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BioWorld - Monday, June 5, 2023
Home » Topics » Regulatory

Regulatory
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Judge's gavel with US flag

SCOTUS: Amgen’s enablement ‘little more than research assignments’

May 18, 2023
By Mari Serebrov
The roadmap and conservative substitution methods Amgen Inc. laid out to “enable” its genus claims for antibodies that inhibit PCSK9 to lower LDL cholesterol are “little more than two research assignments,” the U.S. Supreme Court said in a unanimous opinion handed down May 18 in Amgen Inc. v. Sanofi SA that gave the win to Sanofi. The roadmap “merely describes step-by-step Amgen’s own trial-and-error method for finding functional antibodies — calling on scientists to create a wide range of candidate antibodies and then screen each to see which happen to bind to PCSK9 in the right place and block it from binding to LDL receptors,” the court said in the decision written by Justice Neil Gorsuch.
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Regulatory actions for May 18, 2023

May 18, 2023
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Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Ardelyx, Avidity, Elevar, Flavocure, Hist, Indapta, Intercept, Lumen, Pharmala, Shaman, Takeda, Ultragenyx.
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Regulatory actions for May 17, 2023

May 17, 2023
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Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Medtronic, Sientra.
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Gavel and scales

US-based distributor hit with $487M judgment in False Claims Act case

May 17, 2023
By Mark McCarty
No Comments
The U.S. Department of Justice announced that a judgment of more than $487 million has been lodged against Cameron-Ehlen Group Inc., of Bloomington, Minn., for alleged violations of the False Claims Act (FCA) in connection with the company’s distribution of products used in cataract surgeries. That final amount is more than 10 times the amount alleged to have been billed illicitly to federal health programs, a clear signal that inducement of this sort will be met with severe penalties.
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Stock chart with falling red arrow

Intercept tumbles on US FDA concerns ahead of adcom

May 17, 2023
By Mari Serebrov
No Comments
The U.S. FDA’s release of its briefing document for the upcoming advisory committee meeting on obeticholic acid 25 mg as a fatty liver disease treatment sent Intercept Pharmaceuticals Inc. on a downwards spiral May 17. Soon after the document was released, Intercept stock (NASDAQ:ICPT) dropped as low as $11.41 – down almost 30% from its May 16 close of $16.21. As the day wore on, it regained some of that lost value in heated trading that was more than eight times the company’s average daily volume of 782,285. The rebound helped Intercept close the day at $13.83, down about 15%.
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Regulatory actions for May 17, 2023

May 17, 2023
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Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Aravive, Astellas, Bayer, Bioartic, Bionxt, Biophytis, Cabaletta, Cormedix, Eisai, Kamada, Kimera, Orchard, Phio, Sarepta, Virios, YS.
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Gavel and FTC logo

US FTC suit: Monopoly buster or investment disruptor?

May 16, 2023
By Mari Serebrov
The U.S. FTC’s unprecedented antitrust challenge to Amgen Inc.’s $27.8 billion acquisition of Horizon Therapeutics plc, could be a disruptor to biotech investment if the agency is victorious, some analysts are warning. “With essentially zero commercial overlap [between the two companies], this deal would seem to be a slam dunk under long-established antitrust considerations,” said Christopher Raymond, a senior research analyst with Piper Sandler Research.
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Regulatory actions for May 16, 2023

May 16, 2023
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Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Abbott, BD, Linear Health Sciences.
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propriovisioninc.jpg

FDA-cleared Paradigm designed to replace traditional surgical navigation systems

May 16, 2023
By David Godkin
No Comments
A surgical navigation platform developed by Proprio Inc., that is intended to replace traditional surgical technologies which produce harmful radiation and can impede surgical workflow, won U.S. FDA 510 (k) clearance.
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Abbott - Eterna

FDA approves Abbott's spinal cord stimulator for non-surgical back pain

May 16, 2023
By Annette Boyle
No Comments
Abbott Laboratories received U.S. FDA approval for an expanded indication for its spinal cord stimulator (SCS) devices to include treatment of chronic back pain for individuals who have not had or are ineligible for back surgery. The FDA based its decision on the positive results from the DISTINCT study which showed that 85.2% of patients implanted with the SCS devices achieved significant reduction in back pain compared to 7.1% of those who received conservative medical management.
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