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THE GOOD
Approvals & Labels

PTC Therapeutics receives positive CHMP opinion for Sephience (sepiapterin) to treat phenylketonuria (PKU) in children and adults, regardless of disease severity.
Small molecule, phenylketonuria - Read more

Akeso Biopharma's penpulimab, a PD-1 antibody, receives FDA approval for recurrent or metastatic non-keratinizing nasopharyngeal carcinoma in first-line and later settings, following Ph3 trial.
Monoclonal antibody, nasopharyngeal cancer - Read more

Akeso Biopharma's bispecific antibody ivonescimab (anti-PD-1/VEGF) receives NMPA approval for first-line treatment of PD-L1-positive non-small cell lung cancer following successful Ph3 trial.
Bispecific antibody, lung cancer - Read more

European Commission approves Johnson & Johnson's TREMFYA (guselkumab), an IL-23p19 inhibitor, for moderately to severely active ulcerative colitis following Ph2b/3 QUASAR trials
Monoclonal antibody, ulcerative colitis - Read more

Eli Lilly seeks EMA reconsideration for Kisunla, an Alzheimer's drug rejected due to concerns about insufficient benefits versus brain swelling risks
Monoclonal antibody, alzheimer's disease, drug approval process - Read more

THE GOOD
Business Development

Orion licenses Criceto's APORON, a novel apomorphine spray for treating OFF episodes in Parkinson's patients, excluding US and Canada.
Small molecule, commercialization, nasal spray, Parkinson's disease - Read more

Shionogi acquires partial ownership in Apnimed's sulthiame and another drug program for sleep apnea treatment, contributing both to joint venture SASS.
Small molecule, sleep apnea - Read more

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THE GOOD
Clinical Trials

NETRIS Pharma's NP137, targeting Netrin-1, shows promising Ph2 results for Head & Neck Cancer and Non-Small Cell Lung Cancer, overcoming resistance to immunotherapies
Monoclonal antibody, head & neck cancer - Read more

Pfizer's sasanlimab (anti-PD-1 mAb) plus BCG significantly improved event-free survival in Ph3 trial for high-risk non-muscle invasive bladder cancer patients
Monoclonal antibody, bladder cancer - Read more

Merck & Co. showcases specific survival data from Keytruda (pembrolizumab), an anti-PD-1 antibody, Ph3 trial for resectable head and neck squamous cell carcinoma
Monoclonal antibody, head & neck cancer - Read more

Revolution Medicines' zoldonrasib (RMC-9805), a RAS(ON) G12D-selective inhibitor, shows promising Ph1 results for KRAS G12D mutant non-small cell lung cancer
Small molecule, lung cancer - Read more

Johnson & Johnson's TAR-200 gemcitabine system shows 80% disease-free survival in Ph2b trial for BCG-unresponsive high-risk non-muscle-invasive bladder cancer
Small molecule, medical device, drug-device combo, drug delivery, bladder cancer - Read more

Onc.AI's AI model, Serial CTRS, outperformed traditional metrics in predicting overall survival for non-small-cell lung cancer patients taking GSK's Jemperli in Ph1 trial.
Disease progression tracking, lung cancer, AI - Read more

THE GOOD
Earnings & Finances

AbbVie increases 2025 sales forecasts for Skyrizi and Rinvoq by $900M after impressive Q1 performance.
Monoclonal antibody, small molecule, plaque Psoriasis, big pharma earnings - Read more

Astellas Pharma's Vyloy exceeds sales expectations in Japan, with global expansion driving projected $40B revenue.
Monoclonal antibody, gastroesophageal junction adenocarcinoma - Read more

THE GOOD
Fundraises

Verastem Oncology $75M private placement, funding launch of cancer treatments and research of product candidates
Small molecule, ovarian cancer - Read more

Oryzon Genomics €30M ($34M) capital increase, expanding clinical development in CNS diseases and oncology.
Small molecule, cancer - Read more

Azitra $20M investment from Alumni Capital, develops therapies for Netherton Syndrome and EGFRi-associated rash
Living biotherapeutics, Netherton syndrome - Read more

Araceli Biosciences $11.2M Seed, develops high-content imaging and AI analysis for drug discovery.
Drug discovery, imaging, data analysis, AI, software - Read more

Nuclivision raises €5M (~$5.6M) to launch Nuclarity AI platform improving PET scan imaging for cancer detection
AI, PET Scan, imaging, data analysis, software - Read more

THE GOOD
Investments

AbbVie plans $10B US investment over next decade, including four new manufacturing facilities amid pharmaceutical industry's domestic investment trend
Domestic manufacturing, tariffs - Read more

Amgen pledges $900M Ohio facility expansion, creating 350 jobs amid trend of pharma US investments.
Domestic manufacturing, facility expansion, tariffs - Read more

THE GOOD
Lawsuits

Federal court upholds FDA ruling, requiring pharmacies to stop producing compounded versions of Novo Nordisk’s Wegovy and Ozempic
GLP-1, obesity, compounding, compounding suit - Read more

THE GOOD
Partnerships

Pfizer, Guardant Health, expand alliance using liquid biopsy technology to accelerate cancer therapy development
Drug development, cancer, liquid biopsy - Read more

THE GOOD
Politics & Policy

Federal government negotiating with manufacturers to increase access and affordability of sickle cell gene therapy for Medicaid recipients
Gene therapy, sickle cell disease, drug access, Centers for Medicare and Medicaid Services (CMS) - Read more

HHS clarifies no autism registry planned, only $50 million research project, after NIH director's announcement caused community concern
Autism spectrum disorder, US Department of Health & Human Services (HHS) -Read more [Paywall]

THE GOOD
Product Launches

Gilead ready to launch twice-yearly HIV prevention injection lenacapavir, awaiting FDA approval on June 19
Small molecule, human immunodeficiency virus (HIV), prophylaxis - Read more

THE GOOD
Public Health

New initiative launches to protect vaccine integrity against misinformation, led by University of Minnesota experts with philanthropic funding
Vaccine, vaccine hesitancy - Read more

THE GOOD
Research

Studies identify piperacillin as effective Lyme disease treatment at lower doses, while showing lingering cellular debris may mimic chronic symptoms.
Small molecule, antibiotic, lyme disease - Read more [Paywall]

Large Chinese study shows intensively lowering blood pressure reduces dementia risk by 15% in hypertensive patients.
Dementia, hypertension - Read more

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THE BAD
Approvals & Labels

Novavax may need to conduct another clinical trial for its COVID-19 vaccine, following FDA's request and HHS Secretary intervention
Vaccine, COVID-19, drug approval process - Read more

THE BAD
Clinical Trials

ALX Oncology's CD47 inhibitor evorpacept failed two Ph2 trials for head and neck squamous cell carcinoma when combined with Merck & Co.'s Keytruda.
Fusion protein, head & neck cancer - Read more

Summit Therapeutics’ shares plunge as partner Akeso Biopharma reports disappointing overall survival data for bispecific ivonescimab (PD-1xVEGF) versus Keytruda in PD-L1-positive non-small cell lung cancer
Bispecific antibody, lung cancer - Read more

Vyne Therapeutics' BET blocker VYN202 for plaque psoriasis faces FDA clinical hold after testicular toxicity in dogs halts Ph1b trial.
Small molecule, plaque psoriasis, clinical hold - Read more

THE BAD
Earnings & Finances

Gilead's Q1 revenue misses estimates as oncology sales drop 4%, while HIV drug business grows 6% to $4.6 billion.
Big pharma earnings - Read more

THE BAD
Layoffs

Caribou Biosciences to lay off 32% of workforce amid strategic shift toward cancer cell therapies
Cell therapy, autoimmune disease, lupus erythematosus, cancer - Read more

THE BAD
Strategic Plans

Caribou Biosciences discontinues lupus and leukemia programs to focus on key CAR-T therapies.
Cell therapy, autoimmune disease, lupus erythematosus, cancer, CAR-T, lymphoma, pipeline strategy - Read more

Merck & Co. discontinues Phase 2 trials of monoclonal antibodies with Keytruda and other cancer drug programs.
Monoclonal antibody, colorectal cancer, combo therapy, pipeline strategy - Read more [Paywall]

THE UGLY
No Ugly News today!

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