Biologically Active Substance
GSK set to receive over $500M from mRNA patent settlement tied to BioNTech–CureVac–Pfizer deal
GSK; CureVac; BioNTech; Pfizer; mRNA patents; settlement; royalties; COVID-19 vaccine; influenza vaccine; combination vaccines; licensing; upfront payment; US litigation; global framework; BioNTech acquisition of CureVac
FDA Launches PreCheck Program to Accelerate Domestic Drug Manufacturing
FDA PreCheck; domestic drug manufacturing; pharmaceutical supply chain; API; regulatory streamlining; facility construction; national security; Trump administration
Minghui Raises $131M to Advance PD-1xVEGF Bispecific Antibody Program
Minghui; Chinese biotech; PD-1xVEGF bispecific; fundraising; pre-IPO; ADC trials; JAK inhibitor; oncology; clinical development
Novo Nordisk’s Pipeline Cull Prompts Hopes of Strategic Shift
Novo Nordisk; pipeline cull; GLP-1/GIP co-agonist; obesity drugs; leadership change; strategic shift; semaglutide; Wegovy; R&D pipeline; market competition
Pfizer’s Embattled Obesity Program Loses Another GLP-1 Drug Due to Data and Competition Issues
Pfizer; obesity; GLP-1 agonist; clinical trial; liver injury; danuglipron; lotiglipron; PF-06954522; obesity drug development; competition
Royalty Market Accelerates with XOMA Biotech Acquisitions and OrbiMed’s Major Fundraise
royalty acquisition; XOMA Royalty; biotech M&A; OrbiMed; biopharma financing; mezigitamab; Turnstone Biologics; HilleVax; LAVA Therapeutics; contingent value rights; life sciences investment
FDA Seeks Greater Alignment Between CBER and CDER: Makary Informs Industry Leaders
FDA; CBER; CDER; regulatory harmonization; Marty Makary; George Tidmarsh; Vinay Prasad; cell and gene therapy; biologics; pharmaceutical industry
Biogen Pledges $2 Billion Manufacturing Investment in North Carolina
Biogen; manufacturing investment; North Carolina; Research Triangle Park; biotechnology; antisense oligonucleotides; gene therapy; automation; AI; expansion
Vertex, NHS England Finalize Reimbursement Deal for CF Drug Alyftrek
Vertex; NHS England; Alyftrek; cystic fibrosis; reimbursement agreement; triple therapy; CFTR gene mutation; NICE; UK healthcare
Rhythm’s Oral MC4R Agonist Bivamelagon Shows Promising Results in Rare Obesity Type
Rhythm Pharmaceuticals; oral weight-loss drug; bivamelagon; MC4R agonist; Phase 2 trial; hypothalamic obesity; BMI reduction; clinical trial results