00:43 , Jun 18, 2019 |  BC Extra  |  Clinical News

June 17 Clinical Quick Takes: VBI's HBV vaccine misses secondary endpoint, plus ArQule, Verastem and more

VBI falls with HBV vaccine miss on secondary endpoint  VBI Vaccines Inc. (NASDAQ:VBIV) sank $1.24 (66%) to $0.65 Monday after reporting that two doses of Sci-B-Vac failed to show non-inferior seroprotection at day 168 vs....
19:59 , Nov 16, 2018 |  BioCentury  |  Tools & Techniques

Benchtop manufacturing gets smaller

Publisher’s note: This story originally ran in the Nov. 15, 2018 issue of BioCentury Innovations , a comprehensive source of developments in translational research with knowledgeable perspectives on the key innovations, trends and opportunities in...
22:43 , Nov 15, 2018 |  BC Innovations  |  Tools & Techniques

Benchtop manufacturing gets smaller

MIT scientists continue to break new ground in benchtop manufacturing systems for biologics. Published in Nature Biotechnology last month, the latest advance from the institute centered on an automated, closed system capable of producing clinical-grade...
19:12 , Dec 22, 2017 |  BC Week In Review  |  Clinical News

VBI starts Phase III of Sci-B-Vac to prevent HBV infection

VBI Vaccines Inc. (NASDAQ:VBIV) began the double-blind, international Phase III PROTECT trial of Sci-B-Vac to prevent HBV infection in about 1,600 adults. Subjects will receive a three-dose course of 10 μg Sci-B-Vac or Engerix-B from...
19:11 , Dec 22, 2017 |  BC Week In Review  |  Clinical News

VBI starts Phase III lot consistency trial of HBV vaccine

VBI Vaccines Inc. (NASDAQ:VBIV) began the double-blind, international Phase III CONSTANT trial to evaluate lot-to-lot consistency of Sci-B-Vac to prevent HBV infection. The study will enroll 3,200 adults to receive a three-dose course from one...
01:06 , Aug 5, 2017 |  BioCentury  |  Regulation

Final stretch

Following a long and bumpy regulatory road, it appears Heplisav-B from Dynavax Technologies Corp. is finally in the home stretch. But how the company and FDA handle the final hurdle -- the design of a...
19:54 , Aug 4, 2017 |  BC Week In Review  |  Clinical News

FDA panel backs Heplisav-B, requests details for postmarketing study

FDA's Vaccines and Related Biological Products Advisory Committee voted 12 to 1, with 3 abstentions, that available safety data support the use of HBV vaccine Heplisav-B from Dynavax Technologies Corp. (NASDAQ:DVAX) in adults. The committee...
22:11 , Jul 28, 2017 |  BC Extra  |  Company News

FDA panel backs Heplisav-B, wants rigorous postmarketing study

Dynavax Technologies Corp. (NASDAQ:DVAX) jumped $7.45 (81%) to $16.70 in after-hours trading on Friday after FDA's Vaccines and Related Biological Products Advisory Committee voted 12 to one, with three abstentions, that available safety data support...
23:34 , Jul 26, 2017 |  BC Extra  |  Company News

FDA panel to probe safety of Dynavax HBV vaccine

In briefing documents released ahead of an advisory committee meeting to discuss an NDA for Heplisav-B from Dynavax Technologies Corp. (NASDAQ:DVAX), FDA reviewers said the vaccine led to "a robust immune response" in clinical studies,...
22:49 , Nov 17, 2016 |  BC Week In Review  |  Clinical News

Heplisav-B regulatory update

Dynavax said FDA issued a complete response letter to the company for a BLA for its Heplisav-B HBV vaccine and that it will seek a pharmaceutical or financial partner to advance the program. Dynavax said...