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

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✅ The Good News ✅

THE GOOD
Approvals & Labels

FDA expands ImmunityBio's Anktiva (nogapendekin alfa inbakicept-pmln) label for high-grade papillary non-muscle invasive bladder cancer
Protein therapy, cancer, recombinant IL-15 superagonist, bladder cancer, BCG-unresponsive NMIBC - Read more

Henlius' Adaliget (adalimumab biosimilar) receives DRAP approval in Pakistan for multiple autoimmune diseases
Antibody, autoimmune, biosimilar, monoclonal antibody, rheumatoid arthritis, TNF inhibitor - Read more

THE GOOD
Business Development & Partnerships

Ultragenyx sells two priority review vouchers for combined $413M following FDA gene therapy approvals
Priority review voucher, rare disease, gene therapy, non-dilutive funding - Read more

NorthStar Medical Technologies, Quarkmed partner to streamline actinium-225 radiopharmaceutical regulatory filings in China
Strategic partnership, radiopharmaceuticals, manufacturing, regulatory, commercialization - Read more

Armed Cell Therapeutics licenses CAR T cell programs from Lakefront Biotherapeutics, $9M upfront, $230M milestones
Licensing deal, cell therapy, oncology, milestone payments, royalties - Read more

AstraZeneca, Insitro partner on MASH and cardiomyopathy drug discovery, $40M upfront, $1.5B total
AI/ML, drug discovery, MASH, cardiomyopathy, milestone payments, royalties - Read more

Deep Origin, BioAge Labs partner on AI-driven cardiometabolic drug discovery, milestone payments eligible
Research collaboration, cardiometabolic, AI/ML, small molecule, milestone payments - Read more

Alentis Therapeutics, PinotBio collaborate on next-generation claudin-1 ADCs with upfront payment and milestones
Research collaboration, licensing deal, oncology, antibody-drug conjugate, milestone payments, royalties - Read more

Ocugen, Roots Pharmaceutical license OCU400 gene therapy for MENA retinitis pigmentosa, up to $259M potential payments
Licensing deal, rare disease, gene therapy, milestone payments, royalties, ophthalmology - Read more

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✅ More Good News ✅

THE GOOD
Clinical Trials

Eli Lilly's Omvoh (mirikizumab) Ph3 data show multi-goal disease control in ulcerative colitis and Crohn's disease
Antibody, autoimmune, monoclonal antibody, inflammatory bowel disease, ulcerative colitis, Crohn's disease - Read more

Lundbeck reports Ph1 data for (lu AF28996) in advanced Parkinson's disease, Ph2 trial underway
Small molecule, neurological, prodrug, Parkinson's disease, dopamine receptor agonist, motor fluctuations - Read more

Arrowhead Pharmaceuticals' (ARO-MAPT) shows 73% tau reduction in Ph1 trial, signaling potential Alzheimer's disease benefit
RNA interference, neurological, RNAi therapy, Alzheimer's disease, tau protein, blood-brain barrier - Read more

THE GOOD
Fundraises

OMass Therapeutics raises $310M Series C to advance adrenal disorder therapy pipeline
Small molecule, autoimmune, rare disease, endocrinology - Read more

OrbiMed raises $3B across two funds, targeting global biotech and life sciences investments
Life sciences investment, biopharma, medtech, AI-driven - Read more

Iambic Therapeutics raises $150M IPO, AI-driven drug discovery targeting HER2-positive solid tumors
AI/ML platform, oncology, small molecule, drug discovery, HER2, clinical-stage - Read more

DaltonTx awarded Gates Foundation grant to advance AI-powered tuberculosis drug discovery
AI/ML platform, infectious disease, tuberculosis, drug discovery, platform-enabled - Read more

Seragy raises €12M ($13.4M) to accelerate SeRAS biomarker platform for neurodegenerative diseases
Biomarker discovery, neurodegenerative, proteopathies, Alzheimer disease, platform technology - Read more

THE GOOD
Product Launches

Takeda launches ORZEYFUL (oveporexton), first-in-class orexin agonist, simultaneously in Japan and China for narcolepsy type 1
Small molecule, neurological, rare disease, competitive - Read more

THE GOOD
Regulatory

FDA launches Rare Disease Framework Initiative to standardize flexible drug development for 30 million Americans
Rare disease, regulatory, operational, strategic - Read more

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❌ The Bad News ❌

THE BAD
Clinical Trials

Osivax shifts OVX836 (nucleoprotein) influenza A vaccine to combo strategy after Ph2b miss
Vaccine, infectious disease, influenza, nucleoprotein target, combination therapy - Read more

Vanda Pharmaceuticals halts (VQW-765) alpha-7 nicotinic acetylcholine receptor program after Ph3 failure in social anxiety disorder
Small molecule, neurological, alpha-7 nicotinic acetylcholine receptor agonist, social anxiety disorder, phase 3 trial failure - Read more

THE BAD
Regulatory

Par Health recalls 22 lots of IV argatroban over contamination fears, marking third recall in a month
Small molecule, cardiovascular, operational, recall - Read more

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

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