News

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

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.

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.

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.

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.

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.

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

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

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

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.

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.

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.

The CPhI event, which was originally scheduled for May 5–7, 2020 at the Pennsylvania Convention Center in Philadelphia, PA, will be rescheduled for Sept. 9–11, 2020 at the same venue.

The project, which will be titled the COVID-19 Therapeutics Accelerator, will work to pinpoint which new and repurposed drugs and biologics can treat patients immediately, and which can treat patients long-term.

Through the agreement, Emergent will manufacture the vaccine, which is formulated based on Novavax’s proprietary recombinant protein nanoparticle technology platform and its Matrix-M adjuvant to boost immune responses.

Launched in 2018, the Poseidon network works to bring together pharmaceutical providers to reform the pharmaceutical logistics process.

The decision comes after results were received from a Phase 1, open-label study that evaluated the safety, pharmacokinetics, and preliminary efficacy of the monotherapy

Through the agreement, Bora will obtain ownership of the entire Mississauga site, including all facilities, under the proper regulatory clearances.

New dates for the postponed event are still being determined.