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Immuno-oncology
Top FDA Cancer Regulator Intervened To Reject Replimmune’s Melanoma Drug
According to reporting from multiple outlets, Richard Pazdur, head of the Oncology Center of Excellence at CDER, opposed the consensus opinion of CBER staff to approve the drug. Replimmune’s stock has dropped precipitously since the rejection.
August 4, 2025
·
2 min read
·
Dan Samorodnitsky
Layoff Tracker
Sirona Liquidates TFChem, Merck Will Cut 6,000 Employees
Follow along as
BioSpace
tracks job cuts and restructuring initiatives throughout 2025.
August 4, 2025
·
174 min read
·
BioSpace Editorial Staff
Earnings
BioNTech Commits to Infectious Diseases Amid Questions Over Vaccine Demand
The company expects that the U.S. COVID-19 vaccination rate will be “maybe a couple of points lower” than the prior level of around 20% but that pricing and Comirnaty’s market share will hold steady.
August 4, 2025
·
2 min read
·
Nick Paul Taylor
Press Releases
BioHarvest Sciences to Host Second Quarter 2025 Earnings Call on August 11 at 8:00 a.m. Eastern Time
August 4, 2025
·
2 min read
Press Releases
Medicus Pharma Ltd. Announces a Memorandum of Understanding (MOU) with Helix Nanotechnologies Inc. to Develop Thermostable Infectious Disease Vaccines
The MOU intends to combine proprietary mRNA vaccine platform of HelixNano with proprietary Microneedle array (MNA) delivery platform of Medicus.
August 4, 2025
·
8 min read
CAR-T
Allogene Scraps Immunosuppressive Antibody After Patient Death in Lymphoma Trial
The pivotal Phase II trial is testing Allogene’s CAR T candidate cemacabtagene ansegedleucel for large B-cell lymphoma. ALLO-647 was being used as a preparative lymphodepletion therapy.
August 4, 2025
·
1 min read
·
Tristan Manalac
Obesity
CMS Mulls About-Face in Coverage of GLP-1 Treatments for Obesity: Report
Earlier this year, the Centers for Medicare and Medicaid Services scrapped a previous proposal, from the Biden administration, to include anti-obesity medications in Medicare Part D coverage.
August 4, 2025
·
2 min read
·
Tristan Manalac
Press Releases
Waters Corporation (NYSE: WAT) Reports Second Quarter 2025 Financial Results
August 4, 2025
·
25 min read
Press Releases
BioCardia Provides Update on Timing of Regulatory Activities Seeking FDA Approval and Japan PMDA Approval for CardiAMP® Cell Therapy for Heart Failure and Helix™ Transendocardial Delivery Catheter
August 4, 2025
·
6 min read
Press Releases
AB Science announces the successful completion of a 2.55 million euros private placement
August 4, 2025
·
11 min read
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