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THE GOOD
Approvals & Labels

Arcutis Biotherapeutics lands dermatitis label expansion for Zoryve (roflumilast) from the FDA
Small molecule, atopic dermatitis - Read more

Almirall wins a NICE recommendation for novel eczema treatment
Monoclonal antibody, atopic dermatitis, atopic eczema - Read more

Elevar Therapeutics, Jiangsu Hengrui Pharma aren’t giving up on an approval after surprise FDA rejection
Monoclonal antibody, liver cancer - Read more

THE GOOD
Business Development

Amylyx Pharmaceuticals acquires Ph3 ready GLP-1 asset from Eiger BioPharmaceuticals
GLP-1, post-bariatric hypoglycemia, congenital hyperinsulinism - Read more

Xylocor Therapeutics buys license for SmartCella gene therapy delivery tech
Gene therapy, refractory angina - Read more

THE GOOD
Clinical Trials

Kazia Therapeutics doesn’t let a failed brain cancer clinical trial stop them from seeking FDA accelerated approval
Small molecule, glioblastoma, cancer - Read more

Allucent handed BARDA contract to help with Decentralized Clinical Operations for Healthcare and Research (D-COHRe) initiative 
Decentralized clinical trials, pandemic response, CRO - Read more

Skyhawk Therapeutics touts positive Ph1 clinical trial data
Small molecule, Huntington’s - Read more

THE GOOD
Fundraises

Flagship Pioneering raises monster $3.5B total for 8th fund
Biotech investing, venture capital - Read more

Ideaya Biosciences $200M public offering
Small molecule, cancer - Read more

Immuneel Therapeutics $12M Series A extension
CAR-T cell therapy, cancer - Read more

HepaRegeniX €15M ($16M) Series C
Small molecule, liver disease - Read more

NOWDiagnostics $22.5M Series B
Diagnostics, blood testing - Read more

THE GOOD
Lawsuits

CytoDyn settles with Amarex Clinical
Monoclonal antibody, non-alcoholic fatty liver disease (NASH), HIV, cancer - Read more

THE GOOD
Market Reports

China-based clinical trial numbers jump, outpacing Eastern Europe
Clinical trial geography - Read more

THE GOOD
Mergers & Acquisitions

Illumina buys Fluent Biosciences (terms undisclosed)
Single cell analysis, sequencing - Read more

ReShape Lifesciences merges with Vyome Therapeutics
Metabolic health, immuno-inflammatory diseases, rare disease - Read more

THE GOOD
Partnerships

Pfizer, Evotec go in on drug discovery & research pact
Drug discovery, metabolic disease, infectious disease - Read more

Novo Nordisk secures insulin partnership in Indonesia with local org Biofarma
Insulin, diabetes, manufacturing - Read more

Aspect Biosystems secures $200M partnership with Governments of Canada and British Columbia
Biomanufacturing, bioprinted tissue manufacturing - Read more

THE GOOD
Politics & Policy

CMS adjustments mean patients have greater access to PET imaging agents and radiopharmaceuticals
Medicare, positron emission topography, radiopharm - Read more

And the above news sends Lantheus stock up 30%
Precision diagnostics, radiopharm, cancer - Read more

THE GOOD
Research

Newly discovered “maternal brain hormone” build bone density in mice; potential osteoporosis treatment
Hormone therapy, osteoporosis - Read more

THE GOOD
Strategic Plans

Bayer’s strategic reorg chugs along; thankfully, commercial team layoffs will end this year - Read more 

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THE BAD
Layoffs

Citing increased competition and “payor dynamics”, Indivior makes about-face and lays off 130
Small molecule, opioid addiction treatment - Read more

THE BAD
Market Reports

Potential bad news for GLP-1 makers, as analysis finds Ozempic users stop after 2 years
GLP-1, weight-loss, obesity, diabetes - Read more

THE BAD
Politics & Policy

CDER-CBER misalignment causes concern as the FDA’s 2025 funding bill comes under scrutiny
Center for Biologics Evaluation and Research, Center for Drug Evaluation and Research - Read more [Paywall]

THE UGLY
Withdrawals & Recalls

Medtronic recalls endotracheal tubes due to risk of blockage, death
Medical device, endotracheal tubes - Read more

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

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