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BioWorld - Monday, December 22, 2025
Home » Authors » Randy Osborne

Articles by Randy Osborne

FDA clears Kala DED therapy; stock sinks as payer, pandemic concerns aired

Oct. 27, 2020
By Randy Osborne
Kala Pharmaceuticals Inc.’s anticipated win with Eysuvis (loteprednol etabonate ophthalmic suspension) 0.25% for the short-term (up to two weeks) treatment of the signs and symptoms of dry eye disease (DED) didn’t help shares (NASDAQ:KALA), which closed Oct. 27 at $6.28, down $1.44, or 18.7%, on word of the FDA approval.
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Fee FAAH fo’ Springworks as $410M Jazz deal proves mechanism no has-bean

Oct. 26, 2020
By Randy Osborne
The fatty acid amide hydrolase (FAAH) inhibitor space may seem, in the words of one analyst, “historically a graveyard,” but that didn’t keep Jazz Pharmaceuticals plc from buying Springworks Therapeutics Inc.’s program with a plan to take aim first at post-traumatic stress disorder (PTSD) and associated symptoms.
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M&A cityscape

Not-little Orphan ante, more HCU Warbucks ahead in $517M Retrophin deal

Oct. 23, 2020
By Randy Osborne
CEO Eric Dube said Retrophin Inc. will “share more [about clinical development plans] once the deal has closed” in the fourth quarter of this year and Orphan Technologies Ltd. belongs to his firm, which has seen only animal data so far with OT-58, an enzyme replacement therapy (ERT) for classical homocystinuria (HCU).
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Hospital patient wearing pulse oximeter

As WHO findings disappoint, COVID-19 developers stand in Solidarity

Oct. 20, 2020
By Randy Osborne
The large-scale failure of a handful of drugs repurposed for COVID-19 hasn’t slowed efforts to find existing – and new – therapies as well as vaccines that can fight the pandemic, with research updates continuing to roll out.
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Redeeming qualities in PTSD phase II – for Aptinyx shares, too

Oct. 20, 2020
By Randy Osborne
Aptinyx Inc. CEO Norbert Riedel said the design is unclear of the pivotal trial due next year with the N-methyl-D-aspartate (NMDA) receptor modulator NYX-783 in post-traumatic stress disorder (PTSD), as fine points must be hashed out with the FDA.
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Nectin-4 case built for two? Bicycle puts pedal to the mettle

Oct. 19, 2020
By Randy Osborne
Cambridge, U.K.-based Bicycle Therapeutics plc’s phase I dosing about a month ago of its first patient with nectin-4-targeting BT-8009 put the company on the road to hoped-for success by pursuing the same mechanism of action as Padcev (enfortumab vedotin-ejfv), the antibody-drug conjugate (ADC) from Astellas Pharma Inc. and Seagen Inc.
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Hospital patient wearing pulse oximeter

As WHO findings disappoint, COVID-19 developers stand in Solidarity

Oct. 16, 2020
By Randy Osborne
The large-scale failure of a handful of drugs repurposed for COVID-19 hasn’t slowed efforts to find existing – and new – therapies as well as vaccines that can fight the pandemic, with research updates continuing to roll out.
Read More

Large COVID-19 Solidarity study finds repurposed drugs don’t work

Oct. 16, 2020
By Randy Osborne
Brain with puzzle piece removed

Anavex reaches pivot(al) point with sigma-1 program in PDD

Oct. 15, 2020
By Randy Osborne
CEO Christopher Missling said New York-based Anavex Life Sciences Corp. is still deciding on the dose for the pivotal study with Anavex2-73 (blarcamesine) in Parkinson’s disease dementia (PDD), and called the phase II findings “just the first data run,” about which the firm “wanted to immediately inform shareholders.”
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SCD bid kaput, Cyclerion pedals forth with sGC approach in CNS

Oct. 14, 2020
By Randy Osborne
Cyclerion Therapeutics Inc.’s phase II blowup with sickle cell disease (SCD) candidate olinciguat ended its development, and attention turned to the Cambridge, Mass.-based firm’s earlier-stage effort with IW-6463, a drug in the same class for central nervous system (CNS) disorders.
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