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THE GOOD
Approvals & Labels

GSK's Blujepa (targeting DNA gyrase, topoisomerase IV) receives FDA approval for treating uncomplicated urinary tract infections in adults and pediatric patients aged 12+.
Urinary tract infection (UTI), small molecule - Read more

THE GOOD
Business Development

Merck & Co. pays $200M to in-license Jiangsu Hengrui's experimental LpA-blocking heart drug, joining competitive race for this therapeutic approach
Small molecule, heart disease, cardiovascular disease - Read more

Turn Biotechnologies acquires microvesicle delivery technology from Harvard University and Vesigen Therapeutics for its mRNA aging therapies
mRNA, drug delivery, microvesicles - Read more [Paywall]

Kaken Pharmaceutical pays Alumis $40M upfront, potentially $180M total, for Japan rights to ESK-001 (TYK2 inhibitor) for in dermatological disorders
Small molecule, Plaque Psoriasis - Read more

Relmada Therapeutics in-licenses NDV-01, a sustained-release bladder cancer treatment, from Trigone Pharma
Small molecule, drug formulation, bladder cancer - Read more

Closed Loop Medicine receives US patents for personalized dosing platform, plans to expand into GLP-1 medicines and oral anticoagulants
Digital therapeutics, cardiometabolic disease, obesity, drug dosing, patient adherence - Read more

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THE GOOD
Clinical Trials

Kezar Life Sciences touts positive Ph2a data, showing higher autoimmune hepatitis complete responses with zetomipzomib (targeting LMP7, LMP2) with reduced steroid use versus placebo
Small molecule, autoimmune hepatitis - Read more

Axsome Therapeutics showcases solriamfetol (dopamine-norepinephrine reuptake inhibitor) Ph3 win, meeting endpoints, in ADHD in adults
Small molecule, attention deficit hyperactivity disorder (ADHD) - Read more

THE GOOD
Company Launches

Hillstar Bio launches with $67M to develop precision immunology therapies targeting specific pathogenic cells for autoimmune diseases
Immunotherapy, autoimmune disease - Read more

THE GOOD
Earnings & Finances

WuXi XDC reports 91% revenue growth in 2024, alongside WuXi Biologics and others in the WuXi family
Antibody-drug conjugate (ADC), CDMO (Contract Development & Manufacturing Organization) - Read more

Eisai projects Leqembi Alzheimer's drug to achieve $1.6-1.8 billion in FY2027 sales, en route to $8.6 billion by 2032
Monoclonal antibody, Alzheimer's disease - Read more

THE GOOD
Fundraises

Character Biosciences $93M Series B, developing treatments for vision loss
Protein, age-related macular degeneration (AMD), geographic atrophy - Read more

Navina $55M Series C, AI clinical intelligence company expanding in US healthcare markets
Clinical data, clinical intelligence, AI - Read more

NeuroNOS $2M funding, developing injectable/oral small molecules treatments for autism by regulating nitric oxide levels
Small molecule, autism spectrum disorder - Read more

THE GOOD
Investments

Bharat Biotech invests $75M in first cell and gene therapy facility in Hyderabad, India, expanding beyond vaccines into advanced therapeutics
Cell therapy, cell therapy manufacturing, gene therapy, gene therapy manufacturing - Read more

THE GOOD
Mergers & Acquisitions

MIRA set to acquire SKNY Pharmaceuticals with $5M infusion, expanding pipeline to include SKNY-1 for weight loss and smoking cessation
Undisclosed modality, obesity, smoking cessation - Read more

THE GOOD
Partnerships

GSK, UK Dementia Research Institute partnering to study potential link between Shingrix shingles vaccine and reduced dementia risk
Vaccine, shingles, dementia, Research & Development - Read more

Revvity, Genomics England expanded partnership for DNA sequencing to screen newborns for rare genetic conditions
Genetic screening, rare disease - Read more

PharmAla Biotech & unnamed third-party logistics company, partnering for US clinical trial distribution of LaNeo MDMA
Supply chain, supply contract, small molecule, psychedelics - Read more

Anixa Biosciences, VERDI Solutions partnering on AI-guided personalized cancer vaccines with exclusive negotiation rights
Cancer vaccine, cancer, AI, drug development, Research & Development, commercialization - Read more

THE GOOD
Politics & Policy

DOGE reverses closure of three FDA sites, including St. Louis drug quality lab with valuable testing equipment
Food & Drug Administration (FDA) - Read more [Paywall]

Senate Finance Committee advances Dr. Mehmet Oz's nomination for CMS administrator on 14-13 party-line vote
Centers for Medicare and Medicaid Services (CMS), political appointee - Read more [Paywall]

Senate confirms Makary as FDA commissioner and Bhattacharya as NIH director with Republican and some Democratic support
Food & Drug Administration (FDA), National Institute of Health (NIH), political appointee - Read more [Paywall]

THE GOOD
Research

Tenaya Therapeutics' TN-201 gene therapy reversed HCM symptoms in preclinical models by replacing MYBPC3 gene
Gene therapy, hypertrophic cardiomyopathy, adeno-associated virus (AAV) - Read more

Allegro's injectable hydrogel for osteoarthritis showed no toxicity in preclinical studies
Hydrogel, degenerative joint disease, osteoarthritis - Read more

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THE BAD
Clinical Trials

Cassava Sciences terminates simufilam (targeting filamin A) after Ph3 REFOCUS-ALZ trial shows no benefit for mild-to-moderate Alzheimer's disease
Small molecule, Alzheimer's disease - Read more

Mural Oncology discontinues nemvaleukin alfa (targeting IL-2Rβγ) after Ph3 trial fails to improve overall survival compared to chemotherapy
Fusion protein, ovarian cancer - Read more

CNS Pharmaceuticals' berubicin (targeting topoisomerase II) Ph3 trial for recurrent glioblastoma multiforme fails to show significant improvement in overall survival
Small molecule, glioblastoma, cancer - Read more

THE BAD
Company Shutdown

Lyndra Therapeutics ceases operations despite raising $380M over a decade, unable to secure funding for Ph3 safety study
Drug delivery, drug formulation, long-acting formulation - Read more [Paywall]

THE BAD
Earnings & Finances

CorMedix shares drop 30% after major DefenCath order delayed to 2025, despite profitable Q4
Catheter-related bloodstream infections, medical device - Read more

THE BAD
Layoffs

Alector lays off 13% of workforce, following earlier 17% cut, to extend cash runway through 2026
Monoclonal antibody, Alzheimer's disease, dementia - Read more

THE BAD
Market Reports

Pharma R&D costs rose to $2.23B per drug in 2024, up over $100M from year previous
Drug development, drug approval process - Read more

THE BAD
Politics & Policy

Trump reaffirms plan to impose pharmaceutical tariffs “in the very near future, not the long future, the very near future”; specifics remain unclear
Tariffs - Read more

THE UGLY
Marketing

AstraZeneca and Pfizer violated UK drug marketing rules on LinkedIn, with AstraZeneca penalized for a promotional post mentioning a drug name and indication, while Pfizer penalized for employees liking a LinkedIn post that mentioned one of their drug’s active ingredients
Drug marketing violations, LinkedIn - Read more

THE UGLY
Politics & Policy

NIH removing diverse outside scientific advisers without explanation, raising concerns about potential biases in the new administration
National Institute of Health (NIH), DEI - Read more [Paywall]

THE UGLY
Public Health

NIH ends future funding for studies on health effects of climate change, following Trump administration directives
National Institute of Health (NIH), climate change - Read more

NIH cancels $18 million adolescent HIV prevention program, potentially disrupting ongoing research and treatment trials
National Institute of Health (NIH), human immunodeficiency virus (HIV), acquired immunodeficiency syndrome (AIDS) - Read more [Paywall]

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

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