Amag Pharmaceuticals to present data on Intrarosa at NAMS

Amag Pharmaceutical and Endoceutics announced an oral presentation regarding the effect of time since menopause, age, and previous hormone therapy on treatment efficacy of intravaginal 6.5 mg prasterone at the Annual Meeting of The North American Menopause Society, or NAMS. David Archer and colleagues analyzed combined data obtained from two prospective, randomized, double-blind, placebo-controlled clinical trials to evaluate the effect of daily intravaginal 6.5 mg Intrarosa administered for 12 weeks to women who identified moderate to severe pain at sexual activity as their most bothersome symptom, or MBS, of vulvar and vaginal atrophy, or VVA. The goal of the analysis was to assess the potential influence of time since menopause, age and previous hormone therapy on the response to treatment. Overall, there were 406 women treated with 6.5 mg Intrarosa and 234 women who received placebo. Women were divided into subgroups based upon time since menopause, age and if they had ever taken hormone therapy. While age and prior hormone therapy did not influence the overall efficacy of Intrarosa, the greatest reduction of dyspareunia had a tendency to be observed in women who were 1-2 years post menopause, compared to 3-5 years and more than 6 years post menopause, although the difference did not reach statistical significance.
https://thefly.com/landingPageNews.php?id=2799681

Oramed enrolls first patient in clinical study for oral insulin in NASH

Oramed has enrolled the first patient in an exploratory clinical study of its oral insulin capsule, ORMD-0801, in the treatment of nonalcoholic steatohepatitis, or NASH. The three-month treatment study will assess the effectiveness of ORMD-0801 in reducing liver fat content, inflammation and fibrosis in patients with NASH. Data from preclinical studies and clinical studies of ORMD-0801 demonstrate Oramed’s oral insulin capsule has the potential to reduce inflammation of the liver.
https://thefly.com/landingPageNews.php?id=2799719

Becton Dickinson price target raised to $280 from $250 at Morgan Stanley

Morgan Stanley analyst David Lewis expects Becton Dickinson will guide FY19 revenue growth to 5%-6% during its upcoming Q4 earnings, which he believes “seems achievable if not conservative.” Management is also likely to introduce revenue synergy guidance which should be higher, Lewis predicted. However, he thinks Becton’s reported earnings guidance is likely to come in below the Street consensus. Lewis raised his price target on Becton Dickinson shares to $280 to reflect a roll forward to CY20 estimates and he keeps an Equal Weight rating on the stock.
https://thefly.com/landingPageNews.php?id=2799737

Titan Medical achieves Q3 milestones for SPORT Surgical System

Titan Medical announced that the company has achieved all of its publicly stated Q3 development milestones for the SPORT Surgical System. It completed the improved camera insertion tube engineering confidence build. Titan Medical also completed design enhancements of both the surgeon workstation and patient cart in anticipation of system engineering confidence build by year-end. The company completed and demonstrated full suite of simulation training software for beta testing and filed three Q-submissions containing detailed protocols for animal, cadaver and human confirmatory studies for review by the FDA, approximately one year ahead of plan.
https://thefly.com/landingPageNews.php?id=2799759

Halozyme’s PEGPH20 data featured in Clinical Cancer Research publication

Halozyme announced the publication of nonclinical data for PEGPH20 in Clinical Cancer Research, an American Association for Cancer Research journal. PEGPH20 is the PEGylated version of Halozyme’s proprietary recombinant human hyaluronidase enzyme, rHuPH20. The paper demonstrates an association with increased collagen content, high tumor interstitial pressure, vascular collapse, hypoxia, drug resistance and increased metastatic potential. Treatment with PEGPH20 at the human equivalent dose degraded HA in the TME reversing these changes, and also depleted an important proangiogenic growth factor, VEGF-A165, suggesting that treatment with PEGPH20 may diminish the angiogenic potential of the TME. The accumulation of HA is common in many cancers, particularly in pancreatic cancer. A Phase 3 study evaluating the ability of PEGPH20 plus Abraxane and gemcitabine to increase Progression Free Survival and Overall Survival versus Abraxane and gemcitabine alone in metastatic pancreatic ductal adenocarcinoma patients, is under way.
https://thefly.com/landingPageNews.php?id=2799783

Adamas Pharmaceuticals publishes Phase 3 Gocovri Parkinson’s data

Adamas Pharmaceuticals announced that pooled Phase 3 data of Gocovri extended release capsules were published online in Parkinsonism and Related Disorders. Results from pooled Phase 3 ADS-5102 clinical trials, concluded that dyskinesias in people with Parkinson’s disease can impact a patient’s activities of daily living, or ADLs, across multiple tasks and that treatment with Gocovri can help ameliorate the impairment. Gocovri is the first and only medicine approved by the FDA for the treatment of dyskinesia in patients with Parkinson’s disease receiving levodopa-based therapy, with or without concomitant dopaminergic medications. It is also the only drug approved by the FDA to treat dyskinesia in people with Parkinson’s disease on levodopa therapy, as well as demonstrate a secondary benefit in reducing off time in that population. In the pooled Phase 3 analysis, most adverse reactions were of mild to moderate intensity, and the most common adverse reactions were hallucination, dizziness, dry mouth, peripheral edema, constipation, falls, and orthostatic hypotension. https://thefly.com/landingPageNews.php?id=2799797

Horizon Pharma to hold a webcast

Management provides an overview of the clinical data for Teprotumumab as presented at the Annual Meeting of the American Thyroid Association on a webcast to be held on October 4 at 10:30 am.

Webcast: https://edge.media-server.com/m6/p/azkcmuon
https://thefly.com/landingPageNews.php?id=2799807