BioCentury | May 23, 2020
Translation in Brief

A three-compound dengue treatment; plus reversing antibiotic resistance, AbCellera-Lilly, reducing cholesterol with CRISPR and COVID cash for Sherlock

Hindering dengue by combining host- and virus-targeted drugs  In a Cell Chemical Biology article , Stanford University scientists combined two host-targeted compounds with a virus-targeted compound to yield potent dengue treatment. A DHODH inhibitor tool compound,...
BioCentury | May 19, 2020
Product Development

U.K. expects first access on Oxford vaccine, rolls out antibody study

The U.K. will be “the first to get access” to the University of Oxford’s COVID-19 vaccine, Business Secretary Alok Sharma said Sunday, adding that 30 million doses will be available by September, when Oxford hopes...
BioCentury | May 15, 2020
Regulation

Fourth-line GIST showdown ends in an FDA win for Deciphera, a rejection for Blueprint

FDA approved Qinlock repretinib from Deciphera as fourth-line treatment for advanced gastrointestinal stromal tumors (GIST), marking the first approved therapy for the indication. Also on Friday, competitor Blueprint said FDA issued a complete response letter...
BioCentury | May 13, 2020
Product Development

Gilead secures global access to remdesivir via generic manufacturing deals

The first manufacturing deals for Gilead’s remdesivir, plus a series of grants for institutions across Europe to develop COVID-19 diagnostics and therapeutics, highlight the importance of global collaboration to tackle the pandemic. Gilead Sciences Inc....
BioCentury | May 7, 2020
Regulation

CRISPR comes of age years ahead of schedule with first diagnostic authorization

FDA’s authorization of a CRISPR-based diagnostic for COVID-19 from Sherlock Biosciences is another step in the right direction for COVID-19 diagnostics, but it’s a much bigger win for the CRISPR technology. It represents the first...
BioCentury | Apr 28, 2020
Product Development

Blueprint stumbles in GIST race, clearing path for Deciphera

A Phase III miss for Blueprint’s Ayvakit avapritinib in third- and fourth-line GIST likely means the biotech won’t see its NDA approved in the indication, positioning Deciphera to claim a larger share of late-stage settings....
BioCentury | Apr 22, 2020
Product Development

FDA clears LabCorp’s COVID-19 home collection kits as Congress looks to bolster testing with $25B

LabCorp became the first diagnostic company to have an at-home collection kit for COVID-19 authorized by FDA, a month after the agency cleared its lab PCR test for the novel coronavirus. FDA also gave a...
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...
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