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BioWorld - Friday, April 3, 2026
Home » Topics » Clinical

Clinical
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A headache for Satsuma: Phase III results pose setback for acute migraine candidate

Sep. 10, 2020
By Michael Fitzhugh
A pivotal test of Satsuma Pharmaceuticals Inc.'s dry powder acute migraine candidate, STS-101, found neither of two doses evaluated met the co-primary endpoints, freeing people from pain or their most bothersome symptom two hours post-administration.
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Red blood cells

BETs favor Constellation phase III in MF despite cited Jakafi dosing hitch

Sep. 10, 2020
By Randy Osborne
As Constellation Pharmaceuticals Inc. gears up to start the pivotal phase III study of CPI-0610 in myelofibrosis (MF), Wall Street is mulling how likely are the stars to align for the Cambridge, Mass.-based company with its small-molecule inhibitor of bromodomain and extra-terminal (BET) proteins.
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Hanmi considers options with diabetes candidate efpeglenatide back in-house

Sep. 10, 2020
By David Ho and Gina Lee
HONG KONG – Sanofi SA has finally ended its clinical development of Hanmi Pharmaceutical Co. Ltd.’s efpeglenatide as a type 2 diabetes treatment, and the Korean firm is now considering how to move forward with developing the once-weekly GLP-1 receptor agonist, which employs Hanmi's Lapscovery delivery technology.
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In the clinic for Sept. 10, 2020

Sep. 10, 2020
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Anavex, Arbor, Astrazeneca, Avillion, Bayer, Biohaven, Boehringer Ingelheim, Corcept, Corvus, Diffusion, Forte, Gemini, Haliodx, Histogen, Imcheck, Ocular, Recce, Roche, Sanofi, Satsuma, Seneca, Sobi, Sutro, Takeda, Theratechnologies, VBL, Vertex, Zogenix.
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Phase III bipolar depression data buoy Intra-Cellular plans for sNDA

Sep. 9, 2020
By Michael Fitzhugh
Shares of Intra-Cellular Therapies Inc. (NASDAQ:ITCI) climbed 72.8% to $31.86 on Sept. 9 following news that its FDA-approved schizophrenia drug, Caplyta (lumateperone), could also help improve bipolar depression.
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Patient receiving vaccine

Astrazeneca coronavirus vaccine trial on hold after 'unexplained illness'

Sep. 9, 2020
By Michael Fitzhugh
A phase III trial of AZD-1222, an experimental coronavirus vaccine developed by Astrazeneca plc and Oxford University, has been paused due to an unexplained illness that occurred in the U.K., the company said on Sept. 8.
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Amryt shares jump on top-line phase III data in epidermolysis bullosa

Sep. 9, 2020
By Cormac Sheridan
DUBLIN – Shares in Amryt Pharma plc surged by more than 36% Sept. 9 on news that Filsuvez (AP-101, Oleogel-S10) attained the primary endpoint of a phase III trial in epidermolysis bullosa.
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In the clinic for Sept. 9, 2020

Sep. 9, 2020
Clinical updates, including trial initiations, enrollment status and data readouts and publications: AGTC, Alligator, Ampio, Amryt, Astrazeneca, Aztherapies, Brain Neurotherapy, Cellectar, Clearside, Enterome, Flexion, Intensity, Intra-Cellular, Leukemia & Lymphoma Society, Lipac, Merck, Myokardia, Neurosense, Octapharma, Regenxbio, Roche, Scholar Rock, Sinovac, Trillium, Viking.
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Sputnik V COVID-19 vaccine vials

Early clinical data illuminate Russia’s Sputnik V COVID-19 vaccine

Sep. 8, 2020
By Nuala Moran
LONDON – Results from two non-randomized phase I/II trials of the Russian COVID-19 vaccine Sputnik V that recently received conditional regulatory approval show both a frozen and a freeze-dried formulation of the two-shot vaccine had a good safety profile and induced antibody responses in all 76 participants within 21 days.
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3D heart in chest

All-in-one catheters reduce time, improve accuracy of cardiac procedures

Sep. 8, 2020
By Annette Boyle
New medical instruments with integrated soft electronics could improve diagnosis and treatment of cardiac conditions. The surgical tools use soft materials that conform to the body’s tissue and permit a single catheter to combine diagnostic and therapeutic functions while providing real-time feedback and electrophysiological information.
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