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THE GOOD
Approvals & Labels

AstraZeneca's Imfinzi (durvalumab) wins FDA approval for perioperative gastric cancer and gastroesophageal junction cancer treatment
Antibody, cancer, PD-L1 inhibitor, gastric cancer, perioperative treatment, combination therapy - Read more

Sanofi's Dupixent (dupilumab) wins EU approval for chronic spontaneous urticaria targeting interleukin-4 and interleukin-13 pathways
Antibody, autoimmune, monoclonal antibody, chronic spontaneous urticaria, IL-4/IL-13 inhibition - Read more

Otsuka's Voyxact (sibeprenlimab-szsi) wins FDA accelerated approval for primary immunoglobulin A nephropathy following Ph3 success
Antibody, kidney disease, monoclonal antibody, IgA nephropathy, APRIL inhibitor - Read more

CStone's sugemalimab wins European Commission approval for unresectable stage III non-small cell lung cancer
Antibody, cancer, monoclonal antibody, non-small cell lung cancer, PD-L1 target - Read more

Teva Pharmaceuticals receives European Commission approval for PONLIMSI and DEGEVMA (denosumab) biosimilars targeting bone conditions
Antibody, bone disease, monoclonal antibody, biosimilar, denosumab, osteoporosis - Read more

NICE recommends Alnylam's vutrisiran for ATTR-CM treatment, reaching 1,500 patients across England and Wales
Antisense oligonucleotide, cardiovascular, regulatory, strategic - Read more 

THE GOOD
Business Development & Partnerships

AbbVie, adMare BioInnovations launch lab space award program for Quebec biotechs in key therapeutic areas
Business development partnership, immunology, oncology, neuroscience, small molecule - Read more

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✅ More Good News ✅

THE GOOD
Clinical Trials

Novo Nordisk's amycretin shows competitive Ph2 weight loss results in type 2 diabetes patients
Small molecule, metabolic, GLP-1 agonist, type 2 diabetes, obesity, amylin receptor - Read more

Novartis' ianalumab (anti-BAFF mAb) shows Ph3 success in immune thrombocytopenia, extending time to treatment failure
Antibody, autoimmune, monoclonal antibody, immune thrombocytopenia, BAFF target, combination therapy - Read more

THE GOOD
Fundraises

Human Life CORD raises ¥1.9B ($12.1M) Series C for phase III pulmonary trials
Cell therapy, clinical-stage, pulmonary, manufacturing, stem cell - Read more

Zetagen Therapeutics raises $12.9M Series B1, intratumoral treatments for breast cancer
Oncology, breast cancer, intratumoral treatments, clinical-stage, platform technology - Read more

Nuvalent raises $500M public offering, targeted kinase therapies for cancer
Cancer, kinase inhibitors, clinical-stage, precision medicine - Read more

Samsung Life Science Fund invests in Phrontline Biopharma to advance antibody-drug conjugate oncology therapeutics
Equity investment, oncology, antibody-drug conjugate, solid tumors - Read more

THE GOOD
Regulatory

Sarepta gets FDA approval to test immunosuppressive Elevidys regimen for non-ambulatory DMD patients
Gene therapy, rare disease, regulatory, strategic - Read more

ARPA-H names former DARPA official Alicia Jackson as new director amid ongoing budget cuts
Government funding, biomedical research, strategic, operational - Read more

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THE BAD
Layoffs

Novartis cuts 550 Swiss jobs, invests $26M in automation while expanding North Carolina operations
Small molecule, operational, cost reduction, strategic - Read more

THE BAD
Market Reports

Klick Health survey finds 65% of pharma professionals distrust AI for regulatory compliance submissions
Regulatory, operational, strategic, competitive - Read more

THE BAD
Politics & Policy

NSCEB commission warns US losing biotech edge, recommends federal research overhaul with AI integration
Strategic, regulatory, operational, competitive - Read more

THE BAD
Regulatory

CMS announces 44% price cuts for 15 drugs including Wegovy, saving Medicare $12B annually
GLP-1 agonist, diabetes, regulatory, cost reduction, major transaction - Read more

FDA Director Pazdur challenges Commissioner Makary's expedited drug approval plans over safety concerns
Regulatory, strategic, operational, leadership - Read more

THE UGLY
Regulatory

Angelini faces UK watchdog ruling after Milan speaker called EMA "stupid" at company event
Anticonvulsant, neurological, regulatory, operational - Read more

Lawmakers probe FDA's priority voucher program citing corruption concerns and political favoritism risks
Regulatory, strategic, operational, competitive - Read more

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

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