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THE GOOD
Approvals & Labels

Bavarian Nordic's Vimkunya vaccine receives FDA approval for chikungunya prevention in people aged 12 and older
Vaccine, chikungunya - Read more

Merck & Co.'s Welireg (HIF-2α inhibitor) lands European Commission approval von Hippel-Lindau disease and related tumors
Small molecule, von Hippel-Lindau (VHL), renal cell carcinoma, hemangioblastomas, pancreatic neuroendocrine tumor, cancer - Read more

Biocon Biologics' Yesintek (targeting IL-12, IL-23; ustekinumab biosimilar, Janssen) scores European Commission approval in plaque psoriasis, psoriatic arthritis, and Crohn's disease
Monoclonal antibody, plaque psoriasis, psoriatic arthritis, Crohn’s disease, biosimilar - Read more

Gilead's lenacapavir (capsid inhibitor) receives an FDA PDUFA date
Small molecule, human immunodeficiency virus (HIV), pre-exposure prophylaxis, PDUFA date - Read more

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THE GOOD
Business Development

Biogen pays $165M upfront to Stoke Therapeutics for ex-North American rights to epilepsy drug zorevunersen (targeting SCN1A), with potential $385M in milestones
Antisense oligonucleotide, Dravet syndrome, epilepsy - Read more

KYORIN acquires option to license Cyrano's CYR-064 (cAMP degradation inhibitor) smell loss treatment in Japan, with potential milestone payments and royalties
Small molecule, post-viral loss of smell, hyposmia - Read more

Eisai's Alzheimer's drug Leqembi hits €200M ($209M) sales milestone, triggering €10M ($10.4M) payment to development partner BioArctic
Monoclonal antibody, Alzheimer's disease, milestone payment - Read more

THE GOOD
Clinical Trials

Solid Biosciences showcases positive Ph1/2 data for SGT-003 gene therapy in Duchenne muscular dystrophy, with 110% microdystrophin expression and good tolerability
Gene therapy, Duchenne's Muscular Dystrophy (DMD), AAV - Read more

Henlius publishes Ph1 details for HLX14 (targeting RANKL; denosumab biosimilar, Amgen), showing comparable results to denosumab reference
Monoclonal antibody, osteoporosis, bone metastases, cancer, biosimilar - Read more

Eli Lilly's selective FGFR3 inhibitor shows early Ph1 “safety edge” in bladder cancer subset over Johnson & Johnson’s Balversa
Small molecule, bladder cancer - Read more [Paywall]

Anixa Biosciences and Moffitt's Ph1 CAR-T trial in ovarian cancer clinical trial amendment, allowing eligible patients to receive a 2nd CAR-T dose
Cell therapy, ovarian cancer, CAR-T, clinical trial amendment - Read more

THE GOOD
Fundraises

Humane Genomics (undisclosed) Seed, developing RNA viruses targeting cancer cells, starting with pediatric liver cancer
RNA virus, liver cancer, pediatric cancer, DNA synthesis - Read more

ExoLab Italy €5M ($5.2M) Series A, startup expanding exosome production and research capabilities
Exosomes, manufacturing, research & development, drug delivery - Read more

Perceive Pharma raises $15M Series A to develop small molecule therapeutics preventing glaucoma-associated vision loss
Small molecule, glaucoma, eye disease, ophthalmology - Read more

Atrandi Biosciences $25M Series A, developing single-cell analysis tech and planning US market expansion
Single-cell analysis, molecular analysis, microfluidics - Read more

Sarepta Therapeutics $600M revolving credit facility, developing genetic medicines for rare diseases
Gene therapy, gene-editing, RNA, Beta-sarcoglycan-related limb-girdle muscular dystrophy R4, Duchenne muscular dystrophy, AAV - Read more

Latigo Biotherapeutics targets a $150M raise ($50M raised thus far), developing non-opioid pain treatment targeting Nav1.8 inhibitors
Small molecule, pain, non-opioid - Read more

THE GOOD
Partnerships

Hunter Medical Research Institute, Novartis form strategic partnership to explore innovative medical research and healthcare improvement projects
Research & development - Read more

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THE BAD
Business Development

Gilead declines option to license Arcus Biosciences' kidney cancer drug casdatifan (HIF-2⍺ inhibitor), despite promising early trial results
Small molecule, renal cell carcinoma, kidney cancer - Read more

THE BAD
Clinical Trials

AlgoTherapeutix's topical ATX01 misses Ph2 trial endpoint for chemotherapy-induced peripheral neuropathy pain
Antisense oligonucleotide, chemotherapy-induced peripheral neuropathy, pain, topical - Read more

Ventyx Biosciences' VTX958 (TYK2 inhibitor) misses primary endpoint in Ph2 Crohn’s disease trial
Small molecule, Crohn’s disease, inflammatory bowel disease - Read more

Septerna terminates Ph1 trial of SEP-786 (PTH1R agonist) in hypoparathyroidism after two participants showed severe bilirubin elevation
Small molecule, hypoparathyroidism - Read more

THE BAD
Earnings & Finances

Siegfried's stock falls 6% after forecasting lower 2025 sales growth due to customer destocking and inflation
CDMO - Read more [Paywall]

THE BAD
Lawsuits

Hikma appeals to Supreme Court over Federal Circuit ruling on generic drug labeling dispute with Amarin involving "skinny labeling" practice
Small molecule, dyslipidemia, hypertriglyceridemia, skinny labelling, generic - Read more

THE BAD
Strategic Plans

Basilea declines to advance MRSA antibiotic tonabacase to clinical trials after preclinical evaluation, citing risk-return concerns
Enzyme, Methicillin-resistant Staphylococcus aureus (MRSA), antibiotic - Read more

TME Pharma still on the hunt for NOX-A12 (targeting CXCL12) partner as cash reserves will dry up in June 2025
RNA oligonucleotide, glioblastoma, brain cancer - Read more

THE UGLY
Lawsuits

Novo Nordisk sues KBP Biosciences for fraud, seeking $830M after claiming they received of misleading data for kidney disease hopeful ocedurenone (mineralocorticoid receptor antagonist)
Small molecule, kidney disease, hypertension, fraud, due diligence - Read more

THE UGLY
Politics & Policy

FDA's food division deputy commissioner resigns, citing Trump administration cuts that threaten agency's nutrition and food safety agenda
Federal agency, FDA - Read more [Paywall]

Federal government defends 15% NIH grant reimbursement cap, seeks to lift court block despite multiple lawsuits challenging decision
Federal funding, research funding, indirect cost reimbursement cap - Read more

FDA's medical device safety head Ross Segan and other device center staff terminated during Trump administration layoffs
FDA, medical device, device safety - Read more [Paywall]

Montana considers banning mRNA vaccines amid rising vaccine skepticism
mRNA, vaccine, COVID-19, vaccine hesitancy, anti-vax, public policy - Read more

THE UGLY
Public Health

CDC stops sharing vital flu outbreak data after Trump administration takes office, leaving healthcare workers without crucial information
Influenza, bird flu (H5N1), public health data - Read more

THE UGLY
Withdrawals & Recalls

ICU Medical recalls potassium chloride IV bags due to labeling error that could lead to accidental overdose
IV bags, potassium chloride solution, hypokalemia, labeling issue - Read more

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

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