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VBI Is Ready To Take On HBV Vaccine Market

 
• By Leah Samuel

VBI’s Sci-B-Vac CONSTANT data firmly establishes the hepatitis B vaccine’s advantages over GSK’s longstanding Engerix-B, but it faces a tougher challenge with Heplisav-B from Dynavax. 

Hepatitis B
VBI's hepatitis B vaccine faces tough competition from Dynavax.

With its second pivotal Phase III showing an advantage for VBI Vaccines Inc.’s Sci-B-Vax over Engerix-B, GlaxoSmithKline PLC’s monovalent HBV vaccine, Cambridge, MA-based VBI is preparing for submission and market entry – but it faces a tougher challenge going up against Dynavax Technologies Corp.’s Heplisav-B.

VBI reported on 9 January that the CONSTANT study assessing lot-to-lot manufacturing consistency of its trivalent hepatitis B (HBV) vaccine, comparing safety and immunogenicity of

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Final Chance To Have Your Say: Take Scrip's Reader Survey This Week

 
• By Eleanor Malone

Editor’s note: This is your final call to participate in the survey to better understand our subscribers’ content and delivery needs. The deadline is 20 September.

Shape Our Content: Take The Reader Survey

 
• By Eleanor Malone

Editor’s note: We are conducting a survey to better understand our subscribers’ content and delivery needs. If there are any changes you’d like to see in the coverage topics, content format or the method in which you receive and access Scrip, or if you love it how it is, now is the time to have your voice heard.

Galapagos Expands Point-Of-Care CAR-T Study To The US

 
• By Andrew McConaghie

CEO Paul Stoffels said gaining US clearance for an IND for its novel CAR-T product was demanding, but now opens up a pathway towards a pivotal study starting in 2025.

Analysts Split On Eisai’s Chances Of Changing EU Regulator’s Mind On Leqembi

 
• By Andrew McConaghie

A final rejection of Leqembi could also spell the same fate for Lilly’s rival drug but public outcry and demand for Alzheimer’s therapies might force the regulator’s hand

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Finance Watch: Deerfield Closes $600m-Plus VC Fund; Gates Speeds Up Health Investments

 
• By Mandy Jackson

Private Company Edition: Deerfield’s third innovations fund will back therapeutics and other opportunities, the Gates Foundation – a sometimes funder of biotech firms – will spend $200bn over the next 20 years, and NewLimit raised a $130m series B round, among other financings.

Pipeline Watch: Six Approvals And Thirteen Phase III Readouts

Pipeline Watch is a weekly snapshot of selected late-stage clinical trial events and approvals announced by pharmaceutical and biotech companies at medical and industry conferences, in financial and company presentations, and in company releases and statements.

Pharma Left Hanging After US/UK Trade Pact

 
• By Kevin Grogan

An ‘historic economic prosperity deal’ does not include the sector.