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THE GOOD
Approvals & Labels

Celltrion's Eydenzelt (targeting VEGF; aflibercept biosimilar, Regeneron, Bayer) and Stoboclo/Osenvelt (targeting RANKL; denosumab biosimilar, Amgen) lands European Commission approval for retinal disorders and skeletal-related conditions, respectively
Fusion protein, wet AMD, macular edema following retinal vein occlusion, monoclonal antibody, osteoporosis, multiple myeloma, biosimilar - Read more

ImmunityBio and Serum Institute of India's recombinant BCG receives FDA expanded access for bladder cancer
Recombinant BCG, bladder cancer - Read more

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THE GOOD
Business Development

CSPC Pharmaceutical out-licenses SYS6005 (targeting ROR1) to Radiance Biopharma for up to $1.2B
Antibody-drug conjugate, lung cancer, blood cancer, ovarian cancer - Read more

THE GOOD
Clinical Trials

Ascletis Pharma touts positive interim Ph1b data for ASC30 (targeting GLP-1R) in obesity
Small molecule, obesity - Read more

Bristol Myers Squibb showcases positive Ph3 data for Opdivo (PD-1 inhibitor) plus chemotherapy resectable non-small cell lung cancer
Monoclonal antibody, lung cancer - Read more

Cabaletta Bio's rese-cel (targeting CD19) shows promise in Ph1/2 trial for treating lupus and dermatomyositis
Cell therapy, systemic lupus erythematosus, systemic sclerosis, myositis, CAR-T - Read more

Recce Pharmaceuticals' R327G gel delivers Ph2 success in treating bacterial skin infections, including diabetic foot infections
Small molecule, diabetic foot infections, acute bacterial skin and skin structure infections (ABSSSI), topical - Read more

THE GOOD
Earnings & Finances

Sanofi sells 50% controlling stake in Opella to CD&R, with Bpifrance taking 2%; deal closing expected Q2 2025.
Consumer health - Read more

THE GOOD
Fundraises

Reverb Therapeutics $12 M Seed, biotech company developing immune system treatments for life-threatening diseases
Bispecific antibody, cancer, autoimmune - Read more

Subsense $17M Seed, developing non-surgical nanoparticle brain-computer interface for connecting brains to external sources
Brain-computer interface, nanoparticle - Read more

Altitude Labs (backed by Recursion Pharmaceuticals) launches pre-seed fund to help address funding gap caused by NIH cuts
Pre-seed funding, SBIR (Small Business Innovation Research) program, life science investing, biotech investing - Read more

THE GOOD
IPOs

Anbio Biotechnology announces IPO of 1.6M shares at $5 each, will trade on Nasdaq as "NNNN" starting February 2025
Diagnostics, biomarkers - Read more

Genuine Biotech, a Chinese drug developer, seeks listing on Hong Kong Stock Exchange
Small molecule, human immunodeficiency virus (HIV), cancer, COVID-19 - Read more

THE GOOD
Lawsuits

Lawsuit against Merck & Co. over Gardasil vaccine safety suspended, linked to new HHS Secretary RFK Jr.'s past legal campaign
HPV, vaccine injury - Read more

THE GOOD
Mergers & Acquisition

Flourish Research acquires Diablo Clinical Research, expanding its clinical trial capabilities across multiple therapeutic areas and study phases
CRO, clinical research site - Read more

Report suggests Sycamore Partners' potential buyout of Walgreens is still possible, causing 15% stock price surge
Pharmacy, consumer health - Read more

THE GOOD
Partnerships

AWS (Amazon), Memorial Sloan Kettering Cancer Center partner to accelerate cancer drug discovery using AI and data analytics
Research & development, drug development, drug discovery, AI - Read more

Merck & Co., Epitopea partner to discover hidden tumor antigens using CryptoMap platform for immunotherapy development
RNA, drug discovery, tumor antigen, solid tumor, tumor microenvironment - Read more

THE GOOD
Politics & Policy

Pfizer CEO, at PhRMA Forum, expresses optimism about Trump administration's pro-business stance benefiting pharmaceutical industry
Pharma industry, lobbying - Read more [Paywall]

Trump signs executive order directing policy council to protect IVF access and reduce treatment costs nationwide
In-vitro fertilization, IVF access - Read more

THE GOOD
Public Health

Novartis invests $7.5M in Zero Prostate Cancer's initiative to reduce healthcare disparities and save 100,000 lives by 2035
Drug access, healthcare access, prostate cancer - Read more

Uganda's last eight Ebola patients discharged, marking end of outbreak with no new cases reported, WHO praises response
Ebola virus, infectious disease - Read more [Paywall]

THE GOOD
Product Launches

Google launches Gemini 2.0-powered AI assistant to help scientists with research, emphasizing it will support, not replace, researchers
AI, research & development - Read more

THE GOOD
Research

Arc Institute's Evo 2 AI model expands genetic modeling capabilities to include complex organisms, collaborating with NVIDIA and universities
AI, genome foundation model, drug discovery - Read more

Drug mimicking high-altitude, low-oxygen conditions extends lifespan in mice with mitochondrial disease, showing promise for human treatment
Small molecule, mitochondrial disorder - Read more

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THE BAD
Approvals & Labels

Harmony Biosciences' Wakix (H3 receptor antagonist) sNDA for EDS with idiopathic hypersomnia rejected by FDA due to missed Ph3 study
Small molecule, idiopathic hypersomnia, excessive daytime sleepiness - Read more

THE BAD
Clinical Trials

Supernus Pharmaceuticals' SPN-820 (mTORC1 activator) fails Ph2b trial in treatment-resistant depression
Small molecule, treatment resistant depression - Read more

Exelixis’ Cabometyx (targeting MET, AXL, VEGFR) combined with Opdivo/Yervoy (Bristol Myers Squibb) flops in Ph3 advanced kidney cancer trial
Small molecule, monoclonal antibody, kidney cancer, renal cell carcinoma, drug combo - Read more

THE BAD
Company Shutdown

Spotlight Therapeutics shutters, with their CRISPR-based editing tech not finding clinical footing
Antibody-drug conjugate, gene-editing, CRISPR - Read more

THE BAD
Layoffs

Charles River Laboratories reduces workforce at Memphis CGT facility
Cell therapy, gene therapy, CDMO, CRO - Read more

THE BAD
Politics & Policy

Pfizer CEO expresses concern over potential US tariffs on EU affecting company's European manufacturing plants
Tariffs - Read more

Robert F. Kennedy Jr. pledges to review childhood vaccine schedule, despite earlier promises not to change it
Vaccines, vaccine hesitancy, measles, polio - Read more

HHS and Trump administration promote "biological truth" policy, defining only two sexes and challenging FDA's diversity guidance
Gender identity, gender affirming care - Read more

THE UGLY
Warning Letters, Form 483

FDA issues citations to a number of Indian drugmakers for GMP violations
Quality concerns, GMP violations - Read more

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

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