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BioWorld - Monday, May 11, 2026
Home » Topics » Regulatory

Regulatory
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Breast anatomy

Unique trial strategy muddies the ODAC waters for camizestrant

April 30, 2026
By Mari Serebrov
No Comments
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.
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Leukemia illustration
Immuno-oncology

Laguna Biotherapeutics’ LGNA-100 gains IND clearance

April 30, 2026
No Comments
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.
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Purdue sentenced in federal court, ordered to pay $5B

April 29, 2026
By Karen Carey
No Comments
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.
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FDA looks toward a future of continuous real-time trials

April 29, 2026
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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.
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AI generated image for researcher developing antisense oligonucleotides

Bio Korea 2026 kicks off with spotlight on oligonucleotides

April 29, 2026
By Marian (YoonJee) Chu
No Comments
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.
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Art concept for gene therapy research
Chinabio 2026

China’s new IIT rules could reshape early stage drug development

April 29, 2026
By Tamra Sami
No Comments
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.
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Decorative scales of justice in a courtroom

Supremes weigh in on skinny labels in long-awaited argument

April 29, 2026
By Mari Serebrov
No Comments
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.
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Green approved stamp

MFDS clears Curocell’s anbal-cel as first homegrown CAR T therapy

April 29, 2026
By Marian (YoonJee) Chu
No Comments
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.
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Criminal charges filed against top Fauci aide

April 28, 2026
No Comments
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.
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FDA proposes withdrawing Amgen’s Tavneos

April 28, 2026
No Comments
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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