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Home » Authors » Randy Osborne

Randy Osborne

Articles

ARTICLES

Taking inventory of CMAI, adcom briefing docs add up to favor Otsuka/Lundbeck’s Rexulti in AD agitation

April 12, 2023
By Randy Osborne
Briefing documents suggest smooth sailing for Rexulti (brexpiprazole) at the meeting to deliberate an application to expand the label of the compound from Otsuka Pharmaceutical Co. Ltd. and Lundbeck A/S into agitation related to Alzheimer’s disease (AD) dementia. A joint sit-down on April 14 of the U.S. FDA’s Psychopharmacologic Drugs Advisory Committee (adcom) and the Peripheral and Central Nervous System Drugs Advisory Committee will take up the matter of an add-on indication for Rexulti, a serotonin-dopamine activity modulator for schizophrenia and for the adjunctive treatment of major depressive disorder.
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Kidneys

CD38 special in more ways than one; Hi-Bio shoots down kidney disorder in phase II trials

April 11, 2023
By Randy Osborne
Human Immunology Biosciences Inc. (Hi-Bio) is moving ahead to late-stage work after disclosing positive phase II data from two trials testing the monoclonal antibody felzartamab for primary membranous nephropathy (PMN), a rare autoantibody-mediated autoimmune kidney disease and a leading cause of nephrotic syndrome. CEO Travis Murdoch told BioWorld that his firm is “working through designs for the next study, and planning to engage with regulators,” after which more details will be shared. PMN, he added, has “not been heavily trodden, but increasingly there’s a recognition that there’s an important patient and commercial opportunity” in the indication.
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Multiple myeloma illustration

Nexcella, others gain ground in BCMA; D domain approach by Arcellx touted

April 10, 2023
By Randy Osborne
Word recently from Nexcella Inc. of progress in its potentially BLA-enabling phase Ib/IIa study, with the BCMA-targeted, autologous CAR T therapy called NXC-201 for relapsed/refractory (r/r) multiple myeloma and r/r amyloid light chain amyloidosis, helped put nearer to center stage the class, which has proven attractive to a handful of developers. Among others in the space are Arcellx Inc. and Gracell Biotechnologies Inc.
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Illustration of blood vessel that isn't clotting due to hemophilia

Serpin ‘next wave’ as wide-net Centessa pursues hemophilia B

March 31, 2023
By Randy Osborne
Centessa Pharmaceuticals plc’s launch of a phase I/IIa trial with LB-101, a PD-L1xCD47 candidate that emerged from the Lockbody platform, highlighted the firm’s efforts against solid tumors. But the diversified company has more in the works, including a registrational study with subcutaneous (subcu) Serpinpc, designed to treat hemophilia (hemo) B. Centessa has a program in narcolepsy, too.
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Brexafemme

Scynexis makes good on Brexafemme out-licensing promise in $593M GSK pact

March 30, 2023
By Randy Osborne
The advance of antifungals – a class long needful of new therapies – continued with Scynexis Inc.’s potential $593 million exclusive license agreement with GSK plc for Brexafemme (ibrexafungerp), first cleared by the U.S. FDA in June 2021 and indicated for vulvovaginal candidiasis (VVC) as well as for reduction of recurrent VVC.
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Silhouette made of crumpled paper illustrating depression

Caplyta scores again; results anything but mixed from Intra-Cellular phase III in depression

March 28, 2023
By Randy Osborne
Intra-Cellular Therapies Inc.’s phase III data with Caplyta (lumateperone) 42 mg in major depressive disorder (MDD) with mixed features (MF) and in patients with bipolar depression with MF may augur well for the ongoing, late-stage program with the compound as an adjunctive treatment in MDD.
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DNA, drug development concept art.

Data divided in Unity’s AMD phase II; Envision another study as DME data due soon

March 27, 2023
By Randy Osborne
Hopes remain for Unity Biotechnology Inc.’s UBX-1325 in diabetic macular edema (DME) following a phase II miss in wet age-related macular degeneration (AMD), where data from part A of the study called Envision fell short of the non-inferiority threshold when compared to Eylea (aflibercept, Regeneron Pharmaceuticals Inc.) through 24 weeks.
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Leukemia illustration

Can’t resist? Beigene, Nurix ploys in BTK may dodge blood cancer problems

March 24, 2023
By Randy Osborne
Phase II data that rolled out from Merck KGaA with its Bruton's tyrosine kinase (BTK) inhibitor evobrutinib in relapsed multiple sclerosis (MS) put more eyeballs on the mechanism. It’s already well validated in oncology, but resistance has arisen there, and at least two firms – Beigene Ltd. and Nurix Therapeutics Inc. – are striving for solutions with degrader candidates.
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Shiver me LIMBER: Incyte’s once-a-day Jakafi meets rough seas with CRL from FDA

March 24, 2023
By Randy Osborne
Incyte Corp.’s bid for a once-daily vs. twice-daily version of the Janus kinase inhibitor Jakafi (ruxolitinib) was foiled, at least temporarily, by a complete response letter (CRL) from the U.S. FDA.
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Candida auris

Cidara prevails with US FDA approval of Rezzayo in candidemia, IC; partner Melinta to launch this summer

March 23, 2023
By Randy Osborne
Concerns voiced during January’s U.S. FDA advisory committee meeting failed to deter Cidara Therapeutics Inc. from winning approval by the agency March 22 for once-weekly Rezzayo (rezafungin for injection) to treat a pair of indications – candidemia as well as invasive candidiasis (IC) – in adults with limited or no alternatives.
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View All Articles by Randy Osborne

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