Xofluza, a flu antiviral drug developed by Roche and Shionogi, is now approved in Europe for children age 1 and older. The European Commission decision expands the patient population for the drug, which was previously approved for treating adolescents and adults.
Nephrology products company Vifor Pharma is shelling out about $252 million combined up front to acquire Sanifit Therapeutics and Inositec, developers of drugs for a blood vessel complication affecting some chronic kidney disease patients. Both biotechs are in clinical trials with their respective lead drug candidates.
Epic led global, non-U.S. EMR purchasing in 2020, a year that saw strong activity in the arena despite the pandemic. But certain regions did experience a downswing, including Latin America, where Brazil saw a 50% drop in EMR purchasing.
In Europe, three major categories of care currently being aided by digital tools: distance diagnoses, internal communications, and external collaborations.
Which EHR vendors were the hottest across the globe? The KLAS "Global EMR Market Share 2017" report analyzes new hospital EHR contracts that happened all over the world in 2016.
More big news for Dexcom. Its G5 continuous glucose monitor will soon be available for use in several European countries.
A specialty drug is a class of prescription medications used to treat complex, chronic or rare medical conditions. Although this classification was originally intended to define the treatment of rare, also termed “orphan” diseases, affecting fewer than 200,000 people in the US, more recently, specialty drugs have emerged as the cornerstone of treatment for chronic and complex diseases such as cancer, autoimmune conditions, diabetes, hepatitis C, and HIV/AIDS.
Serious U.S. regulatory lags are driving the medical device business to Europe – with startups, clinical trial sites and market approvals all migrating eastward at a rapid clip. At the same time, the Food and Drug Administration has stated it has the vision for the U.S. to be the world’s leader in medical device innovation and manufacture. […]
LONDON (Reuters) – European drugs regulators gave their backing on Friday for marketing approval to be granted for Bayer’s drug Adempas, designed to treat pulmonary hypertension, and for GlaxoSmithKline’s diabetes medicine Eperzan. The regulator also backed a new drug from Dainippon Sumitomo Pharma called Latuda, for the treatment of schizophrenia, and Bemfola, a new biosimilar […]
(Reuters) - PTC Therapeutics Inc said a committee of the European Medicines Agency did not recommend conditional approval of its drug for the treatment of a rare muscular disorder, sending its shares down as much as 28 percent in premarket trading. The...
ZURICH (Reuters) – Novartis said it would ask the European health regulator to look at its heart failure drug serelaxin again after the body took an unfavorable position on it Friday. “Novartis announced today it will shortly submit a revised filing package, including new data analyses, for re-examination for conditional approval of RLX030, or serelaxin,” […]
Munck Wilson Mandala Partner Greg Howison shared his perspective on some of the legal ramifications around AI, IP, connected devices and the data they generate, in response to emailed questions.
Boston Scientific (BSX) announced it has received the CE Mark for its Vercise Deep Brain Stimulation System for the treatment of dystonia, “a neurological movement disorder characterized by involuntary muscle contractions.” Dystonia is the third most common movement disorder after Parkinson’s disease and essential tremor, and more than 500,000 patients in Europe have it, according […]
The healthcare startups in the race to launch an approved noninvasive, bloodless glucose meter for the growing diabetes patient population is on. While each company etches out its value proposition and aims for commercial launch, a look at what the devices with potential for success in this space have in common. What the successful breakout […]
The standard of care for port site closures in laparoscopic surgery may be changing. Irish medical device startup neoSurgical‘s first commercialized product, neoClose, officially launched this week in the U.S. Today, the Society of Laparoendoscopic Surgeons named the device one of the 2013 Innovations of the Year at the SLS Minimally Invasive Surgery Week Annual Meeting. […]
What with the medical device tax and regulatory hurdles, there is a lot of medical device startups are contemplating beginning business in Europe. But before you leap, look. Is America or Europe right for your company? Here are four tips to mull over from two CEOs who lead startups that have a strong European presence. […]
Think shock absorbers for the human body. Moximed could help active and young patients who have osteoarthritis prolong the amount of time before total knee replacement. The Heyward, Calif.-based company’s Kinespring Knee Implant System is a medical device that absorbs part of the load put on the knee, without changing anatomy. The device is positioned […]
