A recent report released by an FDA task force highlights the financial, manufacturing, and policy issues underlying the drug shortages of important prescription medicines in the United States.
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The agency’s implementation of the SUPPORT Act has included new guidance documents and actions to restrict illicit drugs entering the US.
CHMP has recommended that Ervebo (rVSVΔG-ZEBOV-GP), a vaccine for active immunization against Ebola, be granted conditional marketing authorization in the EU.
The goal of the investment is for the cures to be made available across the globe, including in sub-Saharan Africa’s low-resource communities.
The partners have developed a scalable, cost-effective purification process for adeno-associated viruses.
The CPhI Pharma Index points to Germany as having consolidated itself into a leading pharma industry.
The agency announced it has approved 1171 generic drugs in fiscal year 2019.
The guidance document discusses the preparation and submitting of drug master files as well as FDA’s review process.
The guidance discuses waivers, refunds, and reductions of user fees under sections 735 and 736 of the FD&C Act.
Innoveix Pharmaceuticals, Inc. is voluntarily recalling all sterile compounded drug products due to a lack of assurance of sterility.
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The agency announced that FDA scientists have developed candidate vaccine viruses that may be used to produce influenza vaccines.
The guidance describes an optional streamlined submission process for use of an investigational in vitro diagnostic in a clinical trial for oncology therapies.
AstraZeneca received approval from FDA for Fasenra Pen, a pre-fillled auto-injector pen that allows for self-administration of its asthma biologic therapy, Fasenra (benralizumab).
Following the publication of a statement from the United Kingdom’s Secretary of State for Health and Social Care, Matt Hancock, on the continuity of medicines supply in a ‘no-deal’ Brexit scenario, the UK BioIndustry Association (BIA) has issued a response on Oct. 9, 2019.
Data showed that the drug candidate activated T regulatory cells, believed to serve a crucial role in protecting the body from uncontrolled inflammation or autoimmunity.
The companies agreed to a multi-year research and development collaboration that will focus on AI empowerment and exploration.
Researchers used advanced animal model lab tests to determine the new vector is 10 times more efficient at incorporating corrective genes into bone marrow stem cells than traditional vectors.
The agency seeks comments on a draft guidance designed to make the process conform to its original intent as a communication tool, rather than a roadblock to competition and innovation.
The project will focus on the development of an influenza vaccine that protects against multiple strains of the influenza virus in a single dose.
After months of planning and explaining, Janet Woodcock, director of the Center for Drug Evaluation and Research (CDER), finally gained approval for broad changes in its process and procedures for evaluating and approving new drugs.
A new educational platform by Quality Executive Partners offers on-demand digital courses with technical content, virtual reality, and real-time coaching with an initial focus on sterile product manufacturing and microbiology.
The project focused on accelerating the discovery and development of monoclonal antibodies and aimed to tackle the limitations in the biologics supply chain.
The new board will assume their positions at the 2019 ISPE Annual Meeting & Expo on Oct. 27–30, 2019 in Las Vegas, NV.
In parallel to the priority review designation for its biologics license application, Merck plans to scale up its doses of the investigational Ebola vaccine to meet global outbreak response needs.
The merger creates a combined organization with a leading position in the eClinical market.
The companies aim to integrate glucose sensing with insulin delivery technologies to help change the way diabetes is managed.
FDA approved the drug after a successful open-label study of children aged six to 11 years and living with the condition.
Time is running out on Ned Sharpless’ term as FDA acting commissioner, generating much talk as the administration shows interest in naming a new head for the agency.
The companies plan to create a new curriculum focusing on single-use applications training, cell therapy technology, process efficiency strategies, process development methodologies, and chromatography proficiency.
FDA issued a statement about the importance of reporting adverse events resulting from the use of compounded drugs.
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