BioCentury | Nov 25, 2020
Product Development

Nov. 25 Quick Takes: FDA approves Y-mAbs’ Danyelza; plus NIH’s ACTT-4; COVAXX, Urovant, SomaLogic, Eluminex and Liquidia

FDA approves Y-mAbs’ Danyelza for neuroblastomaShares of Y-mAbs Therapeutics Inc. (NASDAQ:YMAB) were up 17% in after-hours trading Wednesday after FDA granted accelerated approval to Danyelza naxitamab-gqgk plus GM-CSF to treat relapsed or refractory high-risk neuroblastoma....
BioCentury | Nov 20, 2020
Regulation

WHO counters FDA as it recommends against Veklury for COVID-19

The WHO’s new guidance counters FDA’s October approval of Gilead’s Veklury for hospitalized patients, adding to the debate around the drug’s use and variable performance in randomized, controlled trials. In The BMJ on Thursday, the WHO issued a...
BioCentury | Nov 12, 2020
Product Development

COVID mAb data from Lilly, AbCellera suggest monotherapy may soon be superseded by Lilly’s combo

Whether the spike-targeting mAb bamlanivimab from Eli Lilly and AbCellera will have a substantial impact on the COVID-19 pandemic boils down to two factors: the strength of its efficacy and its availability....
BioCentury | Nov 11, 2020
Product Development

Medicare co-pays for COVID-19 mAbs scrapped, bamlanivimab distribution begins

The Trump administration has found a way to eliminate out-of-pocket costs for Medicare beneficiaries who receive COVID-19 mAbs, removing a potential barrier to treatment. The announcement came a day after FDA granted emergency use authorization...
BioCentury | Nov 10, 2020
Regulation

EUA for Lilly, AbCellera COVID mAb despite Phase II miss for authorized dose

FDA’s first emergency use authorization for a SARS-CoV-2-targeting mAb covers the lowest dose of Lilly and AbCellera’s candidate to treat COVID-19 outpatients, a dose that was not effective in the Phase...
BioCentury | Oct 28, 2020
Deals

Supply constraints loom as Regeneron reports positive data on COVID-19 mAb

Days before FDA is expected to decide about their emergency use authorization requests, Regeneron released new data confirming the efficacy of its COVID-19 mAb cocktail and Lilly announced that the U.S. government has contracted to...
BioCentury | Oct 28, 2020
Distillery Therapeutics

Inhibiting IL-33-driven inflammation to treat brain cancer

DISEASE CATEGORY: Cancer INDICATION: Brain cancer Targeting nuclear accumulation of IL-33 could treat glioblastoma multiforme by reducing recruitment of pro-tumorigenic innate immune cells to the tumor microenvironment. In patients with glioblastoma multiforme, high expression of...
BioCentury | Oct 28, 2020
Product Development

Oct. 27 Quick Takes: NIH ends enrollment COVID-19 trial of Lilly’s bamlanivimab; plus Amgen, Kala

NIH trial of Lilly-AbCellera COVID-19 mAb stopped for futilityNIH has ended enrollment in the ACTIV-3 trial of bamlanivimab to treat hospitalized COVID-19 patients due to lack of efficacy when combined with Veklury remdesivir from Gilead Sciences...
BioCentury | Oct 22, 2020
Product Development

Data Byte: AbbVie’s oral JAK takes the lead in coming competition for Dupixent in atopic dermatitis

Phase III data for coming entrants to the atopic dermatitis market show Rinvoq upadacitinib from AbbVie Inc. (NYSE:ABBV) has the edge in efficacy, compared with three other Phase III programs and the marketed therapy Dupixent...
BioCentury | Oct 16, 2020
Politics, Policy & Law

Christie’s COVID-19 treatment raises fairness, safety questions

Former New Jersey Gov. Chris Christie’s treatment for COVID-19 raises questions about the fairness of decisions to grant access to investigational therapies, as well as the safety of exposing patients...
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