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BioWorld - Saturday, May 10, 2025
Home » Authors » Randy Osborne

Randy Osborne

Articles

ARTICLES

Xeris room enough? Lilly trying easier glucagon too; both struck by FDA delays

June 10, 2019
By Randy Osborne
Xeris Pharmaceuticals Inc. CEO Paul Edick said a fourth-quarter launch of Gvoke (ready-to-use glucagon injection) for severe hypoglycemia is "still doable. Is it now a tad more of a stretch? Yes." His remarks came as investors learned that the PDUFA date for the injector pen has been pushed back by three months, putting the new decision time for the severe hypoglycemia treatment at Sept. 10, 2019.
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Lack the knife: Liver mets in CRC submit just as well to laparoscopic procedure

June 5, 2019
By Randy Osborne

Lack the knife: Liver mets in CRC submit just as well to laparoscopic procedure

June 5, 2019
By Randy Osborne
CHICAGO – Though it's not optimal in some other cancer types (such as pancreatic and cervical), the minimally invasive method of laparoscopic surgery in colorectal cancer (CRC) with liver metastases vs. the more dramatic "open" surgery leads to the same rate of survival. That's according to findings unwrapped at the American Society of Clinical Oncology (ASCO) annual meeting, where attendees heard results from the randomized study called Oslo-Comet determining that patients lived more than 6.5 years after surgery, regardless of whether it was laparoscopic or open.
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Response rates questioned but sex harassment survey starts crucial conversation

June 5, 2019
By Randy Osborne
CHICAGO – On its last full day, the American Society of Clinical Oncology (ASCO) annual meeting continued to feature abstracts related less to drug development than to social issues, as lead study author Marina Stasenko, of the Memorial Sloan Kettering Cancer Center in New York, offered details of a survey that found 64% of gynecological oncologists experienced sexual harassment in training or practice. Among women, the rate was 71% and among men 51%, but only 10% reported their incidents to officials. Women were more likely than men to respond that gender affected career advancement (34% vs. 10%) and played a role in setting their salary (42% vs. 6%).
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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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