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Regulatory
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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
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
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
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
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
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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Elderly man with clenched hands holding head

US FDA approves Rexulti as first drug for agitation in Alzheimer’s dementia

May 16, 2023
By Tamra Sami and Karen Carey
On its May 10 PDUFA date, the U.S. FDA approved serotonin-dopamine modulator Rexulti (brexpiprazole) from Otsuka Pharmaceutical Co. Ltd. and H. Lundbeck A/S for agitation in Alzheimer’s dementia, marking the first approved treatment for the indication.
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BIO Korea 2023: Regulatory obstacles stall decentralized clinical trials in Korea

May 16, 2023
By Tamra Sami
Keeping patients at the center of clinical trials is how the global pharma industry views decentralized clinical trials, but bureaucratic red tape from multiple agencies is preventing companies from deploying decentralized trials in South Korea, speakers said during the BIO Korea 2023 conference in Seoul on May 11.
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Woman cooling off in front of fan

Nothing flashy: FDA approves Astellas’ menopause drug

May 16, 2023
By Lee Landenberger
The U.S. FDA has approved a non-hormonal treatment from Astellas Pharma Inc. to reduce the number and severity of hot flashes. Veozah (fezolinetant), an oral, once-daily compound that targets the neurokinin-3 (NK3) receptor, is approved for treating moderate to severe vasomotor symptoms due to menopause. It’s the first NK3 receptor antagonist the FDA has greenlighted for the indication. The approval came on May 12, well before its May 22 PDUFA date. The PDUFA date was originally set for Feb. 22 but the FDA extended it, saying it needed more time to complete the NDA’s priority review. Veozah’s wholesale acquisition cost is $550 for a month’s supply and should be available by early June.
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HTIT oral insulin capsule

HTIT expects to obtain China’s first oral insulin approval

May 16, 2023
By Doris Yu
Hefei Tianhui Incubator of Technologies Co. Ltd. (HTIT)’s NDA for recombinant human insulin capsule ORMD-0801 for type 2 diabetes is under review by the NMPA and, if approved, is expected to be the first oral insulin available in China, where regulators have been on the lookout for new treatment options for the increasingly common disease.
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