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BioWorld - Thursday, June 30, 2022
Home » Topics » Clinical

Clinical
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Springworks preps nirogacestat for NDA on phase III desmoid tumor data

May 24, 2022
By Cormac Sheridan
No Comments
Springworks Therapeutics Inc. plans to file an NDA for its lead drug candidate, nirogacestat, for treating desmoid tumors later this year, as top-line data from a pivotal phase III trial indicate that it provided patients with a substantial progression-free survival benefit.
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Blister drug pack atop globe

‘East to West’ movement of trial data raising diversity, quality concerns

May 24, 2022
By Mari Serebrov
No Comments
Just in case the U.S. FDA didn’t get the message from its advisory committee about drug applications based solely on clinical trial data from China, a trio of U.S. lawmakers wrote to FDA Commissioner Robert Califf to voice their concerns about the “current ‘East to West’ movement of clinical data” to support the approval of me-too drugs.
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Stroke illustration: brain, artery, neurons

Athersys sees 'Treasure' in stroke data, despite trial's missed endpoint

May 24, 2022
By Michael Fitzhugh
No Comments
Shares of Athersys Inc. fell sharply May 20 after its partner and top investor Healios K.K. reported that Multistem (invimestrocel), the experimental cell therapy they've co-developed since 2016, missed the primary endpoint of a Japanese phase II/III ischemic stroke study called Treasure. Many Athersys investors appeared to read the results as bad news for Athersys' ongoing pivotal phase III stroke study, Masters-2.
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Blister drug pack atop globe

‘East to West’ movement of trial data raising diversity, quality concerns

May 23, 2022
By Mari Serebrov
No Comments
Just in case the U.S. FDA didn’t get the message from its advisory committee about drug applications based solely on clinical trial data from China, a trio of U.S. lawmakers wrote to FDA Commissioner Robert Califf to voice their concerns about the “current ‘East to West’ movement of clinical data” to support the approval of me-too drugs.
Read More

Concert builds toward grand finale as CTP-534 hits its mark in pivotal alopecia trial

May 23, 2022
By Cormac Sheridan
No Comments
Concert Pharmaceuticals Inc. is on track for an NDA filing for CTP-543 in alopecia areata during the first half of 2023, following a positive read-out from the first of two phase III trials of the oral Janus kinase 1/2 inhibitor. The molecule hit the primary endpoint of the placebo-controlled Thrive-AA1 study, which was defined as the percentage of patients achieving a SALT (Severity of Alopecia Assessment Tool) score of 20 or less after 24 weeks of therapy.
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Idorsia gears up to file hypertension drug after supportive phase III readout

May 23, 2022
By Richard Staines
No Comments
Idorsia Ltd. looks on course to produce another marketed drug after supportive phase III results for its hypertension drug, aprocitentan. The company’s first U.S. FDA-approved drug, Quviviq (daridorexant), was launched in April and another product, Pivlaz (clazosentan), was approved and launched in April for cerebral vasospasm in Japan.
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Presentation on the EuroPCR 2022 main stage
EuroPCR

Medtronic touts data for Resolute Onyx, Picardia data indicates TAVR shortcut

May 20, 2022
By Catherine Longworth
No Comments
Following last week’s FDA approval of its Onyx Frontier drug eluting stent (DES), Medtronic plc released results at EuroPCR from a real-world, multicenter prospective study using its Resolute Onyx platform for percutaneous coronary interventions (PCI) in the left main artery. Rehovot, Israel-based Pi-Cardia Ltd. also released early data for patients treated with its Short Cut transcatheter device for coronary obstruction prevention.
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Foghorn’s phase I in AML on a partial clinical hold

May 20, 2022
By Lee Landenberger
No Comments
In the wake of a patient’s death, the U.S. FDA has placed a partial clinical hold on Foghorn Therapeutics Inc.’s phase I study of FHD-286 in treating relapsed and/or refractory acute myelogenous leukemia (r/r AML) and myelodysplastic syndrome.
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Athersys sees 'Treasure' in stroke data, despite trial's missed endpoint

May 20, 2022
By Michael Fitzhugh
No Comments
Shares of Athersys Inc. fell sharply May 20 after its partner and top investor Healios K.K. reported that Multistem (invimestrocel), the experimental cell therapy they've co-developed since 2016, missed the primary endpoint of a Japanese phase II/III ischemic stroke study called Treasure.
Read More
EuroPCR

1-year data for next-generation Navitor valve shows improved AS outcomes

May 19, 2022
By Catherine Longworth
No Comments
Abbott Laboratories Inc. presented one-year outcomes from its PORTICO NG study assessing the latest-generation transcatheter aortic valve implantation (TAVI) system, Navitor in patients with severe aortic stenosis. The valve, which includes a new active sealing cuff, builds on the company’s Portico transcatheter heart valve platform.
Read More
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