A rolling review of data on the use of remdesivir, an investigational antiviral medicine, for the treatment of COVID-19 has been started by EMA’s Committee for Medicinal Products for Human Use.

A high-level meeting on COVID-19 policies, organized by EMA under the auspice of the International Coalition of Medicines Regulatory Authorities (ICMRA), has brought together global regulators to ensure a coordinated pandemic response.

Boehringer Ingelheim will use the partnership to reveal novel insights into the complexities of various inflammatory diseases, which opens the potential for a clearer understanding of potential candidate biomarkers.

AbbVie and Allergan have satisfied all required antitrust clearances for the acquisition.

Tabrecta is approved to specifically target metastatic non-small cell lung cancer with a mutation that leads to MET exon 14 skipping (METex14).

Human cells form the source material for cell therapies and they require a variety of assays to detect bacterial, fungal, and viral contaminants.

Conventional cleaning methods can risk product loss of biologics, prompting biopharmaceutical manufacturers to seek alternative criteria to validate cleaning processes.

Quartic.ai and Bright Path Laboratories have agreed to develop an artificial intelligence (AI)-powered continuous manufacturing platform for APIs and other small-molecule drugs using Bright Path Labs’ continuous bioreactor and the Quartic.ai smart manufacturing technology.

CMO Evonik begins capacity expansion of APIs and intermediates at its sites in Dossenheim and Hanau Germany to increase EU supply security for drug products.

The center will be located at NJIT’s Life Sciences and Engineering center and will feature two good manufacturing practices suites that are expected to be completed and operational during the summer of 2020.

Remote, machine health monitoring services reduce the need for on-site visits.

EMA's Committee for Medicinal Products for Human Use has recommended that all ranitidine medicines be suspended within the European Union as a result of the presence of low levels of NDMA.

Catalent will manufacture a mRNA-based COVID-19 vaccine for clinical trials and potential commercialization.

Through the acquisition, Orbis will work to heighten Adare’s Pharmaceutical Technologies business, which handles the development and manufacturing of products for pharmaceutical, animal health, and over-the-counter markets.

Trial begins in the US for the Pfizer-BioNTech mRNA COVID-19 vaccine; manufacturing plans announced.

The extension of the company’s product offerings to include the anti-certolizumab pegol antibodies offers critical reagents for the development of assays for TNF alpha inhibitor biologics and their biosimilars.

The companies have entered into a manufacturing agreement to supply leronlimab, an investigational new drug currently being used in clinical trial protocols for COVID-19.

Kindeva Drug Delivery plans capital investment and jobs growth.

FDA approved hydroxychloroquine sulfate for emergency use as a treatment for some hospitalized patients with COVID-19.

Fujifilm allocates production volumes for COVID-19 treatments in 2021 at its Denmark facility.

Congressional leaders are developing the next version of the 21st Century Cures Act, including provisions to advance research related to the COVID-19 crisis as part of initiatives for bringing innovative therapies to market faster.

Policy makers seek to ensure supplies of new therapies and to limit shortages.

Will moving at “warp speed” to develop a vaccine impact efficacy or safety?

Having a better understanding about compliance will be of benefit when looking for a job or for furthering one’s career, says Siegfried Schmitt, PhD, vice-president, technical, Parexel Consulting.

In light of the hype around chloroquine and hydroxychloroquine as potential COVID-19 treatments, it is important to remember that drug repurposing should never be rushed, irrespective of the urgency of the situation.

FDA’s EUA provides the first new treatment for COVID-19 patients with severe symptoms.

The ASTM standard describes how to evaluate single-use systems for foreign particle analysis.

Supplier of punches and dies to tablet producers, I Holland, has reported that it will be revisiting its webinar series, investigating best practices in tablet manufacture, for those currently working from home.