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THE GOOD
Approvals & Labels

GSK's Trelegy Ellipta (fluticasone furoate/umeclidinium/vilanterol) wins China approval for uncontrolled asthma treatment
Small molecule, respiratory disease, inhaled corticosteroid, asthma, triple therapy - Read more

Huahui Health receives conditional NMPA approval for Libevitug injection targeting chronic hepatitis D virus in adults
Monoclonal antibody, infectious disease, hepatitis D virus, PreS1 target, liver disease - Read more

THE GOOD
Business Development & Partnerships

ST Pharm secures $56M API manufacturing contract with undisclosed US biotech for oligonucleotide treatment
Manufacturing agreement, oligonucleotide, metabolic disease, API production - Read more

Bavarian Nordic, Eurofarma sign exclusive distribution agreement for chikungunya vaccine in Brazil
Distribution agreement, vaccine, infectious disease, royalties - Read more

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✅ More Good News ✅

THE GOOD
Company Launches

J. Craig Venter launches Diploid Genomics, AI-driven startup targeting advanced diagnostic insights with PacBio partnership
Genomic sequencing, diagnostics, strategic, investment - Read more

THE GOOD
Earnings & Finances

Vivani Medical raises $4.5M direct offering, ultra long-acting drug implants development
Clinical-stage, drug implants, ultra long-acting, miniature devices - Read more

THE GOOD
Market Reports

Novo Nordisk's oral Wegovy shows very strong launch with 18,410 weekly prescriptions, surpassing other GLP-1s
Small molecule, metabolic disease, strategic, competitive - Read more

THE GOOD
Politics & Policy

US House of Representatives passes $1.2T spending bill that could restart FDA's rare pediatric disease priority voucher program
Rare disease, regulatory, strategic, pediatric - Read more

THE GOOD
Regulatory

FDA releases draft M4Q(R2) guidance on pharmaceutical registration quality standards for public comment through March 2026
Pharmaceuticals, regulatory, operational, strategic - Read more

NICE reverses decision, recommends NHS funding for Pfizer's Talzenna with Xtandi for advanced prostate cancer
PARP inhibitor, oncology, strategic, cost reduction - Read more

THE GOOD
Strategic Plans

F2G CEO outlines plans to resubmit olorofim FDA application with Phase 3 data by June 2025
Small molecule, infectious disease, strategic, investment - Read more [Paywall]

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THE BAD
Clinical Trials

Bausch Health's amorphous rifaximin SSD formulation fails Ph3 trials for hepatic encephalopathy primary prevention
Small molecule, gastrointestinal, hepatic encephalopathy, liver cirrhosis, rifaximin - Read more

Sanofi plans regulatory filings for amlitelimab targeting OX40-ligand despite mixed Ph3 atopic dermatitis results
Monoclonal antibody, autoimmune, atopic dermatitis, OX40 ligand, combination therapy - Read more

THE BAD
Earnings & Finances

Abbott shares fall 10% as nutrition business drops 8.9%, diagnostics decline 2.5% in Q4 earnings
Medical device, diabetes, financial, operational, competitive - Read more

THE BAD
Mergers & Acquisitions

Merck & Co. backs out of $30B acquisition talks with Revolution Medicines over pricing disagreement
Small molecule, oncology, strategic, major transaction - Read more

THE BAD
Regulatory

CDC's ACIP Chair Milhoan questions polio vaccine necessity, prioritizes individual choice over public health benefit
Vaccine, infectious disease, regulatory, operational - Read more

THE BAD
Strategic Plans

Moderna halts new late-stage infectious disease vaccine trials due to anti-vaccine sentiment under Trump administration
mRNA vaccine, infectious disease, strategic, operational - Read more

THE UGLY
Politics & Policy

US officially withdraws from WHO, citing COVID-19 mishandling and lack of independence from political influence
Infectious disease, strategic, operational, regulatory - Read more

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

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