Industry News

In an opinion article, FDA leaders commit to applying “the best science” to approval decisions.

CPhI has released the agenda for its forthcoming two-week virtual event, CPhI Festival of Pharma.

ECCRT and IDDI have established a partnership for the continuous development of IDDI global team members.

Industry leaders insist they will maintain high standards for clinical trials and regulatory submissions for new vaccines and therapeutics to combat COVID-19.

As public confidence in the drug development process waivers, leading vaccine developers promise to adhere to scientific and regulatory principles.

BIO leaders urge biopharmaceutical companies to apply scientific principles in seeking drug and vaccine approvals.

The agency sent a warning letter after an inspection of the company’s Sangareddy District, India found inadequate cleaning procedures.

The agency sent a warning letter to Acella Pharmaceuticals detailing CGMP violations and failures to oversee contract manufacturers.

Hahn promises transparency in the review and approval of COVID-19 vaccines.

Merck’s anti-PD-1 therapy, Keytruda, has received two new approvals from the Japan Pharmaceuticals and Medical Devices Agency.

The European Commission (EC) and Moderna have concluded exploratory talks on the potential purchase of Moderna’s COVID-19 vaccine candidate for Europeans.

FDA announced it had issued an emergency use authorization for convalescent plasma that would make it easier to provide this treatment to COVID-19 patients.

FDA issued an emergency use authorization for COVID-19 convalescent plasma treatments following a report on NIH concerns about insufficient studies and data.

BioMarin received the complete response letter for valoctocogene roxaparvovec, its gene therapy intended for treating severe hemophilia A.

EC finalizes agreement to purchase millions of doses of AstraZeneca's COVID-19 vaccine.

The UK's MHRA will resume on-site risk based GxP inspections from September 2020.

Novavax has signed an agreement with the UK government for 60 million doses of a COVID-19 vaccine and a Phase III clinical trial.

A new FDA guidance provides answers to such questions about when the agency will seek to visit a site during the COVID-19 pandemic and how it will respond when a needed inspection cannot be conducted safely.

The agency provides recommendations for development and labeling of drugs to treat male patients with breast cancer.

Questions about safety and efficacy surround Putin’s announced approval of a COVID-19 vaccine with no supporting clinical trial results.

The guidance is intended to assist IND sponsors in determining the need for drug-drug interaction studies.

The White House initiative to encourage production of essential medicines in the United States calls on FDA to set the parameters for and implement main aspects of the program.

The award will help a bioanalytics startup commercialize instrument technology for pharmaceutical antibody manufacturers.

The therapy, indicated for a rare form of B-cell non-Hodgkin’s lymphoma, was developed by Kite, a Gilead company, which will manufacture the therapy at its facility in El Segundo, CA.

Healthcare groups met in late July 2020 to discuss the state of the US pharmaceutical supply chain and the impact of COVID-19.

As biopharma companies and research institutes advance the development of COVID-19 vaccines, policy makers and health officials are debating strategies for ensuring fair and equitable distribution of anticipated preventives.

Efforts by regulators seek common approaches to clinical research and biopharmaceutical production needed to wipe out the coronavirus pandemic globally.

Avacta Group has expanded its partnership with Daewoong Pharmaceutical to include Affimer molecules that target viruses, such as coronavirus.