COVID-19 Update

The COVID-19 pandemic has created a rise in demand for R&D and a shift in focus for some contract organizations.

Data and science must guide FDA in making pressure-filled COVID-19 vaccine and therapy approval decisions.

As a result of disruptions caused by COVID-19, CPhI Worldwide 2020 in-person event will not be taking place in Milan, Italy, but instead will be a unique digital experience to connect the global pharma industry.

The guidance document provides recommendations regarding data needed for the manufacturing, development, and approval of a COVID-19 vaccine.

The company has provided updates on its COVID-19 tests under development with Adeptrix and Cytiva, respectively.

FDA is placing emphasis on developing guidance documents more quickly and efficiently, and agency officials expect that such approaches may continue in the future.

The company’s oral COVID-19 vaccine has been chosen to participate in a non-human primate challenge study organized and funded by Operation Warp Speed.

Catalent will offer vial filling, packaging capacity, and additional staffing at the site to support the production of the initial 100 million doses of the vaccine candidate to supply the US market beginning in the third quarter of 2020.

The company has expanded its laboratory test portfolio with five new molecular, serology, and functional assays for COVID-19 vaccine and therapy development programs.

Symbiosis Pharmaceutical Services has signed a supply agreement with AstraZeneca for the sterile manufacture of AZD1222, a COVID-19 recombinant adenovirus vaccine, to be used in clinical trials.

The European Medicines Agency’s (EMA’s) Committee for Human and Medicinal Products (CHMP) has recommended Veklury (remdesivir) be granted conditional marketing authorization in the European Union for the treatment of COVID-19.

Biotechnology company, ILC Therapeutics, has revealed that it has entered into a research partnership with the University of St Andrews aimed at progressing a therapeutic drug that can treat COVID-19 to clinical trials.

Inovio received a $71-million contract from the US Department of Defense to scale up manufacture of its Cellectra smart device to deliver its DNA vaccine.

The companies are expanding their existing collaboration and license agreement to develop mRNA vaccines for infectious diseases.

The guidance document provides recommendations for CGMP expectations to prevent contamination of drugs and exclude sick workers from participating in drug manufacturing.

The decision was made in order to give exhibitors enough time to adjust their plans in the wake of the continuing spread of COVID-19.

FDA has revoked its Emergency Use Authorization hydroxychloroquine and chloroquine, citing new evidence and reanalysis of earlier data confirming that the drugs show no evidence of effectiveness against the coronavirus and raise continued concerns about cardiovascular safety risks.

Cobra Biologics has signed a supply agreement to provide GMP manufacturing for AstraZeneca’s AZD1222 COVID-19 vaccine candidate.

The guidance provides recommendations on statistical considerations to address the impact of COVID-19 on meeting trial objectives for clinical trials conducted during the pandemic.

The International Coalition of Medicines Regulatory Authorities met again on June 12 to discuss policy approaches to the COVID-19 pandemic.

Citing clinical trial data that hydroxychloroquine did not show benefits for COVID-19 patients, FDA removes emergency use authorization for the drug as a treatment for the novel coronavirus.

Catalent will provide vial filling and packaging capacity to AstraZeneca at its manufacturing facility in Anagni, Italy, for the large-scale commercial manufacturing of the University of Oxford’s adenovirus vector-based COVID-19 vaccine candidate.

Oxford Biomedica, has signed a collaboration agreement with the not-for-profit organization, the Vaccines Manufacturing and Innovation Centre, to provide the UK with its first strategic vaccine development and advanced manufacturing capability.

According to a report from commercial law firm, Hill Dickinson, there is general support by the public of the United Kingdom that vaccine regulations should be relaxed in light of the current COVID-19 pandemic.

Will efforts to limit all returns on investment drive biopharma companies away from developing much-needed interventions for COVID-19.

The candidates will be used by the Vaccine Research Center, part of the National Institute of Allergy and Infectious Diseases at the National Institutes of Health.

Catalent will use its GPEx cell line development technology to create a cell line expressing the recombinant VLP at its Madison, WI facility.

The agency published guidance to clarify its enforcement of distribution of drug samples for drug marketing during COVID-19.

The agency has added a COVID-19 innovation resource page and an education resources page to its website.

Novavax announces DoD contract to produce 10 million doses of COVID-19 vaccine candidate.