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 Quick Takes: EMA to require more stringent safety monitoring for vaccines; plus J&J, Clover-Thousand Oaks, Medicago-GSK, Inovio and Synairgen

EMA details additional safety monitoring requirements for vaccinesEMA announced several additional safety monitoring activities it will require of COVID-19 vaccine manufacturers in addition to the normal pharmacovigilance requirements of all medicines. These include the submission...
BioCentury | Sep 29, 2020
Regulation

Inovio’s Phase II/III COVID-19 vaccine study delayed pending resolution of partial hold, funding

FDA’s partial hold on Inovio’s planned Phase II/III COVID-19 vaccine trial comes as the company is seeking additional funding to support the study.  Inovio Pharmaceuticals Inc. (NASDAQ:INO) fell $4.80 (28%) to $12.14 Monday, losing $804...
BioCentury | Sep 9, 2020
Product Development

COVID-19 roundup: SpyBiotech-Serum Institute of India send HBV-based COVID-19 vaccine to clinic; plus Vaxart, Inovio-Thermo Fisher and RedHill

SpyBiotech, Serum Institute of India start vaccine trialU.K. biotech SpyBiotech Ltd. and its partner the Serum Institute of India on Tuesday started a Phase I/II trial of a virus-like particle (VLP)-based COVID-19 vaccine. The vaccine...
BioCentury | Aug 29, 2020
Product Development

Next-wave Th1 cytokine cancer therapies aim for more precise targeting

A growing list of cytokine therapies have been designed to boost cytotoxic immune responses against cancer while sidestepping the limitations of past candidates by controlling where the molecules do and...
BioCentury | Jul 31, 2020
Product Development

Non-human primate data shed light on correlates of protection and duration of immunity to COVID-19 vaccines

Two more COVID vaccine developers have published non-human primate data suggesting efficacy, bringing the total to five. One of the new papers builds on the case for neutralizing antibodies as key correlates of protection; the...
BioCentury | Jul 13, 2020
Regulation

Global regulators at odds on Phase III efficacy threshold for COVID-19 vaccines

Regulators are aligning their guidance on COVID-19 vaccine development through the the International Coalition of Medicines Regulatory Authorities, but they have yet to agree on the criteria for vaccine efficacy. A report released last Friday...
BioCentury | Jul 10, 2020
Finance

2Q20 Wrap: Biotech bounce

After the sudden, COVID-driven market declines that closed out 1Q20, biotech stocks rebounded in the second quarter with a force that has put shares up year to date. Many of the biggest moves came from...
BioCentury | Jul 10, 2020
Finance

After pouring into biotech in 2Q, will generalists stay or will they go?

Investors believe generalists are likely to remain overweight in healthcare until there’s confidence that the broader economy can start to recover. When that will happen and whether some generalists might stick around even after recovery...
BioCentury | Jul 8, 2020
Product Development

NIH, Warp Speed streamline preventive mAb, vaccine testing via clinical trial network

On the back of its first COVID-19 mAb investment, Operation Warp Speed launched a clinical trial network with NIH on Wednesday to streamline testing of the modality in prophylactic settings. The COVID-19 Prevention Trials Network...
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