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THE GOOD
Approvals & Labels

Roche's Gazyvaro (obinutuzumab) wins EU approval for lupus nephritis treatment following Ph3 trial success
Antibody, autoimmune, monoclonal antibody, lupus nephritis, CD20 target, combination therapy - Read more

THE GOOD
Business Development & Partnerships

Bora Pharmaceuticals, Corealis Pharma form strategic alliance for end-to-end oral solid dose development and production
Manufacturing agreement, small molecule, R&D, commercialization - Read more

Biocon buys out Viatris, others from Biocon Biologics for $815M, values subsidiary at $5.5B
Acquisition, biosimilars, diabetes, manufacturing, equity investment - Read more

Pfizer vaults another attempt towards an obesity pill, partnering with YaoPharma on Ph1 asset YP05002, $150M upfront + $1.94B biobucks
Licensing deal, obesity, small molecule, GLP-1 agonist, milestone payments - Read more

Novartis, Relation Therapeutics partner on AI-driven inflammatory skin disease targets, $55M upfront, $1.7B milestones
Research collaboration, autoimmune, AI/ML, milestone payments - Read more

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✅ More Good News ✅

THE GOOD
Clinical Trials

Eli Lilly's Jaypirca (pirtobrutinib) shows 80% progression reduction in Ph3 first-line chronic lymphocytic leukemia trial
Small molecule, cancer, BTK inhibitor, chronic lymphocytic leukemia, second-line treatment - Read more

Johnson & Johnson's Tecvayli (teclistamab) shows 83% progression risk reduction in Ph3 multiple myeloma trial
Antibody, cancer, bispecific antibody, multiple myeloma, combination therapy - Read more

Novartis' ianalumab hits Ph3 endpoints in immune thrombocytopenia, reducing treatment failure risk by 45%
Antibody, autoimmune, monoclonal antibody, immune thrombocytopenia, combination therapy, B-cell depletion - Read more

Assembly Biosciences' ABI-1179 and ABI-5366 helicase-primase inhibitors show strong Ph1 results in recurrent genital herpes
Small molecule, infectious disease, helicase-primase inhibitor, genital herpes, HSV-2 - Read more

Enterprise Therapeutics reports positive Ph1 results for ETD001 epithelial sodium channel blocker targeting cystic fibrosis
Small molecule, respiratory disease, ENaC blocker, cystic fibrosis, inhaled therapy - Read more

CSL's etranacogene dezaparvovec shows durable efficacy in Ph3 five-year study for moderate to severe haemophilia B
Gene therapy, hematologic disorder, adeno-associated virus vector, hemophilia B, factor IX, durable efficacy - Read more

BioNTech and Bristol Myers Squibb report positive Ph2 data for pumitamig in triple-negative breast cancer
Bispecific antibody, cancer, PD-L1/VEGF-A blockade, triple-negative breast cancer, combination therapy - Read more

Kelonia Therapeutics reports positive Ph1 results for in vivo CAR-T therapy targeting multiple myeloma
Cell therapy, cancer, CAR-T, multiple myeloma, in vivo delivery - Read more [Paywall]

THE GOOD
Fundraises

Cellular Origins raises $40M Series A, cell therapy manufacturing automation platform
Cell therapy, manufacturing, platform technology, CDMO - Read more

Relation Therapeutics raises $26M further funding, AI-driven drug discovery platform
AI/ML platform, drug discovery, immunology, metabolic disease, platform technology - Read more

Sidera Bio raises $109M Series A, developing obesity GLP-1/GIP/FGF21 triple agonist
Obesity, GLP-1/GIP/FGF21 triple agonist, metabolic disease, clinical-stage - Read more

SanegeneBio raises $110M Series B, advancing RNAi therapeutics towards registrational studies
RNAi therapeutics, clinical-stage, platform technology, LEAD delivery platform - Read more

D3 Bio raises $108M Series B for global elisrasib oncology trials
Oncology, small molecule, clinical-stage, targeted therapy - Read more

EpilepsyGTx raises $33M Series A, gene therapy for focal refractory epilepsy
Gene therapy, neurological, epilepsy, clinical-stage - Read more [Paywall]

Structure Therapeutics raises $650M public offering, oral therapeutics for metabolic diseases
Small molecule, metabolic diseases, obesity, clinical-stage - Read more

THE GOOD
Investments

Eli Lilly selects Alabama for $6B API facility to produce weight-loss pill orforglipron
Small molecule, metabolic disease, operational, major transaction - Read more

CSL Seqirus opens $1B cell-based flu vaccine and antivenom production facility in Melbourne
Cell-based vaccine, infectious disease, operational, major transaction - Read more

THE GOOD
Regulatory

FDA qualifies PathAI's AIM-NASH as first AI tool for MASH drug development trials
AI diagnostics, metabolic disease, regulatory, operational, competitive - Read more

THE GOOD
Strategic Plans

Saol Therapeutics seeks FDA approval pathway for SL1009 targeting pyruvate dehydrogenase complex deficiency via rare disease framework
Small molecule, metabolic, rare disease, pyruvate dehydrogenase complex deficiency, enzyme replacement - Read more

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THE BAD
Layoffs

Vesalius Therapeutics conducts layoffs in reorganization, second workforce reduction since 2022 cuts
AI-driven drug discovery, neurological, operational, cost reduction - Read more

THE BAD
Politics & Policy

Biosecure Act included in US defense bill, targeting Chinese biopharma companies with federal contract bans
Contract manufacturing, regulatory, strategic, operational - Read more

THE BAD
Strategic Plans

Ose Immunotherapeutics narrows focus to Tedopi lung cancer vaccine, lusvertikimab amid cash concerns
Vaccine, oncology, strategic, financial - Read more

THE UGLY
Regulatory

FDA investigates RSV infant shots from Merck, AstraZeneca and Sanofi amid safety concerns
Monoclonal antibody, infectious disease, regulatory, operational - Read more

FDA requires randomized trials for CAR-T approvals, potentially impacting Gilead and Arcellx's anito-cel timeline
CAR-T, oncology, strategic, operational - Read more

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

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