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FDA diagnostics expansion—tumor-only comprehensive profiling
Tempus AI received FDA approval for a tumor-only indication for its xT CDx next-generation sequencing platform, allowing comprehensive genomic profiling to be run when matched normal (blood or...
Multiple myeloma late-stage wins—mezigdomide and teclistamab
Bristol Myers Squibb disclosed detailed Phase 3 results showing its cereblon E3 ligase modulator mezigdomide more than doubled progression-free survival in relapsed or refractory multiple myeloma...
Obesity market access—CVS formulary moves for Lilly and Novo
CVS Caremark moved to place Lilly’s oral obesity drug Foundayo on its formularies starting June 1, while adding back Zepbound as a preferred option starting Oct. 1. Novo Nordisk’s Wegovy pill and...
Large multi-program China oncology deal—Pfizer and Innovent
Pfizer struck a broad alliance with China’s Innovent Biologics worth up to $10.5 billion for 12 early-stage oncology programs, including antibody-drug conjugates and multispecific antibodies....
Biotech company leadership shakeup—Allogene CEO stepping down
Allogene Therapeutics announced that CEO David Chang will step down at the end of June after eight years in the role. The company said Chang is handing over leadership to Zachary Roberts, who...
Cell and gene therapy outsourcing—CDMO business moves and scaling
Charles River Laboratories’ CEO said the company expects more cell and gene therapy manufacturers to break away from vertically integrated models, following Charles River’s decision to shed its...
Diagnostics innovation—NY approval for Delfi’s blood-based lung cancer LDT
Delfi Diagnostics received New York State Department of Health approval to offer its FirstLook Lung blood-based laboratory-developed test for lung cancer screening. The cell-free DNA assay can now...
FDA–clinical trial acceleration policy discussion
A new analysis examined whether FDA leadership upheaval will derail ongoing efforts to speed early-stage drug development in the U.S. The piece highlighted shared industry and regulatory alignment...
GSK bepirovirsen posts major chronic hepatitis B functional-cure readout
GSK reported Phase 3 functional-cure results for bepirovirsen (an antisense oligonucleotide targeting hepatitis B viral transcripts) across two trials in chronic HBV, with company data showing...
FDA clears AbbVie’s Decnupaz for ultra-rare BPDCN after ImmunoGen buy
The U.S. FDA cleared AbbVie’s antibody-drug conjugate Decnupaz (pivekimab sunirine) for adults with blastic plasmacytoid dendritic cell neoplasm (BPDCN). The approval follows AbbVie’s 2023...
Teal Health moves cervical cancer screening closer to community rollout with WashU pilot
Teal Health partnered with Washington University School of Medicine to study whether community-based outreach and at-home HPV self-collection can raise cervical cancer screening rates in...
AbbVie ADC approval reshapes the BPDCN treatment landscape
Separately from the core approval headline, reporting emphasized that AbbVie’s FDA clearance for Decnupaz is directly tied to the CD123-targeting mechanism obtained through the ImmunoGen...
Antibody-drug conjugates push further into lung and breast oncology with TROP2 updates
New updates on TROP2-directed antibody-drug conjugates (ADCs) highlighted progress across lung and breast cancer programs and pointed to areas for improvement in targeting, dosing, and next-line...
CRO regulatory and market access: Delfi Diagnostics gets New York approval for lung cancer LDT
Delfi Diagnostics said New York State Department of Health approval cleared its FirstLook Lung laboratory-developed test for blood-based lung cancer screening. The company can now offer its...
Lonza touts adaptable manufacturing for in vivo mRNA-LNP delivery
Lonza discussed how adaptable manufacturing platforms could support in vivo mRNA–LNP delivery and reduce the cost and complexity of CMC for newer delivery approaches. The company’s process...
Gene Solutions wins FDA Breakthrough Device Designation for SPOT-MAS multiomics cancer test
The FDA awarded Gene Solutions Breakthrough Device Designation to SPOT-MAS 10, a blood-based, adjunctive multiomics early detection test for ten cancer types in asymptomatic adults aged 40 and...
AbbVie expands ADC pipeline again while CMS moves No Surprises Act arbitration
While AbbVie’s ADC approval expands oncology options, CMS finalized a rule aimed at simplifying payer-provider disputes under the No Surprises Act by streamlining arbitration. Provider groups...
EV-backed biopharma: Human Longevity and Insilico launch longevity foundation-model newco
Human Longevity launched a new company focused on longevity foundation models (HLFM) and partnered with Insilico Medicine to build AI-powered platforms intended to decode aging mechanisms and...
Hepatitis B – functional cure results with bepirovirsen
GSK reported phase 3 readouts for bepirovirsen, an antisense oligonucleotide designed to target hepatitis B virus (HBV) transcripts, with “functional cure” after treatment discontinuation in a...
Oncology FDA approvals – AbbVie’s Decnupaz wins clearance for BPDCN
AbbVie secured U.S. FDA approval for Decnupaz (pivekimab sunirine), a CD123-targeting antibody-drug conjugate for adults with blastic plasmacytoid dendritic cell neoplasm (BPDCN). The approval...