Cordis and Medinol announced today that the FDA approved its Elunir drug-eluting stent for the treatment of patients with narrowing or blocked coronary arteries. The stent, designed by Medinol and distributed exclusively by Cordis in the U.S., features a novel metallic spring tip and the narrowest strut width of any stent on the market in […]
Clinical Trials
Lung cancer expert: Smoking stigma still hurting patients, families and research
A number of therapies designed to treat patients with lung cancer have been approved this year, including products from Novartis (NYSE:NVS), Merck (NYSE:MRK) and Bristol-Myers Squibb (NYSE:BMY). That progress is exciting for Dr. Fred Hirsch, the head of the International Association for the Study of Lung Cancer. “We do have a lot of good things to tell the […]
Fractyl raises $44m Series D for Revita DMR tech
Fractyl Laboratories said today that it raised $44 million in a Series D round, led by an undisclosed investor and first-time investors GV, True Ventures and the IDO Fund. Returning investors included Deerfield Management Company, Bessemer Venture Partners and others. The company said it plans to use the round’s proceeds to fund the continued development […]
Regeneron scraps Eylea combo therapy after disappointing early trial results
Regeneron (NSDQ:REGN) is scrapping plans for a new combination drug pairing its Eylea with angiopoietin2 antibody nesvacumab after disappointing results from mid-stage clinical trials, according to a press release it published on Monday. Regeneron received results from 2 Phase 2 trials, the Ruby and Onyx studies, which reported that the combination drug “did not provide sufficient differentiation […]
Dexcom inks continuous glucose monitoring deal with UnitedHealth
Shares in Dexcom (NSDQ:DXCM) rose 4% today after the company announced a partnership with UnitedHealth (NYSE:UNH) to assess if data from a continuous glucose monitor can help people with Type II diabetes manage their condition in a cost-effective way. UnitedHealth is slated to use CGM data, as well as diet and exercise activity, in a study […]
Rebiotix expands Phase I trial of microbiota product after initial study success
Rebiotix said today it is expanding the Phase 1 study of its investigative RBX7455 drug designed to prevent recurrent Clostridium difficile infections after initial success in its two introductory cohorts in the trial. The Roseville, Minn.-based company’s RBX7455 is a lyophilized, non-frozen oral capsule formation of its Microbiota Resoration Therapy which it says is designed to “rehabilitate […]
Egalet’s extended-release, abuse-deterrent opioid succeeds in Ph3 trial
Shares in Egalet Corp. (NSDQ:EGLT) soared this morning in pre-market activity after the company reported that its abuse-deterrent, extended-release oxycodone candidate met the primary endpoint of a Phase III pain relief trial. The Wayne, Penn.-based company compared the efficacy and safety of its product to a placebo in opioid-experienced and opioid-naïve patients with moderate-to-severe chronic […]
GSK to use Owlstone’s breath biopsy device in Phase II COPD trial
GlaxoSmithKline (NYSE:GSK) is slated to use Owlstone Medical‘s breath biopsy device in a phase II trial of its drug for chronic obstructive pulmonary disease, danirixin. The diagnostics company’s breathalyzer will be used to help GSK identify which patients will most benefit from the drug, as well as evaluate the effects of danirixin, according to the pharma company. […]
Bayer’s antibiotic drug-device combo fails in late-stage trial
Bayer (ETR:BAYN) reported last week that its antibiotic drug-device combination product failed in a phase III trial. In the 725-patient Inhale trial, Bayer’s Amikacin Inhale did not out-perform a placebo as a treatment for Gram-negative pneumonia in patients on ventilators. Bayer licensed the rights to Nektar Therapeutics‘ (NSDQ:NKTR) antibiotic-delivery product for $175 million in 2007, according […]
GSK, Innoviva seek expanded label for triple inhaler
GlaxoSmithKline (NYSE:GSK) and Innoviva (NSDQ:INVA) have submitted data from the landmark Impact trial to the FDA in the hopes of landing an expanded label for the Trelegy Ellipta triple inhaler. The two companies are hoping that their therapy could be used to treat airflow obstruction and to reduce exacerbations in people with chronic obstructive pulmonary disease. Trelegy Ellipta, […]