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Home » Topics » Regulatory

Regulatory
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Red blood cells on blue background

Pfizer’s Beqvez taking on Hemgenix with FDA nod in hemophilia B

April 26, 2024
By Jennifer Boggs
Pfizer Inc.’s Beqvez (fidanacogene elaparvovec) won FDA approval for use in adults with hemophilia B, making it the second adeno-associated viral (AAV) vector-based gene therapy available for patients in the U.S., following the late 2022 approval of CSL Behring’s Hemgenix (etranacogene dezaparvovec).
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US FDA expands promotional guidance, keeps footnote

April 25, 2024
By Mari Serebrov
The U.S. FDA issued a revised draft guidance, “Promotional labeling and advertising considerations for prescription biological reference and biosimilar products,” to help ensure promotional communications involving reference biologics or their follow-ons are accurate, truthful and not misleading.
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Woman using VR headset

US FDA’s device center launches home health care initiative

April 25, 2024
By Mark McCarty
The U.S. FDA’s device center launched a new health care program designed to provide patients with a seamless home health care environment that stitches together various health care functions into an integrated system that eases the patient’s use of such technologies. The initiative, part of the agency’s health equity agenda, will rely on augmented and virtual reality and requires the development of a prototype that will be rolled out in underserved areas with several overarching objectives, including the democratization of clinical trial participation.
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Immuno-oncology

Hookipa Pharma cleared to advance HB-700 into clinical trials

April 25, 2024
Hookipa Pharma Inc. has received clearance from the U.S. FDA for its IND application for HB-700, a novel arenaviral therapeutic vaccine for the treatment of KRAS-mutated cancers. The HB-700 program is a replicating 2-vector therapy designed to treat KRAS-mutated lung, colorectal, pancreatic and other cancers by targeting the five most prevalent KRAS mutations in these disease indications.
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US FDA approves Pivya for uncomplicated UTIs

April 24, 2024
By Lee Landenberger
The U.S. FDA approved Utility Therapeutics Ltd.’s Pivya (pivmecillinam), an oral prodrug of injectable mecillinam, on its April 24 PDUFA date for female adults with uncomplicated urinary tract infections (UTIs) caused by Escherichia coli, Proteus mirabilis and Staphylococcus saprophyticus.
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Chinese flag on flagpole

EU takes aim at China’s med tech anticompetitive practices

April 24, 2024
By Mark McCarty
The EU has declared that it will investigate the anticompetitive practices of the People’s Republic of China where medical devices are concerned, a clear sign that device makers in the European Union succeeded in persuading Brussels that the Made in China 2025 initiative represents an intolerable form of economic adversarialism.
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K DTx VIVIDBrain

Korea taps into AI, DTx boom with new approvals, investments

April 24, 2024
By Marian (YoonJee) Chu
South Korean med-tech companies Nunaps Co. Ltd. and Share & Service are the latest to clear domestic approvals for digital therapeutics as the government ramps up R&D funding for artificial intelligence-based medical technologies.
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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.
Read More
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