Tuesday, April 9, 2019
ChromaDex reports results for preclinical study using B3 vitamin NR
ChromaDex reported that results of a new preclinical study showed that supplementation with B3 vitamin nicotinamide riboside, or NR, helps maintain heart function in mice by stimulating a conserved cellular response called the “mitochondrial unfolded protein response”, or UPRmt, that helps maintain mitochondrial function. The study also presents preliminary human data to support future testing of NR in humans. The independent study results were published yesterday in the Journal of the American College of Cardiology, or JACC. This study follows clinical results from last year highlighting the potential for NR supplemention to improve cardiovascular health
Mallinckrodt announces retrospective analysis on Acthar Gel published
Mallinckrodt announced data from a retrospective chart review that analyzed physician assessments of 91 U.S. patients diagnosed with uveitis who had been treated with Acthar Gel in the previous 12 months. All patients had completed or were still receiving treatment at the time of the review. In response to a survey question, physicians reported that 84% of patients who completed or were still in treatment with Acthar Gel had improvement in disease status overall, and 86% had improvements in vision. Uveitis is a cause of preventable blindness in adults. Results of the study were recently published online ahead of print in the Journal of Ocular Pharmacology and Therapeutics. Acthar Gel is FDA-approved for the treatment of severe acute and chronic allergic and inflammatory processes involving the eye and its adnexa such as: keratitis, iritis, iridocyclitis, diffuse posterior uveitis and choroiditis, optic neuritis, chorioretinitis and anterior segment inflammation. The study was a retrospective medical record review of physicians’ assessments of 91 patients diagnosed with uveitis, most of whom had moderate to severe visual impairment, who were treated with Acthar Gel. Average time since diagnosis was four years. All patients had received treatment with Acthar Gel in the past 12 months and had either completed a course of Acthar Gel or were receiving Acthar Gel treatment at the time of data collection. There were 17 different initial dosing regimens documented in the study, however, most patients were prescribed an initial regimen of 40-80 units, administered subcutaneously once or twice weekly. According to the Acthar Gel prescribing information, usual dosing of Acthar Gel is 40-80 units via subcutaneous or intramuscular injection every 1-3 days. Based on notes in medical records, physicians reported that overall disease status had improved in 84% of patients after therapy with Acthar Gel. Overall 86% had improvements in vision, 27% had improvements in eye pain, 26% had improvements in vitreous haze, 24% had reduction of background medication use, 23% had improvements in vitreous flare and 18% had improvements in macular edema. The study was a retrospective collection of data from medical records, which may be incomplete.
EMA agrees to Soligenix’s Pediatric Investigation Plan for SGX942
Soligenix announced that the Pediatric Committee, or PDCO, of the European Medicines Agency, or EMA, agreed to the Company’s Pediatric Investigation Plan, or PIP, for SGX942, or dusquetide. It was also agreed that the Company may defer conducting the PIP until successful completion of its ongoing pivotal Phase 3 clinical study evaluating SGX942 as a treatment for oral mucositis in patients with head and neck cancer, or HNC. As part of the regulatory process for the registration of new medicines in Europe, pharmaceutical companies are required to provide a PIP outlining their strategy for investigation of the new medicinal product in the pediatric population. Soligenix will be able to file the adult indication MAA prior to completion of the PIP because the PDCO permitted the Company to defer conducting the pediatric program until the benefit/risk of treatment has been established in the adult population. Following a potential approval of the SGX942 MAA for treatment of oral mucositis in adult patients with HNC, Soligenix will work with PDCO and EMA to include appropriate pediatric data in the approved labeling.
Alkermes says ALPINE study met pre-specified primary endpoint
Alkermes announced positive results from ALPINE, a first-of-its-kind, six-month study evaluating the efficacy, safety and tolerability of ARISTADA and INVEGA SUSTENNA when used to initiate patients experiencing an acute exacerbation of schizophrenia in the hospital and maintain treatment in an outpatient setting. Patients randomized to the ARISTADA treatment group were initiated using the ARISTADA INITIO regimen followed by ARISTADA every two months. Patients randomized to the INVEGA SUSTENNA treatment group were initiated using a loading dose of INVEGA SUSTENNA followed by INVEGA SUSTENNA every month. The ALPINE study met its pre-specified primary endpoint, demonstrating that both ARISTADA and INVEGA SUSTENNA had statistically significant and clinically meaningful reductions in Positive and Negative Syndrome Scale total scores from baseline at Week 4. Additionally, PANSS total scores continued to improve at Week 9 and Week 25, the study’s pre-specified secondary endpoints. Improvements in PANSS total scores from baseline were similar and not statistically different between treatment groups at any assessment time point during the study.
Morgan Stanley downgrades Biohaven to Equal Weight on valuation
Morgan Stanley analyst Matthew Harrison downgraded Biohaven Pharmaceutical to Equal Weight from Overweight, citing his view that the stock’s current valuation reflects a balanced risk/reward. However, he noted that he continues to see a high probability of success for lead product candidate rimegepant in the acute treatment of migraine and expects approval of the drug in early 2020. Harrison has a $55 price target on Biohaven shares.
Myriad Genetics submits 1st PMA application module to FDA for test
Myriad Genetics announced that it has submitted the first module of its premarket approval, or PMA, application to the FDA for its myChoice HRD CDx test. Myriad is submitting myChoice HRD as a companion diagnostic for the identification of patients with ovarian, fallopian or primary peritoneal cancer who have received three or more lines of therapy and whose tumors harbor a BRCA mutation or are BRCA wild type yet are deficient in homologous recombination DNA repair and sensitive to their last round of platinum and could derive clinical benefit from treatment with the poly ADP ribose inhibitor Zejula.
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