The shortage of semiconductor products has plagued the U.S. medical device industry for better than a year, but there is legislation in play in Washington that might bring some relief. The White House held a July 25 briefing during which President Joseph Biden promised his support for the CHIPS Plus Act of 2022, a development that could break a legislative logjam.
Turkey needs to provide a level playing field for foreign and domestic drug producers. That’s the recommendation of three World Trade Organization (WTO) arbitrators in a dispute resolution between Turkey and the EU.
The cost of providing COVID-19 vaccines and therapies for a possible fall surge in the U.S. is coming at the expense of testing and personal protection equipment. While other countries are planning for the expected surge by placing their orders for vaccines and therapies, “we are starting to lose our place in line,” White House Coronavirus Response Coordinator Ashish Jha said during a June 9 media briefing.
Advanced manufacturing company Linamar Corp. has created Linamar Medtech to leverage its skills in precision manufacturing in the medical device and components space. The new venture, which will operate as a separate division under the Linamar umbrella, builds on recent programs producing a range of products, including ventilator systems and parts, part of the COVID-19 pandemic response.
A congressional investigation into COVID-19 vaccine manufacturing failures at Emergent Biosolutions Inc. unveiled more troubling issues at the company’s Bayview facility in Baltimore, which had been awarded a lucrative U.S. government contract to produce vaccines for Johnson & Johnson.
Building on its partnership with the World Health Organization (WHO) to improve access in Sub-Saharan Africa to vaccines, drugs and medical technologies, the EU committed at least €24.5 million (nearly US$27 million) to fund projects aimed at tackling some of the barriers to that access.
The U.S. is making strides in addressing the drug and device supply chain vulnerabilities revealed by the COVID-19 pandemic, but there’s still a lot of work to do to reduce dependance on sole source suppliers and foreign manufacturing, according to a new Health and Human Services (HHS) report.
On the success of last year’s establishment of a global mRNA vaccine technology transfer hub in South Africa, the World Health Organization (WHO) announced its next step Feb. 23: the creation of a global biomanufacturing training hub in South Korea that will serve low- and middle-income countries wanting to produce biologics, such as vaccines, insulin, monoclonal antibodies and cancer treatments.
Moderna Inc. reached a milestone of sorts Jan. 31 as the U.S. FDA fully approved its COVID-19 vaccine, Spikevax (elasomeran), for use in adults. Meanwhile, the Moderna and Pfizer Inc.-Biontech SE vaccines are in the sights of the U.S. Congressional Progressive Caucus, which is pushing the Biden administration to do more to ensure global vaccination.
With COVID-19 taking a toll on the U.S. FDA’s inspection program, warning letters stemming from drug facility inspections have been few and far between for the past two years. Aurobindo Pharmaceutical Ltd., of Hyderabad, India, was one of the exceptions.
