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Chimerix Crashes On Ph III Brincidofovir Flop; Dead End?

 
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Shares of Chimerix Inc. crashed on Dec. 28 – plummeting as low as 82% – on word the firm's Phase III SUPPRESS trial of its oral antiviral brincidofovir failed to achieve its primary endpoint of preventing clinically significant cytomegalovirus (CMV) infection in patients through week 24 after undergoing hematopoietic cell transplantation (HCT).

US Officials: Global Crises Require Accelerated Drug Evaluation

 
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With the world experiencing three major health crises in the past decade – severe acute respiratory syndrome, H1N1 pandemic influenza and Ebola – and the potential for other emerging diseases to turn into an epidemic, such as the Middle East respiratory syndrome coronavirus (MERS-CoV), there's a critical need for the rapid evaluation of experimental therapies, US officials said, laying out their argument in an Aug. 5 Perspectives article in the New England Journal of Medicine.

Emergent awarded $19.7m to make ZMapp-like Ebola cocktail

 
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Emergent BioSolutions snagged a $19.7m contract from the Biomedical Advanced Research and Development Authority (BARDA) to develop and manufacture three Ebola monoclonal antibodies (mAbs), which are the same as those used to make Mapp Biopharmaceuticals' ZMapp – a drug that gained quick fame last year at the height of the Ebola outbreak in West Africa.

More positive safety results for NewLink/Merck Ebola vaccine

 
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Yet another study has shown an experimental Ebola vaccine from NewLink Genetics and its partner Merck to be safe, with the product eliciting robust antibody responses in all 40 of the healthy adults who received it at Walter Reed Army Institute of Research in Silver Spring, Maryland and at the National Institutes of Health (NIH) in Bethesda, Maryland.

Emergent BioSolutions to team its Ebola vaccine with GSK's in Phase I

 
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Emergent BioSolutions has completed the manufacture of the first clinical lot of a modified vaccinia Ankara (MVA) Ebola Zaire vaccine candidate (MVA EBOZ) that will be used in a Phase I trial together with GlaxoSmithKline's Chimp Adenovirus type 3 (ChAd3) Ebola vaccine candidate as a heterologous boost. The Phase I study will be conducted in the UK at the Jenner Institute in Oxford, supported by a grant from the Wellcome Trust and the UK Department for International Development. Under several agreements that it signed with the University of Oxford, GSK, and the US National Institutes of Health's National Institute of Allergy and Infectious Diseases (NIAID), Emergent has performed proof of concept work and manufactured the MVA EBOZ vaccine candidate at a 200L scale in an avian cell line. Manufacturing in this cell line has significant advantages including removing the requirement for eggs from the manufacturing process, consistency of manufactured vaccine lots, and increases in doses delivered, the company said. The scalable process has the potential to meet the demand for multi-million doses in a few months.

Ebola survivor nurse suing Texas hospital

 
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Nina Pham, one of two Dallas nurses who became infected with Ebola after caring for a Liberian man, Thomas Eric Duncan, who died of the disease, is suing her employer, Texas Health Presbyterian, her lawyer said.

US Capitol Capsule: Record approvals, new legislation: Big things happening in rare diseases

 
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With approvals of drugs in the US to treat orphan conditions hitting an all-time high in 2014, new legislative efforts with new incentives that have the potential to be enacted in 2015 and science moving at an unprecedented pace because of new molecular research capabilities, big things are happening in rare diseases, officials declared at a 27 February conference hosted by the National Institutes of Health (NIH).

ZMapp's 'moment-of-truth' efficacy trial starts

 
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Researchers are finally able to test whether the experimental drug ZMapp earned the attention it's been getting since this past fall or whether it's all hype – the drug's moment of truth.

BARDA funds ZMapp-like Ebola drugs from Medicago, Fraunhofer

 
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The Biomedical Advanced Research and Development Authority (BARDA), part of the US Department of Health and Human Services, has awarded contracts to biotech Medicago and nonprofit research and development firm Fraunhofer to make ZMapp-like Ebola drugs, the head of the agency revealed on 24 February.

Brincidofovir mortality rate holds up in Chimerix's adenovirus study

 
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The latest results from Chimerix's ongoing clinical trial for brincidofovir in the treatment of adenovirus in immunocompromised patients show that trial's mortality rate is holding steady as the study transitions to the pivotal Phase III trial.

BARDA grants $30m to advance NewLink/Merck Ebola vaccine

 
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NewLink Genetics and its partner Merck have been awarded $30m from the US Biomedical Advanced Research and Development Authority (BARDA) to support the manufacturing and development activities of their investigational vaccine rVSV-EBOV against Ebola, which has infected more than 19,300 people, killing over 7,500.

Joint pain leads to NewLink/Merck Ebola vaccine trial 'pause'

 
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After reports of mild joint pain in four healthy volunteers, Swiss researchers on 11 December temporarily suspended a Phase I safety trial of an experimental Ebola vaccine, rVSV-EBOV, which is being developed by NewLink Genetics and Merck.

Makers of 3 Ebola vaccines granted US liability protection

 
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The companies involved in making the three lead Ebola vaccines gained liability protection in the US on 9 December by a declaration from the Obama administration acting under the Public Readiness and Emergency Preparedness (PREP) Act of 2005.

US Ebola-free, for now

 
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With the discharge of New York aid worker Dr Craig Spencer from Manhattan's Bellevue Hospital on 11 November, the US was declared free of Ebola – at least for the time being.

2nd Texas nurse survives Ebola; discharged from hospital

 
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Texas nurse Amber Vinson, who became infected with Ebola while treating Thomas Eric Duncan, the Liberian man who arrived in Dallas on 20 September and developed the virus about five days later – dying on 8 October – was discharged from Emory University Hospital on 28 October.

Ebola drugs, vaccines advance; US frets

 
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Ebola continued to dominate Washington and consumed much of the US conversation on 16 October as President Barack Obama suggested he may appoint a "czar" to oversee the situation and as top health and science leaders were hauled in front of Congress to explain why the nation appears so poorly prepared to handle the virus and what steps are being taken to get on track.

Nurse gets Ebola survivor plasma; ZMapp maker ups efforts

 
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In light of the urgent need for medicines to treat Ebola – which has killed more than 4,000 people, infecting about 8,400 – Mapp Biopharmaceutical has stepped up its efforts to produce more ZMapp, focusing on improving the expression of the antibodies in Nicotiana, the plant in which the drug is manufactured, said Larry Zeitlin, the company's president.

Brincidofovir prescribed to 2nd Ebola patient; Chimerix leaps

 
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All Wall Street eyes were on Chimerix again on 7 October after the news broke that a second Ebola patient in the US was being treated with the firm's experimental nucleotide analogue lipid-conjugate brincidofovir (CMX001).

Chimerix's brincidofovir grabs Ebola spotlight; Tekmira fades

 
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For weeks, Tekmira Pharmaceuticals has been the darling of Wall Street, with the firm's experimental medicine, TKM-Ebola, sharing the spotlight with privately held Mapp Biopharmaceutical's ZMapp as the shining lights of hope against Ebola, a disease that is ravaging West Africa.

Tekmira Ebola drug used in American doc, others

 
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After much speculation, Nebraska doctors at a special biocontainment unit treating an American physician infected with the Ebola virus confirmed on 22 September the experimental drug he received was indeed Tekmira's Pharmaceuticals' RNA interference (RNAi) medicine TKM-Ebola.

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