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BioWorld - Tuesday, June 16, 2026
Home » Authors » Randy Osborne

Articles by Randy Osborne

Step aside, chemo: Merck NSCLC Keytruda outcome marks 'extraordinary' era

June 5, 2018
By Randy Osborne
CHICAGO – Speaking at the American Society of Clinical Oncology meeting, John Heymach of Houston's MD Anderson Cancer Center, called new phase III data with Merck & Co. Inc.'s Keytruda (pembrolizumab) "a double whammy" of upside for advanced non-small-cell lung cancer (NSCLC) patients: non-chemotherapy benefit with lower side effects. "An era in which chemotherapy was the only option for NSCLC patients has drawn to a close," he said.
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Abi darned: Data confirm Zytiga black-white effects, call for trial race inclusion

June 4, 2018
By Randy Osborne
CHICAGO – A call for trials more inclusive of racial and ethnic minorities opened the annual meeting of the American Society of Clinical Oncology (ASCO), as researchers unveiled the first prospective study of the hormonal therapy Zytiga (abiraterone) from Johnson & Johnson for advanced prostate cancer (PC) in black men vs. white men. Findings ratified what clinicians already had observed retrospectively: Black men respond better to the drug than white men.
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Stimulating ADHD results due soon from Kempharm as anti-abuse wagers pop

June 4, 2018
By Randy Osborne
After the approval by the FDA in February of Apadaz for short-term management of acute pain, eyes turned to Coralville, Iowa-based Kempharm Inc.'s partnering talks, which are expected to yield fruit by the year's end. (See BioWorld, Feb. 26, 2018.)
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Results send red flare-up in Clementia's FOP effort but analysts unbothered

May 29, 2018
By Randy Osborne
Excitement ran high last week – at the company, anyway – when Montreal-based Clementia Pharmaceuticals Inc. rolled out positive data from part B of its ongoing phase II trial testing palovarotene, a retinoic acid receptor gamma agonist, to treat the rare, life-threatening genetic bone disease called fibrodysplasia ossificans progressiva (FOP).
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Food-drug administration 'Blooms' into dual strategy for better odds of success

May 25, 2018
By Randy Osborne
A new understanding of how the almost 100-year-old ketogenic diet works to reduce seizures is guiding Bloom Science Inc. in its twin-pronged approach, which involves developing a medical food for epilepsy as well as an oral drug for orphan indications within the category.
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Endocyte wows with late, early stage cancer efforts targeting prostate, bone

May 23, 2018
By Randy Osborne
The phrase "game changer" in the context of prostate cancer seems like a bold claim, but at least one analyst sees that degree of potential for one of Endocyte Inc.'s pipeline candidates. But first, consider the West Lafayette, Ind.-based firm's chimeric antigen receptor T-cell (CAR T) effort, which drew attention at the American Association for Cancer Research (AACR) meeting last month in Chicago.
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To eclipse Relypsa? FDA's nod for Lokelma bringing pressure in hyperkalemia

May 22, 2018
By Randy Osborne
Astrazeneca plc's long-time-coming approval of Lokelma (sodium zirconium cyclosilicate) oral suspension for adults with hyperkalemia puts another weapon in the hands of doctors, and there's more coming down the pike, albeit far off.
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Protein diet: Aurinia lupus odds good, but don't overlook FSGS

May 21, 2018
By Randy Osborne
As Aurinia Pharmaceuticals Inc. marches ahead with the phase III trial testing what could become the first approved lupus nephritis (LN) therapy, company backers are watching with interest another, lesser known indication where the cyclosporine analogue voclosporin might also work: focal segmental glomerular sclerosis (FSGS), a glomerular disease that can cause nephrotic syndrome. A phase II experiment is slated to start next month. Both conditions involve high amounts of protein in the urine, or proteinuria.
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Post-Aimovig, CGRP space takes stock as three more line the migraine runway

May 21, 2018
By Randy Osborne
Amgen Inc. having scored the first of four expected approvals in the calcitonin gene-related peptide (CGRP) receptor class with Aimovig (erenumab) for preventing migraine, Wall Street set about handicapping odds for the others in a large market.
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Sweeter pH balance sheet aiding Onconano's efforts: $11.7M gained via series A

May 18, 2018
By Randy Osborne
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