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THE GOOD
Approvals & Labels

Distalmotion lands FDA de novo clearance for hernia repair in outpatient setting
Surgical robotics, inguinal hernia repairs - Read more

THE GOOD
Clinical Trials

Novo Nordisk sMASHes the accelerator towards MASH approval for semaglutide after positive Ph3 showing
GLP-1, metabolic dysfunction-associated steatohepatitis - Read more

Biofrontera’s “highly significant” Ameluz + photodynamic therapy Ph3 skyrockets stock
Small molecule, basal cell carcinoma, photodynamic therapy, cancer - Read more

Nanoscope Therapeutics touts positive 2-year Ph2b data for retinitis pigmentosa gene therapy hopeful MCO-010
Gene therapy, retinitis pigmentosa, eye disease - Read more

Bristol Myers Squibb showcases promising 52 week Ph3 Cobenfy data in schizophrenia
Small molecule, schizophrenia - Read more

Curevo Vaccine posts positive amezosvatein shingles vaccine Ph2 data, similar efficacy but better lower dose reactogenicity events at highest dose compared to Shingrix (GSK)
Vaccine, shingles - Read more

Supernus Pharmaceuticals posts “promising” Ph2a data for SPN-820 in major depressive disorder
Small molecule, major depressive disorder - Read more

CARsgen Therapeutics clinical holds on three cell therapy assets lifted by FDA
Cell therapy, cancer, CAR-T - Read more

Roche’s posts data to back up Elecsys Amyloid Plasma Panel being able to rule out an Alzheimer’s disease diagnosis
Diagnostics, blood test, Alzheimer’s disease - Read more

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THE GOOD
Fundraises

Garuda Therapeutics $47M raise, blood stem cell therapies
Cell therapy, stem cells, self-renewing stem cells - Read more [Paywall]

Eupraxia Pharmaceuticals $44.5M private placement
Small molecule, eosinophilic esophagitis, knee osteoarthritis, microsphere-based drug delivery - Read more

Alpha Cognition $25M public offering and proposed reverse stock split
Small molecule, Alzheimer’s disease, mild traumatic brain injury - Read more

Ataraxis AI $4M Seed raise, AI precision medicine for cancer
Precision medicine, cancer, AI, multi-modal diagnostic tests - Read more

Persperity Health $1M Pre-seed, sweat-sending tech focused on women’s health
Medical device, sweat sensing, women’s health - Read more

THE GOOD
Lawsuits

Apotex, Heritage Pharmaceuticals pay combined $49.1M to settle antitrust, price-fixing allegations
Generic, price-fixing, antitrust - Read more

THE GOOD
Partnerships

Formosa Pharmaceuticals partners with DÁVI Farmacêutica to commercialize ophthalmic medicine APP13007 in Portugal
Small molecule, inflammation and pain following ocular surgery - Read more

THE GOOD
Regulatory

FDA reconsidering last year’s CAR-T secondary cancer black box warnings
Cell therapy, cancer, CAR-T, black box warning - Read more

THE GOOD
Strategic Plans

Roche mulls over “speedy path” to FDA approval if trontinemab does well in Ph3 Bispecific antibody, Alzheimer’s disease - Read more

Kymera Therapeutics makes full pivot to immunology, seeks partners for cancer assets beyond Ph1
Small molecule, proteolysis-targeting chimeras, cancer, immunology - Read more

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THE BAD
Clinical Trials

ESSA Pharma halts masofaniten Ph2 after conducting futility analysis
Small molecule, prostrate cancer - Read more

THE BAD
Earnings & Finances

Regeneron Pharmaceuticals’ Eylea franchise growth comes into doubt after slower-than-expected high-dose format adoption, shares sink nearly 10%
Fusion protein, neovascular (wet) age-related macular degeneration (AMD) - Read more

THE BAD
Lawsuits

Big pharmas Bristol Myers Squibb, Johnson & Johnson, AstraZeneca asks judge to revive their IRA legal challenge
Inflation reduction act, drug pricing, drug price negotiations - Read more

THE BAD
Partnerships 

Leo Pharma, Kyowa Kirin terminate Dovobet distribution, co-promotion agreement in Japan
Small molecule, psoriasis vulgaris - Read more

THE UGLY
Layoffs

Maven Clinic, a month after a $125M Series F, cuts 10% of their staff (60 people)
Women’s health, health tech - Read more [Paywall]

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

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