Biosimilars could be brought to market much quicker in North America if a Trump administration proposal makes it into a new US-Canada-Mexico (USMCA) trade pact, according to press reports. Citing people familiar with the matter, the Wall Street Journal says…
Irish medtech sees continuing import boom from UK
Ireland’s medtech industry is importing more raw materials to keep pace with demand for its products, according to data published by the foreign exchange specialist Fexco International Payments. The analysis, of more than 7,500 transactions made through Fexco International Payments,…
Medical devices are bigger culprit in antibiotic-resistant infections than surgical procedures: CDC analysis
Dive Brief: Healthcare-associated infections (HAIs) that are antibiotic-resistant resulted more frequently from use of temporary medical devices than from surgical procedures, according to an analysis of patient data from 5,626 sites reported to the Centers for Disease Control and Prevention’s…
How to be compliant: What EU MDR 2020 regulations mean for you
Concerned about what the new EU MDR 2020 regulations mean to you? Volker Watzke, Domino Printing Sciences, offers advice on how to become compliant as quickly and efficiently as possible The deadline for ensuring compliance with the European Union’s Medical…
Medical device industry lags behind in quality management tech – report suggests
The medical device industry lags behind in technology adoption and Quality-as-an-Asset mindset, according to a report. The survey from the “State of Medical Device Product Development & Quality Management Report 2020” report, undertaken by Greenlight Guru, indicates that 81% of medical…
FDA approves Global Blood Therapeutics’ sickle cell pill
Global Blood Therapeutics has seen its sickle cell disease drug approved by the FDA, promising to be the first treatment targeting the root cause of the condition. The FDA has approved Oxbryta (voxelotor), a daily tablet for the treatment of…
COPD Market Expected to Grow as Number of Cases Continues Rising
Chronic obstructive pulmonary disease (COPD) is a group of diseases that causes breathing difficulties in nearly 16 million Americans and more than 250 million people around the world. It is estimated that COPD, which includes emphysema and chronic bronchitis, causes…
FDA Approves Sanofi’s Toujeo to Treat Childhood Type 1 Diabetes
The U.S. Food and Drug Administration (FDA) approved an expanded indication for Sanofi’s Toujeo (insulin glargine injection) for blood sugar control in adult and pediatric patients who are ages six years and older. Previously, Toujeo was approved only for adults…
Buying top-quality excipients is now as easy as ordering pizza
Buying top-quality excipients is now as easy as ordering pizza Guaranteeing the quality of your products is extremely important in our branch. The same applies to excipients. The rules associated with this ensure that they shouldn’t simply be bought from…
Torrent made children’s OTC meds with bacteria-tainted water, FDA says
In August, Torrent Pharmaceuticals recalled dozens of lots of over-the-counter cough syrups, nasal sprays and rectal suppositories that put children and adults at risk of bacterial infection. Now, the FDA has lambasted the Indian drugmaker for a poorly designed water…