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BioWorld - Tuesday, July 7, 2026
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BioWorld, Clinical
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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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Immutep reports positive interim phase II results in Keytruda combo basket trial

Feb. 26, 2020
By Tamra Sami
PERTH, Australia – Sydney-based Immutep Ltd. reported positive interim data for its phase II basket trial in non-small-cell lung cancer (NSCLC) and head and neck squamous cell carcinoma for its lead immunotherapy in combination with Merck & Co. Inc.’s anti-PD-1 therapy, Keytruda (pembrolizumab).
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Shock away? Adrenomed’s adrecizumab hits phase II endpoint in septic shock

Feb. 26, 2020
By Cormac Sheridan
DUBLIN – Adrenomed AG disclosed Feb. 21 that its first-in-class antibody, adrecizumab, hit the primary safety and tolerability endpoint of a phase II trial in septic shock.
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IMV’s phase II ovarian cancer data trend positive while the stock reverses

Feb. 25, 2020
By Lee Landenberger
Updated results from IMV Inc.’s ongoing phase II trial of DPX-Survivac to treat advanced recurrent ovarian cancer show the company’s lead candidate was active and well-tolerated in patients.
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NGM studios’ top-line phase II NASH premiere whets appetite for Alpine 2/3 sequel

Feb. 24, 2020
By Randy Osborne
NGM Biopharmaceuticals Inc. wowed investors with positive preliminary top-line results from the 24-week double-blind, randomized, placebo-controlled fourth cohort of an adaptive phase II study testing aldafermin in nonalcoholic steatohepatitis (NASH).
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VMAT2 carry-through brings Waterloo for Austedo TS bid by Teva

Feb. 20, 2020
By Randy Osborne
Teva Pharmaceutical Industries Ltd.’s Austedo (deutetrabenazine) lived up to the lack of expectations in pediatric Tourette syndrome (TS), missing identical primary endpoints in a pair of late-stage trials.
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