Novartis and Amgen’s migraine drug erenumab has got a further boost with new phase 3 data showing it halved migraine days in 50% of patients. The companies published top line results from STRIVE around a year ago, but they have…
New Teva CEO axes R&D chief Hayden in boardroom shakeup
Shares in troubled Teva Pharmeceuticals have ticked up after incoming CEO Kare Schultz pledged to tackle “internal inefficiencies”, shaking up the company and axeing three high-profile executives. This includes Michael Hayden, who has been the company’s head of research since…
Catalyst to re-submit rare disease drug after trial success
Catalyst Pharmaceuticals is to go back to the FDA with new data from Firdapse, its treatment for ultra-rare neuromuscular disease, Lambert- Eaton myasthenic syndrome (LEMS). The drug was rejected last February when the FDA refused to review Firdapse, saying its…
Vanessa Research starts Phase 2 clinical trials in early 2018 for Shylicine™
Vanessa Research, Inc. (VRI), an emerging healthcare and biotech company, attended its first meeting with the European Medicines Agency in October and will now start its Phase 2 clinical trials in the first quarter of 2018 for the rare disease…
Lilly looks to devices to revive diabetes division
Eli Lilly has unveiled a new partnership with diabetes device maker Dexcom to breathe new life into its diabetes division. The deal will see Dexcom’s continuous glucose monitors integrated into Lilly’s Connected Diabetes Ecosystem – a portfolio of diabetes devices including smart-pens,…
Experimental opioid digital pill successful in early trial
Another ‘digital pill’ that tracks adherence to a common opioid could be on its way to market thanks to a successful initial feasibility study. Earlier this month, the FDA approved the first-ever digital pill in the form of Otsuka…
Amazon more interested in shipping medical devices… for now
Amazon is setting its sights on shipping medical devices rather than pharmaceuticals – at least for the time being. Earlier this year, rumours of the retail giant’s imminent entry into the medicines market arose after news broke that it had…
Samsung Bioepis’ trastuzumab biosimilar gets EC approval for breast cancer
The European Commission (EC) has approved Samsung Bioepis’ Ontruzant, a biosimilar version of Genentech’s Herceptin (trastuzumab), for the treatment of breast cancer in early and metastatic stages and also for metastatic gastric cancer. Trastuzumab, which is a monoclonal antibody, is…
Microsoft starts to support clinical trials
Technology leader Microsoft has entered into a partnership with the life sciences consulting firm Parexel. This is to develop software capable of accelerating drug development for clinical trials. The partnership will utilize Microsoft’s Azure cloud computing platform. With this system,…
Alzheimer’s Disease Drug Fast Tracked by FDA
The FDA has given Fast Track Designation to an Alzheimer’s disease (AD) clinical drug that targets an underlying—and often untreated—pathology of the disease. Biopharmaceutical company Alzheon Inc.’s lead clinical investigational drug ALZ-801, a novel, oral anti-amyloid optimized prodrug of tramiprosate,…
