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THE GOOD
Approvals & Labels

FDA approves Sanofi's Qfitlia (targeting antithrombin) for hemophilia prevention with infrequent self-administered injections
siRNA, hemophilia - Read more

FDA expands Novartis' Pluvicto (targeting PSMA) label for castration-resistant prostate cancer
Radiopharm, prostate cancer - Read more

IASO Bio's Equecabtagene Autoleucel (targeting BCMA) approved in Macau for adults with relapsed/refractory multiple myeloma after three prior therapies
Cell therapy, multiple myeloma, CAR-T - Read more

Sanofi and Regeneron's Dupixent (targeting IL-4Rα) lands Japanese PMDA for COPD in adults inadequately controlled with existing treatments
Monoclonal antibody, chronic obstructive pulmonary disease (COPD) - Read more

Bristol Myers Squibb's subcutaneous Opdivo (targeting PD-1) nabs positive EMA recommendation
Monoclonal antibody, cancer, drug formulation, solid tumor - Read more

Abbott's Volt pulsed field ablation system receives European CE mark for atrial fibrillation treatment
Medical device, atrial fibrillation, pulsed field ablation - Read more

Visby Medical's at-home Women's Sexual Health Test receives FDA approval for detecting chlamydia, gonorrhea, and trichomoniasis without prescription
At-home testing, diagnostics, sexually transmitted diseases, women's health - Read more

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⬇️ More Good News ⬇️

THE GOOD
Business Development

Novo Nordisk in-licenses Lexicon Pharmaceuticals's oral obesity drug LX9851 (targeting ACSL5) for up to $1 billion plus royalties
Small molecule, obesity, cardiometabolic disease - Read more

Merck KGaA exercises $85M option for global commercialization to Abbisko Therapeutics’ pimicotinib (CSF-1R)
Small molecule, commercialization, Tenosynovial giant cell tumor - Read more [Paywall]

Eisai sells rights for Pariet (H+/K+-ATPase) in China to Peak Pharma for 15.7B JPY ($105M) upfront + undisclosed milestones
Small molecule, gastric ulcer, duodenal ulcer, reflux esophagitis - Read more

ERS Genomics licenses CRISPR/Cas9 tech to Jumpcode Genomics to enhance next-generation sequencing capabilities and applications
Gene-editing, CRISPR, Cas9, next-generation sequencing (NGS) - Read more

THE GOOD
Clinical Trials

BioNTech's bispecific antibody BNT327 (targeting PD-L1xVEGF-A) delivers 85.4% response rate in Ph2 trial for small-cell lung cancer as first-line treatment with chemotherapy
Bispecific antibody, lung cancer - Read more

Palatin Technologies' PL8177 (melanocortin-1 receptor agonist) delivers 33% clinical remission in ulcerative colitis patients in Ph2 trial
Peptide, ulcerative colitis - Read more

Shanton Pharma touts promising Ph2b data for SAP-001 (targeting URAT1) in refractory gout
Small molecule, gout - Read more

GenFleet Therapeutics' showcases promising Ph2 efficacy for fulzerasib (KRAS G12C inhibitor) combined with cetuximab (targeting EGFR) in non-small cell lung cancer, especially in brain-metastatic patients
Small molecule, lung cancer, monoclonal antibody, combo therapy- Read more

Dermata Therapeutics’ Xyngari met all primary endpoints in Ph3 trial for moderate-to-severe acne
Siliceous spicules, acne, topical - Read more

THE GOOD
Fundraises

DBV Technologies lands $306.9M ($125.5M upfront) financing, advancing Viaskin peanut allergy patch through BLA submission and potential US launch
Medical device, peanut allergy - Read more

Vivani Medical $8.25M private placement, developing miniature drug implants for weight management with extended cash runway
GLP-1, implant, drug delivery, obesity - Read more

Heartflow $98M convertible notes financing, AI technology for coronary artery disease, funding R&D
Coronary artery disease, AI, diagnostics - Read more

Intelliseq secures €4.5M ($4.9M), bioinformatics company developing DNA analysis tools for genetic diagnostics and international expansion
Diagnostics, bioinformatics, genetic screening - Read more

THE GOOD
Lawsuits

Johnson & Johnson wins appeal against Mylan, blocking generic competition for its schizophrenia drug Invega Trinza due to dosing patent
Patent suit, generic, small molecule, schizophrenia - Read more [Paywall]

THE GOOD
Mergers & Acquisitions

Ayrmid offers to buy bluebird bio for $45 million, surpassing previous $30 million bid from Carlyle Group and SK Capital
Gene therapy, M&A strategy - Read more

THE GOOD
Partnerships

AbbVie, Johnson & Johnson collab with Columbia University & Apheris, sharing molecular data to enhance OpenFold3 AI model for drug discovery
AI, drug discovery, drug design - Read more

THE GOOD
Politics & Policy

Pharma CEOs from AstraZeneca, Sanofi, Lilly, and Pfizer met with Chinese President Xi amid US-China trade tensions
Big pharma strategy, lobbying - Read more

GSK urges UK to grant broader access to national health data for improving drug development success rates
Research & Development, drug development, health data - Read more

THE GOOD
Research

Study finds gender-affirming hormones reduce HIV risk among transgender individuals by 37%, supporting the gender affirmation framework theory
Gender-affirming care, human immunodeficiency virus (HIV) - Read more [Paywall]

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THE BAD
Approvals & Labels

Milestone Pharmaceuticals' Cardamyst nasal spray for heart condition rejected by FDA due to manufacturing facility concerns
Small molecule, nasal spray, paroxysmal supraventricular tachycardia - Read more

Eli Lilly's Kisunla (targeting pGlu3-Aβ) for early symptomatic Alzheimer's disease, rejected by European regulators due to safety concerns
Monoclonal antibody, Alzheimer's disease - Read more

THE BAD
Lawsuits

US court upholds Colorado's power to limit drug prices, rejecting Amgen's challenge to state price controls on Enbrel
Drug Pricing - Read more [Paywall]

THE BAD
Layoffs

BioAtla cuts 30% of staff, prioritizes mecbotamab vedotin (targeting AXL) and BA3182 (targeting EpCAMxCD3) while seeking partners for other cancer therapies
Antibody-drug conjugate (ADC), lung cancer, bispecific T-cell engager, adenocarcinoma - Read more

THE BAD
Strategic Plans

Spero Therapeutics discontinues SPR206 antibiotic program after pipeline reprioritization, focusing on tebipenem HBr instead
Small molecule, antibiotic, pipeline strategy, bacterial infection, pneumonia - Read more

Relmada Therapeutics reconsiders phase 2 development of psilocybin extract for obesity despite phase 1 safety data, citing competitive landscape concerns
Small molecule, psychedelics, pipeline strategy, obesity, metabolic disease - Read more

THE UGLY
Politics & Policy

Senate Democrats accuse Pfizer of massive tax evasion by shifting profits offshore, reporting zero US taxable income despite $20 billion in sales
Tax Investigation - Read more

NIH cuts $1.2 million from Columbia University's chronic fatigue research, halting promising drug studies and forcing layoffs
Federal funding, chronic fatigue - Read more

HHS emergency response unit faces dissolution, with BARDA moving to new office and other functions to CDC
US Department of Health & Human Services (HHS), Biomedical Advanced Research and Development Authority (BARDA) - Read more [Paywall]

FDA official Peter Marks resigns after ultimatum from HHS, citing RFK Jr.'s rejection of "truth and transparency" on vaccines
Center for Biologics Evaluation and Research (CBER) - Read more

THE UGLY
Public Health

Texas measles outbreaks balloons to 400 cases, surpassing 2024's total amid low vaccination rates
Measles, infectious disease, infectious disease outbreak - Read more [Paywall]

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

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