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Home » Topics » Regulatory

Regulatory
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Gavel and FTC logo

Attorney predicts ‘all-out battle’ over FTC noncompete rule

April 24, 2024
By Mark McCarty
The U.S. Federal Trade Commission’s final rule for noncompete clauses in employment contracts would seem to endanger life science patents and trade secrets, but there is a question of whether the agency stepped outside its statutory bounds in forming the rule. The U.S. Chamber of Commerce has already filed suit on the rule, but Joshua Rich of McDonnell Boehnen Hulbert & Berghoff LLP told BioWorld, that the Chamber is unlikely to be the last entity to file suit over the rule.
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CAR T cell with map of China as nucleus
China’s CAR T market comes of age

China grapples with providing access to CAR T therapies

April 24, 2024
By Tamra Sami, Ruchita Kumar, and Sahil Arora
The process of manufacturing autologous T-cell therapies is technically challenging when compared with other oncology drugs, making the overall cost of developing CAR T therapies significantly higher. A challenging reimbursement environment for drugs listed on China’s National Reimbursement Drug List also means that most patients will have to pay out of pocket to access CAR T therapies. Taken together, complex logistics – production, manufacturing and supply chain – and complicated administration requirements are key bottlenecks that inflate the input costs involved in developing these specialized treatment options.
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Antibodies attacking cancer cell
Immuno-oncology

Oncoc4 to advance anti-Siglec-10 antibody into clinic

April 24, 2024
The FDA has cleared Oncoc4 Inc.’s IND application for ONC-841, a potential first-in-class Siglec-10-blocking antibody for the treatment of solid tumors.
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Day One’s Ojemda approved in US for rare pediatric cancer

April 23, 2024
By Karen Carey
Becoming the first type II RAF inhibitor for relapsed or refractory BRAF-altered pediatric low-grade glioma, Day One Biopharmaceuticals Inc.’s Ojemda (tovorafenib, DAY-101) gained U.S. FDA accelerated approval on April 23, a week earlier than its expected PDUFA date, bringing the Brisbane, Calif.-based company a rare pediatric disease priority review voucher.
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Remsima SC

Samsung Bioepis, Celltrion make biosimilar inroads in Europe, US

April 23, 2024
By Marian (YoonJee) Chu
Samsung Bioepis Co. Ltd. and Celltrion Inc. are making headway in Europe and U.S. with respective follow-on biologic products, with Samsung Bioepis the latest to gain EMA approval for Pyzchiva, a Stelara (ustekinumab, Janssen Pharmaceuticals Inc.) biosimilar, on April 23.
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FDA approved metal stamp
Biopharma regulatory actions and approvals March 2024

US FDA makes history with 30 drugs approved in March

April 23, 2024
By Amanda Lanier
In March, the U.S. FDA approved 30 new drugs, marking the highest monthly count in BioWorld’s records. The previous highest month of June 2020, with 29 FDA approvals, is followed by November 2017’s 27 approvals.
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China clears Immuneonco’s CD47 inhibitor for pivotal trials

April 23, 2024
By Tamra Sami
China’s National Medical Products Administration has cleared Immuneonco Biopharmaceuticals Co. Ltd.’s’ IMM-01 (timdarpacept) to enter a pivotal phase III trial in combination with Beigene Co. Ltd.’s PD-1 inhibitor, tislelizumab, in relapsed or refractory classical Hodgkin lymphoma patients who relapsed or progressed after treatment with PD-1 inhibitors.
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Colorectal cancer illustration

Genfleet’s KRAS G12C inhibitor moving into phase III

April 23, 2024
By Tamra Sami
Genfleet Therapeutics Inc. has entered the KRAS G12C inhibitor race in the U.S. as it gears up to begin phase III trials of GFH-925 (IBI-351) in patients with refractory metastatic colorectal cancer (CRC) following FDA clearance.
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CAR T cell with map of China as nucleus
China’s CAR T market comes of age

CAR T pipelines bloom to treat world’s largest cancer population

April 23, 2024
By Tamra Sami, Ruchita Kumar, and Sahil Arora
As of Jan. 31, 2024, there were more than 300 CAR T trials registered in China, surpassing the U.S. and becoming the country with the most CAR T therapy clinical trials. Among them, CD19 is the most frequently studied target, according to BioWorld and Cortellis. The rapid evolution of CAR T-cell therapies in China has escalated over the past decade from the start of the first clinical trials in 2013 to the country becoming an established host for CAR T-cell-related trials by 2017, according to Yongxian Hu and researchers from Zhejiang University in Hangzhou, China. Chinese cell therapy companies – backed by $2.37 billion in funding in 2021 – have since significantly increased basic research and trial output for CAR Ts, which was welcomed by large patient demand.
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China in red on globe

Royal Philips hit with FDA warning over facility in China

April 23, 2024
By Mark McCarty
Royal Philips NV may feel it has had enough recent interaction with the U.S. FDA, but the company is now in receipt of a warning letter from the agency over a facility located in Suzhou, China. The FDA was none too fond of the facility’s handling of a contract manufactured data cable used in CT systems because of malfunctions that may have delayed diagnostic imaging procedures, representing yet another regulatory distraction for a company that recently cleared a long-running conflict with the FDA over CPAP machines.
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