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…
Merz splits into 3 businesses for better customer focus
Merz, going for a strong customer focus, recently did something many of its pharma peers have done over the last few years: split into distinct operating businesses. The aesthetics unit, now called Merz Aesthetics, is the largest of the three, beating…
J&J now has to fight thousands more Risperdal claims, thanks to Pennsylvania’s high court
Johnson & Johnson has been battling legal issues on several fronts—ranging from opioids to talc to medical devices—and Wednesday, its fight got a little tougher. Pennsylvania’s Supreme Court ruled that lower courts had erred in dismissing two lawsuits from Risperdal patients…
AHA: Janssen drops clinical sites for smartphones, wearables in 100% virtual Invokana study
Johnson & Johnson’s pharmaceutical arm Janssen is launching its first completely virtual clinical trial, using personal smartphones and wearable devices to track participants with no in-person site visits required. The decentralized study, dubbed CHIEF-HF, aims to gather real-world evidence…
