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BioWorld - Sunday, May 3, 2026
Home » Authors » Randy Osborne

Articles by Randy Osborne

Hail fellow well Enzamet: Xtandi shines, with J&J's Erleada drawing eyes, too

June 4, 2019
By Randy Osborne
An appreciative audience at the American Society of Clinical Oncology (ASCO) heard details of two important prostate cancer trials, including an interim analysis of the international randomized, phase III Enzamet study finding that 80% of men with metastatic hormone-sensitive prostate cancer (mHSPC) were alive after three years when given the non-steroidal anti-androgen (NSAA) drug Xtandi (enzalutamide) from New York-based Pfizer Inc. and Astellas Pharma Inc., of Tokyo, along with standard of care therapy. That number compared with 72% of men who received other NSAAs along with the typical treatment.
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Kisqali rally: Monaleesa younger-women benefit spotlights CDK 4/6 class

June 4, 2019
By Randy Osborne
CHICAGO – A crowded briefing session at the American Society of Clinical Oncology (ASCO) annual meeting heard society expert Harold Burstein declare that the "golden age" of cancer research is continuing with data from the phase III trial called Monaleesa-7 with Kisqali (ribociclib, Novartis AG).
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Studies on care imbalance escort ACA to center stage; 'hard to imagine' imagined

June 4, 2019
By Randy Osborne
CHICAGO – With three featured abstracts that dealt with studies of socioeconomic disparities in access to medical help, as well as proof of boons conferred by the Affordable Care Act (ACA), panel members at the American Society of Clinical Oncology (ASCO) annual meeting found themselves in uncommonly delicate territory.
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Gathering round the FIHR: Will record keepers warm to new MCODE standards?

June 4, 2019
By Randy Osborne
CHICAGO – On the opening day of the American Society of Clinical Oncology (ASCO) annual meeting, the group's president Monica Bertagnolli unveiled the first standards of the Minimal Common Oncology Data Elements (MCODE) project, a cooperative venture to make uniform the methods of data sharing and thereby bring clinicians "one step closer to the real goal of learning from every patient with cancer."
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Herpes cross-out forgiven, investors back to Genocea; cancer vaccine persuasive

June 4, 2019
By Randy Osborne
CHICAGO – Word from Genocea Biosciences Inc. of success with part A of its ongoing phase I/IIa trial testing the neoantigen vaccine candidate GEN-009 rolled out at the American Society of Clinical Oncology (ASCO) annual meeting and pushed shares (NASDAQ: GNCA) up 19.6%, or $1.10, to trade this afternoon at $6.71, after rising as high as $11.28.
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Don't fence me out: Trials in lung cancer should ease sign-up criteria, study says

June 4, 2019
By Randy Osborne
CHICAGO – Problems for researchers in enrolling lung cancer studies, as well as the woes felt by patients trying to gain entry so they can try prospective new drugs, could largely go away if investigators adopt eligibility criteria backed by work detailed at the American Society of Clinical Oncology (ASCO) meeting.
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On the EVe of big change in urothelial, Seagen ADC nets response rate of 44%

June 4, 2019
By Randy Osborne
CHICAGO – Seattle Genetics Inc. (Seagen) and Tokyo-based partner Astellas Pharma Inc. saw their antibody-drug conjugate (ADC) enfortumab vedotin (EV) highlighted at the American Society of Clinical Oncology (ASCO) annual meeting by way of the abstract for data from a single-arm phase II trial in 125 patients with locally advanced or metastatic urothelial cancer.
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Lung story short: Merck's Keytruda guts, glory story offers hope on two fronts

June 4, 2019
By Randy Osborne
CHICAGO – Merck & Co. Inc.'s Keytruda (pembrolizumab) gained still more laurels at the American Society of Clinical Oncology (ASCO) meeting, where attendees learned of two victorious experiments with the anti-PD-1 immunotherapy.
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Keep Kalm and Cara on: Second phase III data due later this year, then NDA submission

May 30, 2019
By Randy Osborne
"We're running as fast as we can to look at other populations," said Cara Therapeutics Inc. CEO Derek Chalmers after the company disclosed positive top-line data from the pivotal phase III trial called Kalm-1 with Korsuva (CR-845/difelikefalin) for injection in hemodialysis (HD) patients with moderate to severe chronic kidney disease (CKD)-associated pruritus (CKD-aP).
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Going all the way, NMDA work sped up as chances weighed for big players

May 24, 2019
By Randy Osborne
Word from the FDA to Axsome Therapeutics Inc. about the effort with its oral N-methyl-D-aspartate (NMDA) receptor antagonist, AXS-05, in depression – and the company's accelerated push with the compound – had Wall Street watching the NMDA space with even more interest than usual.
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