Locally acting therapies are like a religion to Flexion Therapeutics (NSDQ:FLXN) co-founder & CEO Dr. Mike Clayman, who spent decades at Eli Lilly (NYSE:LLY) with the company’s co-founder, Dr. Neil Bodick, watching promising compounds fail in late-stage trials on the heels of unanticipated safety results. “That’s part of the reason, not the whole reason but part of […]
Pharmaceuticals
FDA approves first once-monthly buprenorphine injection to treat opioid addiction
Indivior (LON:INDV) shares jumped today after the FDA approved its once-monthly buprenorphine injection for the treatment of opioid addiction in adult patients who have started therapy with a transmucosal buprenorphine product. The company’s once-monthly injection is the first medication-assisted treatment option of its kind, the regulatory agency touted. Before Indivior’s Sublocade was approved, all other available […]
Ascensia Diabetes Care highlights women helping to advance diabetes care
In support of World Diabetes Day earlier this month, Ascensia Diabetes Care published 30 portraits of women who are working to advance diabetes care. The company’s CEO, Michael Kloss, said he was inspired by the theme of this year’s annual event, Women and Diabetes, and turned within the company for nominations of inspiring women. “We initially […]
NIH launches first large-scale trial of long-acting injectable HIV prevention drug
The National Institutes of Health said today that it has launched the first large-scale clinical trial of a long-acting injectable drug for HIV preparation in sexually-active women. The NIH is funding the study in partnership with ViiV Healthcare and the Bill & Melinda Gates Foundation. The study, which is being conducted in southern and eastern […]
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 […]
Onduo taps Glytec’s insulin therapy software as part of virtual diabetes clinic
Glytec has inked a deal with Onduo to integrate the company’s Glucommander Outpatient insulin management software into Onduo’s virtual diabetes clinic. Onduo, a joint venture of Sanofi (NYSE:SNY) and Verily, is reportedly working to develop a platform that brings together medical devices, software and support from healthcare experts to help people manage their Type II diabetes. The […]
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 […]
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 […]
One Drop wants to help lead a healthcare revolution for people with diabetes – here’s how
When Jeff Dachis was diagnosed with Type I diabetes four years ago, he remembers leaving the doctor’s office with a sinking feeling in his chest. “I had about six minutes with a nurse practitioner and was given an insulin pen and a prescription and a pat on the back – and I was out the […]
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 […]