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Home » Authors » Randy Osborne

Articles by Randy Osborne

Roche joins Alexion, Viela in NMOSD market with Enspryng approval

Aug. 17, 2020
By Randy Osborne
Rays of light beaming from eye

Delivering the goods: Regenxbio, Adverum explore alternate routes in AMD

Aug. 14, 2020
By Randy Osborne
Earlier this month, an update on phase I/IIa data rolled out from Rockville, Md.-based Regenxbio Inc. with RGX-314 for age-related wet macular degeneration (AMD). The company has a pivotal program in subretinal delivery of the compound set to start by the end of this year, and questions about routes of administration – always an issue in AMD – continue to simmer.
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Stock chart, compass

‘Bearing’ down: With the NRF2 persist after dicey FDA updates, Reata well enough left -olone?

Aug. 12, 2020
By Randy Osborne
Wall Street dinged Reata Pharmaceuticals Inc. earlier this week after mixed regulatory news on the nuclear factor erythroid-2 related factor 2 (NRF2) activators omaveloxolone for Friedreich’s ataxia (FA) and bardoxolone for Alport syndrome (AS), but the Plano, Texas-based firm stayed resolute, and its recent deal with Blackstone Life Sciences (BXLS) provides cause for optimism. Increased clarity on paths forward “debunks the bear-case view” of Reata, in the opinion of Jefferies analyst Maury Raycroft, who went as far as to say in a report that the stock “overreaction create[d] a buying opportunity.”
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Amyloid plaque on nerve cell

Yes we aducanumab? Biogen/Eisai AD bid gains traction, outlook still divided

Aug. 11, 2020
By Randy Osborne
News from Biogen Inc. and partner Eisai Co. Ltd. that U.S. regulators accepted the BLA related to aducanumab for Alzheimer’s disease (AD) – and assigned it priority review, no less – set Wall Street abuzz.
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COVID-19 vaccine vials

From Russia with flub? Safety jitters ripple after quick COVID-19 vaccine approval

Aug. 11, 2020
By Randy Osborne
Reports out of Russia that the country approved a COVID-19 vaccine came with more questions than answers, as some in the rest of the world fretted over the apparently paltry degree of testing. Though the product has not completed phase III trials – human research thus far has involved only two groups of volunteers of 38 people each – Russia President Vladimir Putin is said to have declared Gam-COVID-Vac adequately studied.
Read More
Clostridium difficile bacteria

Wall Street C.’s the diff – and how – as Ecospor opens door for Seres

Aug. 10, 2020
By Randy Osborne
Mark Wilcox, professor of medical microbiology at the University of Leeds, said Seres Therapeutics Inc.’s top-line phase III data with oral microbiome therapeutic SER-109 against recurrent Clostridium difficile infection (CDI) are “about as good as it gets” in the tough-to-treat patient population.
Read More
Amyloid plaque on nerve cell

Yes we aducanumab? Biogen/Eisai AD bid gains traction, outlook still divided

Aug. 7, 2020
By Randy Osborne
News from Biogen Inc. and partner Eisai Co. Ltd. that U.S. regulators accepted the BLA related to aducanumab for Alzheimer’s disease (AD) – and assigned it priority review, no less – set Wall Street abuzz, especially as the companies noted in their press release that the FDA “if possible, plans to act early” on the anti-amyloid beta (a-beta) monoclonal antibody. Regulators’ decision came about 30 days after they took receipt of the submission; they could have waited 60.
Read More
Heart and lungs

Gleevec paycheck in Aerovate series A, inhaling $72.6M for new imatinib PAH route

Aug. 6, 2020
By Randy Osborne
A promising but side effect-ridden phase III study by Novartis AG with oral imatinib in pulmonary arterial hypertension (PAH) led Boston-based Aerovate Therapeutics Inc. to start exploring two years ago an aerosol form of the kinase inhibitor, and the project has won backing to the tune of $72.6 million in series A money.
Read More

FDA clears GSK’s Blenrep in multiple myeloma; black box and REMS for eye tox

Aug. 6, 2020
By Randy Osborne
About two weeks after European regulators gave their go-ahead for Blenrep (belantamab mafodotin-blmf), the B cell maturation antigen (BCMA)-targeting therapy from Glaxosmithkline plc (GSK) for relapsed/refractory multiple myeloma (MM), the FDA did likewise.
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Coronavirus vaccine illustration

COVID-19 vaccine race growing ‘titer’ as Novavax unveils phase I data

Aug. 5, 2020
By Randy Osborne
With strong results in hand from the phase I stage of its phase I/II study testing a would-be COVID-19 subunit vaccine, Novavax Inc.’s president of R&D, Gregory Glenn, said “it’s possible we could go down in the dose” as work proceeds and get similar efficacy.
Read More
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