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Home » Authors » Randy Osborne

Articles by Randy Osborne

Alpha-galactosidase enzyme

Protalix, Chiesi win US go-ahead for Elfabrio in Fabry disease

May 10, 2023
By Randy Osborne
On the heels of the marketing OK in Europe, Protalix Biotherapeutics Inc. and the Chiesi Group’s global rare diseases unit scored approval of Elfabrio (pegunigalsidase alfa-iwxj) from the U.S. FDA for adults with Fabry disease.
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Protalix, Chiesi win US go-ahead for Elfabrio in Fabry disease

May 10, 2023
By Randy Osborne
Multiple sclerosis

Et tu, Bruton? New approach in MS gains ground despite Merck partial hold

May 9, 2023
By Randy Osborne
Watchers of the Bruton’s kinase (BTK) inhibitor space may be casting renewed skepticism in that direction after Merck KGaA disclosed April 12 that the U.S. FDA placed a partial clinical hold on the sign-up of more patients in work testing evobrutinib in relapsing multiple sclerosis (MS) – but BTK efforts in MS continue in various quarters.
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Hands holding holographic intestine

Crohn’s T-cell mystery in crosshairs of Tscan, Amgen deal; $530M potential

May 9, 2023
By Randy Osborne
Tscan Therapeutics Inc.’s Wall Street-pleasing deal with Amgen Inc. in Crohn’s disease (CD) could expand into ulcerative colitis, but meanwhile is bringing $30 million up front with the potential for more than $500 million in preclinical, clinical, regulatory and commercial milestone payments, plus tiered single-digit royalties. Shares of Waltham, Mass.-based Tscan (NASDAQ:TCRX) closed May 9 at $3.40, up $1.25, or 58%, as the world learned of the multiyear collaboration with Amgen, of Thousand Oaks, Calif., that will use Tscan’s target discovery platform, Targetscan, to identify the antigens recognized by T cells in patients with CD.
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Mirv’n on up: Elahere boosts Immunogen’s economics with phase III win in PROC

May 3, 2023
By Randy Osborne
Immunogen Inc. scored a major win in top-line data from the confirmatory phase III trial called Mirasol evaluating the approved antibody-drug conjugate Elahere (mirvetuximab soravtansine-gynx, “mirv”) vs. chemotherapy in patients with folate receptor alpha-positive platinum-resistant ovarian cancer (PROC). The victory led shares of the Waltham, Mass.-based firm to close May 3 at $12.26, a rise of $7.06, or 135%.
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Kidney disease illustration

Travere to deal with FDA after Filspari door number two opens weak in FSGS Duplex trial

May 2, 2023
By Randy Osborne
Saddled with disappointing results from a phase III trial with Filspari (sparsentan) in focal segmental glomerulosclerosis (FSGS), officials of Travere Therapeutics Inc. stressed the differences between that disorder and IgA nephropathy (IgAN) – for which the drug was cleared by the U.S. FDA in February. Two-year IgAN efficacy data are due in the fourth quarter of this year.
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No letup by Sanofi in Pompe; Maze deal valued as high as $750M

May 1, 2023
By Randy Osborne

A mid-stage prospect for Pompe disease (PD) – this one from Maze Therapeutics Inc. – caught the eye of Sanofi SA, and the pair signed a potential $750 million deal to move along the oral glycogen synthase (GYS1) inhibitor MZE-001, a substrate reduction therapy.


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Top 4D? Phase I gene therapy data in wet AMD climb chart; Adverum, Regenxbio also in play

April 28, 2023
By Randy Osborne
Touting what’s been so far the “cleanest safety profile that’s been presented with genetic medicine in the eye,” deemed “a game changer for this field,” 4D Molecular Therapeutics Inc. CEO David Kirn said phase III planning will begin in later this year to test gene therapy 4D-150 in wet age-related macular degeneration (AMD).
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Vowst

Seres’ Vowst set to joust in rCDI with approval in hand and supply chain ready

April 27, 2023
By Randy Osborne
The supply chain for Seres Therapeutics Inc.’s oral microbiome therapeutic Vowst, formerly known as SER-109, to prevent recurrent Clostridium difficile infection (rCDI) is “well-established,” said David Arkowitz, the firm’s chief financial officer and head of business development. “It’s the same supply chain that we used for phase III [trials], and we’ve been manufacturing product for launch for some time.” Arkowitz spoke during a conference call with investors April 27, regarding the previous day’s U.S. FDA go-ahead for Vowst, cleared for adults with rCDI, including first recurrence following antibacterial therapy.
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Vowst

Seres wins FDA nod for Vowst in recurrent C. difficile infection

April 27, 2023
By Randy Osborne
As expected, Seres Therapeutics Inc. gained U.S. FDA approval of the BLA for the oral microbiome therapeutic Vowst, formerly known as SER-109, for prevention of recurrent Clostridium difficile infection (rCDI), accepted for priority review in October of 2022 without an advisory committee meeting.
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