News

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.

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.

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.

The agency is postponing the inspection of most foreign facilities through April 2020.

The company is using its LEAPS peptide technology to develop the immunotherapy, which may be able to reduce COVID-19 viral load and tissue damage.

The new BIOSTAT STR Generation 3 with BIOBRAIN bioproduction platform offers process intensification with automated feed and bleed and integrated cell retention functionality.

European Union and national authorities are continuing to work on the prevention and management of nitrosamine impurities in medicines.

The Indian government has issued a notification of the restriction on the export of 26 APIs and formulations, including paracetamol, progesterone, and vitamin B12, as a result of the outbreak of COVID-19.

The global safety organization of Novartis is in the process of conducting a comprehensive review of a limited number of cases where patients treated with Beovu (brolucizumab) have experienced severe vision loss, inflammation, and potential retinal vasculitis.

The new center expands the company’s R&D capabilities and will help it advance its portfolio of rare disease gene therapy programs.