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THE GOOD
Approvals & Labels

Stealth resubmits elamipretide to FDA for Barth syndrome after addressing safety and manufacturing concerns
Small molecule, rare disease, mitochondrial disorder, Barth syndrome, orphan drug - Read more

EU approves Merck KGaA's Ogsiveo (nirogacestat), first therapy for desmoid tumors based on Ph3 data
Small molecule, cancer, gamma secretase inhibitor, desmoid tumors, rare disease, orphan drug - Read more

Health Canada approves Valneva's IXCHIQ for chikungunya prevention in adolescents 12+ following sustained antibody data
Vaccine, infectious disease, live-attenuated vaccine, chikungunya virus, adolescent population, antibody persistence - Read more

Health Canada approves Iovance Biotherapeutics' Amtagvi (lifileucel) TIL therapy for advanced melanoma after prior treatment failure
Cell therapy, cancer, TIL therapy, melanoma, autologous T cell, metastatic - Read more

FDA approves Roche's Tecentriq for PD-L1 positive muscle-invasive bladder cancer after Ph3 Success
Monoclonal antibody, cancer, PD-L1 inhibitor, bladder cancer, precision medicine, biomarker-driven - Read more

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THE GOOD
Business Development & Partnerships

Boehringer Ingelheim, Palatin Technologies partner on diabetic retinopathy therapies in $327M deal
Licensing deal, diabetic retinopathy, small molecule, R&D, milestone payments - Read more

Upperton, Oxford partner to develop oral Adenovirus-vectored vaccine formulation with VaxHub funding
Research collaboration, vaccine, oral delivery, infectious disease, drug delivery, UK - Read more

Novo Nordisk partners with GoodRx to offer Ozempic and Wegovy at $499/month for self-pay patients
Commercialization, GLP-1, weight loss, pricing agreement, US - Read more

Avixgen, U.S. biotech company partner on peptide drug delivery platform with 500B KRW deal
Licensing deal, peptide-based technology, drug delivery, milestone payments, Asia, US - Read more

Khondrion, Medvisis partner on exclusive license for sonlicromanol in Switzerland/Liechtenstein for primary mitochondrial disease treatment
Licensing deal, rare disease, commercialization, small molecule, European - Read more

GC Biopharma, Thai Red Cross Society partner on plasma-derived therapy manufacturing training and technology transfer
Manufacturing agreement, plasma-derived therapies, technology transfer, workforce training, Asia - Read more

RemeGen, Santen partner on RC28-E ophthalmic drug in Asia; deal worth up to RMB 1.29 billion with RMB 250M upfront
Licensing deal, ophthalmic disease, biologics, milestone payments, royalties, Asia - Read more

Novartis, Atropos Health partner to develop AI models accelerating rare disease diagnosis, focusing on PNH
Research collaboration, rare disease, AI/ML, diagnostics, PNH, R&D - Read more

Merck KGaA, Skyhawk partner on RNA-targeting neurological drugs in deal worth up to $2B
Research collaboration, neurological, small molecule, RNA targeting, milestone payments, drug discovery - Read more

THE GOOD
Clinical Trials

Reunion Neurosciences' psilocybin-like drug RE104 shows positive Ph2 results for postpartum depression, advancing to Ph3
Small molecule, neurological, psychedelic compound, postpartum depression, psilocybin-like, mental health - Read more

Aptose Biosciences' Ph1/2 trial shows tuspetinib triple therapy improves outcomes across diverse acute myeloid leukemia populations
Small molecule, cancer, kinase inhibitor, acute myeloid leukemia, combination therapy, FLT3 - Read more

Enlivex Therapeutics' Allocetra shows positive Ph2 results for macrophage reprogramming therapy in moderate-to-severe knee osteoarthritis
Cell therapy, autoimmune, macrophage reprogramming, osteoarthritis, knee osteoarthritis - Read more

THE GOOD
Fundraises

Kriya Therapeutics raises $313.3M funding for gene therapy pipeline targeting chronic conditions
Gene therapy, rare disease, ophthalmology, neurological, clinical-stage - Read more

Anocca raises $46M financing to advance TCR-T therapy for pancreatic cancer
Cell therapy, oncology, pancreatic cancer, T-cell immunotherapy, clinical-stage, platform technology - Read more

THE GOOD
Lawsuits

Vanda wins court battle against FDA, forcing agency to respond on Hetlioz jet lag indication
Small molecule, sleep disorder, regulatory, legal dispute, FDA approval - Read more

THE GOOD
Mergers & Acquisitions

THL Partners acquires Headlands Research from KKR, plans to expand clinical trial network
Clinical trial services, business operations, strategic, major transaction, clinical trial diversity - Read more

THE GOOD
Politics & Policy

Kennedy-led MAHA strategy leaked, emphasizing vaccine safety overhaul and faster access to certain investigational drugs (despite recent FDA rejections)
Vaccine framework, regulatory, strategic, operational - Read more

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THE BAD
Business Development & Partnerships

Genentech terminates Adaptive Biotechnologies' $2B TCR cell therapy partnership
Deal termination, cell therapy, oncology, licensing deal, R&D - Read more

THE UGLY
Regulatory

FDA delays review of Neurizon's ALS drug NUZ-001 until October 3 amid staffing shortages
Small molecule, neurological, regulatory, clinical development, amyotrophic lateral sclerosis - Read more

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

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