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BioWorld - Friday, September 22, 2023
Home » Topics » Regulatory

Regulatory
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Timing is everything in US Rx price negotiations

Sep. 6, 2023
By Mari Serebrov
No Comments
Forget location. It’s timing, timing, timing when it comes to escaping the first round of U.S. Medicare price negotiations due to pending biosimilar competition. Under the Inflation Reduction Act (IRA), only single-source drugs that have been approved for a specific length of time are subject to the forced negotiations, which focus on drugs with the biggest Medicare spend, not necessarily the highest price tag. Since the IRA gives biologics a 12-year safe harbor from negotiations, which aligns with the biologic exclusivity provided by the Biologic Price Competition and Innovation Act, it creates a scenario in which the innovator could be facing negotiations just as its first biosimilar competition prepares to launch. That creates a lot of what-ifs.
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Ultomiris

AZ gets CRL asking for REMS changes to rare disease sBLA

Sep. 6, 2023
By Lee Landenberger
No Comments
While the U.S. FDA didn’t ask for more study data or have safety or efficacy concerns, it does want modifications to Alexion, Astrazeneca Rare Disease’s sBLA for Ultomiris (ravulizumab-cwvz) to treat adults with the rare central nervous system disease neuromyelitis optica spectrum disorder. The agency has issued a complete response letter (CRL) requesting changes to Ultomiris’ Risk Evaluation and Mitigation Strategy (REMS) to better validate patients’ meningococcal vaccination status or prophylactic administration of antibiotics before being treated.
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Time for US biosimilar path to catch up with the science?

Sep. 6, 2023
By Mari Serebrov
No Comments
Now that the U.S. FDA has nearly 15 years of experience with developing and implementing a biosimilar pathway, it’s time for that regulatory path to catch up with the science, according to experts that have been involved in biosimilar development even before Congress passed the Biologics Price Competition and Innovation Act that created the framework for the U.S. biosimilar market.
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Regulatory actions for Sept. 6, 2023

Sep. 6, 2023
No Comments
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Nanjing Changcheng Medical Equipment, Techsomed Medical Technologies, Venturemed Group.
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FDA approved icons and medical professional

FDA drops three draft guidances for 510(k)s, including a predicate best practices draft

Sep. 6, 2023
By Mark McCarty
No Comments
The U.S. FDA’s concerns about the 510(k) program over the past decade-plus are practically the stuff of regulatory urban legend, but the agency has just unveiled a trio of draft guidances to address some of those concerns. Perhaps the most significant of these is a draft guidance for selection of a predicate device for a 510(k) filing, a document that may come across to industry as little more than an attempt to limit the devices that a manufacturer can recite in a 510(k) filing.
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Regulatory actions for Sept. 6, 2023

Sep. 6, 2023
No Comments
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Arcturus, Aspargo, Astrazeneca, CSL, Inmune, Italfarmaco, Krystal, Nykode, Uniqure, Viatris, Wave, X4.
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RNA strand
Endocrine/Metabolic

Wave submits CTA for WVE-006 for α1-antitrypsin deficiency

Sep. 6, 2023
No Comments
Wave Life Sciences Ltd. has submitted its first clinical trial application (CTA) for WVE-006 for α1-antitrypsin deficiency (AATD).
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Court challenges to IRA Rx price negotiations piling up

Sep. 5, 2023
By Mari Serebrov
No Comments
The queue of lawsuits challenging the constitutionality of the U.S. Inflation Reduction Act’s (IRA) prescription drug price negotiations continues to grow. Novartis AG is the latest drug company, but probably not the last, to join the line. It filed its challenge in federal court in New Jersey Sept. 1, a few days after the Centers for Medicare & Medicaid Services included the company’s heart failure drug, Entresto (sacubitril and valsartan), on its list of the 10 drugs subject to the first round of IRA negotiations.
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Regulatory actions for Sept. 5, 2023

Sep. 5, 2023
No Comments
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Nanjing Changcheng Medical Equipment, Guardant Health, Gendius, Icecure Medical, Medimaps Group, Rapid Medical, Techsomed.
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FDA sees lack of alternatives for Datascope balloon pumps despite recalls

Sep. 5, 2023
By Mark McCarty
No Comments
The U.S. FDA recently posted another round of recalls for the Cardiosave line of intra-aortic balloon pumps (IABPs) by Datascope Corp., advising users to make sure they have a backup unit at the ready in the case of device failure. However, the agency noted that “alternative treatments are limited,” a clear sign that this market lacks competition, most likely due to a lack of incentives for the private sector to invest in this class of devices.
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