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  • Biotech & Pharma Updates | December 9 - 10, 2025

Biotech & Pharma Updates | December 9 - 10, 2025

🧬 FDA approves Fondazione Telethon's gene therapy for Wiskott-Aldrich syndrome - first gene therapy approved from a non-profit sponsor, Formation Bio + Lynk Pharmaceuticals partner on TYK2 inhibitor LNK01006 with $605M total deal value, InduPro Therapeutics + Sanofi partner on bispecific PD-1 agonist for autoimmune disorders with undisclosed equity investment, Roche's giredestrant (oral SERD) shows 30% risk reduction in Ph3 early estrogen receptor-positive breast cancer trial, PsiThera raises $47.5M Series A for AI-designed oral drugs for immune conditions, Great Point Partners acquires majority stake in Lenis Group - specialty pharmaceutical distributor in Central and Eastern Europe, FDA finalizes guidance on promotional materials for biologics and biosimilars requiring accurate + non-misleading advertising

All the top Biotech & Pharma news in one daily newsletter.

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✅ The Good News ✅ 

THE GOOD
Approvals & Labels

FDA approves Fondazione Telethon's gene therapy Waskyra targeting WAS gene for Wiskott-Aldrich syndrome - first gene therapy approved from a non-profit sponsor
Gene therapy, rare disease, ex vivo gene therapy, Wiskott-Aldrich syndrome, WAS gene, pediatric- Read more

Boehringer Ingelheim's JASCAYD (nerandomilast) wins China approval for progressive pulmonary fibrosis following Ph3 success
Small molecule, respiratory disease, PDE4B inhibitor, progressive pulmonary fibrosis, antifibrotic therapy - Read more

FDA grants first Commissioner's Priority Review approval to USAntibiotics' Augmentin XR in two months
Small molecule antibiotic, infectious disease, regulatory, operational - Read more

THE GOOD
Business Development & Partnerships

Formation Bio, Lynk Pharmaceuticals partner on TYK2 inhibitor LNK01006, $605M potential deal value
Licensing deal, autoimmune, small molecule, milestone payments, subsidiary formation - Read more

InduPro Therapeutics, Sanofi partner on bispecific PD-1 agonist for autoimmune disorders with undisclosed equity investment
Research collaboration, autoimmune, bispecific antibody, equity investment - Read more

Oxford BioTherapeutics, GSK collaborate on novel cancer antibody targets using OGAP-Verify platform, undisclosed upfront payment
Research collaboration, oncology, antibody, drug discovery, milestone payments - Read more

Polpharma Biologics, Libbs Farmacêutica license autoimmune biosimilar for exclusive commercialization in Brazil
Licensing deal, autoimmune, biosimilar, commercialization - Read more

Nanexa, Moderna license PharmaShell drug delivery platform, $3M upfront, $500M potential milestones
Licensing deal, drug delivery, milestone payments, royalties - Read more

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 More Good News 

THE GOOD
Clinical Trials

Pfizer's Tukysa (tucatinib) shows 36% progression reduction in Ph3 first-line HER2-positive breast cancer maintenance therapy
Small molecule, cancer, HER2-positive breast cancer, HER2 target, maintenance therapy - Read more

Roche's giredestrant (oral SERD) shows 30% risk reduction in Ph3 early estrogen receptor-positive breast cancer trial
Small molecule, cancer, selective estrogen receptor degrader, breast cancer, estrogen receptor positive - Read more

GRI Bio reports positive Ph2a results for GRI-0621 targeting immune cell modulation in idiopathic pulmonary fibrosis
Small molecule, fibrotic disease, idiopathic pulmonary fibrosis, immune cell modulator, collagen turnover - Read more

THE GOOD
Fundraises

PsiThera raises $47.5M Series A, AI-designed oral drugs for immune conditions
Autoimmune, AI/ML platform, small molecule, tumor necrosis factor - Read more

Bioxodes raises €5.5M ($6.4M) Series A extension for thrombotic and inflammatory disease therapies
Clinical-stage, thrombotic diseases, inflammatory diseases, anticoagulant, stroke - Read more

BlossomHill Therapeutics raises $84M Series B extension, advancing macrocyclic cancer assets
Cancer, small molecule, autoimmune, clinical-stage - Read more

Citius Oncology raises $18M registered direct offering, supporting LYMPHIR commercial launch
Oncology, clinical-stage, cancer, commercialization-stage - Read more

EpilepsyGTx raises $33M Series A, single-dose gene therapy for refractory epilepsy
Gene therapy, neurological, epilepsy, clinical-stage - Read more

Biocytogen Pharmaceuticals completes STAR Market IPO, antibody drug discovery platform company
Platform technology, antibody, drug discovery, preclinical - Read more

THE GOOD
Mergers & Acquisitions

Great Point Partners acquires majority stake in Lenis Group, specialty pharmaceutical distributor in Central and Eastern Europe
Specialty pharmaceuticals, strategic, major transaction, operational - Read more

THE GOOD
Regulatory

FDA finalizes guidance on promotional materials for biologics and biosimilars requiring accurate, non-misleading advertising
Biologics, biosimilars, regulatory, operational - Read more

THE GOOD
Politics & Policy

UK cuts payment rate for newer medicines to 14.5% in 2026, down from current 22.5% rate
Branded medicines, regulatory, financial, strategic - Read more

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❌ The Bad News

THE BAD
Earnings & Finances

Apple Tree Partners files bankruptcy to continue funding portfolio biotechs amid investor dispute
Venture capital, financial, operational, major transaction - Read more

THE BAD
Layoffs

CDMO Adare Pharma Solutions closing Philadelphia facility, cutting 137 jobs due to adverse economic conditions
Manufacturing services, operational, cost reduction, strategic - Read more

Pfizer cuts over 200 Swiss jobs, reducing workforce to 70 employees in cost-reduction effort
Operational, cost reduction, strategic, financial - Read more

👹 The Ugly News 👹

THE UGLY
No Ugly News Today!

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

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