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The Good News

THE GOOD
Approvals & Labels

AstraZeneca's Baxfendy wins FDA approval for uncontrolled hypertension, targeting aldosterone synthesis following Ph3 success
Small molecule, cardiovascular, aldosterone synthase inhibitor, hypertension, combination therapy - Read more

GSK's Arexvy (respiratory syncytial virus vaccine) gains Japan label expansion for at-risk adults aged 18–49 following Ph3b data
Vaccine, infectious disease, recombinant protein vaccine, RSV, immunocompromised patients, respiratory disease - Read more

Boehringer Ingelheim's JASCAYD (nerandomilast) approved in Japan for idiopathic pulmonary fibrosis and progressive pulmonary fibrosis following Ph3 success
Small molecule, pulmonary fibrosis, PDE4B inhibitor, idiopathic pulmonary fibrosis, antifibrotic - Read more

THE GOOD
Business Development & Partnerships

Boston Scientific invests $1.5B for 34% stake in MiRus, with option to acquire TAVR system for $3B
Equity investment, cardiovascular, medical devices, milestone payments, acquisition option - Read more

Fujifilm Healthcare Americas, Ardent Health partner on AI-enabled enterprise imaging platform across 30+ hospitals
Licensing deal, AI/ML, diagnostics, digital health, commercialization - Read more

Regeneron, Parabilis Medicines collaborate to create antibody-helicon conjugate drug class, $75M upfront, $2.3B deal
Research collaboration, peptide therapy, antibody-drug conjugate, oncology, milestone payments, equity investment - Read more

CellBxHealth, AdventHealth collaborate on CTC-based cancer monitoring across two multi-centre studies
Research collaboration, oncology, diagnostics, liquid biopsy, R&D - Read more

Kariya Pharmaceuticals, NeuraLight partner to advance brain-penetrant GLP-1 therapies using precision biomarker platform
Research collaboration, neurological, small molecule, diagnostics, R&D - Read more

AstraZeneca, Roche Diagnostics partner on three-year AI cancer biomarker adoption across nine Asian markets
Research collaboration, oncology, AI/ML, diagnostics, biomarkers - Read more

Edison Innovations, Illuminare Biotechnologies cement royalty-bearing licensing agreement supporting Illuminare-1 Phase II clinical trial
Licensing deal, small molecule, surgical/intraoperative imaging, royalties, clinical trials - Read more

Context Therapeutics, BioAtla amend CT-202 license, removing milestones for $4.5M upfront and $2M final payment
Licensing deal, oncology, bispecific antibody, milestone payments, royalties - Read more

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More Good News

THE GOOD
Clinical Trials

Vincentage's VCT220 (orforglipron rival) meets Ph3 primary endpoints for obesity, prompting China NMPA submission
Small molecule, metabolic, GLP-1 receptor agonist, obesity, type 2 diabetes - Read more

Ipsen's (corabotase) Ph2 data supports Ph3 advancement for long-acting neurotoxin targeting glabellar lines
Protein therapy, aesthetic medicine, neurotoxin, recombinant neuroinhibitor, glabellar lines - Read more

Merck & Co.'s (sacituzumab tirumotecan) hits Ph3 mark in endometrial cancer, beating chemotherapy in survival outcomes
Antibody-drug conjugate, cancer, small molecule, endometrial cancer, TROP2, non-small cell lung cancer - Read more

Microbiotica's MB097 shows positive Ph1b results combined with pembrolizumab in advanced melanoma with anti-PD-1 resistance
Microbiome therapy, cancer, combination therapy, melanoma, anti-PD-1 resistance, immune checkpoint inhibitor - Read more

THE GOOD
Fundraises

NanoViricides closes ~$2M registered direct offering, broad-spectrum antiviral development
Infectious disease, antiviral, nanomedicine, clinical-stage - Read more

Accro Bioscience raises $50M Series C to advance immune mediated disease clinical pipeline
Autoimmune, small molecule, clinical-stage, ulcerative colitis - Read more

Full-Life Technologies raises $150M Series D, advancing radiotherapeutics pipeline and Belgium manufacturing
Radiopharmaceuticals, oncology, clinical-stage, manufacturing, prostate cancer - Read more

Wonderlab Bio receives undisclosed investment from Jetstream Venture Fund for R&D expansion
Cell therapy, regenerative medicine, iPSC, off-the-shelf, preclinical - Read more

THE GOOD
Investments

Bristol Myers Squibb weighs $1B Houston manufacturing plant that could employ 500 people
Small molecule, manufacturing, strategic, major transaction - Read more

THE GOOD
Market Reports

Revolution Medicines' (daraxonrasib) Ph3 RAS inhibitor on track for FDA approval in metastatic pancreatic ductal adenocarcinoma by Q3
Small molecule, cancer, RAS inhibitor, pancreatic cancer, non-small cell lung cancer - Read more

THE GOOD
Mergers & Acquisitions

Quince Therapeutics merges with Orphai Therapeutics in reverse merger after rare disease phase 3 failure
Cell therapy, rare disease, strategic, major transaction - Read more

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The Bad News

THE BAD
Clinical Trials

BioMarin Pharmaceutical's BMN 401 (INZ-701) misses key Ph3 skeletal healing endpoint in ENPP1 deficiency
Protein therapy, rare disease, enzyme replacement therapy, ENPP1 deficiency, hypophosphatemic rickets - Read more

THE BAD
Lawsuits

Novartis terminates plant contract with Chinese CDMO Porton Pharma Solutions, threatens $64M in legal claims
Small molecule, infectious disease, operational, financial - Read more

Supreme Court rejects IRA drug pricing challenges from AstraZeneca, Novo Nordisk, J&J, and others
Small molecule, multi-disease, regulatory, revenue impact, competitive - Read more

👹 The Ugly News 👹

THE UGLY
Adverse Events

Amgen's Tavneos linked to 20 deaths in Japan, prompting Kissei to discourage new patient prescriptions
Small molecule, autoimmune, regulatory, safety - Read more

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

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