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BioWorld - Saturday, February 7, 2026
Home » Topics » Clinical

Clinical
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Brain teaser

Lilly shares leap on phase II Alzheimer's disease data

Jan. 11, 2021
By Michael Fitzhugh
Shares of Eli Lilly and Co. (NYSE:LLY) leapt 11.7% to $185.94, their second biggest gain since 2010, after a phase II trial showed its beta-amyloid-targeting monoclonal antibody, donanemab, appeared to slow by 32% decline in a composite measure of cognition and daily function in patients with early symptomatic Alzheimer’s disease vs. placebo.
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Mosaico team in Mexico City

First-ever phase III trials of HIV vaccine in Latin America

Jan. 11, 2021
By Sergio Held
CAJICA, Colombia – A phase III trial for an HIV vaccine developed Janssen Vaccines & Prevention BV is finally moving forward in Latin America and elsewhere in the world after a delay of more than a year caused by slow regulatory progress and worsened by a string of COVID-19 lockdowns.
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Ascentage’s New Year’s resolution includes getting its first candidate to market

Jan. 11, 2021
By Gina Lee
HONG KONG – Tapping into synergies it sees between the U.S. and Chinese biotech industries, Suzhou, China-based Ascentage Pharma Group Corp. Ltd. is aiming to get its most advanced candidate, HQP-1351 (olverembatinib dimesylate) to market this year for patients with TKI-resistant chronic myeloid leukemia.
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In the clinic for Jan. 11, 2021

Jan. 11, 2021
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Adverum, Aptevo, Aslan, Biomarin, Can-Fite, Cara, Celon, Codagenix, Dalcor, Dr. Reddy's, Edesa, Inflarx, Jupiter Orphan, Kintor, Lilly, Mediwound, Mesoblast, Neurorx, Oric, Redhill, Relief, Ultimovacs.
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3D heart in chest

Registry study offers no help to SAVR for valve-in-valve aortic stenosis patients

Jan. 8, 2021
By Mark McCarty
Much of the noise surrounding transcatheter aortic valve replacement (TAVR) vs. its surgical counterpart has to do with residual paravalvular leak. However, a new paper in the Journal of the American College of Cardiology (JACC) seems to have overwritten that consideration. The underlying registry study indicates that procedural success and outcomes at one year are superior in TAVR to in SAVR – yet another piece of evidence that seemingly tips the scales even more toward TAVR devices.
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Doctor examining child in wheelchair

Sarepta DMD phase II hangs in ‘balance’ as disparity in North Star leads astray

Jan. 8, 2021
By Randy Osborne
Sarepta Therapeutics Inc.’s miss on a key phase II ambulatory endpoint in its Duchenne muscular dystrophy (DMD) trial may have been caused by a dramatic disparity in functional ability at baseline among older vs. younger patients afflicted with the progressively worsening disorder. In any case, Wall Street had knives out, carving 51% of the value away from shares (NASDAQ:SRPT) of the Cambridge, Mass.-based firm, which closed at $82.29, a loss of $86.66, or 51%.
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In the clinic for Jan. 8, 2021

Jan. 8, 2021
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Biogen, Can-Fite, Denovo, Dynavax, Dermbiont, Felix, Gradalis, Graybug, Inmed, Immutep, Leading Bio, Northsea, Oncosec, Prilenia, Proqr, Remd, Rhovac, Sarepta, Translate Bio, Ultragenyx.
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Silhouette of person walking with a cane

Chariot to admire: Alnylam finds place in sun with Helios-A phase III

Jan. 7, 2021
By Randy Osborne
Alnylam Pharmaceuticals Inc. said the 164-patient Helios-A phase III study with next-generation RNAi drug vutrisiran hit its primary endpoint as well as both secondary goals in the treatment of hereditary transthyretin-mediated amyloidosis with polyneuropathy. The primary endpoint was change from baseline in the modified Neuropathy Impairment Score at nine months as compared to historical placebo data from the Apollo phase III study of Alnylam’s Onpattro, cleared by the FDA for ATTR polyneuropathy in August 2018.
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RoActemra

Further data show IL-6 inhibitors may provide COVID-19 benefit after all

Jan. 7, 2021
By Nuala Moran
LONDON – The U.K. is to make treatment with interleukin-6 (IL-6) inhibitors standard of care for critically ill COVID-19 patients after a randomized trial found the arthritis drugs significantly improve survival.
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Coronavac press conference in Brazil
Optimism in Brazil

Sinovac’s COVID-19 vaccine more than 78% effective in Brazil trials

Jan. 7, 2021
By Sergio Held
CAJICA, Colombia – Brazil's Butantan Institute and the government of the state of Sao Paulo released efficacy results on Jan. 7 for Coronavac, developed by China’s Sinovac Biotech Ltd., that suggest the COVID-19 vaccine is more than 78% effective.
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