Thermo Fisher is focused on investing to expand three specific areas of demand: biologics, cell and gene therapy, and drug product development and commercial capabilities. / read more /
Mylan and Pfizer announced a postponement of the transaction that would see Mylan and Upjohn Combined until the second half of the year as a result of the current COVID-19 pandemic. / read more /
The European Federation of Pharmaceutical Industries and Associations (EFPIA) has welcomed the latest statement by the members of the European Council on efforts to tackle COVID-19. / read more /
Prior to the global market downturn, data from the United Kingdom BioIndustry Association (BIA) and Informa Pharma Intelligence have revealed that biotech companies in the UK had raised £309 million (US$379 million). / read more /
AstraZeneca has announced that it has achieved approval in Japan for Lokelma (sodium zirconium cyclosilicate) for the treatment of patients with hyperkalemia (elevated blood potassium levels). / read more /
In light of the current COVID-19 pandemic, the agencies co-chaired the first global regulators meeting to facilitate development of vaccines against SARS-CoV-2, which causes COVID-19. / read more /
Data and analytics company GlobalData announced that there is a strain on the global biopharma industry’s supply chain due to the ongoing outbreak of COVID-19. / read more /
ProBioGen will facilitate the development of Immunogenesis’ monoclonal antibody candidate and will be responsible for manufacturing the drug at its new facility in Berlin, Germany. / read more /
Grifols has entered into a formal collaboration with US Federal public health agencies, including the Biomedical Advanced Research Development Authority (BARDA) and the Food and Drug Administration (FDA), to produce a treatment that specifically targets COVID-19. / read more /
As compounds become more complex in nature and biological ingredients are more widely used, stability testing approaches must follow suit and provide flexibility for developers. / read more /
No matter why change may be needed, it is important to comply with all the relevant regulatory requirements, says Siegfried Schmitt, PhD, vice-president, technical, Parexel Consulting / 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.
