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Home » Authors » Randy Osborne

Articles by Randy Osborne

Liver disease

Durect hit? DNMT inhibitor may have found home in AH

March 24, 2021
By Randy Osborne
With so many headlines touting drugs in development for the likes of nonalcoholic steatohepatitis and nonalcoholic fatty liver disease, an illness in the same ballpark has been back-seated: alcoholic hepatitis (AH), which is on the rise, under-recognized and brings a one-month mortality rate that averages 26%.
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Adult checking child blood glucose level

Three of a kind in glucagon game as FDA turns over Zealand’s card

March 23, 2021
By Randy Osborne
“We’re launching at the right time,” said Frank Sanders, president of Zealand Pharma A/S’s business in the U.S., in the wake of clearance granted by the FDA for the Copenhagen, Denmark-based firm’s glucagon analogue Zegalogue (dasiglucagon) in severe hypoglycemia.
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Savara goes back for seconds; inhaled fix for aPAP at last?

March 22, 2021
By Randy Osborne
As the firm doubles down on a therapy for the rare and terrible lung disease called autoimmune pulmonary alveolar proteinosis (aPAP), Savara Inc. met with little trouble raising money, disclosing March 15 a public offering that grossed $130 million.
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Multiple sclerosis

Can ya, Gilenya? J&J’s Ponvory for MS aims to intervene in sphingosine

March 19, 2021
By Randy Osborne
Now that Johnson & Johnson (J&J), through its Janssen Pharmaceuticals unit, has won the FDA’s nod for Ponvory (ponesimod), market factors will decide how the once-daily oral selective sphingosine-1-phosphate receptor 1 modulator fares against several others already approved in the class.
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Fallopian tubes, ovaries and uterus

Libtayo KO in cervical as contenders crowd late-stage ring

March 17, 2021
By Randy Osborne
Libtayo (cemiplimab-rwlc) became the first PD-1 therapy to score a phase III win in cervical cancer, a pleasing development not only for investors in Regeneron Pharmaceuticals Inc. and partner Sanofi SA but for patients with the stubborn disease.
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Virus cells

Oncolytic virus’ past in question but promising future lyse ahead

March 16, 2021
By Randy Osborne
When Amgen Inc. won approval of the oncolytic virus (OV) therapy Imlygic (talimogene laherparepvec, t-vec) for melanoma in late October 2015, hopes ran high for the space. The mood has since faded in some quarters – but hardly all.
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Red blood cells

AACR yet to come, Red-letter day arrives for Rubius’ RTX-240 in solid tumors

March 15, 2021
By Randy Osborne
The question of whether Rubius Therapeutics Inc. would disclose data with its cellular therapy, RTX-240, ahead of the American Association for Cancer Research (AACR) meeting next month was answered in a market-satisfying way as the Cambridge, Mass.-based firm rolled out positive findings from the ongoing phase I/II experiment.
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Delta dawn? Faded rose from days gone by may bloom again in SCLC

March 12, 2021
By Randy Osborne
The sad phase III fate of Abbvie Inc.’s rovalpituzumab tesirine, also known as rova T, in advanced small-cell lung cancer (SCLC) has not discouraged other drug developers targeting delta-like ligand 3 (DLL3) – not all of them, anyway.
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FDA Approved stamp

Up for adoption, Aveo’s baby Fotivda finally cleared in RCC

March 11, 2021
By Randy Osborne
Aveo Oncology Inc. CEO Michael Bailey said the shifting treatment paradigm in renal cell carcinoma (RCC) represents “an advantageous opportunity” for the company with Fotivda (tivozanib), approved March 10 for adults with relapsed or refractory, advanced disease who have received two or more systemic therapies.
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Brain and encephalography

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

March 9, 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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