Maintaining pharmaceutical operations during a pandemic through innovation and remote technologies
G Balaji and Ravi Kalla explains how Pharma 4.0 can be implemented at a CRO to enable work to continue even during a global pandemic.
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G Balaji and Ravi Kalla explains how Pharma 4.0 can be implemented at a CRO to enable work to continue even during a global pandemic.
The neutralising antibody therapy bamlanivimab (LY-CoV555) is authorised for emergency use in recently diagnosed patients who are at risk of developing severe COVID-19.
The acquisition will strengthen Merck’s oncology pipeline with VLS-101, an investigational antibody-drug conjugate in trials for haematological malignancies and solid tumours.
The COVID-19 vaccine candidate BNT162b2, made by Pfizer and BioNTech, has demonstrated over 90 percent efficacy in its first interim analysis during its Phase III trial.
The clinical trial testing the REGN-COV2 antibody cocktail should be altered, according to the Independent Data Monitoring Committee (IDMC).
The agency has compiled a list of essential medicines, medical countermeasures and critical inputs, as directed by Trump’s executive order in August.
The European Commission (EC) has approved Zejula, the first PARP-inhibitor monotherapy approved in the EU for patients with advanced ovarian cancer, regardless of their biomarker status.
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.