In this week’s news, US working to stop Covid-19 disruption, US FDA redefines “biologics” and more…
US FDA taking proactive approach to Covid-19 related supply disruption
The US FDA says the drug and medical device industries will be disrupted by the coronavirus outbreak that has sickened tens of thousands worldwide.
The US regulator outlined its efforts to prevent the outbreak that began in Wuhan – a major pharmaceutical and device manufacturing region – from impacting US supply lines.
It wrote “We are keenly aware that the outbreak will likely impact the medical product supply chain, including potential disruptions to supply or shortages of critical medical products.
“We are not waiting for drug and device manufacturers to report shortages to us—we are proactively reaching out to manufacturers as part of our vigilant and forward-leaning approach to identifying potential disruptions or shortages.”
The agency has contacted hundreds of drug and device firms and synced up with regulators, including the European Medicines Agency, to assess signs of potential manufacturing discontinuances or interruptions.
The FDA also pointed out there are no licensed vaccines, gene therapies, or blood derivatives that are manufactured in China.
US FDA finalises “biological products” definition ahead of drug rejig
The US FDA has issued a final rule amending its definition of “biological product.”
The move comes one month before the agency is due to re-designate certain older biological products – including insulin and human growth hormone – as biologics.
The amendment is the final stage of the process prompted by the Biologics Price Competition and Innovation Act of 2009 (BPCIA).
As of next month more than 100 products approved under new drug applications (NDAs) will be switched to biologics license applications (BLAs).
US FDA Commissioner Stephen Hahn said, “This transition will open new pathways for manufacturers to bring biosimilar and interchangeable versions of insulin and other transitioning products to market, facilitating greater competition in the marketplace.
Also in the news
Biopharmaceutical quality systems are the first line of defence against hackers according to an expert quizzed by Bioprocess Insider.
UK politicians are seeking to appoint a Chair of the Medicines and Healthcare products Regulatory Agency (MHRA). The closing date for applications is 17 March 2020.
The US NIH has held a workshop on the use of primates in early phase drug research. According to Science the focus was on the opportunities and challenges involved.
The coronavirus outbreak that began in China has prompted a surge in new clinical studies. Read STAT’s report here.
Humanetics has said it will buy all of DSM’s assets related to the API for BIO 300, a drug designed to protect against radiation poisoning.
Some developments of note in the CDMO space:
Bioprocess Insider put Catalent’s acquisition of cell therapy CDMO Masthercell in context with help from Dark Horse Consulting.
Wuxi Biologics has confirmed its manufacturing operations in Wuxi, Shanghai and Suzhou are fully operational.
EirGenix has been approved by Japan’s Pharmaceutical and Medical Devices Agency (PMDA), See press release.