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THE GOOD
Approvals & Labels

Johnson & Johnson goes for the “broadest” group of patients with nipocalimab FDA approval application
Monoclonal antibody, generalized myasthenia gravis (gMG) - Read more

GSK’s RSV shot approved by European Commission for adults 50-59 years
Adjuvanted vaccine, respiratory syncytial virus (RSV) - Read more

THE GOOD
Clinical Trials

AbbVie touts Ph3 data that could expand Ubrelvy label beyond treating migraines to preventing them
Small molecule, migraine headache - Read more

Gain Therapeutics gains Ph1 win, positive safety data in Parkinson’s-targeting GT-02287
Small molecule, Parkinson’s disease - Read more

Arcutis Biotherapeutics’ positive long-term results build upon Ph3 data for roflumilast cream 0.05% in treating atopic dermatitis
Small molecule, topical, atopic dermatitis - Read more

THE GOOD
Company Incubation

Activation Capital selects 10 startups for Frontier BioHealth program
Business building, pharmaceutical, biotech, medical device - Read more

THE GOOD
Earnings & Finance

Stada Arzneimittel’s posts healthy H1 2024 growth, CEO remains mum over sales by current private equity owners
Consumer healthcare, generic, biosimilar, specialty pharma - Read more

As Novo Holdings acquisition looms (and the FTC spectre waits in the wings), Catalent reports estimate-beating revenue numbers
CDMO, contract development, biomanufacturing - Read more

THE GOOD
Fundraises

Japanese conglomerate Lotte launches healthcare and biopharmaceutical venture capital arm
Venture capital, venture investment - Read more

New Enterprise Associates raises $468M secondary fund
Venture capital, healthcare investment, life science investment - Read more

Oncology Ventures closes first fund, $30M
Venture capital, early-stage startups, oncology, cancer - Read more

Ancilia Biosciences $4.2M financing
Live biotherapeutics, virus-resistant bacteria, CRISPR - Read more

RevolKa JPY250M ($1.7M) Series A extension
Drug discovery, AI, protein engineering - Read more

PsychoGenics $3M Small Business Innovation Research (SBIR) grant
Drug discovery, AI-enabled phenotyping, CNS disorders, neurological disorders - Read more

EydisBio $2.6M Small Business Innovation Research (SBIR) grant
Small molecule, systemic sclerosis, scleroderma - Read more

THE GOOD
Investments

Public-private partnership in Plano, Texas to bring 3 million sqft of life science space to reality at Texas Research Quarter 
Life science park, life science innovation space - Read more

THE GOOD
Lawsuits

Pennsylvania judge sides with Novo Nordisk, Eli Lilly on hearing arguments related to gastrointestinal symptoms related to GLP-1 use
GLP-1, obesity, diabetes, side effects, gas­tro­pare­sis - Read more [Paywall]

THE GOOD
Partnerships

Fujitsu, Paradigm Health partner to combat “drug loss”; approved drugs unavailable inside Japan due to Japanese-patient clinical trial mandates
Drug development, clinical trial, AI - Read more

CancerVax, Flashpoint Therapeutics sign research agreement regarding CancerVax’s “Universal Cancer Treatment“ platform
Cancer vaccine, platform technology, ewing sarcoma - Read more

Qiagen, AstraZeneca to develop companion diagnostics for complex rare diseases
Diagnostics, genotype assay, precision medicine - Read more

THE GOOD
Product Launches

Clinical-grade MDMA manufacturer PharmAla Biotech launches online tool easing access to clinical trial-required batch info (eg. CMC data)
Small molecule, MDMA, psychedelic, quality - Read more

THE GOOD
Regulatory

FDA’s CDER forms a unified AI council, consolidating currently separated AI-related steering committees and policy working groups
Drug development, AI, AI-enabled R&D - Read more

THE GOOD
Research

Afrigen Biologics to explore synthetic DNA as plasmid DNA alternative for mRNA vaccines, enabled by $2.05M grant from CEPI
mRNA, plasmid, synthetic DNA - Read more

New research elucidates mechanism behind the micronuclei rupture and collapse process and its tie-in to cancer
Cancer development, chromosomal instability - Read more

THE GOOD
Strategic Plans

Biocon Biologics begins planning Bmab 1200 (Stelara biosimilar) launch in multiple countries after reaching settlement and license agreement with Janssen (Johnson & Johnson)
Monoclonal antibody, autoimmune, biosimilar - Read more

Lemonaid Health (23andMe subsidiary) jumps on the GLP-1 bandwagon, telemedicine Ozempic, Wegovy, compounded semaglutide offering
GLP-1, weight loss, telemedicine - Read more

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THE BAD
Clinical Trials

Merck’s Keytruda stumbles in new lung cancer and skin cancer indications, clinical trials stopped early
Monoclonal antibody, lung cancer, carcinoma, skin cancer - Read more

THE BAD
Fundraises

Cell & gene therapy fundraises slump as investors look for surer bets
Cell therapy, gene therapy, advanced therapy, drug development - Read more

THE BAD
Layoffs

BioMarin continues job cuts, 225 workers across California sites - Read more

Repare Therapeutics to cut approximately 25% of workforce (around 45 staffers)
Small molecule, ovarian cancer, endometrial cancer - Read more

THE BAD
Market Reports

IRA’s biosimilar reimbursement change, meant to boost biosimilar adoption, has a “limited” impact thus far
Inflation reduction act, biosimilar - Read more

THE UGLY
Warnings Letters, Form 483

Global Calcium handed FDA Form 483 after site inspection in Tamil Nadu, India
Site inspection, active pharmaceutical ingredient (API) manufacturing - Read more

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