BioCentury | Nov 21, 2020
Product Development

Could an approval of Biogen’s Alzheimer’s therapy still be an option?

For almost any other compound, the nearly unanimous advisory committee vote that Biogen’s Alzheimer’s therapy aducanumab suffered would make its chances of approval vanishingly small. But this mAb...
BioCentury | Nov 20, 2020
Translation in Brief

Long-term gene therapy study in dogs with hemophilia A; plus a comparison of HBV vaccine adjuvants and mAb that alleviates chemotherapy side effects

Long-term study of AAV gene therapy in dogs finds genome integration, clonal expansionA team led by University of Pennsylvania scientists showed in Nature Biotechnology that adeno-associated viral (AAV8 or AAV9) gene therapy corrected factor VIII...
BioCentury | Nov 20, 2020
Product Development

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

Efficacy data from the first two Phase III trials of COVID-19 vaccines shattered expectations and validated mRNA as a vaccine modality. The findings also mark the start of the search for correlates of protection. An...
BioCentury | Nov 20, 2020
Deals

China in-licensing play LianBio follows $310M crossover round with broad Pfizer deal

Pfizer’s deal with LianBio will provide the Perceptive-backed, cross-border start-up with a commercial infrastructure in China, while giving the pharma a drug hunter and development partner led by veteran China biotech executives Bing Li and Debra...
BioCentury | Nov 19, 2020
Finance

Syncona enters kidney disease space with gene therapy newco Purespring

The launch of Purespring Therapeutics marks the next phase of Syncona’s strategy in moving gene therapy from targeting rare monogenic diseases to more complex, highly prevalent settings. On Thursday, Syncona Ltd. (LSE:SYNC) launched its sixth...
BioCentury | Nov 19, 2020
Product Development

EUAs for BioNTech-Pfizer, Moderna COVID-19 vaccines, readouts from AZ and J&J could come in December

The U.S. government is finalizing plans for review, allocation prioritization, and distribution in December of two COVID-19 vaccines in the wake of the completion of a Phase III trial of an mRNA vaccine candidate from...
BioCentury | Nov 19, 2020
Product Development

Preclinical POC for Codiak’s IL-12 therapy highlight retention benefits of exosomes

Data presented at SITC last week provide preclinical proof of concept for Codiak’s IL-12 therapy and highlight the ability of its exosome-based approach to extend retention in the tumor microenvironment. Codiak BioSciences Inc. (NASDAQ:CDAK) uses...
BioCentury | Nov 19, 2020
Product Development

COVID-19 vaccines that could report Phase III data before Moderna, Pfizer-BioNTech products become broadly available

Strong efficacy data from the two leading COVID-19 vaccines suggest the window for testing additional vaccine candidates in the U.S. could soon start to close. Of the more than 200 vaccines in development for COVID-19,...
BioCentury | Nov 18, 2020
Product Development

COVID-19 vaccines shatter efficacy projections: Data Byte

With Moderna’s announcement Monday that its COVID-19 vaccine produced 94.5% protection in a Phase III trial, two mRNA vaccines have beaten their projected efficacy thresholds. The findings bode well both for other mRNA vaccines and...
BioCentury | Nov 18, 2020
Product Development

Nov. 17 Quick Takes: Phase III miss for BrainStorm’s ALS program; plus Novo, BioMarin-Deep Genomics, Lexicon, Seed-Lilly and RhoVac

BrainStorm sees path forward for ALS therapy despite Phase III missBrainStorm Cell Therapeutics Inc. (NASDAQ:BCLI) shed $7.92 (66%) to $4.02 on Tuesday after its mesenchymal stem cell therapy NurOwn missed the primary endpoint in a...
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