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Home » Authors » Randy Osborne

Randy Osborne

Articles

ARTICLES

Dosey-dough? Wave stumbles vs. Ionis/Roche in HD dance but new 32-mg cohort could unlock gold

Dec. 30, 2019
By Randy Osborne
Shares of Cambridge, Mass.-based Wave Life Sciences Ltd. (NASDAQ:WVE) lost 49.5% of their value, or $7.82, to close at $7.99 as investors learned of top-line data from the ongoing phase Ib/IIa Precision HD2 trial testing WVE-120102 in Huntington’s disease. 
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Hand adding piece to puzzle

ConvertibleCARs ACCELerate with Astellas’ takeover of Xyphos; ‘tonneau’ potential in new approach?

Dec. 27, 2019
By Randy Osborne
Astellas Pharma Inc.’s early 2018 buyout of Universal Cells Inc. (UC) may have laid the groundwork for longer-range steps in allogeneic CAR T-cell therapy, but Xyphos Biosciences Inc. CEO James Knighton told BioWorld that the buyout of his firm provides the Tokyo-based giant for now with “an incredibly elegant solution that has tremendous potential.”
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Audentes encore: Astellas plunks $120M to scoop up Xyphos in I-O deal worth up to $665M

Dec. 27, 2019
By Randy Osborne

MUM’s the word, but win by Ideaya portending strategy that’s no secret

Dec. 24, 2019
By Randy Osborne
Unveiled by Oxfordshire, U.K.-based Immunocore Ltd. at the November meeting of the Society for Immunotherapy of Cancer (SITC) in National Harbor, Md., were encouraging new findings from the phase I/II study with tebentafusp (also known as IMC-gp100), a bispecific protein in the pivotal works for metastatic uveal melanoma (MUM). The results showed a correlation between treatment-induced immune response and improvement in overall survival (OS) and tumor shrinkage in advanced uveal as well as cutaneous melanoma.
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Cancer cell

Taz-mania: Devil in details as Epizyme adcom votes ES yes 11-0 but wants more data

Dec. 18, 2019
By Randy Osborne
Though they made known their reservations about the patient sample size and queried front-line vs. second-line use of tazemetostat, members of the FDA’s Oncologic Drugs Advisory Committee (ODAC) voted 11-0 to recommend approval of the oral, first-in-class EZH2 inhibitor from Cambridge, Mass.-based Epizyme Inc.
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Lungs

What’s afta Trikafta? Proteostasis on the skids as phase II in CF ‘underwhelms’

Dec. 17, 2019
By Randy Osborne
Proteostasis Therapeutics Inc. CEO Meenu Chhabra pointed to a “new reality in cystic fibrosis [CF] research” faced by her firm and others: the challenge of enrolling the best patients.
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"Major depressive disorder" book, medical chart

Gemini Ascendant: Axsome questions, get good phase III answers in MDD

Dec. 16, 2019
By Randy Osborne
Fueled by new positive data, Axsome Therapeutics Inc. plans to seek approval during the second half of 2020 for its dextromethorphan/bupropion modulated delivery tablet, AXS-05, an oral NMDA receptor antagonist to treat major depressive disorder.
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Face with digital focus on eye

TED talk: Briefing docs, buzz presage fairly smooth adcom on Horizon

Dec. 12, 2019
By Randy Osborne
Hitches for Horizon Pharma plc seem unlikely in the upcoming FDA advisory panel to mull the BLA for teprotumumab in thyroid eye disease (TED), though regulators did take issue with the clinical activity score (CAS) as calculated by the company.
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Abdominal snowman melts for Iterum but proposition solid with sulopenem in UTI

Dec. 11, 2019
By Randy Osborne
Shares of Iterum Therapeutics plc (NASDAQ:ITRM) slid 36%, or $1.73, to close at $3.12 after the Dublin-based firm disclosed the much-anticipated but less-than-stellar results from the phase III trial called Sulopenem for Resistant Enterobacteriaceae, or SURE 3, testing oral and I.V. versions of the drug in complicated intra-abdominal infections (cIAI).
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Equillium tell: Fast track for itolizumab shows FDA faith that CD6 targeter could hit mark in lupus nephritis

Dec. 10, 2019
By Randy Osborne
Shares of Equillium Inc. (NASDAQ:EQ) closed at $4.75, up 69 cents, or 17%, after trading as high as $5.25 as Wall Street hailed the FDA’s granting of fast track status to itolizumab – the first clinical-stage anti-CD6 therapy – for the treatment of lupus nephritis (LN). 
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View All Articles by Randy Osborne

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