Biologically Active Substance – Page 2

Novartis antibody ianalumab clinches another Phase 3 win in rare blood disease (ITP)

2 weeks ago talkbio0Tagged Autoimmune, Autoimmune thrombocytopenia, B-cell depletion, ianalumab, Infrequent, Inosine Triphosphate, Novartis, Phase 3, platelet levels, Psychological inhibition, regulatory submissions, Sjögren 's disease, TNFRSF13C protein, human, treatment failure, VAY736

Novartis; ianalumab; VAY736; primary immune thrombocytopenia; ITP; rare disease; Phase 3; time to treatment failure; safe platelet levels; eltrombopag; autoimmune; B-cell depletion; BAFF-R inhibition; Sjögren’s disease; regulatory submissions

Bayer-allied NextRNA Therapeutics winds down operations after missing a milestone in their collaboration

2 weeks ago talkbio0Tagged Bayer, Dana-Farber, Funding, Long Intergenic Non-Protein Coding RNA, Massachusetts biotech, missed milestone, Neoplasms, NextRNA, Plant seeds, Series, shutdowns

NextRNA Therapeutics; Bayer; lncRNA; long non-coding RNA; oncology; biotech wind-down; missed milestone; Massachusetts biotech; seed and Series A funding; Dana-Farber; Carl Novina; 2025 biotech shutdowns

Endpoints 11: Biopharma’s most promising startups revealed live in Boston this September

2 weeks ago talkbio0Tagged Aves, Biopharma, biotech startups, biotechs, Boston event, Endpoints, GALA peptide, Industry, Rating (action), real-time, State Room

Endpoints 11; biotech startups; biopharma; Boston event; State Room; awards gala; early bird rate; industry insiders; 2025 most promising biotechs; real-time reveal

GSK set to receive over $500M from mRNA patent settlement tied to BioNTech–CureVac–Pfizer deal

2 weeks ago talkbio0Tagged BioNTech, BioNTech acquisition, COVID19 (disease), CureVac, global framework, Influenza virus vaccine, Licensing, Litigation, Pfizer, RNA, Messenger, royalties, settlement, SmithKline Beecham, U.S., upfront payment, Vaccines, Vaccines, Combined

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

2 weeks ago talkbio0Tagged alpha 1-antitrypsin, Construction worker, domestic drug manufacturing, Facility (object), National Security, Pharmaceutical Supply Chain, PreCheck, regulatory streamlining, Trump administration, United States Food and Drug Administration

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

2 weeks ago talkbio0Tagged Chinese biotech, Clinical Development, Inhibitor, Janus kinase, Minghui, Neoplasms, PD-1xVEGF bispecific, pre-IPO ', therapeutic autologous dendritic cells, trials

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

2 weeks ago talkbio0Tagged competition, GLP-1/GIP co-agonist, Leadership Change, Market, Nordisk, Obesity, pipeline cull, R&D pipeline, semaglutide, strategic shift, Wegovy

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

3 weeks ago talkbio0Tagged Agonist, Clinical Trials, competition, Danuglipron, Drug Development, Glucagon-Like Peptide 1, Injury of liver, lotiglipron, Obesity, PF-06954522, Pfizer

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

3 weeks ago talkbio0Tagged Arenaria, Biological Factors, Biological Science Disciplines, biopharma financing, Conditional, HilleVax, Investments, LAVA, M&A, mezigitamab, OrbiMed, royalty acquisition, XOMA Royalty

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

3 weeks ago talkbio0Tagged Biological Factors, CBER, CDER, Cells, Drug Industry, gene therapy, George Tidmarsh, Makary, Marty, Prasad, regulatory harmonization, United States Food and Drug Administration

FDA; CBER; CDER; regulatory harmonization; Marty Makary; George Tidmarsh; Vinay Prasad; cell and gene therapy; biologics; pharmaceutical industry