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BioWorld - Thursday, January 15, 2026
Breaking News: BioWorld 2025 Year in ReviewBreaking News: BioWorld MedTech 2025 Year in ReviewBreaking News: Trump administration impacts continue to roil the life sciences sector
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BioWorld, Clinical
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Astrazeneca's Imfinzi stumbles in first-line bladder cancer trial

March 6, 2020
By Michael Fitzhugh
In a setback for Astrazeneca plc's plans to tackle previously untreated cases of advanced bladder cancer, neither its immune checkpoint inhibitor, Imfinzi (durvalumab), nor a pairing of it with the investigational drug tremelimumab beat standard-of-care (SOC) chemotherapy in improving overall survival (OS) during a phase III trial evaluating the treatments as first-line (1L) care for patients with advanced disease.
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Onzeald to potter’s field, Nektar bempeg plans revealed

March 6, 2020
By Randy Osborne
During its Feb. 27, 2020, conference call on the previous year’s fourth-quarter results – though not in a related press release – Nektar Therapeutics Inc. let news drop that the prospective breast cancer (BC) therapy Onzeald (etirinotecan pegol) for patients with brain metastases had failed in top-line phase III outcomes.
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Gene editing illustration

Editas, Allergan see first patient dosed with CRISPR candidate for LCA10

March 4, 2020
By Michael Fitzhugh
An experimental gene editing therapy for an inherited form of blindness has become the first in vivo CRISPR medicine to be administered to patients, according to Editas Medicine Inc. and its partner, Allergan plc, which licensed the candidate in 2018.
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Sihuan starts clinical trial of Ebola drug favipiravir for COVID-19

March 4, 2020
By Elise Mak
BEIJING – Beijing-based Sihuan Pharmaceutical Holdings Group Ltd. said it has initiated clinical trials of broad-spectrum antiviral favipiravir to treat COVID-19. China now has six clinical trials investigating the drug, originally developed for influenza and also tested against Ebola virus disease.
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Rays of light beaming from eye

After some trying times, AGTC ‘night star’ on the rise in XLRP and beyond

March 3, 2020
By Randy Osborne
Strongly favorable six-month data disclosed on Jan. 9 by Applied Genetic Technologies Corp. (AGTC) from its ongoing phase I/II program with an adeno-associated virus (AAV) gene therapy for X-linked retinitis pigmentosa (XLRP) did more than provide a whopping stock boost.


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Cool beans: Boston phase III exportin success to broader Xpovio label?

March 3, 2020
By Randy Osborne
With new phase III multiple myeloma (MM) data in hand from Newton, Mass.-based Karyopharm Therapeutics Inc.’s Xpovio (selinexor), Wall Street began speculating about what the results might mean in the marketplace.
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T cells

TIGIT-al camera snapshot shows cancer bids fill the frame

Feb. 27, 2020
By Randy Osborne
During a recent investor event related to early drug development, Basel, Switzerland-based Roche Holding AG touted research by the firm’s Genentech unit into the cancer target known as TIGIT, or T-cell immunoreceptor with Ig and ITIM domains, and the pharma giant is hardly alone in the sizzling space.
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Kadmon TCT data provide ‘Incyte,’ GVHD odds looking better

Feb. 27, 2020
By Randy Osborne
New York-based Kadmon Holdings Inc.’s recent oral late-breaker session on KD-025 in chronic graft-vs.-host disease (cGVHD) at the Transplantation & Cellular Therapy (TCT) meeting – along with data that rolled out from two studies testing competitor Jakafi (ruxolitinib) from Incyte Corp. – signaled potential advantages in the former’s candidate, already highly regarded.
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Menlo, Vanda see mixed results after missing primary endpoints in pruritus trials

Feb. 26, 2020
By Michael Fitzhugh
Readouts from two ambitious pruritus trials this week yielded starkly different reactions from investors seeking broader meaning in the outcomes.
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Architectural pillars

Judge orders HHS to fill 10-year data gap on Clinicaltrials.gov

Feb. 26, 2020
By Mari Serebrov
While the staff at the U.S. Department of Health and Human Services (HHS) is currently all hands-on-deck in responding to the COVID-19 outbreak, some of the agencies in the department may have to divert resources to get sponsors of drug and device clinical trials to fill in nearly a decade-long data gap on Clinicaltrials.gov. That’s if a judge’s decision handed down this week stands.
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