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Home » Topics » Regulatory

Regulatory
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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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Medicare puzzle

US Medicare may tighten coverage for leg, foot ulcer treatments

April 30, 2024
By Mark McCarty
U.S. Medicare coverage of products for leg and foot ulcers has undergone a second review in less than a year thanks to pushback from stakeholders after the August 2023 issuance of proposed non-coverage policies for more than 100 cell and tissue-based products.
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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 30, 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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Natural killer cell attacking cancer cell
Immuno-oncology

IND for Syena’s SY-307 cleared by FDA

April 30, 2024
Replay Holdings LLC and The University of Texas MD Anderson Cancer Center report that the FDA has cleared the IND application for PRAME TCR/IL-15 NK (SY-307), an engineered T-cell receptor natural killer (TCR-NK) cell therapy for relapsed/refractory myeloid malignancies.
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Purple-tinted test tubes and dropper

Final LDT rule likely to favor larger players in lab space

April 29, 2024
By Mark McCarty
The U.S. FDA’s final rule for regulation of lab-developed tests was hardly a shock to the world of regulation, but the final rule might provide a shock for sorts for smaller entities in the diagnostics space. Analysts with Leerink Partners said most companies they routinely track are unlikely to be immediately affected by the final rule, but noted that FDA regulation might make it tougher for smaller, new entries to the space to get to market.
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Sanders pressures international industry to back Pandemic Accord

April 29, 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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FDA approved icons and medical professional
LSX World Congress

Integra will not launch any product in the EU before the US

April 29, 2024
By Shani Alexander
Integra Lifesciences Holdings Corp. will not launch any new product in the EU before the U.S. because of the challenging requirements under the new Medical Device Regulation, Stuart Hart, chief medical officer at the Princeton, New Jersey-based company, told delegates at the LSX conference in London.
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EspritB

FDA approves Abbott’s below-the-knee resorbable scaffold

April 29, 2024
By Annette Boyle
Abbott Laboratories received U.S. FDA approval for its Esprit below-the-knee (BTK) everolimus-eluting resorbable scaffold system for use in chronic limb-threatening ischemia well ahead of the expected second half 2024 time frame. Esprit showed clear superiority to angioplasty in the LIFE-BTK trial presented at last year’s Transcatheter Cardiovascular Therapeutics conference and published in The New England Journal of Medicine.
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