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.

FDA officials are rolling out guidance and support for researchers striving to assess potential treatments for COVID-19 while the agency tries to object to premature optimism and regain public credibility.

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.

FDA is offering advice and added flexibility to help sponsors adjust ongoing and planned clinical research programs during the COVID-19 outbreak.

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.

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.

The program features clickable PDFs and videos that display the best practice applications to clean and disinfect key equipment and surfaces, while allowing for customers to find the suitable cleaning products for their cleanroom operations.

The decision comes after a state-of-emergency was declared in Washington, DC, due to the ongoing outbreak of COVID-19.

The test will use Applied Biosystems TaqPath Assay technology and will work to provide patient results within four hours of a sample being received by a lab.

This article explores another proactive advocacy approach that a bio/pharmaceutical company may take through participation in the development of new and revised monographs in the various pharmacopoeias.

On March 11, 2020, Chancellor Rishi Sunak delivered the 2020 Budget to the government of the United Kingdom, revealing the proposed spending and tax plans for the conservative government for the coming year.

The National Institute for Health and Care Excellence (NICE) has issued a positive recommendation for Teva Pharmaceutical’s migraine therapy, Ajovy (fremanezumab).

Rapid deployment kits can facilitate tech transfer and allow for communication between operators onsite and experts offsite, despite travel bans and other limitations posed by the coronavirus (COVID-19) pandemic.

EMA, along with its partners across the European medicines regulatory network, are keeping a close watch on the pharmaceutical supply chains in the European Union as a result of the potential impact of COVID-19.

The trade and packaging fair, which was originally scheduled for May 7–13, 2020 in Düsseldorf, Germany, will be rescheduled for Feb. 25–March 3, 2021 in the same location.