A professor who conducted fast-track trials during last year’s Ebola outbreak says next time such trials must be part of humanitarian response… because there will be a next time.
Danish biotech Bavarian Nordic has signed a $9m contract from Johnson & Johnson to improve stability of their joint Ebola vaccine. After options and milestone awards, payment could total $33m.
Aid agencies in countries hardest hit by Ebola rely on manual, paper-based data collection according to one expert who says CDISC templates and mobile data capture would help.
Lack of funding is threatening development of a nasal spray vaccine shown to provide long-term protection for non-human primates against the Ebola virus, the lead researcher told this publication in an exclusive interview.
GSK is keeping its Ebola vaccine production in-house, despite previously leaked documents which suggested the company could not ramp up volume of BS-2 manufacturing without impacting its other vaccine lines.
Quintiles reported almost 14% growth in revenue, which was largely due to increasing revenue from its Integrated Health Services (IHS), which saw almost 35% quarterly growth.
The World Health Organisation says a meeting between drugmakers and high-level government representatives last week has yielded plans to fast-track scale-up of Ebola vaccines in the face of incomplete trials and leaked production problems.
Ebola vaccine developers can seek scientific guidance and approval through a rolling assessment system established by EMA to accelerate the process review.
The head of the US National Institutes of Health has said the organisation would have developed a finished Ebola vaccine by now if its funding had not been slashed over the last decade.
The lack of an Ebola vaccine decades after the virus was discovered is due in part to IP protections in trade deals like TTIP that discourage innovation according to NGO, Health Action International (HAI).
The WHO has accused biopharma firms of failing to invest in R&D to tackle Ebola due to the disease’s prevalence in poor African nations, as the death toll surpasses 4,000.
US academics have licensed a mobile clean room design from Xoma for a vaccine and medical countermeasure plant being built in Texas as part of an HHS-funded project.
As more than half a dozen companies are now vying to help treat and vaccinate Ebola victims in West Africa, where nearly 3,000 people have died from the illness, GlaxoSmithKline is taking the lead in getting product manufactured.
The Pharma industry has responded to the Ebola crisis in West Africa with developmental vaccines and aid donations, but drugmakers still need to be incentivised to develop new therapies according to the WHO.
Protalix shares rocketed 18% then reversed in one weekend after the Israeli protein manufacturer clarified it is not in talks to produce Ebola drug ZMapp.
ZMapp, the experimental Ebola therapy given to a handful of infected patients in West Africa, is being produced in tobacco plants for Mapp Biopharmaceutical by CMO Kentucky Bioprocessing in collaboration with drugmaker Defyrus.
A candidate Ebola vaccine that uses Immunovaccine's formulation technology has stopped cynomolgus monkeys from catching the disease in a preclinical study.
G-CON has responded to the ongoing Ebola virus outbreak in West Africa by retooling its “vaccine facility in a box” PODs as patient isolation units to help stop the spread of the disease.
Access to portable and flexible technology could be one way of containing transmissible diseases says G-CON as it launches a more readily deployable version of its ‘POD’ manufacturing suite.
Efficacy and safety data from use of unapproved Ebola virus treatments should be shared according to an expert panel convened by the World Health Organisation (WHO) this week.
As the death toll from the world’s most expansive Ebola outbreak nears 1,000, multiple companies are stepping up efforts to bring antibodies and other vaccines to human trials, though none seem likely to be ready until 2015 at the earliest.
Two Americans stricken with the Ebola virus in Liberia were flown back to the US following treatment with an unapproved treatment manufactured from tobacco plants in Kentucky. Manufacturing of the treatment is expected to ramp up as the patients improve.
The worst Ebola virus outbreak in history continues to spread in West Africa as biopharma companies are hampered by funding issues in trying to bring treatments and vaccines to human trials, a scientist says.
Regulations governing the production of vaccines in China have been praised by WHO director general Margaret Chan following an assessment of the CFDA's oversight of the sector conducted last October.
