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Home » Authors » Randy Osborne

Articles by Randy Osborne

Hair and scalp under magnifying glass

SALT lick? Concert not cowed by big pharma players in alopecia

March 8, 2021
By Randy Osborne
Concert Pharmaceuticals Inc. CEO Roger Tung said determining who leads isn’t easy in the phase III race that pits his firm against Eli Lilly and Co. and Pfizer Inc. in alopecia areata. That’s because neither of the other companies has “been very direct about the timelines they’re on,” he told BioWorld. “We’ve been pretty clear that our goal is to have an NDA filing in early 2023.”
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Red and white blood cells

FDA to ring ide-cel bell; BCMA in play with Allogene on mezzanine

March 5, 2021
By Randy Osborne
As the March 27 PDUFA date nears for idecabtagene vicleucel (ide-cel, also known as BB-2121), the B-cell maturation antigen (BCMA)-directed chimeric antigen receptor CAR T-cell therapy from Bristol Myers Squibb Co. and Bluebird Bio Inc., investors are looking with increased favor on the approach.
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$117M series B provides XTENded runway for Amunix

March 4, 2021
By Randy Osborne
Amunix Pharmaceuticals Inc. CEO Angie You told BioWorld that her firm has already done most of the optimization with its unique T-cell engager platform, so that the effort now is mostly “about cranking out more INDs.”
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Brain and encephalography

Metamorphosis in Takeda deal as Ovid banks $196M for soticlestat in DS, LGS

March 3, 2021
By Randy Osborne
Having rung the bell in phase II last summer, Ovid Therapeutics Inc. and Takeda Pharmaceutical Co. Ltd. signed a pact giving the latter global rights to develop and commercialize soticlestat, a first-in-class inhibitor of cholesterol 24-hydroxylase for the treatment of developmental and epileptic encephalopathies including Dravet syndrome (DS) and Lennox-Gastaut syndrome (LGS).
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Silhouettes

Neurocrine schizophrenia thesis intact post-Interact? Opinions differ on phase II data

March 2, 2021
By Randy Osborne
San Diego-based Neurocrine Biosciences Inc.’s good-and-bad top-line phase II data with d-amino acid oxidase inhibitor luvadaxistat, also known NBI-1065844 and TAK-831, in schizophrenia likely came as little surprise to many, given earlier experience in the general pathway.
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Vaccination

As COVID-19 vaccines feel variant strain, FDA panel backs J&J single shot

Feb. 26, 2021
By Randy Osborne
As expected, the FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) looked favorably upon the latest COVID-19 entry: Ad26.COV2.S, a one-shot product that emerged from the same Johnson & Johnson (J&J) platform, AdVac, that let the firm devise an Ebola vaccine cleared in Europe last year.
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J&J's COVID-19 vaccine Ad26.COV2.S

One upmanship? J&J’s COVID-19 single-shot vaccine shortish on efficacy, long on other benefits

Feb. 24, 2021
By Randy Osborne
Briefing documents released by the FDA related to the Vaccines and Related Products Advisory Committee meeting slated for Friday suggest that the COVID-19 vaccine from Johnson & Johnson (J&J) will sail smoothly to an emergency use authorization.
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SERDs heard louder, clearer in BC; Sanofi phase II data this half

Feb. 23, 2021
By Randy Osborne
Astrazeneca plc officials, during the firm’s Feb. 11 conference call on fourth-quarter earnings, highlighted the oral selective estrogen receptor degrader (SERD) camizestrant in breast cancer (BC), which Cristian Massacesi, head of late-stage oncology development, said bears “best-in-class potential, in terms of providing superior clinical benefit at a well-tolerated dose” of 75 mg once per day.
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Liver illustration

IBAT they can: Albireo, leading with biliary atresia phase III, draws Street favor with blockbuster strategy

Feb. 22, 2021
By Randy Osborne
Although progressive familial intrahepatic cholestasis (PFIC) tends to draw more hoopla in the race, and Mirum Pharmaceuticals Inc. looks due to beat Albireo Pharma Inc. to market in Alagille syndrome (ALGS), the most revenue likely lies in a third rare pediatric liver disease where the firms compete: biliary atresia (BA). Mirum, of Foster City, Calif., completed its rolling NDA several weeks ago for maralixibat – an inhibitor of the apical sodium-dependent bile acid transporter designed to drive more excretion of bile acids as a way of lowering their level systemically – in cholestatic pruritus in patients with ALGS one year of age and older.
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Pass the SIRPa? Alx sweet on CD47-axis in solid tumors, phase II soon

Feb. 19, 2021
By Randy Osborne
As developers continue their race in the anti-CD47 space, Gilead Sciences Inc. remains high profile with magrolimab, which has reached phase III development for myelodysplastic syndromes. Meanwhile, Alx Oncology Inc., of Burlingame, Calif., is emerging with potentially the first drug targeting the CD47-SIRPa axis to treat solid tumors as well as hematologic malignancies.
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