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BioWorld - Sunday, May 22, 2022
Home » Topics » Clinical

Clinical
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Galactose skeletal formula

Agent 007’s efficacy in galactosemia no secret; ATI Bond for meeting with FDA

Jan. 8, 2020
By Randy Osborne
No Comments
Applied Therapeutics Inc. (ATI) CEO Shoshana Shendelman said positive top-line findings with aldose reductase inhibitor AT-007 in galactosemia were “the data we needed, and we’re going to move as quickly as we can to get in and speak to the FDA about this, not only to firm up our NDA filing but also to get into the pediatric study.”
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Biodegradable polymer stents show well in study against durable polymers

Jan. 7, 2020
By Mark McCarty
No Comments
While the disappearing drug-eluting stent seems to have faded from view for the time being, several manufacturers have invested in fabrication of drug-eluting stents with polymers that absorb once the drug of elution has done its work. A new study indicates that patients who have already had a myocardial infarction fare better on stents made with these biodegradable polymers, an outcome that may soon push second-generation DES devices into med-tech history.
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Jealous of Apellis? APL-2 strong vs. Soliris in PNH, but opinion split

Jan. 7, 2020
By Randy Osborne
No Comments
Apellis Pharmaceuticals Inc.’s CEO, Cedric Francois, said his firm’s phase III study called Pegasus testing pegcetacoplan, or APL-2, in paroxysmal nocturnal hemoglobinuria (PNH) “finally established that there is an important unmet medical need in this disease.”
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1-6-Saluda-Evoke.png

Saluda’s closed-loop SCS system continues to see positive results as company awaits word from FDA

Jan. 6, 2020
By Liz Hollis
No Comments
Saluda Medical Pty. Ltd., of Artarmon, Australia, made waves in 2019, winning the CE mark for its Evoke closed-loop spinal cord stimulation (SCS) system. The good news kept coming following the publication of results from a pivotal study in The Lancet Neurology.
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Test tubes, capsules, dropper

U.K. group issues CID trial recommendations to accelerate access to innovative drugs

Jan. 6, 2020
By Nuala Moran
No Comments
LONDON – A high level U.K. group, involving industry, academia, patients, health technology assessment and regulatory representatives, has set out guidelines for designing complex cancer trials and is calling for their rapid implementation to reduce clinical development timelines.
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Gravitas grounded?

Incyte's itacitinib fails phase III test against acute GVHD

Jan. 3, 2020
By Michael Fitzhugh
No Comments
A closely watched bid by Incyte Corp. to tackle acute graft-vs.-host-disease (GVHD) with the JAK1 inhibitor itacitinib has fallen flat in pivotal testing, leaving analysts skeptical about the drug's future and pessimistic about the company's R&D chops.
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Despite its phase III failure, Novan vows to forge on

Jan. 3, 2020
By Lee Landenberger
No Comments
While Novan Inc.’s phase III failure in treating molluscum contagiosum for patients ages 6 months and older battered its stock Friday, the company intends to take the positive data it gleaned to the FDA to discuss an NDA submission and a possible phase III trial for next year.  
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Gamida Cell closes in on phase III readout for blood cancer therapy

Jan. 2, 2020
By Michael Fitzhugh
No Comments
Nearly four years after its start, a phase III trial of Gamida Cell Ltd.'s ex vivo expanded cord blood candidate, omidubicel, for hematologic malignancies is fully enrolled, the company said.
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Skin irritation on hands

One down, two left: Durect discontinues developing DUR-928 to treat psoriasis

Jan. 2, 2020
By Lee Landenberger
No Comments
Earlier this week, Durect Corp.’s DUR-928 was being tested in three different indications. But by week’s end, it’s now down to two. 
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Satsuma seeds drug-device nasal combo that could juice migraine market

Jan. 2, 2020
By Randy Osborne
No Comments
With many on Wall Street transfixed by the three injectable calcitonin gene-related peptide (CGRP) therapies cleared in the prophylactic migraine market, Satsuma Pharmaceuticals Inc.’s prospects with STS-101 may have gone overlooked, at least until lately. 
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