Updated to include a statement from Abbott. Dexcom (NSDQ:DXCM) touted data today from a head-to-head trial comparing its G5 mobile continuous glucose monitoring system with Abbott‘s (NYSE:ABT) recently-approved FreeStyle Libre Flash glucose monitoring system. The I-Hart study, which enrolled 40 people with Type I diabetes, found that Dexcom’s device reduced patients’ time spent in hypoglycemia by […]
Clinical Trials
Verily, Sanofi and other industry players team up with NIH to advance Parkinson’s therapies
The National Institutes of Health is joining forces with the tech and pharmaceutical industries to speed the development of new drugs for Parkinson’s disease and identify biomarkers for the debilitating condition. Companies participating in the public-private partnership include Celgene (NSDQ:CELG), GlaxoSmithKline (NYSE:GSK), The Michael J. Fox Foundation for Parkinson’s Research, Pfizer (NYSE:PFE), Sanofi (NYSE:SNY) and Verily. Combined the […]
Sunovion touts pivotal Ph3 trial for Parkinson’s drug
Gearing up for a springtime FDA submission, Sunovion Pharmaceuticals reported today that its apomorphine sublingual film succeeded in a pivotal Phase III trial in patients with Parkinson’s disease who experience motor fluctuations. Without revealing the study’s full results, the Marlborough, Mass.-based company said that the trial met its primary and key secondary endpoints and that […]
Anika extends deal with UMass Amherst to develop rheumatoid arthritis therapy
Anika Therapeutics (NSDQ:ANIK) has inked a deal to extend its two-year-long collaboration with the Institute for Applied Life Sciences at the University of Massachusetts Amherst. The group plans to focus its efforts on developing a novel therapeutic candidate to treat rheumatoid arthritis. Anika and UMass reported that it hopes to bring the product into clinical trials […]
TapImmune brings therapeutic vaccines into the clinic for ovarian, breast cancer
In the past decade, new innovations and well-funded research have heralded in the era of immunotherapy. The pace of change within the field has amazed Peter Hoang, the chief executive of a Jacksonville, Fl.-based company working to develop therapeutic vaccines for cancer. “15 years ago, if you or I walked into a venture capitalist’s office, […]
Pulmatrix wins EU nod for inhaled dry-powder anti-fungal trial
The UK Medicines and Healthcare Products Regulatory Agency has given Pulmatrix (NSDQ:PULM) the go-ahead to launch its first-in-human study for an inhaled formulation of the anti-fungal drug, itraconazole. The company is evaluating its drug, Pulmazole, as a treatment for allergic bronchopulmonary aspergillosis in patients with asthma. The 42-patient Phase I/Ib study is slated to assess the drug’s safety […]
WaveForm touts clinical trial data for continuous glucose monitor
WaveForm Technologies said today that it has finished four clinical trials of its continuous glucose monitoring system and that it expects to win CE Mark clearance for the device this year. The WaveForm CGM system is designed to be worn for 14 days and includes a sensor insertion tool, a small sensor wire, a polymer […]
Medtronic touts therapy delivered via SynchroMed pump in patients with post-stroke spasticity
Medtronic (NYSE:MDT) touted data today showing that intrathecal baclofen therapy delivered via the company’s SychroMed II infusion pump performed better than the conventional treatment for patients with severe post-stroke spasticity. The medtech titan’s SynchroMed II pump is the only device approved in the U.S. for ITB therapy. The Sisters study pitted Medtronic’s ITB therapy against oral […]
Svelte Medical launches pivotal trial for drug-eluting stent-on-a-wire
The first patient has been enrolled in Svelte Medical System‘s Optimize pivotal trial, which is designed to evaluate the safety and efficacy of Svelte’s drug-eluting stent integrated delivery system and rapid exchange platforms. The 2,000-person trial comes in the wake of a first-in-man trial for Svelte’s product and a study comparing the system with Medtronic‘s […]
Eyenovia sets range for IPO
N.Y.-based startup Eyenovia updated its regulatory filings to reveal that it plans to offer 2.73 million shares priced between $10 – $12 apiece in its initial public offering. The 7-person company, which is developing a device to deliver small doses of drugs to the eye, is applying to list on the Nasdaq exchange under the […]