Pharmaceutical Technology Editors

The European Federation of Pharmaceutical Industries and Associations (EFPIA) has welcomed the latest statement by the members of the European Council on efforts to tackle COVID-19.

AstraZeneca has revealed that it will collaborate with Silence Therapeutics on the discovery, development, and commercialization of small interfering RNA (siRNA) therapeutics for the treatment of cardiovascular, renal, metabolic, and respiratory diseases.

Grifols has entered into a formal collaboration with US Federal public health agencies, including the Biomedical Advanced Research Development Authority (BARDA) and the Food and Drug Administration (FDA), to produce a treatment that specifically targets COVID-19.

The strategic alliance provides an integrated product offering around drug discovery and development.

The company has developed mathematical algorithms that generate simple cell-count data from a few days of culture.

The new NAB Nanosep device provides increased binding capacity.

The company has launched new high volume eight- and 12-channel pipettes, offering a capacity of 1250 µL per channel.

The transgenic mouse R&D platform will support the discovery of fully-human monoclonal antibodies.

Noting traditional clinical trials for COVID-19 convalescent plasma will take time, FDA is allowing physicians to submit requests for single-patient emergency INDs.

Bayer, Novartis, Mylan, Teva, report that they are working on supply.

In light of the current COVID-19 pandemic, the agencies co-chaired the first global regulators meeting to facilitate development of vaccines against SARS-CoV-2, which causes COVID-19.

The company announced the status of new and ongoing clinical trial activities during the COVID-19 pandemic.

Thermo Fisher is focused on investing to expand three specific areas of demand: biologics, cell and gene therapy, and drug product development and commercial capabilities.

Enhancements to Augury’s AI-based machine health platform include new capabilities and collaboration tools for personnel working remotely.

FDA has been working closely with other government agencies and academic centers that are investigating the use of the drug chloroquine to determine whether it can be used to treat patients with mild-to-moderate COVID-19.

Novartis will donate up to 130 million doses of generic hydroxychloroquine to support the global COVID-19 pandemic response.

Emergent BioSolutions will help develop and manufacture an oral vaccine candidate and will develop plasma-based antibody therapeutics.

Belgian-based bioprocessing provider, Univercells, has launched a CDMO, Exothera, that will support developers of cell and gene therapies through process development and production of viral vectors.

In a daily press briefing on March 18, 2020, the World Health Organization (WHO) announced that, along with its partners, it will be organizing a large international study that will compare various untested treatments for COVID-19.

The facility, which handles discovery chemistry services, will accelerate its operations over the next few weeks while taking precautions to guarantee the health and safety of its employees across every site.

Synairgen, a respiratory drug discovery and development company, has announced that it has received expedited approvals to conduct a trial of its inhaled formulation of interferon-beta-1a, SNG001, in COVID-19 patients.

The acquisition will expand Dover’s biopharma and hygienic applications capabilities by enhancing its portfolio of flow control technologies with flow rate sensors.

USP technical advisors will offer assistance to drug developers to ensure material quality and testing.

The partners have initiated an observational case-control study of siltuximab in patients with COVID-19 who have developed serious respiratory complications.

The guidance details considerations FDA has set in place to assure the safety of participants while maintaining compliance with good clinical practices and minimizing risks to trial integrity.

Evonik has announced that it has developed a collagen platform that has been made with fermentation-based processes and does not use any animal or human-derived materials.

The Pharmacovigilance Risk Assessment Committee (PRAC) of EMA has recommended that women stop taking 5-mg ulipristal acetate (Esmya and generic medicines) for the treatment of uterine fibroids while a safety review into potential liver injury risk is performed.

An NIH study of a COVID-19 vaccine is enrolling Seattle-based healthy adult volunteers.

Following reports, that are particularly circulating social media, questioning whether non-steroidal anti-inflammatories (NSAIDs), such as ibuprofen, worsen COVID-19, the European Medicines Agency (EMA) has issued advice.

FDA postpones routine domestic facility inspections due to the COVID-19 pandemic.