Liberia

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).

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 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.

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 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.

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.

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).

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.

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.

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.