Participants in two dosing cohorts in Moderna’s mRNA-1273 study reached or exceeded neutralizing antibody titers generally seen in convalescent sera. / read more /
The International Coalition of Medicines Regulatory Authorities held a virtual meeting of regulators from around the world to discuss policy issues and regulatory requirements to respond to the ongoing COVID-19 pandemic. / read more /
As Operation Warp Speed initiative to provide new COVID-19 vaccines and therapeutics for patients ramps up, biopharma companies and federal agencies have been working overtime and assuming considerable risk to be able to supply billions of doses of any safe and effective preventive. / read more /
Vibalogics will manufacture additional clinical trial material for the lead COVID-19 vaccine candidate currently in development by the Janssen Pharmaceutical Companies of Johnson & Johnson. / read more /
The European Medicines Agency is emphasizing the need for the research community to pool resources to determine which COVID-19 treatments and preventions are safe and effective. / read more /
The EU Executive Steering Group on Shortages of Medicines Caused by Major Events met on May 13, 2020 to discuss measures the European Union is taking to ensure the availability of medicines during the COVID-19 pandemic. / read more /
Ori Biotech and CellGenix announced a non-exclusive strategic partnership to achieve closed-system preparation, formulation, and addition of CellGenix media and growth factors within CGT manufacturing for users of the Ori platform / read more /
Michelle McMurry-Heath will assume the role of BIO president and CEO on June 1, 2020 after Jim Greenwood, who has led the organization since 2005, retires from the positions. / read more /
Suppliers to the bio/pharma industry are sharing news about the business operations during the global COVID-19 pandemic. To view current information about the company’s business operations, click the company name. / read more /
Evonik opened a new facility for GMP manufacturing of bioresorbable polymers and excipients for pharmaceutical and medical applications in Birmingham, Alabama, USA. / read more /
Industry must never become complacent about the safety of drug products and should seek to continually perform surveillance even if the drug is well-established. / read more /
The article reports on the CuDAL-Excel program designed for industry practitioners to calculate the USP passing probability of content uniformity and dissolution tests for both sampling plan 1 and sampling plan 2 scenarios, and for both immediate release and extended release requirements. / read more /
In Pharmaceutical Technology's ongoing Pharmacopoeia Compliance Series, experts explain the revision process for global and national pharmacopoeias, best practices for monitoring changes, and how to participate in revisions. Other features include FDA warning letters, building a quality culture, and essentials for DOE and QRM.
