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THE GOOD
Approvals & Labels

Takeda's Takhzyro (targeting plasma kallikrein) nabs EMA approval for subcutaneous administration via pre-filled syringe in hereditary angioedema patients aged 12+
Monoclonal antibody, hereditary angioedema - Read more

Indivior's Sublocade (partial mu-opioid receptor agonist, kappa-opioid receptor antagonist) lands FDA approval in treating opioid use disorder
Small molecule, opioid use disorder - Read more

Medtronic received FDA approval for BrainSense, an adaptive deep-brain stimulator to treat motor symptoms of Parkinson's disease
Medical device, deep-brain stimulation, Parkinson's disease - Read more

PRESENTED BY TLDR BIOTECH
The 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
Clinical Trials

BioCryst Pharmaceuticals showcases positive Ph3 data for Orladeyo (plasma kallikrein inhibitor) in pediatric hereditary angioedema
Small molecule, hereditary angioedema - Read more

OSE Immunotherapeutics' lusvertikimab (IL-7R antagonist) delivers positive Ph2 results in moderate to severe ulcerative colitis
Monoclonal antibody, ulcerative colitis - Read more

Hengrui Medicine showcases positive Ph3 data for dalpiciclib (CDK4/6 inhibitor) + endocrine therapy in reducing recurrence risk in hormone receptor-positive, HER2-negative breast cancer
Small molecule, breast cancer - Read more [Press release in Chinese]

Axsome Therapeutics' Symbravo (meloxicam, (COX)-2 inhibitor + rizatriptan, 5-HT 1B and 5-HT 1D receptor agonist) delivers positive Ph3 data in treating migraines
Small molecule, migraine, combo therapy - Read more

PepGen touts positive Ph2 data for PGN-EDODM1 (DMPK modulator) in myotonic dystrophy type 1
Oligonucleotide, myotonic dystrophy type 1 - Read more

Astria Therapeutics initiates Ph3 trial for navenibart (plasma kallikrein inhibitor) in hereditary angioedema
Monoclonal antibody, hereditary angioedema, clinical trial initiation - Read more

AN2 Therapeutics submits amended Ph3 statistical plan to FDA for EBO-301 in MAC lung disease
Small molecule, MAC lung disease - Read more

Entrada Therapeutics' exon 44 skipping therapy for Duchenne muscular dystrophy cleared FDA clinical hold; Ph1b trial to start enrolling patients in 2026
Oligonucleotide, Duchenne’s muscular dystrophy (DMD) - Read more

THE GOOD
Company Launches

Kineticos Life Sciences launches Kinvard Bio, licensing Harvard research to combat antimicrobial resistance through KAMRA I fund
Small molecule, infectious disease, antimicrobial resistance - Read more

OS Therapies launches subsidiary OS Drug Conjugates in-order to drive partnerships in the US and China for it’s pH-triggered ADC development platform
Antibody-drug conjugate, clinical development, platform technology - Read more

THE GOOD
Earnings & Finances

Eyenovia restructures debt, defers payments until September 2025, provides some breathing room as “strategic alternatives” continues
Small molecule, pediatric progressive myopia, drug-device combo - Read more

THE GOOD
Fundraises

OrganOx $142M raise, expands commercial reach for liver transplant preservation system with international approvals
Organ transport, donor tissue preservation, organ transplant, liver failure - Read more

THE GOOD
Investments

Amgen to invest $200 million in new Indian tech center focused on AI and data science for drug development
New facility, AI, data science, drug development - Read more

THE GOOD
Mergers & Acquisition

Blackstone is close to acquiring Summit Partners-backed VaxCare Corp for $1.7 billion including debt, according to sources
Vaccine, vaccine management - Read more

Maravai acquires Officinae Bio's DNA/RNA business, integrating AI-enabled mRNA design with drug manufacturing capabilities
DNA, mRNA, drug substance manufacturing, AI - Read more

THE GOOD
Partnerships

Pfizer, Summit Therapeutics collaborating to test ivonescimab (targeting PD-1, VEGF) with Pfizer's ADCs for solid tumors
Antibody-drug conjugate, bispecific antibody, solid tumor, cancer, clinical collaboration - Read more

Simbec-Orion, Avance Clinical sign MOU to formalize partnership offering global clinical trial solutions for biotech companies
CRO, CRO partnership - Read more

Swarm Oncology, Cellex partnership to advance T cell therapies for solid cancers through manufacturing and development support
Cell therapy, solid tumor, cancer, CDMO, cell therapy manufacturing, T cell therapy - Read more

THE GOOD
Patient Access

NKGen Biotech administered troculeucel to a frontotemporal dementia patient under FDA-cleared compassionate use program
Cell therapy, frontotemporal dementia, Natural Killer (NK) cell, compassionate use - Read more

THE GOOD
Politics & Policy

Democrats voice concern over FDA layoffs from DOGE initiative, citing risks to drug review process
Drug approval process, Food & Drug Administration (FDA) - Read more

THE GOOD
Product Launches

Labcorp launches blood test for genomic profiling of advanced solid tumors, guiding personalized cancer treatment decisions
Genomic profiling, blood test, diagnostic test, cancer, personalized medicine - Read more

THE GOOD
Public Health

US CDC participates in WHO flu vaccine planning meeting despite Trump's planned withdrawal from the organization
Vaccine, World Health Organization (WHO), influenza vaccine, CDC - Read more [Read more]

THE GOOD
Research

CytoDyn reports promising survival outcomes in metastatic triple-negative breast cancer patients treated with leronlimab, initiates pre-clinical studies
Monoclonal antibody, breast cancer - Read more

PRESENTED BY YOU?
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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.

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THE BAD
Approvals & Labels

FDA declines to expand Invivyd's Pemgarda (targeting SARS-CoV-2 spike protein receptor binding domain) emergency use authorization to treat COVID-19 in immunocompromised individuals
Bispecific antibody, COVID-19 - Read more

THE UGLY
Criminal Acts

Police officer killed in shootout after armed man took hospital staff hostage at UPMC Memorial
Shooting - Read more

THE UGLY
Lawsuits

Deerfield sues Alcon Research for allegedly attempting to block Aurion Biotech's NYSE listing to acquire it cheaply
Activist investor, M&A strategy - Read more

THE UGLY
Public Health

Small study suggesting rare vaccine side effects similar to long Covid sparks online controversy, highlighting misuse of scientific research
Vaccine, COVID-19, adverse event, long Covid, vaccine hesitancy - Read more [Paywall]

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

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