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On 6 August 2020, US President Donald Trump signed an executive order, dubbed ‘Buy American’, with the aim of increasing the production of essential medicines in the US for domestic use. Here, Victoria Rees discusses the order and what it means for drug manufacturers in the US and rest of…
Innocoll Holdings Limited has announced the commercial launch of the XARACOLL® (bupivacaine HCI) implant, a non-opioid treatment for acute post-surgical pain for up to 24 hours in adults following open inguinal hernia repair.
The safety and immunogenicity of CORVax12, a novel DNA-encodable COVID-19 vaccine, will be evaluated in 36 healthy volunteers.
Eli Lilly will provide the US government with vials of its COVID-19 antibody therapy bamlanivimab (LY-CoV555) if the treatment is granted Emergency Use Authorisation.
Clinical trials for AZD1222, the AstraZeneca COVID-19 vaccine candidate, have resumed across the world after confirmation it is safe to do so.
The study will establish whether NOviricid can improve COVID-19 patient outcomes and survival in 840 recently diagnosed African American patients with comorbidities.
There are significant interpretational differences between the European Medicines Agency (EMA) and US Food and Drug Administration (FDA)’s guidance on active pharmaceutical ingredient (API) starting materials. In this article, Dave Elder explores the ambiguity in guidance from both agencies and addresses why industry struggles to identify and justify starting materials…
The FDA has given marketing authorisation for Veklury (remdesivir) to treat COVID-19 patients requiring hospitalisation.
The FDA is requiring that the prescribing information for nonsteroidal anti-inflammatory drugs (NSAIDs) include warnings about potential foetal kidney problems if taken by women over 20 weeks pregnant.
The US Food and Drug Administration (FDA) has approved Inmazeb (atoltivimab, maftivimab, and odesivimab-ebgn) for the treatment of Zaire ebolavirus infection in adults and children.
J&J has paused its Phase III trial for its COVID-19 vaccine candidate following an unexplained illness in a study participant.
The US government will develop and manufacture AstraZeneca’s investigational monoclonal antibody cocktail, AZD7442, a potential prophylactic treatment for COVID-19.
The FDA has given small molecules APG-115 and APG-1252, two cancer treatments, Orphan Drug Designation.
Eli Lilly has given an update on its neutralising antibody programmes, including its combination therapy in patients with COVID-19.
The FDA has released new guidance for sponsors regarding Emergency Use Authorizations for potential COVID-19 vaccines.
