Industry News

Global regulatory authorities have published a report describing the aligned positions on COVID-19 vaccine development, which were agreed upon by meeting participants of the second workshop on COVID-19 vaccine development.

The agency is hoping to restart performing on-site domestic inspections during the week of July 20, 2020 depending on factors such as the status of COVID-19 in the state of inspection and local rules and guidelines.

FDA officials are moving to clarify standards and requirements for vetting and approving viable preventives.

BARDA and DOD have awarded a $450-million contract to Regeneron Pharmaceuticals to manufacture and supply an investigational double antibody cocktail in development for treating COVID-19.

SGS has announced the receipt of approval from Belgium’s Federal Agency for Medicines and Health Products (FAMHP) to begin a new clinical trial of a potential treatment for patients with COVID-19 related respiratory failure.

The European Commission has approved Lynparza (olaparib) for use in patients with germline BRCA-mutated (gBRCAm) metastatic pancreatic cancer within the European Union.

The European Directorate for the Quality of Medicines and Healthcare (EDQM) has published a new general chapter (2.6.32) in the European Pharmacopoeia (Ph. Eur.) supplement 10.3.

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.

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

Emer Cooke, currently the director of the Regulation and Prequalification Department at the World Health Organization (WHO) in Geneva, has been nominated by EMA’s management board to be the new executive director of EMA.

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.

Members of the European Commission, EMA, and FDA met in a virtual two-day meeting to discuss ongoing joint initiatives and upcoming priorities.

The agency will be waiving fees for scientific advice for academia developing orphan drugs.

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.

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.

The report highlights agency’s accomplishments in 2019, including its relocation to Amsterdam.

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.

The Biomedical Catalyst has been relaunched, meaning that innovative biotech companies will have the opportunity to access a share of £30 million (US$38 million) in grant funding.

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

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

The 120-day pilot program was set up to help reduce the availability of unapproved opioids illegally offered for sale online.

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

The European Commission is pledging EUR 300 million (US$339 million) to Gavi for vaccines for infectious diseases, in addition to an earlier pledge of more than EUR 1.5 billion (US$1.7 billion) made on May 4, 2020.

The protocol on Northern Ireland (NI) once Brexit has been completed has received mixed opinions in industry, according to various press releases.