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FDA approvals and label expansions in breast cancer
The FDA approved Arvinas and Pfizer’s Veppanu (vepdegestrant) for ESR1-mutated, metastatic estrogen receptor-positive, HER2-negative breast cancer that has progressed after at least one endocrine...
FDA label expansion for Alzheimer’s agitation
Axsome Therapeutics’ Auvelity (dextromethorphan/bupropion) won FDA approval to treat agitation in Alzheimer’s disease, giving the company access to a large, previously underserved indication. The...
Regulatory scrutiny and potential withdrawal risk for Tavneos (avacopan)
The FDA is moving toward market withdrawal for ChemoCentryx’ Tavneos (avacopan), after new information surfaced that the agency says undermines evidence of effectiveness. The dispute centers on...
Big biotech biotech restart: Arvinas-Pfizer PROTAC approval momentum and ESR1 testing infrastructure
Beyond the single-drug approval, the FDA’s action ties Veppanu access to ESR1 mutation identification, pulling molecular diagnostics further into the center of clinical workflow. Guardant Health’s...
Next-wave CAR-T portfolio consolidation at Johnson & Johnson
Johnson & Johnson is discontinuing two CAR-T programs for B-cell lymphoma, ending work on JNJ-9530 and JNJ-4496 months after the company highlighted the assets as potentially best-in-class. The...
Biopharma manufacturing operations: Samsung Biologics union strike begins
Samsung Biologics union workers began a five-day strike over wage disputes, after a prior April rally and near-unanimous strike authorization. With production disruption risk now moving from...
Large IPOs: Seaport Therapeutics and Hemab Therapeutics debut amid IPO resurgence
Seaport Therapeutics and Hemab Therapeutics pushed forward with large, upsized IPOs, adding more capital to biotech as the public-market window stays open. Seaport joined Nasdaq with gross...
Early diagnostics innovation: AI-enabled pancreatic cancer detection
Oregon Health & Science University (OHSU) researchers unveiled an innovative early-detection approach for pancreatic cancer using a nanoparticle-based technique. The work targets the long-standing...
Rare disease gene therapy pathway: UniQure seeks UK approval for AMT-130
UniQure said it plans to submit a marketing application for its Huntington’s gene therapy AMT-130 (embrace) to UK regulators later this year after a positive meeting with drug regulators. The...
Biotech equity and innovation funding: Hypervision Surgical raises for hyperspectral intraoperative AI
Hypervision Surgical raised £17 million (about $23 million) in a Series A financing for its surgical hyperspectral imaging platform. The company’s approach combines spectral sensing with...
Regulatory approvals: breast cancer PROTAC + companion diagnostics
The FDA approved Arvinas’ first-in-class PROTAC Veppanu (vepdegestrant) for a defined subgroup of metastatic, estrogen receptor-positive, HER2-negative breast cancer patients whose disease...
Regulatory approvals: Alzheimer’s agitation label expansion
Axsome Therapeutics won FDA approval expanding Auvelity’s label to include treatment of agitation in Alzheimer’s disease. The approval provides an additional indication for the...
Company transactions: acquisitions and strategic deals
Infinite Epigenetics agreed to acquire Tally Health, creating a broader platform for adult DNA methylation datasets, epigenetic diagnostics, and personalized healthspan interventions. The deal...
Oncology companion diagnostics: Guardant–Nuvalent collaboration
Guardant Health and Nuvalent entered a multi-year strategic collaboration to develop and potentially commercialize oncology companion diagnostics using Guardant’s liquid and tissue biopsy...
Biotech funding and capital markets: IPO activity
Hemab Therapeutics priced an upsized IPO, raising $301.5 million gross proceeds, after selling 16.75 million shares at $18 per share, the top end of its proposed range. The company targets...
Clinical development: obesity and label strategy in late-stage switching populations
Amgen launched multiple late-stage obesity trials for MariTide, including a study designed to evaluate the drug in patients switching away from rival GLP-1 therapies from Eli Lilly and Novo...
Cell & gene therapy science: new extracellular vesicle mechanism for cancer immunotherapy
Weill Cornell Medicine researchers reported that activated T cells secrete extracellular vesicles carrying DNA that can enter tumor and immune cells to enhance antigen processing and presentation....
Immunology and T-cell dysfunction: restoring protein recycling to reverse exhaustion
UC San Diego scientists reported in Cell that impaired protein recycling programs help drive T-cell exhaustion in mice. The study identifies a proteostasis failure in exhausted T cells, where...
FDA oversight: oncology ctDNA switching skepticism from advisory committee
An FDA oncology advisory panel voted 6–3 against switching patients to AstraZeneca’s oral SERD camizestrant based on ESR1 mutations detected in circulating tumor DNA. The vote reflected panel...
Biopharma labor and operations: Samsung Biologics strike
Samsung Biologics’ union workers began a five-day strike over wage disputes after a April rally and near-unanimous voting among union members. The work stoppage raises near-term operational risk...