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THE GOOD
Approvals & Labels

argenx’s gMC antibody fragment lands China’s NMPA approval
Antibody fragment, protein, generalized myasthenia gravis - Read more

THE GOOD
Business Development

Sionna Therapeutics in-licenses abandoned AbbVie cystic fibrosis assets
Small molecule, drug combo, cystic fibrosis - Read more

THE GOOD
Clinical Trials

Pliant Therapeutics touts positive long-term Ph2a data
Small molecule, primary sclerosing cholangitis (PSC), liver fibrosis - Read more

THE GOOD
Earnings & Finances

Sobi posts impressive Q2 2024 growth across their portfolio
Small molecule, hematology, immunology - Read more

THE GOOD
Fundraises

Cardurion Pharmaceuticals $260M Series B; small molecules targeting heart failure and a rare arrhythmia
Small molecule, cardiovascular, heart failure, catecholaminergic polymorphic ventricular tachycardia - Read more

Asceneuron $100M Series C
Small molecule, Alzheimer’s - Read more

CatalYm $150M Series D
Monoclonal antibody, solid tumor, cancer - Read more

Scorpion Therapeutics $150M Series C
Small molecule, breast cancer - Read more

Thyme Care $95M Series C
Cancer care enabler, collaborative care model, patient journey - Read more

Huma $80M raise
AI digital health platform, remote patient monitoring - Read more

Neuspera $23M Series D
Medical device, urinary urge incontinence (UUI) implantable sacral neuromodulation - Read more

NovoNutrients $18M Series A
Food biotech, CO2 to food - Read more

Predicta Biosciences $5.2M Seed raise
Diagnostic and monitoring platform, non-invasive diagnostics, multiple myeloma, cancer - Read more

THE GOOD
Investments

CordenPharma invests €900M ($981M) in GLP-1 manufacturing capacity
GLP-1 peptide, manufacturing - Read more

THE GOOD
Lawsuits

Johnson & Johnson proposes $505M settlement for former (now bankrupt) talc suppliers settlement trust for talc claimants
Talc, cancer - Read more

THE GOOD
Partnerships

Vertex Pharmaceuticals, Orum Therapeutics partner on developing new Casgevy conditioning regiment; Orum gets $15M upfront, $310M biobucks
Degrader-antibody conjugates, gene editing therapy, conditioning therapy- Read more

Vertex Pharmaceuticals, Genomics drug discovery collab extension and expansion
Casual disease pathways, precision medicine, drug discovery - Read more

SOTIO Biotech, Biocytogen ADC R&D and licensing agreement; Biocytogen gets $325.5M upfront and biobucks
Antibody-drug conjugate, solid tumor - Read more

SPI Pharma, Inimmune partner on development, commercialization of vaccine adjuvant systems
Vaccines, adjuvant systems - Read more

Inocras, Watchmaker Genomics genomic tools development partnership expansion
Genome sequencing, bioinformatics, deep sequencing - Read more

THE GOOD
Patient Access

Medicare propose 2025 start date to cover some digital therapeutics
Digital therapeutics, medicare, mental health, CMS - Read more

THE GOOD
Politics & Policy

Cali attorney and 21 attorneys general file amicus brief in support of drug price transparency laws - Read more

THE GOOD
Regulatory

Field trip! The FDA wants to visit a cell & gene therapy site near you, but not for inspections
Cell & gene therapy manufacturing, facility tour - Read more

THE GOOD
Research

Small molecule mitochondrial protectant prevented organ damage from COVID-19 in mice
Small molecule, COVID-19, organ damage - Read more

LLMs/AI answering real world clinical questions? Depends on the system, and purpose-built models might be the way
Clinical setting, AI, LLM, patient care - Read more

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THE BAD
Approvals & Labels

Orexo receives “unexpected” FDA CRL
Naloxone, nasal spray, opioid overdose reversal - Read more

THE BAD
Patient Access

ICER doesn’t like Verona Pharma’s COPD treatment price, says will restrict access
Small molecule, drug pricing, chronic obstructive pulmonary disease (COPD) - Read more

Novo Nordisk’s decision to pull long-acting insulin product (in light of Ozempic and Wegovy success) draws scrutiny
Insulin, diabetes, obesity - Read more

THE BAD
Politics & Policy

Big Pharma’s DTC ad-spending tax “loophole” comes under fire again
Drug ads, taxation, direct-to-consumer - Read more

AstraZeneca isn’t admitting the IRA loss easily, submits appeal alongside Johnson & Johnson and Bristol Myers Squibb
Drug pricing, inflation reduction act - Read more

THE UGLY
Lawsuits

PBM-targeting drug pricing lawsuit in Hawaii tossed out
Pharmacy benefit manager, drug pricing - Read more [Paywall]

Masimo sues activist investor PolitanCapital Management over “material misstatements and omissions” in shareholder materials
Medical device, patient monitoring, pulse oximeter - Read more

THE UGLY
Warning Letters, Form 483

FDA finds Jiangsu Hengrui facility in an abysmal state, multiple concerns
Form 483, drug manufacturing, contaminants, quality control - Read more

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

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