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BioWorld - Wednesday, May 6, 2026
Home » Authors » Randy Osborne

Articles by Randy Osborne

Geron no mo': J&J gallops from imetelstat tie-up but phase III vision quest lives

Sep. 28, 2018
By Randy Osborne
Geron Corp.'s shares took a major hit as Johnson & Johnson unit Janssen Biotech Inc. ended their collaboration and license deal, leaving the telomerase inhibitor imetelstat to go it alone into the upcoming phase III trial.
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Bi-cycling in rare disease: Acer's candidate looking to grab Ravicti pie share

Sep. 28, 2018
By Randy Osborne
Gearing up for an NDA filing for selective adrenergic modulator Edsivo (celiprolol) in vascular Ehlers-Danlos syndrome (vEDS), Acer Therapeutics Inc. has begun drawing attention for another candidate in the pipeline: ACER-001 in urea cycle disorder (UCD), where company-watchers are placing bets on its odds of taking market share from the only approved therapy in the space, Ravicti (glycerol phenylbutyrate), from Horizon Pharma plc.
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Wall Street's RASP gasp hails spect-ocular result in Aldeyra DED phase IIb

Sep. 27, 2018
By Randy Osborne
With its reactive aldehyde species (RASP) inhibitor reproxalap a winner in phase IIb results against dry eye disease (DED) and already undergoing study at the phase III stage in allergic conjunctivitis (AC), Aldeyra Therapeutics Inc. might be able to pull off a dual NDA submission.
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Thinking outside the box: Copiktra proviso chagrins investors but not analysts

Sep. 26, 2018
By Randy Osborne
Wall Street apparently wasn't much pleased with the boxed warning on Verastem Inc.'s first approved product, trimming shares (NASDAQ:VSTM) by 19.6 percent, or $1.74, so they closed Tuesday at $7.15, even though analysts pointed out that the side effects with Copiktra (duvelisib) can be handled by doctors.
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Amarin aces MACE, plans sales force hike to match new demand for Vascepa

Sep. 25, 2018
By Randy Osborne
Investors will have to wait until November to find out the details of Amarin Corp. plc's cardiovascular (CV) outcomes trial with Vascepa, but Wall Street heard enough Monday to increase the share value of the Dublin-based company by 315 percent, or $9.41, closing at $12.40.
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Nailing colors to the mast: Deciphera girds for battle, goes 'Rydapt' to finish line

Sep. 24, 2018
By Randy Osborne
With Blueprint Medicines Corp. due to start screening patients soon for the phase II Pathfinder trial that will test avapritinib in systemic mastocytosis (SM), investors are weighing the chances of several players in the disease and mulling how success might most rightly be judged.
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Tight genes may fit AMD; Adverum to zip up market via new vector approach?

Sep. 21, 2018
By Randy Osborne
This summer, Adverum Biotechnologies Inc. drew Wall Street's eyeballs to a potential gene therapy for wet age-related macular degeneration (AMD) when the company made known that its IND had become active for ADVM-022 (AAV.7m8-aflibercept).
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PD PDUFA stammer: FDA wants more time to mull Acorda's Inbrija package

Sep. 14, 2018
By Randy Osborne
Days after a court decision torpedoed four patents protecting Acorda Therapeutics Inc.'s Ampyra (dalfampridine) – clearing the way for generic versions of the only drug approved in the U.S. for improving walking in people with multiple sclerosis – the company learned that the FDA has extended the PDUFA date for its NDA related to Inbrija (levodopa inhalation powder) to treat off-period symptoms in people with Parkinson's disease (PD) on a carbidopa/levodopa regimen.
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Romancing the zone: Bids for China partners likened to amour, deals heating up

Sep. 12, 2018
By Randy Osborne
BOSTON – To explain best practice in making cross-border investments, especially those in China, Biopharm America panelists quickly seized upon the metaphor of groping to form a romantic relationship.
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Pfizer catalyzer? Pharma VC board seat more good than bad, 'firsthand look'

Sep. 10, 2018
By Randy Osborne
BOSTON – During a panel talk at Biopharm America on how collaborations between pharmaceutical firms and venture capital (VC) are changing the industry, New York-based Pfizer Inc.'s Anthony Berry said that "oftentimes we might look to join [as a limited partner (LP)] in a fund that might have a specific niche or opportunity" representing "a complement to what we're doing, not necessarily in direct competition with something we might be doing on our own." Such moves "certainly help us get a firsthand look at those companies from a different perspective than just being shopped around from the outside."
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