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✅ The Good News ✅
THE GOOD
Approvals & Labels
Boehringer Ingelheim's Jascayd (nerandomilast) gains MHRA approval for idiopathic and progressive pulmonary fibrosis after Ph3 success
Small molecule, pulmonary, PDE4B inhibitor, idiopathic pulmonary fibrosis, antifibrotic - Read more
THE GOOD
Business Development & Partnerships
HanchorBio, InxMed partner on preclinical combination studies evaluating HCB101 with FAK inhibitor and FAP-targeted ADC
Research collaboration, oncology, antibody, small molecule, drug discovery - Read more
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✅ More Good News ✅
THE GOOD
Clinical Trials
Keenova Therapeutics' Xiaflex (collagenase clostridium histolyticum) succeeds in Ph3 trial for plantar fibromatosis
Protein therapy, musculoskeletal, enzyme injection, plantar fibromatosis, collagen targeting - Read more
Ipsen's Dysport (abobotulinumtoxinA) meets Ph3 goals in both episodic and chronic migraine trials
Protein therapy, neurological, botulinum toxin, migraine, prophylactic treatment - Read more
Fate Therapeutics' FT819 (anti-CD19 CAR-T) shows early Ph1 promise in treatment-resistant systemic sclerosis
Cell therapy, autoimmune, CAR-T, systemic sclerosis, anti-CD19, off-the-shelf - Read more
Seres Therapeutics reports Ph1 SER-155 (microbiome therapy) data showing 80% response rate in immune checkpoint inhibitor-related enterocolitis
Microbiome therapy, cancer, immune checkpoint inhibitor, enterocolitis, gastrointestinal inflammation - Read more
THE GOOD
Fundraises
MindRank raises $52M Series B, advancing AI-discovered oral GLP-1 obesity pill to Phase III
AI/ML platform, obesity, small molecule, GLP-1, clinical-stage - Read more
Alchemab Therapeutics raises $34M Series A extension from British Business Bank, advancing AI-enabled antibody pipeline
Clinical-stage, antibody, AI/ML platform, neurological, rare disease - Read more
Allotera Therapeutics closes $35M financing to advance off-the-shelf CAR-T therapies for T-cell cancers
Cell therapy, oncology, CAR-T, allogeneic, clinical-stage, hematological malignancies - Read more
Genesys University Seed Fund holds $30M first close, targeting early-stage life sciences startups
Life sciences, venture capital, early-stage, biotechnology - Read more
THE GOOD
Politics & Policy
HHS drafts COVID vaccine injury compensation table under RFK Jr.'s leadership
mRNA vaccine, infectious disease, regulatory, operational - Read more
THE GOOD
Regulatory
Saol Therapeutics resubmits SL1009 (DCA) to FDA for pyruvate dehydrogenase complex deficiency with new survival data
Small molecule, neurological, metabolic, pyruvate dehydrogenase complex deficiency, mitochondrial disease, rare disease - Read more
AstraZeneca, Daiichi Sankyo near UK price deal for Enhertu breast cancer drug NHS access
Antibody-drug conjugate, breast cancer, regulatory, pricing - Read more
Sanofi offers EU concessions to halt probe over misleading flu vaccine campaign against CSL Seqirus
Vaccine, infectious disease, regulatory, competitive - Read more
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❌ The Bad News ❌
THE BAD
Business Development & Partnerships
GSK terminates Alector neurodegenerative partnership after dual Phase 2/3 clinical failures
Partnership termination, neurological, antibody, milestone payments - Read more
THE BAD
Clinical Trials
AstraZeneca, Ionis Pharmaceuticals' Wainua (eplontersen) fails Ph3 trial for transthyretin-mediated amyloid cardiomyopathy
Antisense oligonucleotide, cardiovascular, small molecule, transthyretin amyloid cardiomyopathy, TTR silencer, phase 3 trial failure - Read more
THE BAD
Regulatory
FDA pauses release of complete response letters amid pharma petition challenging proprietary information disclosures
Regulatory policy, multi-disease, operational, strategic - Read more
FDA issues untitled letter to Lundbeck over misleading efficacy claims for migraine drug Vyepti
Monoclonal antibody, migraine, regulatory, competitive - Read more
Dr. Reddy's halts generic semaglutide supply after discovering active pharmaceutical ingredient specification issues
Small molecule, metabolic disease, operational, competitive - Read more
FDA issues warning letter to Amphastar Pharmaceuticals subsidiary over GMP violations at California facility
Manufacturing compliance, GMP violation, operational, regulatory - Read more
You’re all caught up on the latest Pharma & Biotech News!
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