The U.K.’s Medicines and Healthcare products Regulatory Agency (MHRA) published guidance March 19 aimed at prioritizing and providing assistance for clinical trial applications submitted for trials targeting COVID-19.
The U.K.’s National Institute for Health and Care Excellence (NICE) said Gillian Leng was appointed its new chief executive. Leng has held the post of deputy chief executive at NICE since 2007 and is also currently its director of health and social care. She will step into the new role on April 1 when Andrew Dillon, who has led the organization since its establishment in 1999, steps down.
The U.S. Department of Health and Human Services (HHS) said it launched a public-private partnership to create a U.S.-based, high-speed, high-volume emergency drug packaging solution using low-cost prefilled syringes. Working with HHS' Office of the Assistant Secretary for Preparedness and Response (ASPR), the new consortium for Rapid Aseptic Packaging of Injectable Drugs, or RAPID, will enable the Strategic National Stockpile (SNS) to fill and finish, on a rapid basis, hundreds of millions of prefilled syringes to respond quickly and efficiently to widespread health emergencies, such as the novel coronavirus outbreak. Projects are under evaluation to expedite that process and could yield results within six months. ASPR awarded Apiject Systems America, the public benefit corporation leading RAPID, with an award valued up to $456 million for research and development of blow-fill-seal (BFS) prefilled syringes, rapid prototyping and stability testing of select medical countermeasures from the SNS in those devices. Apiject Systems America will recruit the private and philanthropic investment necessary to create year-round domestic manufacturing facilities of aseptic BFS prefilled syringes for population-scale surge response capacity during health emergencies.
The Institute for Clinical and Economic Review (ICER) release a draft evidence report assessing the comparative clinical effectiveness and value of obeticholic acid (Intercept Pharmaceuticals Inc.) for the treatment of nonalcoholic steatohepatitis (NASH). To enable clinical experts and patient advocates to respond to the COVID-19 pandemic, ICER expanded the timeframe for that assessment, and the draft report will now be open to public comments until 5 p.m. ET on June 24, 2020. The report will be subject to deliberation during a public meeting of the Midwest Comparative Effectiveness Public Advisory Council, one of ICER’s three independent evidence appraisal committees, on a date to be determined.