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THE GOOD
Approvals & Labels

Soleno Therapeutics' Vykat XR (diazoxide choline) lands FDA approval to treat hyperphagia in patients with Prader-Willi syndrome
Small molecule, Prader-Willi syndrome - Read more

Fresenius' denosumab (targeting RANKL) biosimilars Conexxence and Bomyntra approved by FDA for all Prolia and Xgeva indications, with launch in mid-2025 following Amgen settlement
Monoclonal antibody, biosimilar, osteoporosis - Read more

Junshi Biosciences' toripalimab (targeting PD-1) approved in Singapore for first-line treatment of nasopharyngeal carcinoma
Monoclonal antibody, nasopharyngeal cancer - Read more

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THE GOOD
Clinical Trials

Candel Therapeutics' viral immunotherapy CAN-2409 delivers promising Ph2a data in advanced non-small-cell lung cancer
Oncolytic virus, lung cancer, herpes simplex virus (HSV) - Read more

Merck & Co. touts comparable results for Keytruda (Targeting PD-1) subcutaneous formulation versus intravenous version in Ph3 trial for non-small cell lung cancer
Monoclonal antibody, lung cancer, drug formulation - Read more

Vaximm's showcases promising Ph2 data for oral vaccine VXM01 (anti-VEGFR-2) combined with avelumab (PD-L1 inhibitor) in glioblastoma trial
Vaccine, monoclonal antibody, combo therapy, glioblastoma - Read more

Alzinova's ALZ-101 (targeting soluble oligomeric Aβ assemblies) vaccine delivers positive Ph1b trial in early Alzheimer's disease
Vaccine, Alzheimer's disease - Read more

Regulus Therapeutics touts positive Ph1b results for ASO farabursen (targeting miR-17) in polycystic kidney disease
Antisense oligonucleotide, polycystic kidney disease - Read more

Chemomab Therapeutics' showcases positive Ph2 data for nebokitug (targeting CCL24) in primary sclerosing cholangitis
Monoclonal antibody, primary sclerosing cholangitis (PSC) - Read more

THE GOOD
Earnings & Finances

Alvotech reports record 2024 revenue from product sales and milestones, achieving positive EBITDA for the first time
Biosimilar - Read more

THE GOOD
Fundraises

Galatea Bio $25M funding, AI-driven genomic research company to expand clinical platform for genetic risk analysis
Precision medicine, AI, biomarker, drug discovery, diagnostics - Read more

Kelso Pharma secures £140M ($181M) in acquisition funding to expand in UK and Europe, already acquiring ALTURiX
Specialty Pharmaceuticals, drug formulation - Read more

VQ Biomedical raises $5M Seed round, developing medical device to treat severe lung injuries less invasively
Medical device, lung injury - Read more

Constructive Bio lands strategic investment from Longe.VC (amounted undisclosed), creating platform for genetic code reprogramming to engineer biology
Cellular biofactory, manufacturing - Read more

Ace Pharmaceuticals investment from Colesco (amount undisclosed) to accelerate growth through acquisitions and new product launches.
Custom pharmaceutical solutions, compounding - Read more

Savara $200M non-dilutive debt financing from Hercules Capital for rare respiratory disease drug MOLBREEVI
Recombinant human granulocyte colony-stimulating factor, autoimmune pulmonary alveolar proteinosis - Read more

THE GOOD
Investments

Chiesi invests €430M ($466M) to redevelop Milan site for inhalers and biologics, creating 300 jobs by 2029
Biologics manufacturing, inhaler manufacturing, new facility - Read more

THE GOOD
Mergers & Acquisitions

Alcon acquires majority stake in Aurion Biotech, cell therapy development for corneal endothelial diseases
Cell therapy, corneal edema secondary to corneal endothelial dysfunction - Read more

Kardigan acquires heart health tech firm Prolaio to bolster cardiovascular data platform and enhance R&D efforts
Cardiovascular disease, data analysis, clinical data - Read more

THE GOOD
Partnerships

CytoSite Bio, Lantheus collab to develop granzyme B-targeted PET imaging tracer for assessing immunotherapy effectiveness
PET Scan, imaging tracer, clinical development - Read more

THE GOOD
Product Launches

Eli Lilly's DTC platform LillyDirect platform now offers Alzheimer's care
Direct-to-consumer, telehealth, Alzheimer's disease - Read more

THE GOOD
Research

Onco-Innovations' second-generation PKNP nanoparticle therapy shows low toxicity when combined with radiation for colorectal cancer treatment
Nanoparticle, enzyme, colorectal cancer - Read more

Hyundai ADM Bio's PenetriumTM demonstrates anti-metastatic effects in triple-negative breast cancer by softening treatment-hardened ECM barriers
Pseudo-resistance-targeting agent, cancer - Read more

Groundbreaking study reveals successful 10-day transplant of gene-edited pig liver into brain-dead human, offering hope for organ shortage solutions
Gene-editing, gene-edited organs, liver transplant - Read more

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THE BAD
Clinical Trials

Equillium's Ph3 trial of itolizumab (anti-CD6) failed to meet primary endpoint for acute graft-versus-host disease treatment.
Monoclonal antibody, graft versus host disease (GvHD) - Read more

THE BAD
Layoffs

Nkarta cuts workforce by 33%, including executives, to extend runway into 2029 while focusing on autoimmune cell therapy development
Cell therapy, autoimmune disease, allogeneic cell therapy, natural killer (NK) cells - Read more

Arbutus Biopharma cuts 57% of workforce to focus on imdusiran whilst halting all other research
RNAi, Hepatitis B - Read more

THE BAD
Politics & Policy

Trump's proposed drug tariffs may incentivize US manufacturing, but generic drugmakers lack resources to meet reshoring demands
Tariffs, generic, domestic manufacturing - Read more [Paywall]

THE UGLY
Politics & Policy

HHS Secretary Kennedy announces 10,000 layoffs and significant restructuring, reducing department by 25% through consolidation of divisions and regional offices
US Department of Health & Human Services (HHS), public agency layoffs - Read more

Non-medically qualified anti-vaccine advocate David Geier chosen to lead HHS autism-vaccine study despite scientific consensus
Vaccine hesitancy, US Department of Health & Human Services (HHS), autism spectrum disorder - Read more [Paywall]

THE UGLY
Public Health

Kansas reports 23 measles cases, mostly in unvaccinated children, potentially linked to Texas and New Mexico outbreaks
Measles - Read more

THE UGLY
Regulatory

Survey reveals 90% of US biotechs rely on imports; Trump's tariffs could raise costs and delay FDA filings for half
Drug approval process, tariffs - Read more

THE UGLY
Warning Letters, Form 483

FDA warns India's Aspen Biopharma Labs for contamination risks, poor equipment cleaning, and inadequate recordkeeping at dilapidated Hyderabad facility
Quality concerns - Read more

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

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