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THE GOOD
Approvals & Labels

InnoCare's HIBRUKA (orelabrutinib) BTK inhibitor approved in Singapore for relapsed/refractory marginal zone lymphoma
Small molecule, cancer, BTK inhibitor, marginal zone lymphoma, non-Hodgkin's lymphoma, relapsed/refractory - Read more

THE GOOD
Business Development & Partnerships

Servier, Kaerus Bioscience partner on fragile X syndrome therapy KER-0193 in $450M deal
Licensing deal, rare disease, neurological, small molecule, milestone payments - Read more

Novonesis, Novo Nordisk partner to develop synbiotic supplements targeting metabolic health via gut microbiome
Research collaboration, metabolic health, microbiome, diagnostics, synbiotic supplements, biomarkers - Read more

Sirnaomics, Bloomage Biotech partner on RNAi therapeutics and delivery platforms; Bloomage invests HKD 138M for 9.44% stake
Equity investment, RNAi therapeutics, aesthetic medicine, strategic partnership, co-development, drug discovery - Read more

Matica Bio, Cirsium Biosciences partner on AAV manufacturing to enhance gene therapy production efficiency and accessibility
Manufacturing agreement, gene therapy, AAV manufacturing, CDMO, viral vector production, strategic partnership - Read more

Remedium Bio, Eli Lilly collaborate on gene therapies for diabetes and obesity using Prometheus platform; includes upfront payment, equity investment
Research collaboration, gene therapy, metabolic disease, equity investment, milestone payments - Read more

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THE GOOD
Clinical Trials

Pfizer, BioNTech COVID-19 booster shows strong immune response against LP.8.1 variant in Ph3 data
Vaccine, infectious disease, mRNA vaccine, COVID-19, booster, elderly population - Read more

Eisai's Ph1b trial shows orexin agonist E2086 outperforms modafinil for narcolepsy type 1 wakefulness
Small molecule, neurological, orexin receptor agonist, narcolepsy type 1, sleep disorder - Read more

Rapport's RAP-219 AMPA receptor inhibitor shows 78% seizure reduction in Ph2 focal epilepsy trial
Small molecule, neurological, epilepsy, focal epilepsy, AMPA receptor modulator, drug-resistant seizures - Read more

Alkermes' alixorexton improves wakefulness and cognition in Ph2 trial for narcolepsy type 1 patients
Small molecule, neurological, orexin receptor agonist, narcolepsy, cognitive impairment, sleep disorder - Read more

Takeda's orexin-2 agonist oveporexton succeeds in Ph3 trials for narcolepsy type 1, showing significant wakefulness improvements
Small molecule, neurological, orexin-2 receptor agonist, narcolepsy, sleep disorders, cataplexy - Read more

BioNTech's dual-targeting cancer drug pumitamig shrinks tumors in 75% of small cell lung cancer patients in Ph2 trial
Bispecific antibody, cancer, immunotherapy, small cell lung cancer, PD-1 pathway, VEGF target - Read more

Atom Therapeutics' lingdolinurad (URAT1 inhibitor) demonstrates Ph3 superiority over allopurinol in gout treatment efficacy and safety
Small molecule, autoimmune, URAT1 inhibitor, gout, urate-lowering therapy - Read more

Dianthus' claseprubart shows efficacy in Ph2 trial for generalized myasthenia gravis, advancing to pivotal studies
Antibody, autoimmune, monoclonal antibody, myasthenia gravis, complement inhibitor, subcutaneous administration - Read more

Regeneron's allergen-blocking antibodies REGN1908-1909 and REGN5713-5715 meet Ph3 endpoints for cat and birch pollen allergies
Antibody, allergic disease, monoclonal antibody, immunotherapy, allergic rhinitis, FelD1/BetV1 target - Read more

Eli Lilly's Jaypirca shows "compelling" Ph3 results against chronic lymphocytic leukemia as potential first-line BTK inhibitor
Small molecule, cancer, BTK inhibitor, chronic lymphocytic leukemia, blood cancer, first-line treatment - Read more

JCR Pharmaceuticals presents five-year data showing pabinafusp alfa's sustained benefits in Hunter syndrome patients
Protein therapy, genetic disease, enzyme replacement therapy, mucopolysaccharidosis, blood-brain barrier, lysosomal storage disorder - Read more

THE GOOD
Fundraises

NRG Therapeutics raises £50M ($67M) Series B, developing mitochondria-targeting drugs for Parkinson's and ALS
Neurological, small molecule, mitochondria-targeting, Parkinson's disease, ALS, preclinical - Read more

LB Pharmaceuticals files for $228M IPO to fund late-stage schizophrenia drug trials
Central nervous system, small molecule, schizophrenia, clinical-stage, psychiatric disorders - Read more

Epigenic Therapeutics raises $60M Series B, advancing therapies for hepatitis B and hypercholesterolemia
Infectious disease, hypercholesterolemia, platform technology, gene silencing, epigenetic modulation, preclinical - Read more

BoobyBiome raises £2.5M ($3.4M) Seed funding for breast milk microbiome solutions
Microbiome, infant health, platform technology, biotechnology, biobank - Read more

Integra Therapeutics raises €10.7M ($12.5M) to advance gene writing platform for next-gen therapies
Gene therapy, platform technology, gene writing tools, preclinical, cell therapy, CRISPR - Read more

THE GOOD
Regulatory

FDA creates "green list" for GLP-1 ingredient imports in win for consumers, while avoids direct action against compounders challenging Novo Nordisk and Eli Lilly
GLP-1 agonist, obesity, regulatory, competitive, operational - Read more

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THE BAD
Approvals & Labels

FDA rejects Saol Therapeutics' SL1009 for pyruvate dehydrogenase complex deficiency despite Ph3 secondary endpoint improvements
Small molecule, metabolic disease, rare disease, mitochondrial disease, pediatric patient population, FDA regulatory - Read more

THE BAD
Lawsuits

ToolGen sues Lonza for patent infringement over CRISPR-Cas9 RNP technology used in CASGEVY gene therapy production
CRISPR gene therapy, sickle cell disease, beta-thalassemia, patent litigation, intellectual property - Read more

THE UGLY
No Ugly News Today!

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