delta T cell therapy, T-cell engager - Read more

PRESENTED BY YOU?
Get the attention of 1800+ 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
Approvals & Labels

Australia rejects Eisai and Biogen's Leqembi (anti-beta amyloid) for mild Alzheimer's disease, citing safety concerns outweighing efficacy
Monoclonal antibody, Alzheimer's disease, Alzheimer's dementia - Read more

THE BAD
Business Development

Sanofi returns immune checkpoint inhibitor BND-22 (ILT2 antagonist) to Biond Biologics, citing R&D prioritization, despite promising phase 1 results
Monoclonal antibody, cancer, solid tumor - Read more

THE BAD
Clinical Trials

Lexicon Pharmaceuticals advances pilavapadin (AAK1 inhibitor) to Ph3 trials for diabetes-related pain - despite not beating failing in Ph2b
Small molecule, pain, non-opioid pain, diabetes-related pain - Read more

Biohaven Pharmaceutical's BHV-7000 (Kv7.2/7.3 potassium channel activator) flops in Ph3 trial for bipolar mania
Small molecule, bipolar disorder, bipolar mania - Read more

Pliant Therapeutics discontinues Ph2b/3 trial of bexotegrast (αvβ6, αvβ1 integrins inhibitor) in idiopathic pulmonary fibrosis due to safety imbalance between treatment and placebo groups
Small molecule, Idiopathic pulmonary fibrosis - Read more

Neumora Therapeutics pauses two Ph3 trials of navacaprant for major depressive disorder after earlier Ph3 failure, implementing study design changes
Small molecule, major depressive disorder - Read more

THE BAD
Mergers & Acquisition

Vincerx Pharma faces uncertain future after Oqory reverse merger collapses, threatening cash reserves
Antibody-drug conjugate (ADC), cancer, solid tumor - Read more

THE BAD
Patient Access

Indian pharma companies warn Trump's tariff threats could raise US drug prices without relocating manufacturing
Generic, drug pricing, tariffs - Read more

THE UGLY
Criminal Acts

DOJ investigates Semler Scientific's QuantaFlo test marketing, which led to PAD diagnoses increasing UnitedHealth's government reimbursements
Peripheral artery disease, fraud, diagnostics - Read more [Paywall]

THE UGLY
Politics & Policy

HHS spokesman Thomas Corry abruptly resigns amid tensions with Secretary RFK Jr. and his team
US Department of Health & Human Services (HHS), political appointee - Read more [Paywall]

THE UGLY
Public Health

Trump administration ends 5,800 USAID contracts, cutting HIV, polio, and malaria programmes in impoverished African communities
Low- and middle-income countries, polio, malaria, human immunodeficiency virus (HIV) - Read more

You’re all caught up on the latest Pharma & Biotech News!

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