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BioWorld - Sunday, May 31, 2026
Home » Topics » Clinical

Clinical
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Mycovia antifungal poised for NDA filing after phase III wins

Jan. 6, 2021
By Michael Fitzhugh
Mycovia Pharmaceuticals Inc. said new phase III data on its oral antifungal, oteseconazole, showed that 37 weeks after women with a history of recurrent vulvovaginal candidiasis received a dose of the medicine for an episode of acute yeast infection, just 5.1% saw a recurrence of infection vs. 42.2% of those treated with fluconazole. Furthermore, oteseconazole proved noninferior to fluconazole in the resolution of symptoms at day 14 of the study.
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Sickle cells

Imara wraps up a phase IIa in sickle cell with mixed results

Jan. 6, 2021
By Lee Landenberger
Imara Inc. reported a mixed bag of phase IIa study data for its lead candidate, IMR-687, for treating sickle cell disease in adults, bringing an end to a study that the company found cumbersome and that eventually stung its stock.
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In the clinic for Jan. 6, 2021

Jan. 6, 2021
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Creative Medical, Erasca, Imara, Infinity, Inovio, Millendo, Mycovia, Ocuphire, Regenxbio, Seres, Vir, Windtree, Zentalis.
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Vaccination

China's CNBG/Sinopharm COVID-19 vaccine is 79% effective

Jan. 5, 2021
By Elise Mak and Gina Lee
HONG KONG – China National Biotec Group (CNBG) said that BBIBP-CorV, one of the two COVID-19 vaccines it currently has under development, provides 79.34% protection against the coronavirus.
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Inserting cartridge into Lightdeck

Brainbox heads into pivotal trial of concussion diagnostic test with $23M in new funding

Jan. 5, 2021
By Annette Boyle
A new $23 million in funds gives Brainbox Solutions Inc. a head start as it begins enrollment in the pivotal clinical trial of its mild traumatic brain injury (TBI) diagnostic and prognostic test. Bioventures Investors took the lead in the series A financing. The Tauber Foundation, the Virginia Tech Carilion Innovation and Seed Funds, Genoa VC, Pharmakon Holdings LLC, and Astia Angels participated in the fundraising round along with qualified investors including the Cleveland Cavaliers' Kevin Love, a mental health advocate.
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Emboliner in glass arch

Emboline scoops up $10M in series C funding

Jan. 5, 2021
By Meg Bryant
Emboline Inc., which is developing technology to reduce the chance of stroke during transcatheter heart procedures, completed a $10 million series C financing. The funds are earmarked to gain initial commercial approval of the company’s Emboliner device and to launch a U.S. pivotal study. The round, which included new and existing investors, follows a $5 million bridge round of financing that closed last January.
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PS, it works: Atyr, Cerecor add to COVID-19 treatment data

Jan. 5, 2021
By Randy Osborne
COVID-19 vaccines have taken most of the limelight lately, but therapies are making progress, too, with San Diego-based Atyr Pharma Inc. and Cerecor Inc., of Rockville, Md., separately offering favorable phase II news.
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In the clinic for Jan. 5, 2021

Jan. 5, 2021
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Abbvie, Aeglea, Arch, Asclepix, Atyr, Bioxcel, Cerecor, Chemomab, Cyclo, Destiny, Genmab, Ideaya, Inflarx, Inhibrx, Metacrine, Ocuphire, Replimune, Sanbio.
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Calithera's phase II Cantata trial ends in discord

Jan. 4, 2021
By Michael Fitzhugh
A metastatic renal cell carcinoma (RCC) trial once expected to pave a path to registration for the Calithera Biosciences Inc. candidate telaglenastat failed to show a benefit from the drug in a new analysis of the pivotal phase II study, Cantata. While company executives voiced confidence in the drug's prospects in another indication, non-small-cell lung cancer (NSCLC), analyst and investor faith appeared less sturdy, as company shares (NASDAQ:CALA) fell 44.6% to $2.72 on Jan. 4.
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Oh say, can you ADC? Dawn’s early light in the past for burgeoning sector

Jan. 4, 2021
By Randy Osborne
Sutro Biopharma Inc.’s stock-perking news in early December with STRO-002, a folate receptor alpha-targeting antibody-drug conjugate (ADC) to treat ovarian cancer, reminded investors of potential in the class, which has been more than realized in recent years and could yield more upside in the near term. As of the Oct. 30 cutoff date, STRO-002 tallied one complete response and nine partial responses in the challenging indication, which works out to an overall response rate of 32% (10 out of 31) in evaluable patients.
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