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Big pharma M&A: Biogen expands immunology with Apellis
Biogen agreed to acquire Apellis Pharmaceuticals in a deal valued at about $5.6 billion, securing two already-commercialized immunology franchises. The acquisition includes kidney drug Empaveli...
Big pharma M&A: Lilly bets on orexin biology with Centessa
Eli Lilly agreed to acquire Centessa Pharmaceuticals for about $6.3 billion upfront, aiming to expand its neuroscience pipeline with orexin receptor 2 (OX2R) agonists. The deal follows positive...
Big pharma to AI discovery: Lilly extends Insilico Medicine pact
Eli Lilly is expanding its collaboration with Insilico Medicine, extending the company’s AI-driven drug discovery strategy into additional therapeutic areas. The multibillion-dollar expansion...
Regulation: FDA delay on Orca Bio cell therapy decision
The FDA postponed its decision on Orca Bio’s T cell therapy by three months, extending the agency’s deadline to July 6. The delay follows the filing of additional manufacturing data, pushing the...
Cell therapy at scale: ICON and Advarra link for AI-driven site operations
ICON partnered with IRB and clinical trial management technology provider Advarra to build an integrated, AI-driven site network aimed at reducing clinical trial startup delays. The agreement...
Clinical stage oncology: Oric advances PRC2 inhibitor into Phase 3 in prostate cancer
Oric Pharmaceuticals moved its prostate cancer program toward late-stage testing, planning a registrational Phase 3 program for an investigational PRC2 inhibitor after reporting results from a...
Market and funding: GenomeWeb Top 40 tracks -7% decline
The GenomeWeb Top 40 index fell about 7% in March, tracking broader weakness across omics, diagnostics, and clinical laboratory stocks. The Nasdaq Biotech Index declined roughly 3%, while most of...
Cell therapy and trials: IPF trial endpoints lift United’s Tyvaso program
United Therapeutics said its second Phase 3 idiopathic pulmonary fibrosis trial for Tyvaso (treprostinil) met endpoints, strengthening the case for regulatory momentum and a potential priority...
Diagnostics: Baebies gets FDA 510(k) and CLIA waiver for triplex respiratory test
Baebies announced FDA 510(k) clearance and a CLIA waiver for a triplex respiratory molecular test on its Finder point-of-care platform. The assay distinguishes influenza A, influenza B, and...
Biotech insolvency and regulatory outcomes: IO Biotech shuts down after FDA refusal
IO Biotech filed for bankruptcy and ceased operations after what it described as an FDA refusal that derailed its cancer vaccine Cylembio. The Danish biotech’s wind-down follows a Phase 3 miss in...
Dealmaking: big pharma moves into new neuroscience and immunology growth engines
Eli Lilly agreed to acquire Centessa Pharmaceuticals for up to $7.8 billion, paying $38 per share plus contingent value rights tied to clinical approvals, to expand its neuroscience pipeline....
FDA scrutiny of drugs after adverse events: Tavneos safety signal expands
The FDA identified eight deaths tied to Amgen’s Tavneos (avacopan) and flagged more than 70 cases of severe liver injury associated with the autoimmune therapy. The agency’s update heightens...
Regulatory pathway for prior CRLs: FDA meetings signal new review strategy for setbacks
FDA is exploring a path forward for therapies that previously received complete response letters (CRLs), according to a report on unusual meetings with FDA’s chief counsel involving Biohaven,...
Oncology advances: early-stage data and preclinical immune mechanisms
A phase 1 trial testing ceralasertib (an early DNA damage response inhibitor) combined with durvalumab produced promising early results in recurrent or metastatic non-small cell lung cancer and...
Target discovery and platform licensing: Merck expands immunology antibody engine
Merck entered an antibody discovery collaboration with Infinimmune, with total potential payments up to $838 million for candidates that advance into clinical development and commercialization....
Inflammation and immunology drug development: IL-22/IL-13 and atopic dermatitis targets in focus
Infinimmune’s immunology focus shows up again through its preclinical and early-stage program set, with IL-22-directed biology positioned for inflammatory disease areas such as atopic dermatitis....
Precision oncology: biomarkers and molecular mechanisms to refine cancer treatment decisions
Researchers linked leukocyte telomere length to the risk of premature rupture of membranes (PROM) using UK Biobank data, expanding telomere biology into pregnancy risk contexts rather than only...
Cell and gene therapy manufacturing: automation moves toward place-of-care HSC workflows
A collaboration involving Trenchant BioSystems, the University of Massachusetts Chan Medical School, and Caring Cross aims to develop a scalable hematopoietic stem cell (HSC) manufacturing...
Biotech funding and pipeline scaling: Semarion raises to expand cell assay tech
Semarion raised $3.8 million to scale its cell assay technology for drug discovery. The company’s SemaCyte platform is designed to enable adherent cell models to be handled as assay-ready,...
Clinical-stage company updates and financing appetite: obesity pipeline IPO activity
Kailera Therapeutics is preparing for an initial public offering to fund clinical development of its obesity portfolio, including the weekly GLP-1/GIP peptide ribupatide. The filing positions...