Former U.S. FDA Commissioner Margaret Hamburg has added her voice to concerns that the incoming Trump administration’s pledge to slim down federal agencies will damage public health. “These are certainly challenging times,” Hamburg told delegates at the World Science Forum, Budapest, Hungary, meeting to discuss issues dominating the interface between science and policy.
Vaginal microbiome specialist Freya Bioscience ApS has added $11.8 million to its series A, bringing the total for the round to $50 million. Of the additional $11.8 million, $10.4 million comes from the Gates Foundation and is designated for the development of vaginal microbiome-based immunotherapies for treating bacterial vaginosis, a cause of preterm birth and other pregnancy complications.
The EMA has changed its mind about an earlier decision that the risks of Leqembi (lecanemab) outweigh the benefits and is now recommending the Alzheimer’s disease drug is approved for a subgroup of patients. That follows an appeal by Eisai Co. Ltd. and a re-examination of the data, after details relating to 274 patients with two copies of the ApoE4 gene were removed from the file.
Biontech SE is extending its relationship with Biotheus Inc. from a licensing deal to a full-scale acquisition, agreeing to pay $800 million cash and up to $150 million in milestone payments for the Chinese oncology specialist.
Alentis Therapeutics SA is poised to expand its reach in Claudin-1 biology, after closing a $181.4 million series D that will fund phase I/II trials of two antibody-drug conjugates (ADCs) targeting the transmembrane protein, which is overexpressed on a number of squamous cell tumors.
Autolus Therapuetics plc has been granted FDA approval for Aucatzyl (obecabtagene autoleucel) for the treatment of acute lymphoblastic leukemia in adults, becoming the first marketed CAR T therapy that does not have a risk evaluation and mitigation strategy attached to its label. The approval of Aucatzyl was based on results of the Felix clinical trial in relapsing/remitting ALL, which showed a strong safety profile compared to existing CAR T-cell therapies. The conduct of the trial was dogged by the COVID-19 pandemic, but of the 65 patients from an initial dosed cohort of 95 for whom efficacy was evaluated by the FDA, 63% achieved overall complete remission.
Microbiome specialist Enterobiotix Ltd. has reported positive results for the phase Ib trial of its EBX-102 fecal microbiota therapy in patients with stable liver cirrhosis. The placebo-controlled study involved first-in-human dosing with the company’s encapsulated oral formulation of microbiota derived from the stools of healthy donors. After initial dosing, patients were followed up for 12 weeks to assess changes in a range of clinical and blood biomarkers.
“I think elections are like pregnancy. … Everyone puts all of the energy into D-day – the birth. We’ve had the gender reveal, but what really, really matters is what happens now and the path ahead.” That was the instant response of Emma Walmsley, CEO of GSK plc, reacting to breaking news from the U.S. that Donald Trump has won a second term in office.
OSE Therapeutics SA has reported positive data for lusvertikimab in a phase II trial in ulcerative colitis, boosting the monoclonal antibody’s prospects of becoming the first anti-interleukin-7 therapy to reach the market.
Just ahead of the EMA setting out its latest thinking on regulation in the new era of artificial intelligence (AI), the industry has put forward its position on how to ensure AI rules enable, rather than hinder, the drug development and approval process.
