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Illustration of brain with electrical activity background

Epitel snags FDA clearance for two epilepsy devices

May 1, 2024
By Annette Boyle
Epitel Inc. received U.S. FDA clearances for two epilepsy-focused technologies that simplify detection and analysis of seizures in patients with suspected epilepsy. The Remi remote electroencephalogram monitoring system is a wearable device that allows patients to continue with their daily activities for extended periods without the restrictions of wires, while still capturing intermittent seizures. The Remi Vigilenz artificial intelligence system uses machine learning to identify and note seizure events in the Remi EEG records.
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U.S. FDA headquarters

FDA wary of impact of retirements on inspectional activities

May 1, 2024
By Mark McCarty
The U.S. FDA’s senior managers often lament the lack of routine increases in taxpayer funding, a concern that Michael Rogers, the associate FDA commissioner for regulatory affairs, reiterated during a May 1 webinar. Rogers said the agency’s field inspectorate will be working through a large number of retirements over the next few years, a predicament he said will continue to be “a huge challenge” to overcome.
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Dollar signs in blister packs

Two more challenges to US Rx price negotiations dismissed

April 30, 2024
By Mari Serebrov
The U.S. government chalked up another win April 29 against the constitutional challenges to the Inflation Reduction Act’s provision mandating direct Medicare price negotiations for selected prescription drugs.
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​Zogenix acquisition at heart of SEC insider trading settlement​

April 30, 2024
Three people have agreed to pay more than $170,000 to settle U.S. SEC insider trading charges related to UCB SA’s $1.9 billion acquisition of Zogenix Inc.
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Full US approval for Pfizer/Genmab cervical cancer drug Tivdak

April 30, 2024
By Karen Carey
Ten days early, the U.S. FDA granted full approval under priority review to Pfizer Inc. and Genmab A/S’s antibody-drug conjugate Tivdak (tisotumab vedotin) to treat cervical cancer.
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US FDA to listen, not just talk, about adcom reforms

April 30, 2024
By Mari Serebrov
It’s been a year since U.S. FDA Commissioner Robert Califf first started talking about reforming the agency’s advisory committee process. Now the FDA is moving beyond talking about it to listening. The agency has scheduled an all-day listening session June 13 to get feedback on optimizing the use of adcoms and the processes involved.
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Sanders pressures international industry to back Pandemic Accord

April 30, 2024
By Mari Serebrov
Looking beyond the U.S. biopharma industry, Sen. Bernie Sanders (I-Vt.) is now pushing the International Federation of Pharmaceutical Manufacturers and Associations to get on board with the World Health Organization’s proposed Pandemic Accord aimed at making diagnostics, treatments and vaccines available to everyone who needs them.
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Takeda’s Fruzaqla leads list of positive CHMP opinions

April 30, 2024
By Lee Landenberger
Amidst a slew of end-of-week, positive EMA Committee for Medicinal Products for Human Use (CHMP) opinions is Takeda Pharmaceutical Co. Ltd.’s Fruzaqla (fruquintinib). The selective inhibitor of vascular endothelial growth factor receptors-1, -2 and -3 is for adults with previously treated metastatic colorectal cancer.
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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 30, 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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WHO pandemic deal doesn’t protect developing countries, groups say

April 30, 2024
By Tamra Sami
The latest World Health Organization’s (WHO) Pandemic Agreement falls short of protecting all countries in future pandemics, said international patient groups and public health organizations.
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