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Inhaled antibody treatment for COVID-19 shows success in pre-clinical trials
Researchers have developed a monoclonal antibody called AR-711 that is highly neutralising against COVID-19 in an inhaled formulation.
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Therapeutics
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Bioprocessing & Bioproduction In-Depth Focus 2020
Articles in this in-depth focus discuss the challenges facing advanced therapy medicinal product developers and which leadership qualities could be implemented to drive innovation in biologics.
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Study suggests dolutegravir is the optimal first-line HIV medication
Researchers comparing dolutegravir to efavirenz suggest dolutegravir increases viral suppression and has similar rates of adverse events.
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The FDA requires changes to NSAID labelling
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.
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Telstar’s centre in the UK consolidates its business growth with move to new higher-capacity modern installation
Specialised in aseptic and containment barrier Isolation technology systems, Telstar UK has seen increased demand for its products from all across the life sciences sector has grown significantly in the past few years.
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Bioanalytical testing services market to become a $4.5 billion industry
A report found the rise in outsourcing, growing popularity of biologics and expanding acceptance of quality-by-design approaches would drive the market expansion.
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European Pharmaceutical Review Issue 5 2020
In this issue you can find articles discussing the supply chain implications of Trump's 'Buy American' order, guidance on how to identify and justify starting materials for regulatory approval by both the EMA and FDA, as well as some of the latest developments in oral biologic drug delivery techniques. Also…
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MHRA joins international regulatory consortium
By joining the Access Consortium, the MHRA will work together with agencies from Australia, Canada, Singapore and Switzerland to expedite therapeutic product approvals.
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NIAID trial to identify potential COVID-19 treatments for further development
The adaptive ACTIV-5/BET study will test two monoclonal antibody therapies in hospitalised COVID-19 patients to establish if they warrant larger clinical trials.
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US FDA approves the first Ebola virus treatment – Inmazeb
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.
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US enters agreement for experimental prophylactic COVID-19 antibody cocktail
The US government will develop and manufacture AstraZeneca’s investigational monoclonal antibody cocktail, AZD7442, a potential prophylactic treatment for COVID-19.
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EC signs a joint procurement contract for remdesivir
The European Commission (EC) has signed a joint procurement contract to ensure an uninterrupted supply of Veklury (remdesivir) for participating countries.
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Trial testing anti-coronavirus hIVIG plus remdesivir in COVID-19 patients
The ITAC trial will establish if adding hyperimmune intravenous immunoglobulin (hIVIG) to a remdesivir regimen can improve hospitalised COVID-19 patient outcomes.
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NoveCite to develop stem cell therapies for COVID-19 related respiratory distress
NoveCite has an exclusive licence to develop and commercialise mesenchymal stem cell therapies to treat acute respiratory conditions such as Acute Respiratory Distress Syndrome (ARDS).
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Dolutegravir plus lamivudine shows non-inferior HIV-1 suppression in Phase III trials
Dolutegravir plus lamivudine was as effective at suppressing HIV-1 in adult trial participants as a three-drug regimen, dolutegravir plus tenofovir disoproxil fumarate/emtricitabine (TDF/FTC).
