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BioWorld - Sunday, December 14, 2025
Home » Topics » Clinical

Clinical
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Biodegradable polymer stents show well in study against durable polymers

Jan. 7, 2020
By Mark McCarty
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
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
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
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
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
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
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
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
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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Check-Cap-12-31

Check-Cap’s prep-free colon cancer screening pill hits endpoints in U.S. pilot study

Dec. 31, 2019
By Meg Bryant
Check-Cap Ltd., of Isfiya, Israel, reported positive results from a U.S. pilot study of its C-Scan System, a preparation-free, ingestible scanning capsule-based technology aimed at preventing colorectal cancer (CRC) through early detection of precancerous polyps. The company is currently preparing an IDE submission with the U.S. FDA and plans to launch a pivotal clinical trial in late 2020.
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