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THE GOOD
Approvals & Labels

FDA approves Tonix's Tonmya, first new cyclobenzaprine-based treatment for fibromyalgia in 16 years
Small molecule, neurological, fibromyalgia, chronic pain, sublingual delivery, first-in-class - Read more

FDA approves Precigen's Papzimeos, first immunotherapy targeting HPV for recurrent respiratory papillomatosis in Ph1/2 trial
Gene therapy, infectious disease, viral vector, HPV-related disease, rare disease, immunotherapy - Read more

FDA grants Novo Nordisk's Wegovy accelerated approval for non-cirrhotic metabolic dysfunction-associated steatohepatitis (MASH) with moderate-to-advanced liver fibrosis after Ph3 success
Protein therapy, metabolic, GLP-1 agonist, MASH, liver fibrosis, FDA approval - Read more

THE GOOD
Business Development & Partnerships

Ryght AI, Biorasi partner to provide AI-powered site selection and feasibility solutions for clinical trial sponsors
Strategic partnership, AI/ML, clinical trials, global, therapeutic areas, drug discovery - Read more

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✅ More Good News ✅

THE GOOD
Clinical Trials

VISEN's Ph2 trial: Navepegritide (CNP prodrug) boosts growth velocity in achondroplasia patients over 104 weeks
Protein therapy, metabolic, CNP prodrug, achondroplasia, growth disorder, pediatric - Read more

THE GOOD
Earnings & Finances

Lundbeck raises Vyepti migraine drug's US peak sales forecast to $1.1 billion after 54% growth
CGRP antagonist, migraine, neurological, financial, revenue growth, strategic - Read more

THE GOOD
Fundraises

Lobe Sciences raises $341K private placement for rare disease therapeutics development
Rare disease, biopharmaceutical, therapeutics - Read more

CPTx and NanoCell secure EU Eurostars Grant for in vivo CAR T therapy using immune-silent ssDNA
Cell therapy, in vivo CAR T therapy, oncology, autoimmune disease, gene therapy, platform technology - Read more

ZYUS Life Sciences raises $420K private placement for cannabinoid pharmaceuticals in pain management
Cannabinoid-based therapeutics, pain management, pharmaceutical, early-stage - Read more

OXB (formerly Oxford Biomedica) raises $81.4 million to expand U.S. commercial-scale capabilities for viral vector manufacturing
Gene therapy CDMO, viral vector manufacturing, strategic, financial, capacity expansion, major transaction - Read more

THE GOOD
Lawsuits

Amgen wins court reversal of $50.3M patent verdict to Lindis over Blincyto patent infringement
Bispecific antibody, oncology, patent litigation, legal reversal - Read more

THE GOOD
Product Launches

AstraZeneca launches direct-to-consumer home delivery service for self-administered FluMist vaccine ahead of flu season
Nasal spray vaccine, infectious disease, direct-to-consumer, operational, strategic - Read more

THE BAD
Approvals & Labels

FDA delays Omeros' approval decision on narsoplimab (anti-MASP-2) for hematopoietic stem cell transplant-associated thrombotic microangiopathy by 3 months
Antibody, autoimmune, monoclonal antibody, transplant complication, TA-TMA, regulatory approval - Read more

THE BAD
Clinical Trials

Pfizer's Phase 3 inclacumab fails to reduce vaso-occlusive crises in sickle cell disease patients
Antibody, hematologic disease, monoclonal antibody, sickle cell disease, P-selectin inhibitor, vaso-occlusive crises - Read more

THE BAD
Politics & Policy

Kennedy scraps mRNA respiratory vaccine funding while backing cancer applications at HHS
mRNA vaccine, oncology, regulatory, strategic, policy shift - Read more

THE UGLY
Politics & Policy

NIH director orders immediate review of all research, threatening to cut projects not aligned with priorities
Research funding, health policy, strategic, regulatory, operational - Read more

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

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