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Home » Topics » Regulatory

Regulatory
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Architectural pillars

Natera bests Neogenomics in district court patent litigation

Dec. 28, 2023
By Mark McCarty
Natera Inc., said it has won a preliminary injunction against Neogenomics Inc., which halts any distribution of the latter’s RaDaR (Residual Disease and Recurrence) assay for detection of residual cancer DNA. The matter is anything but closed, and Neogenomics stated that it will appeal the decision, suggesting that this dispute will roll into and play out through much of 2024.
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CE Mark
’23 in review

EU continues struggle with rollout of new device regs in 2023

Dec. 28, 2023
By Mark McCarty

Regulation of medical devices is always a messy and complicated task, but that has proven to be particularly true of the European Union’s (EU) Medical Device Regulation (MDR). Thanks largely to problems with the capacity of notified bodies (NBs) to review renewals of existing CE marks, patients in the EU may experience a significant dearth of medical devices over the next couple of years, a nightmare scenario that has all stakeholders scrambling for solutions.


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Kidneys
Nephrology

Jemincare obtains approvals to advance five drugs into clinical trials

Dec. 28, 2023
Jiangxi Jemincare Group Co. Ltd. has reported that its wholly owned subsidiary company, Shanghai Jemincare Pharmaceutical Co. Ltd., recently received approvals for clinical trials of five of its drugs in the fields of cancer, kidney and infectious diseases.
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Third-party manufacturing flaws delay Zealand’s NDA in rare pediatric disease

Dec. 27, 2023
The U.S. FDA issued a complete response letter for Zealand Pharma A/S’s NDA seeking approval of dasiglucagon for the prevention of treatment of hypoglycemia in pediatric patients with congenital hyperinsulinism, citing deficiencies identified during an inspection at a third-party contract manufacturing facility.
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US FDA continues working through year-end guidance to-do list

Dec. 27, 2023
By Mari Serebrov
Drug guidances are still pouring forth from the U.S. FDA as 2023 winds to an end. The latest batch deals with issues as varied as the reformulation of drug products that use carbomers manufactured with benzene, potency assurance for cellular and gene therapies, the quality of topical eye treatments, and the development of drugs and biologics for rare diseases.
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Top Trends Drug Pricing, capsule with coins

EU pharma reform seeks to provide equitable access; threatens data exclusivity, incentives

Dec. 27, 2023
By Nuala Moran
As their term in office winds to a close, MEPs in the two main political groupings of the European Parliament still have huge differences of opinion over the proposed reform of the EU pharmaceutical regulation and how best to achieve the stated aims of improving patient access whilst encouraging innovation.
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U.S. Capitol building
‘23 in review

US FDA, Congress, fail to resolve lab-developed test mess

Dec. 27, 2023
By Mark McCarty

As calendar year 2023 limps to the finish line, a number of important regulatory developments emerged and then submerged, but one development that is also a non-development took center stage in the world of med tech. The U.S. FDA has proposed a regulation for lab-developed tests (LDTs), an issue that has been simmering for the better part of a decade thanks in no small part to Congress’ failure to pass legislation that would eliminate the FDA’s controversial approach to rulemaking.


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Apple Computer Inc. logo

Apple Watch ITC verdict paused by US appeals court

Dec. 27, 2023
By Holland Johnson
In the latest salvo of the ongoing battle between Apple Inc. and Masimo Corp. over the use of a blood oxygen technology, a U.S. federal appeals court paused an International Trade Commission (ITC) ban on Apple’s watches. Apple reported on Dec. 19 that it would pull the Apple Watch Ultra 2 and Apple Watch Series 9 from its website on Dec. 21 and from its retail locations after Dec. 24, in response to an exclusion order issued by the ITC in October.
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Regulatory actions for Dec. 27, 2023

Dec. 27, 2023
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Coherus, Cvrx, Sofwave Medical.
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Photomicrograph of bone marrow aspirate showing myeloblasts of acute myeloid leukemia
Cancer

FDA clears Senti Biosciences’ IND for SENTI-202

Dec. 27, 2023
Senti Biosciences Inc. has received clearance of its IND application from the FDA for SENTI-202, an off-the-shelf chimeric antigen receptor natural killer (CAR-NK) cell therapy product candidate designed to selectively target and eliminate CD33- and/or FLT3-expressing hematologic malignancies, such as acute myeloid leukemia (AML) and myelodysplastic syndrome, while sparing healthy bone marrow cells.
Read More
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