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Home » Topics » Regulatory

Regulatory
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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.
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3D illustration demonstrating antibody-drug conjugate.
Immuno-oncology

Adcentrx’s ADC targeting Nectin-4 receives FDA clearance to enter clinic

July 18, 2023
Adcentrx Therapeutics Inc. has received FDA clearance of its IND application for ADRX-0706 for the treatment of select advanced solid tumors.
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Baby with bandage on thigh

Infant RSV prophylactic scores US win

July 17, 2023
By Mari Serebrov
Sanofi SA and Astrazeneca plc had a lot to celebrate July 17 when the FDA approved Beyfortus (nirsevimab) ahead of schedule, making it the first respiratory syncytial virus (RSV) prophylactic for infants in the U.S. “This is just really an historic day,” Michael Greenberg, a Sanofi vice president and medical head of the company’s North America vaccines unit, told BioWorld. The companies had been expecting the FDA decision later this quarter. The earlier approval suggests the FDA appreciated the urgency of having time for health systems and doctors to get the drug ahead of the next RSV season, Greenberg said.
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After FDA rejection, GC Biopharma refiles Alyglo’s BLA

July 17, 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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Regulatory actions for July 17, 2023

July 17, 2023
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Neuronetics.
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Tablet, health professional, EHR/medical icons

US-based EHR vendor hit with $31M fine in whistleblower lawsuit

July 17, 2023
By Mark McCarty
The False Claims Act (FCA) has generated billions of dollars in fines each year in the U.S., and Atlanta-based Nextgen Healthcare Inc., is the latest to find itself on the wrong end of a whistleblower lawsuit based on the FCA. The U.S. Department of Justice reported that Nextgen will hand over $31 million to settle allegations that the vendor of electronic health records (EHR) not only misrepresented the capabilities of its software, but also paid kickbacks to physician providers to use its software, a pair of violations that have dinged the company’s finances and its reputation.
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CMS draws flak for radiation oncology cuts in doc fee draft for calendar 2024

July 17, 2023
By Mark McCarty
The U.S. CMS has released the draft Medicare physician fee schedule for calendar year 2024, inviting rebuttal from physician groups thanks to a proposed cut in rates of 1.25%. However, the draft’s proposed cut of roughly 2% for radiation oncology services has also provoked stakeholders who blasted the proposal as a detriment to cancer care, a particularly ironic move given the emphasis on the Biden administration’s Cancer Moonshot.
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Regulatory actions for July 17, 2023

July 17, 2023
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Astellas, Cel-Sci, Emmaus, Gilead, Scisparc.
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Viiv Healthcare’s HIV treatment cabotegravir approved in China

July 14, 2023
By Doris Yu
Viiv Healthcare Group’s long-acting therapies to treat human immunodeficiency virus (HIV), including cabotegravir as an oral tablet and as an injectable, have been approved by China’s NMPA, expanding the company’s presence in the sector and giving HIV patients in the country a new treatment option.
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