BioCentury | Nov 30, 2020
Product Development

Moderna says Warp Speed improved quality, but not speed of its COVID-19 vaccine development

...included more than 7,000 people over the age...
BioCentury | Nov 24, 2020
Product Development

Nov. 24 Quick Takes: Elevian raises $15M; plus AZ-Ionis, Genmab, Moderna and Novartis

...2018 with $5.5 million in seed funding to develop a regenerative platform around GDF11 to treat age-related...
BioCentury | Nov 24, 2020
Product Development

AstraZeneca’s data add another landmark on the road to correlates of protection for COVID-19: Data Byte

Phase III data from a third COVID-19 vaccine, AstraZeneca’s AZD1222, shed more light on the neutralization titers needed to confer protection and have implications for other vaccines packaged in viral vectors.  AstraZeneca plc (LSE:AZN; NASDAQ:AZN) and the...
BioCentury | Nov 24, 2020
Product Development

Nov. 23 Quick Takes: NIH panel says bamlanivimab should not be considered COVID-19 SOC; plus Eiger, Shionogi-Roche, Kiniksa, Schrödinger, Halozyme-Horizon and Immunicum-DCPrime

NIH panel says bamlanivimab should not be considered standard-of-care for COVID-19NIH’s COVID-19 Treatment Guidelines Panel said there is not enough data to recommend either for or against use of bamlanivimab from Eli Lilly and Co. (NYSE:LLY)...
BioCentury | Nov 21, 2020
Regulation

Nov. 20 Quick Takes: Approvals in Europe for Alnylam, Alexion therapies; plus FDA priority review for ADC, Sanofi and more

...therapy targeting the HAO1 mRNA that encodes glycolate oxidase, to treat primary hyperoxaluria in all age...
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 20, 2020
Product Development

Phase III COVID-19 vaccine data kick-start next phase: mapping efficacy to antibody levels

...risk of developing severe disease.All the vaccine developers that have reported immunogenicity data in different age...
...the partners reported top-line data showing the efficacy of the vaccine was maintained across different age...
BioCentury | Nov 20, 2020
Regulation

Dec. 10 FDA panel could be gateway to first emergency authorization of COVID-19 vaccine

A Dec. 10 FDA advisory committee meeting could be the springboard for emergency use authorization for BNT162b2, enabling high-risk patients to receive by mid-December the first doses of the mRNA vaccine candidate against SARS-CoV-2 from BioNTech and Pfizer....
BioCentury | Nov 20, 2020
Product Development

The first COVID-19 vaccine data in the elderly may bode well for the next candidates: Data Byte

...A comparison of neutralization titers and protection data across candidates and age groups By selina koch...
...and BioNTech SE (NASDAQ:BNTX), and for the most part, the vaccines’ titers fell less with age...
...BNT162b2.Only Ad5-nCoV from CanSino Biologics Inc. (HKEX:6185; Shanghai:688185) produced somewhat lower neutralization titers that fell farther with age...
BioCentury | Nov 19, 2020
Finance

Syncona enters kidney disease space with gene therapy newco Purespring

...GT005, a gene therapy that expresses CFI to treat geographic atrophy (GA) secondary to dry age-related...
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