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THE GOOD
Approvals & Labels

Chongqing Precision Biotech's Pujiolunxi wins NMPA approval for pediatric relapsed or refractory B-cell acute lymphoblastic leukemia
Cell therapy, cancer, CAR-T, B-cell acute lymphoblastic leukemia, pediatric, relapsed refractory - Read more

Chiesi's Procysbi (mercaptamine) wins NHS Scotland approval for nephropathic cystinosis treatment
Small molecule, rare disease, mercaptamine, nephropathic cystinosis, pediatric - Read more

Alembic Pharmaceuticals receives FDA approval for generic dasatinib tablets treating Philadelphia chromosome-positive chronic myeloid leukemia
Small molecule, cancer, kinase inhibitor, chronic myeloid leukemia, Philadelphia chromosome-positive - Read more

Venus Remedies secures Vietnam approvals for methotrexate, cefuroxime and irinotecan across multiple therapeutic indications
Small molecule, cancer, chemotherapy, methotrexate, antibiotic, cephalosporin - Read more

THE GOOD
Business Development & Partnerships

AstraZeneca's Evinova, Harbour BioMed partner on AI-driven biologics development platform integration
Research collaboration, AI/ML, antibody, oncology, drug discovery - Read more

PharmaMar receives $10 million milestone payment from Janssen for Yondelis commercial achievement
Licensing deal, oncology, milestone payments, rare disease - Read more

Eli Lilly, SanegeneBio partner on $1.2B RNAi metabolic disease platform with targeted delivery technology
Research collaboration, metabolic diseases, RNAi, milestone payments - Read more

Eli Lilly, MeiraGTx partner on eye gene therapy AAV-AIPL4, $75M upfront, $400M milestones
Licensing deal, rare disease, gene therapy, milestone payments - Read more

Voyager Therapeutics, Transition Bio partner on TDP-43 small molecule discovery, single-digit million upfront, $500M milestones
Research collaboration, neurological, small molecule, drug discovery, milestone payments - Read more

Lyell Immunopharma, Innovative Cellular Therapeutics license colorectal cancer CAR-T therapy, $70M upfront, $820M milestones
Licensing deal, oncology, cell therapy, milestone payments - Read more

Novo Nordisk, Emcure partner to distribute Wegovy as Poviztra in India
Commercialization partnership, obesity, GLP-1, distribution agreement - Read more

GENFIT, EVerZom collaborate on exosome-based regenerative therapy EViv for acute-on-chronic liver failure
Research collaboration, rare disease, regenerative medicine, exosome technology, licensing option - Read more

Eli Lilly, Insilico Medicine expand AI drug discovery partnership with $100M+ potential deal value
Research collaboration, AI/ML, small molecule, drug discovery, milestone payments - Read more

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✅ More Good News ✅

THE GOOD
Clinical Trials

Summit Therapeutics, Akeso Biopharma's ivonescimab shows 26% overall survival benefit in Ph3 non-small-cell lung cancer study
Bispecific antibody, cancer, PD-1/VEGF bispecific, non-small cell lung cancer, EGFR-mutated, combination therapy - Read more

Regeneron's Dupixent (dupilumab) achieves Ph3 success in allergic fungal rhinosinusitis, receives FDA priority review
Monoclonal antibody, autoimmune, inflammatory diseases, allergic fungal rhinosinusitis, hypereosinophilic syndrome, IL-5 pathway - Read more

Merck & Co.'s enlicitide decanoate cuts LDL cholesterol over 50% in Ph3 atherosclerotic cardiovascular disease studies
Small molecule, cardiovascular, PCSK9 inhibitor, hypercholesterolemia, LDL cholesterol reduction - Read more

AstraZeneca's baxdrostat shows 14 mmHg blood pressure reduction in Ph3 treatment-resistant hypertension trial
Small molecule, cardiovascular, aldosterone synthase inhibitor, resistant hypertension - Read more

Amgen's Repatha (evolocumab) cuts first major cardiovascular events 25% in Ph3 primary prevention trial
Monoclonal antibody, cardiovascular, PCSK9 inhibitor, primary prevention, cholesterol lowering - Read more

Ionis Pharmaceuticals' Tryngolza (olezarsen) shows sustained triglyceride reductions in Ph3 severe hypertriglyceridaemia studies at AHA
Antisense oligonucleotide, metabolic, severe hypertriglyceridemia, apoC-III target, acute pancreatitis prevention - Read more

Vor Bio's telitacicept meets primary endpoint in Ph3 trial for immunoglobulin A nephropathy in China
Protein therapy, autoimmune, BAFF/APRIL inhibitor, IgA nephropathy, B-cell targeting - Read more

CRISPR Therapeutics reports positive Ph1 data for CTX310 targeting ANGPTL3 showing durable lipid lowering
Gene therapy, metabolic, CRISPR, ANGPTL3 target, lipid lowering - Read more

Rivus presents positive Ph2 data for HU6 in metabolic dysfunction-associated steatohepatitis at AASLD meeting
Small molecule, metabolic, MASH, liver fat reduction, obesity - Read more

MiNK Therapeutics reports positive clinical results for agenT-797 cell therapy in checkpoint inhibitor-resistant solid tumors
Cell therapy, cancer, iNKT cell therapy, checkpoint inhibitor resistant, combination therapy - Read more

Roche's fenebrutinib (BTK inhibitor) shows positive Ph3 results for relapsing and primary progressive multiple sclerosis
Small molecule, neurological, BTK inhibitor, multiple sclerosis, B cell targeting - Read more

Cogent Biosciences' bezuclastinib plus sunitinib hits Ph3 endpoints for gastrointestinal stromal tumors, eyes FDA submission
Small molecule, cancer, tyrosine kinase inhibitor, gastrointestinal stromal tumor, combination therapy - Read more

Leucid Bio reports positive Ph1/2 data for LEU011 CAR-T therapy in relapsed/refractory solid tumors
Cell therapy, cancer, CAR-T, solid tumors, lateral CAR platform - Read more

Camurus' CAM2056 (semaglutide) shows superior weight loss versus Wegovy in Ph1b obesity trial
Protein therapy, metabolic, GLP-1 agonist, obesity, semaglutide, monthly dosing - Read more

Madrigal's Rezdiffra (resmetirom) shows promise for metabolic dysfunction-associated steatohepatitis cirrhosis in Ph3 data
Small molecule, metabolic, THR-β agonist, MASH, cirrhosis, liver fibrosis - Read more

AtaiBeckley's BPL-003 shows positive Ph2b results for treatment-resistant depression, supporting second-dose efficacy and safety
Small molecule, neurological, psychedelic therapy, treatment-resistant depression, intermittent dosing - Read more

A2 Bio's A2B694 achieves first CAR-T complete response in non-small cell lung cancer patient in Ph1/2
Cell therapy, cancer, CAR-T, non-small cell lung cancer, mesothelin target, solid tumors - Read more

THE GOOD
Company Launches

Ex-Lilly diabetes executives launch 501 Ventures VC firm targeting next-generation obesity treatments
Metabolic health therapeutics, obesity, strategic, investment - Read more [Paywall]

THE GOOD
Fundraises

Onchilles Pharma raises $25M Series A1, dual-action cancer biologics targeting ELANE pathway
Oncology, biologic, ELANE pathway, immune-activating, solid tumors - Read more

Accipiter Biosciences raises $12.7M Seed, developing de novo multifunctional biologics
Platform technology, de novo biologics, immunology, oncology, computational platform, preclinical - Read more

Elephas Biosciences raises $40M Series B-2, live tumor profiling platform commercialization
Oncology, biomarker discovery, immunotherapy, platform technology, diagnostic platform - Read more

Eccogene targets $150M HKEX IPO for MASH, obesity drug development
Obesity, MASH, small molecule, clinical-stage - Read more [Paywall]

Iambic raises $100M+ Series, AI-driven drug discovery and pipeline advancement
AI-driven, oncology, small molecule, clinical-stage - Read more

Precision BioSciences raises $75M equity offering, ARCUS gene editing platform development
Gene editing, CRISPR, clinical-stage, platform technology - Read more

THE GOOD
Investments

Merck Foundation commits $22M over five years to improve heart disease care access equity
Cardiovascular, strategic, investment, health equity - Read more

THE GOOD
Mergers & Acquisitions

Pfizer beats Novo Nordisk with $10B Metsera acquisition after fierce bidding war and anti-trust concerns
GLP-1 receptor agonist, obesity, strategic, major transaction - Read more

Galecto acquires Damora Therapeutics for blood cancer treatments, raises $284.9M in Series C funding
Monoclonal antibody, oncology, strategic, major transaction - Read more

THE GOOD
Regulatory

CMS launches voluntary model to negotiate lower Medicaid drug prices with pharma companies
Regulatory, financial, cost reduction, strategic - Read more

FDA removes decades-old safety warnings on hormone replacement therapy for menopausal women
Hormone therapy, women's health, regulatory, strategic - Read more

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THE BAD
Approvals & Labels

FDA extends review of Rhythm's Imcivree (setmelanotide) MC4R agonist for hypothalamic obesity by three months
Small molecule, metabolic, MC4R agonist, hypothalamic obesity - Read more

THE BAD
Clinical Trials

Gilead's Trodelvy (sacituzumab govitecan) fails Ph3 trial for first-line hormone receptor-positive breast cancer treatment
Antibody-drug conjugate, cancer, breast cancer, TROP-2 target, metastatic disease - Read more

Eledon's tegoprubart (anti-CD40 ligand antibody) misses Ph2 primary endpoint in kidney transplant rejection prevention
Antibody, transplant rejection, monoclonal antibody, kidney transplant, CD40 ligand target, immunosuppression - Read more

Neurocrine's NBI-770 fails Ph2 trial for major depressive disorder, missing primary endpoint versus placebo
Small molecule, neurological, major depressive disorder, protein inhibitor, treatment-resistant depression - Read more

AnaptysBio discontinues rosnilimab (PD-1 agonist) development for ulcerative colitis after Ph2 failure
Antibody, autoimmune, PD-1 agonist, ulcerative colitis, phase 2 failure - Read more

THE BAD
Layoffs

Kezar cuts 70% of workforce after FDA cancels meeting on autoimmune hepatitis drug zetomipzomib
Small molecule, autoimmune, operational, cost reduction, strategic - Read more

Catalent cuts 77 more Maryland jobs in gene therapy division amid ongoing customer demand shifts
Gene therapy, rare disease, operational, cost reduction - Read more

THE BAD
Regulatory

NAD refers Pfizer's challenge of BridgeBio's Attruby ads to federal agencies after BridgeBio declines participation
Small molecule, cardiovascular, competitive, regulatory - Read more

THE BAD
Strategic Plans

Sana, CAMP4 halt clinical programs to prioritize preclinical diabetes, rare disease candidates
Cell therapy, autoimmune, strategic, operational - Read more

Zuckerberg-backed Biohub hires EvolutionaryScale's 50-person team, effectively ending the $142M AI startup
AI platform, strategic, major transaction, operational - Read more [Paywall]

THE UGLY
Clinical Trials

Patient death prompts FDA clinical hold on Intellia Therapeutics' nexiguran ziclumeran CRISPR therapy for transthyretin amyloidosis
Gene therapy, cardiovascular, CRISPR, transthyretin amyloidosis, liver toxicity, TTR gene - Read more

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

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