Dive Brief: Two long-term studies of FDA-mandated registries have linked Boston Scientific’s left atrial appendage closure device, called Watchman, to significant reductions in stroke risk. In a paper posted in the Journal of the American College of Cardiology Monday, researchers presented…
FDA qualifies tool for assessing safety of implanted devices
Dive Brief: FDA qualified a tool designed to make it easier for developers of active implantable medical devices (AIMDs) to prepare safety test results, it announced Thursday. The tool, which was developed by ZMT Zurich MedTech, generates statistical data based…
New Anti-Aging Clinical Trial Begins. For $1 Million, You Can Be a Trial Participant
A Kansas-based company launched a clinical trial in Colombia to reverse aging. But will it work? An American biotech company has launched clinical trials in Colombia to test a new therapy designed to reverse the aging process, and in turn,…
Almirall takes a leap into dermatology digital health innovation
The company is launching a call for innovation for early-stage start-ups focused on developing digital health services and solutions to tackle some of the present and future dermatological challenges The call was launched at the first Barcelona Health Hub Summit,…
BACK Real-world or real evidence? Real-world or real evidence?
There was a time when the distinction between data from clinical trials and data from any other source was clear. Clinical trials created clinical evidence to determine regulatory decisions and guide clinical practice; whereas all other data was of second…
Novartis says mid-stage pipeline is setting up strong growth spurt
Novartis kicked off its R&D update in London this morning by pledging to bring at least 10 drugs into pivotal trials in 2020 and 2021 from a mid-stage pipeline packed with 60 projects. All told, the Swiss group says it…
Acadia’s Nuplazid Hits the Mark in Late-Stage Dementia-Related Psychosis Trial
Shares of ACADIA Pharmaceuticals are soaring in premarket trading after the company announced full positive results from its Phase III HARMONY study evaluating Nuplazid (pimavanserin) for the treatment of dementia-related psychosis. The stock is up more than 20% to $53.26.…
Mylan and Biocon launch Herceptin biosimilar in US
Mylan and Biocon have launched their Herceptin biosimilar Ogivri in the US, the second challenger to Roche’s breast and stomach cancer blockbuster. The companies said that they launched Ogivri at a “competitive advantage” compared with Herceptin (trastuzumab) but gave no…
Astellas buys gene therapy company for $3bn
Astellas has announced it will be acquiring gene therapy specialists Audentes Therapeutics for a total equity value of approximately $3 billion, adding a new focus area to its drug discovery efforts. The deal gives Astellas access to Audentes’ AT132, in…
Neurocrine and Xenon agree $1.75bn epilepsy R&D tie-up
Two biotechs, Neurocrine Biosciences and Xenon, have announced a licence and collaboration agreement to develop first-in-class treatments for epilepsy in a deal worth up to $1.75 billion. Epilepsy is one area of neurology where pharma is having limited success –…
