BioCentury | Apr 2, 2020
Product Development

COVID-19 roundup: EMA seeks to rein in chloroquine use; plus cash for CEPI, WHO’s SOLIDARITY grows, CytoDyn, EUSA, Chembio, PCR Biosystems and more

EMA said Wednesday that chloroquine and hydroxychloroquine should only be used to treat COVID-19 in clinical trials or national emergency use programs to preserve availability for autoimmune indications, such as lupus. The agency’s statement came...
BioCentury | Mar 31, 2020
Product Development

COVID-19 roundup: Qiagen, BD-BioMedomics, Rendu, Vaxart, Cobra, GigaGen, Houston Methodist, Anaqua-WideTrial

FDA’s emergency use authorization for a Qiagen test Tuesday comes amid a flurry of advancements in therapeutic, vaccine and diagnostic COVID-19 programs, including GigaGen’s unveiling of a polyclonal antibody program derived from convalescent COVID-19 patients....
BioCentury | Mar 28, 2020
Product Development

COVID-19 roundup: FDA approves Abbott’s 5-minute test; plus Trump signs stimulus bill, WHO readies master protocol, CytoDyn mAb data and more

FDA granted emergency approval Friday to a trio of diagnostics for COVID-19, including a molecular point-of-care test from Abbott that can detect COVID-19 in minutes. The approvals came as President Donald Trump signed a $2...
BioCentury | Mar 28, 2020
Management Tracks

Bernard joins Qiagen as CEO; plus CytomX, Recursion, 89bio, Heptares, Fusion, Freeline, Cognition, I-Mab, Seres and more

Qiagen N.V. (NYSE:QGEN; Xetra:QIA) said Thierry Bernard will become the permanent CEO after serving on an interim basis since October. Bernard, who joined Qiagen in 2015 as SVP of the molecular diagnostics business area, takes...
BioCentury | Mar 27, 2020
Product Development

COVID-19 roundup: biopharmas scramble to reassess clinical timelines; plus CEPI-Dynavax, and emergency approvals for Vero, Fosun

More than a dozen biopharmas Thursday announced delays or disruptions to clinical programs and regulatory timelines as companies begin to turn their attention to managing their trials through the COVID-19 crisis. The setbacks came as...
BioCentury | Mar 24, 2020
Product Development

March 23 COVID-19 roundup: Gilead looks to expand access to remdesivir, antiviral gains Orphan designation; plus N.Y.’s chloroquine trial, Celltrion and more

As Gilead begins shifting its individual compassionate use authorizations for COVID-19 candidate remdesivir to broader expanded access programs, the antiviral was granted Orphan Drug designation Monday. The day also saw several companies begin work on...
BioCentury | Mar 17, 2020
Product Development

Phase II data bring Blueprint closer to major market expansion for Ayvakit

With positive initial data for Ayvakit in indolent systemic mastocytosis, Blueprint is moving into position to expand its only approved drug into a much larger patient population while sticking to its strategy of focusing on...
BioCentury | Feb 28, 2020
Product Development

WHO reports China making 1.6M COVID-19 diagnostic kits per week, describes therapy and vaccine R&D priorities

A WHO report on a Feb. 16-24 mission to China to assess the COVID-19 outbreak summarizes the situation on the ground, highlights countermeasure R&D initiatives, challenges and needs, and identifies critical knowledge gaps. What stands...
BioCentury | Feb 27, 2020
Politics, Policy & Law

Plotting a scientific path to counter COVID-19

In a global online forum Tuesday night, scientific leaders from companies developing vaccines, therapies and diagnostics to address the COVID-19 outbreak discussed opportunities for collaboration, highlighted challenges, and called for sustained global initiatives to create...
BioCentury | Feb 14, 2020
Product Development

AML’s growing options

For acute myelogenous leukemia patients, 2017 marked the end of a more than 40 year drought in which chemotherapy was the only treatment option. In the last three years, eight new AML therapies have come...
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