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Regulatory
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Regulatory actions for Oct. 5, 2022

Oct. 5, 2022
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Aurora Spine.
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Regulatory actions for Oct. 5, 2022

Oct. 5, 2022
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Cue, Galapagos, Immutep, Kezar, Kira, Oncternal and Theratechnologies.
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Telehealth illustration

FDA’s tweak of mobile medical apps guidance introduces transparency requirement

Oct. 4, 2022
By Mark McCarty
The U.S. FDA’s finalized guidance for clinical decision support (CDS) software was not an entirely isolated policy change inasmuch as there were several other guidances that were edited and reissued two days after the CDS final was published. One of these is the guidance for device software functions and mobile medical apps, which now encodes a transparency requirement as seen in the CDS guidance, a change that may represent a hazard for the unwary medical software developer.
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United Kingdom flag, map

MHRA eyes 10% boost in user fees, cost recovery charges

Oct. 4, 2022
By Mark McCarty
The U.K. Medicines and Health Care Products Regulatory Agency (MHRA) announced recently that it is considering an increase in the fees it levies on industry for a variety of services and actions, such as premarket applications. One of these is a 10% indexation increase in all statutory fees, but there are also some proposed increases in cost recovery charges and an additional 22 new fees for cost recovery that would be new to applicants seeking access to the U.K. market.
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Biosimilars: Portrait of a maturing landscape

Oct. 4, 2022
Although it’s a make-or-break market for many novel drugs, the U.S. is still testing the waters with biosimilars to some extent. That’s expected to change when at least seven biosimilars, including an interchangeable, referencing Abbvie Inc.’s Humira (adalimumab) are set to launch in the U.S. within the first seven months of next year. Next week, BioWorld will look at the significance of that looming competition and how the global biosimilars market is evolving amid a changing landscape of players, policies and pipelines.
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US solicitor general asked to weigh in on skinny labels

Oct. 4, 2022
By Mari Serebrov
Teva Pharmaceuticals USA Inc.’s quest to get the U.S. Supreme Court to overturn the Federal Circuit and preserve label carveouts, or so-called skinny labels, continued Oct. 3 with the high court asking the solicitor general to weigh in.
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Liver

FDA greenlights Taiho’s FGFR inhibitor Lytgobi for intrahepatic cholangiocardinoma

Oct. 4, 2022
By Tamra Sami
The U.S. FDA has approved Taiho Oncology Inc.’s Lytgobi (futibatinib) for adults with previously treated, unresectable, locally advanced or metastatic intrahepatic cholangiocarcinoma harboring fibroblast growth factor receptor 2 (FGFR-2) gene fusions or other rearrangements. The approval arrived on its Sept. 30 PDUFA date.
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Japan’s MHLW approves raft of new drugs

Oct. 4, 2022
By Tamra Sami
Japan’s Ministry of Health, Labor and Welfare (MHLW) approved a slew of new drugs in the last week of September, including Japan’s first sustained release GIP/GLP-1 receptor agonist for type 2 diabetes from Eli Lilly and Co. and Mitsubishi Tanabe Pharma Corp.; a self-administered injectable drug for rheumatoid arthritis from Eisai Co. Ltd. and Nippon Medac Co. Ltd.; a CAR T from Legend Biotech Corp. and Janssen Pharmaceutical KK; and two drugs from Astrazeneca plc, one in asthma and the other in pediatric plexiform neurofibromas in neurofibromatosis type 1.
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Regulatory actions for Oct. 4, 2022

Oct. 4, 2022
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Multi Radiance Medical, QT Medical.
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Regulatory actions for Oct. 4, 2022

Oct. 4, 2022
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Aeglea, Calithera, Eagle, Mesoblast, Poxel, Prometheus, Santhera, Seneca, Taiho, Tonix.
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