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Regulatory
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US court challenges to IRA on the grow

July 18, 2023
By Mari Serebrov
Johnson & Johnson and its Janssen pharmaceutical companies added their name July 18 to the growing list of biopharma companies and organizations challenging the Inflation Reduction Act’s (IRA) mandated drug price negotiations.
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SEC still cleaning up insider trading from Pandion deal

July 18, 2023
By Mari Serebrov
The U.S. SEC is settling insider trading charges against Nirdosh Jagota, former vice president of global regulatory affairs at Merck & Co. Inc., stemming from Merck’s $1.85 billion acquisition of Pandion Therapeutics Inc. in 2021.
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China approves Daiichi Sankyo/Astrazeneca’s Enhertu for HER2 low metastatic breast cancer

July 18, 2023
By Tamra Sami
China’s NMPA approved Daiichi Sankyo Co. Ltd. and Astrazeneca plc’s Enhertu (fam-trastuzumab deruxtecan) as the first HER2-directed therapy for patients with HER2-low metastatic breast cancer.
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After FDA rejection, GC Biopharma refiles Alyglo’s BLA

July 18, 2023
By Marian (YoonJee) Chu
GC Biopharma Corp., formerly Green Cross Corp., said July 17 that it refiled the BLA for its intravenous immune globulin agent Alyglo (GC-5107B; IVIG-SN 10%) to the U.S. FDA – nearly a year and a half after the regulator’s initial rejection.
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Mosquito and dengue vaccine

Takeda withdraws US BLA for dengue fever vaccine Qdenga

July 18, 2023
By Tamra Sami
Takeda Pharmaceutical Co. Ltd. has voluntarily withdrawn its U.S. BLA for its dengue fever vaccine, Qdenga (TAK-003), following discussions with the FDA centered on “aspects of data collection, which cannot be addressed within the current BLA review cycle,” the company said in a statement.
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HLB's Elevar subsidiary confirms FDA to review rivoceranib by 2024

July 18, 2023
By Marian (YoonJee) Chu
Elevar Therapeutics Inc. said that the U.S. FDA accepted its NDA for oral tyrosine kinase inhibitor rivoceranib in combination with PD-1 inhibitor camrelizumab (Airuika) as a first-line treatment for liver cancer. The FDA stamped an official PDUFA target action date of May 16, 2024.
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Regulatory actions for July 18, 2023

July 18, 2023
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Baird Medical, Reddyport.
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Quidel, Medtronic hit with class I recalls

July 18, 2023
By Mark McCarty
Recalls are a fact of life in the medical technology space, and Medtronic plc and Quidel Cardiovascular Inc., have both been forced to report class I recalls. Dublin-based Medtronic announced a recall of more than 348,000 cardiac electrophysiology devices due to issues that could prevent high-voltage therapy while San Diego-based Quidel is recalling nearly 7,800 Triage cardiac panels because of a risk of false negatives for patients being assessed for an infarct.
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Amyloid plaque on nerve cell

US CMS proposes loosening its leash on amyloid PET scans

July 18, 2023
By Mari Serebrov
Responding to medical advances and new standards of care in Alzheimer’s, the U.S. Centers for Medicare & Medicaid Services (CMS) is proposing to end its 10-year-old coverage with evidence development policy that has limited Medicare reimbursement of amyloid PET scans to once in a lifetime for beneficiaries – and then only when they’re used in a CMS-approved trial.
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Regulatory actions for July 18, 2023

July 18, 2023
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Antengene, Arrowhead, Dong-A, Elevar, Madrigal.
Read More
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