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FDA real-time trial data initiative for oncology
The FDA is preparing to use real-time clinical trial data review in oncology, starting with studies from Amgen and AstraZeneca. The agency’s approach aims to reduce the lag between trial conduct...
Biotech IPO funding and market access
Avalyn Pharma raised $300 million in an upsized IPO to fund late-stage development of reformulated inhaled respiratory therapies. The company priced its offering at $18 per share, with gross...
Acquisition / rare disease commercial expansion
Chiesi agreed to buy KalVista Pharmaceuticals for about $1.9 billion, adding Ekterly (sebetralstat) to its rare disease portfolio. The acquisition is designed to bolster Chiesi’s presence in...
Gene therapy regulatory pursuit after US setback
UniQure said it plans to seek UK approval of its Huntington’s gene therapy AMT-130 after a positive meeting with UK regulators. The company pointed to three-year analyses from ongoing studies in...
Biotech financing / early clinical pipeline capital raise
Tacalyx secured €11 million in a first closing of a seed extension round to advance TCX-201, an antibody-drug conjugate targeting an undisclosed tumor-associated carbohydrate antigen. The funding...
Platform/diagnostic partnership in oncology companion testing
Guardant Health and Nuvalent entered a multi-year strategic collaboration to develop and potentially commercialize oncology companion diagnostics using Guardant’s tissue and liquid biopsy assets....
Clinical trial signal / neurodevelopmental and metabolic link
Researchers reported that once-weekly semaglutide can reduce heavy drinking days in people with alcohol use disorder and obesity, based on results published in The Lancet from a small trial. The...
Research breakthrough / immune mechanism for cancer killing
Weill Cornell Medicine researchers reported in Cancer Cell that activated T cells release extracellular vesicles carrying DNA fragments that can boost anti-tumor immune activity. The study ties a...
FDA leadership shuffle at vaccines and biologics
The FDA named Katherine Szarama as acting director of the Center for Biologics Evaluation and Research (CBER), according to an HHS official cited by STAT. CBER regulates vaccines, gene therapies,...
Oncology regulatory decisions on camizestrant
The FDA’s oncology advisory ecosystem moved against AstraZeneca’s oral SERD camizestrant in two separate settings, extending uncertainty over the “new paradigm” that would broaden how and when the...
Confirmatory trial failure threatens accelerated approval for Krazati
Bristol Myers Squibb’s Krazati (fruquintinib) lost support as its confirmatory trial in second-line colorectal cancer failed to replicate required benefit, putting the company’s...
CAR T and cell therapy platform: memory-enriched CAR T shows remission signal
A first-in-human study reported that stem cell memory CAR T cells (T_SCM) achieved complete remissions at low doses without chemotherapy preconditioning, according to the research description. The...
Gene therapy regulatory path: UniQure seeks UK approval for Huntington’s AMT-130
UniQure said it plans to submit a marketing application for its Huntington’s gene therapy AMT-130 to UK regulators in the third quarter, after a positive meeting with drug regulators there. The...
AAV gene therapy for HIV: long-term SHIV suppression signal
Researchers at Oregon Health & Science University reported long-term suppression of SHIV replication in macaques using an AAV gene therapy encoding a CCR5-blocking antibody derived from...
M&A: Chiesi buys KalVista to expand hereditary angioedema portfolio
Chiesi Group agreed to acquire KalVista Pharmaceuticals in a deal valued at about $1.9 billion to add Ekterly (sebetralstat), the first oral, on-demand hereditary angioedema (HAE) therapy for...
IPO: Avalyn Pharma raises for inhaled pulmonary fibrosis programs
Avalyn Pharma priced a $300 million IPO to fund late-stage studies of inhaled therapies for pulmonary fibrosis, including a reformulated inhaled form of pirfenidone for progressive pulmonary...
FDA real-time trial pilot direction
The FDA is moving toward real-time clinical trial data review, using new technologies to reduce reporting lag for regulators. The agency plans to start with oncology studies led by Amgen and...
Company deal: Guardant and Nuvalent expand companion diagnostic collaboration
Guardant Health and Nuvalent entered a multi-year strategic collaboration to develop and potentially commercialize oncology companion diagnostics. The companies plan to use Guardant’s tissue and...
Huntington’s gene therapy regulatory push
UniQure said it will seek UK approval for its Huntington’s disease gene therapy AMT-130 after meeting with UK regulators and planning a marketing application later this year. The submission will...
Big Pharma M&A in rare disease immunology
Chiesi Group is buying KalVista Pharmaceuticals in a roughly $1.9 billion deal to expand its rare disease portfolio with Ekterly (sebetralstat), an oral on-demand therapy for hereditary angioedema...