Following a discussion that focused more on a new personalized trial strategy rather than the proposed therapy, the U.S. FDA’s Oncologic Drugs Advisory Committee (ODAC) voted 3-6 April 30 that Astrazeneca plc’s camizestrant demonstrated a clinically meaningful benefit in treating patients with HR+/HER2- metastatic breast cancer.
Laguna Biotherapeutics Inc. has obtained IND clearance from the FDA for its cancer immunotherapeutic LGNA-100 (QUAIL-100). The planned first-in-human phase I study will evaluate LGNA-100 in pediatric and young adult participants with high-risk acute leukemias and myelodysplastic syndromes following αβ-depleted hematopoietic stem cell transplantation (HSCT) to prevent leukemic relapse.
More than five years after pleading guilty to its role in the opioid epidemic, Purdue Pharma LP was sentenced in federal court and ordered to pay $5 billion in criminal penalties.
Taking advantage of new technologies to eliminate the lag time in reporting trial data to the U.S. FDA, the agency is moving toward a real-time clinical trial pilot program that will build on two proof-of-concept trials initiated by Amgen Inc. and Astrazeneca plc.
Three decades of trial-and-error, and the resulting safety data, in the oligonucleotide-based therapeutic space have paved way for the present-day innovations and the promise of “programmable,” precision medicine for patients, speakers at Bio Korea 2026 said April 28.
China’s investigator-initiated trial (IIT) system is increasingly being used to generate early human data in cell and gene therapies, and new changes that widen the pathway are expected to drive more multinational companies to conduct IITs in China, panelists said during the Chinabio Partnering Forum in Shanghai April 28-29.
The U.S. Supreme Court’s ruling in Hikma Pharmaceuticals USA Inc. v. Amarin Pharma Inc. could either discourage the development of generic drugs under a skinny label or make innovators think long and hard about investing hundreds of millions of dollars in developing new indications for drugs already on the market.
South Korea’s Ministry of Food and Drug Safety (MFDS) approved Curocell Inc.’s Rimqarto (anbalcabtagene-autoleucel; anbal-cel) April 29 as the first homegrown CAR T-cell therapy to treat patients with advanced diffuse large B-cell lymphomas.
An alleged coverup of NIH-funded gain-of-function research at China’s Wuhan Institute of Virology has led to criminal charges against a former career scientist and top aide to Tony Fauci, the head of the National Institute of Allergy and Infectious Diseases in the time of the COVID-19 pandemic.
Alleging “untrue statements” included in the approval application for vasculitis drug Tavneos (avacopan), the U.S. FDA’s Center for Drug Evaluation and Research is proposing to withdraw the NDA for small-molecule C5aR antagonist at the center of Amgen Inc.’s 2022 buyout of Chemocentryx Inc. for $3.7 billion.
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