
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.

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.

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

The acquisition will expand Nexelis’ immunology testing expertise.

The action involves allowing specific National Institute for Occupational Safety and Health-approved respirators not regulated by FDA to be used in healthcare settings to increase the number of respirators available in the United States.

The conference, which was originally scheduled for March 31–April 3, 2020 at the Messe München in Germany, will be rescheduled for Oct. 19–22, 2020 at the same location.

Research from data and analytics company GlobalData shows that CAR-T cell therapy innovations across APAC will make the global market for these therapies more competitive.

FDA issued a notice to drug compounders regarding the transition of licensure of biologics to the Public Health Service Act.

The technology enables the rapid production of large numbers of recombinant antibodies at 80-mL scale.

A guidance document answers questions regarding the transition of biologics applications from under the FD&C Act to the PHS Act.

The deal is expected to close during the first half of 2021.

The therapy works by transferring pathogen-specific antibodies from plasma gathered from recovered individuals into an infected patient, which may help the patient’s immune system respond and increase recovery.

The organization is postponing its annual meeting to July 2020 because of the developing COVID-19 outbreak.

Under the agreement, Takeda will divest the rights, title, and interest to 18 over-the-counter and prescription products sold in Brazil, Mexico, Argentina, Colombia, Ecuador, Panama, and Peru.

The acquisition will give Gilead access to Forty Seven’s investigational lead product candidate, magrolimab, a monoclonal antibody in clinical development for the treatment of numerous cancers.

The partners will use ProBioGen’s DirectedLuck transposase technology to support development and large-scale manufacturing of ImmunOs’ biologics.

With the first announced drug shortage tied to the coronavirus outbreak, FDA emphasizes urgency for monitoring drug supply chain.