BioCentury | Aug 5, 2020
Product Development

I-SPY COVID brings new set of targets to master protocols for acute respiratory distress

While most master protocols for COVID-19 have converged on an overlapping set of experimental therapies, the COVID R&D Alliance’s adaptive trial is kicking off with five therapeutic targets largely untouched in the indication. Three members...
BioCentury | Jul 30, 2020
Product Development

Finding immunosuppression sweet spot could be next up for COVID-19 after second IL-6 failure

A Phase III miss for a second IL-6 inhibitor in COVID-19 patients could be the death knell for the drug class in the disease. But the mortality benefit demonstrated by dexamethasone suggests a broader immunosuppressive...
BioCentury | Jul 29, 2020
Product Development

July 28 Quick Takes: Spectrum gains on NSCLC data; plus Nabriva, Farxiga, Chi-Med, Merck-Lumos, BeiGene, Aerie, jCyte and moreBy BioCentury Staff

Spectrum therapy hits Phase II endpoint Poziotinib met the prespecified primary endpoint in the ZENITH20 Phase II trial in previously treated non-small cell lung cancer (NSCLC) patients with HER2 exon 20 insertion mutations (Cohort 2),...
BioCentury | Jul 24, 2020
Regulation

Data Bytes: CHMP’s July recommendations

Among the 11 new medicines recommended for approval by EMA’s CHMP is the first antibody-drug conjugate, and most advanced BCMA-targeted agent, for multiple myeloma patients: GSK’s Blenrep belantamab mafodotin. FDA’s Oncologic Drugs Advisory Committee unanimously...
BioCentury | Jul 18, 2020
Product Development

COVID-19 mAb developers weigh master protocols as they set clinical strategies

Drugmakers developing the first crop of COVID-specific mAbs are facing the question of whether to pursue independent, company-sponsored trials or participate in master protocols that have been successful for repurposed drugs during the pandemic. So...
BioCentury | Jul 17, 2020
Product Development

Dexamethasone included in Novartis’ not-for-profit COVID-19 portfolio

The first therapy to show a mortality benefit in COVID-19 patients, dexamethasone, is among the 15 generic and over-the-counter drugs Novartis plans to provide at zero-profit to up to 79 low- and middle-income countries under...
BioCentury | Jul 14, 2020
Product Development

Immune-targeted mAb from Biocon, Equillium to enter global trials after Indian approval in COVID-19 patients

Biocon’s report of reduced mortality in hospitalized COVID-19 patients treated with Alzumab and its resulting emergency approval in India has prompted Equillium to send the immune modulator into a global testing. Equillium Inc. (NASDAQ:EQ), which...
BioCentury | Jul 7, 2020
Product Development

Four late-stage COVID-19 vaccine trial protocols harmonized, Fauci says

In a live-streamed conversation, NIH director Francis Collins and NIAID director Anthony Fauci discussed progress in standardizing protocols of Phase III trials for COVID-19 vaccines, as well as the ongoing need for therapies that can...
BioCentury | Jul 2, 2020
Product Development

First Phase III data for an IL-6 mAb in COVID-19 disappoint

A Phase III miss for IL-6 inhibitor Kevzara may not reflect a broader problem with the target or the strengthening theory that immune modulators are the best line of defense against severe forms of COVID-19....
BioCentury | Jun 30, 2020
Product Development

The U.K.’s push for COVID-19 master protocols pays off again with definitive data on lopinavir-ritonavir

The U.K.’s RECOVERY trial and broader strategy to encourage master protocol participation are proving their value again, this time with data showing that the lopinavir-ritonavir antiviral cocktail has no clinical benefit in hospitalized patients not...
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