Amgen Inc., of Thousand Oaks, Calif., in collaboration with the Duke Clinical Research Institute disclosed plans to initiate the Cardiovascular Multi-dimensional Observational Investigation of the Use of PCSK9 inhibitors (cvMOBIUS) study, the first large-scale real-world study to assess lipid management and the impact of PCSK9 inhibitors on cardiovascular (CV) outcomes in clinical practice. While there is strong evidence demonstrating the efficacy of PCSK9 inhibitors from various randomized clinical trial studies, there is less information on the effectiveness of these medicines on CV outcomes in real-world practice, the company noted. The cvMOBIUS study will be conducted across the U.S. and Canada and will begin patient enrollment this month. A prospective observational registry of 8,500 adults eligible for treatment with a PCSK9 inhibitor will be followed for five years. In parallel, an electronic health record-based registry will follow a broader population of adults hospitalized with atherosclerotic CV disease at participating sites.
Bristol-Myers Squibb Co. (BMS), of New York, extended the expiration date of the offers to exchange notes issued by Celgene Corp., of Summit, N.J., for up to $19.85 billion aggregate principal amount of new notes to be issued by BMS and cash and the related consent solicitations being made by BMS on behalf of Celgene. The new date is 5 pm ET Nov. 20. (See BioWorld, Aug. 27, 2019.)
Bristol-Myers Squibb Co., of New York, and Pfizer Inc., of New York, disclosed the start of a randomized, controlled study, GUARD-AF (ReducinG stroke by screening for UndiAgnosed atRial fibrillation in elderly inDividuals). The study seeks to determine if earlier detection of atrial fibrillation (a-fib) through screening in previously undiagnosed men and women at least 70 years of age in the U.S. ultimately impacts the rate of stroke, compared to usual standard medical care. This study will also assess potential bleeding leading to hospitalization, and therefore provide an evaluation of net clinical benefit or harm. A-fib is the most common type of significant irregular heart rhythm, and it is estimated that 8 million people in the U.S. will be affected this year, the companies said.
Dermira Inc., of Menlo Park, Calif., is disclosing new scientific findings highlighting the role of IL-13 in amplifying itch and the role lebrikizumab plays in reducing itch at the 10th World Congress on Itch in Sydney. In laboratory experiments, cultured human sensory neurons were stimulated with IL-13 and subsequently introduced to several common itch-inducing agents (pruritogens), including histamine, serotonin and bovine adrenal medulla peptide 8-22. The experiments demonstrated that IL-13 directly interacts with human sensory neurons, enhancing the itch induced by those itch-inducing agents. When lebrikizumab was introduced, it significantly inhibited those potentiated itch signals to known pruritogens, demonstrating that lebrikizumab has the potential to block enhanced itch signals in inflammatory skin conditions such as atopic dermatitis. The finding supports the results observed in Dermira's phase IIb dose-ranging study.
Common shares of Liminal Biosciences Inc. are now approved for trading on Nasdaq and available starting Monday, Nov. 18, under the ticker symbol LMNL. The company's common shares continue to trade on the Toronto Stock Exchange as LMNL. Liminal operates from Cambridge, U.K., Rockville, Md., and Laval, Quebec. The company is designed to discover, develop and commercialize small-molecule compounds for respiratory, liver and renal diseases.
Data from Oragenics Inc., of Tampa Fla., demonstrating the first complete chemical synthesis of a bicyclic ring of semisynthetic homologs of Mutacin 1140 analogue using orthogonally protected lanthionines with solid-phase peptide synthesis were published in November's Journal of Peptide Science. Oragenics is developing antibiotics against infectious diseases and treatments for oral mucositis.
Pieris Pharmaceuticals Inc., of Boston, and the University of Pittsburgh began a multiyear collaboration to study patient stratification strategies for streamlining therapeutic interventions as well as identifying and validating asthma targets. The school's research focused on long-term assessments of asthma patients, including responsiveness to a range of therapies. The research is informed by longitudinal samples of bronchoalveolar lavage fluid, bronchial epithelial brushings and blood, including peripheral blood mononuclear cells. Pieris will fund the research study.
Redhill Biopharma Ltd., of Tel-Aviv, Israel, said it will voluntarily delist its ordinary shares from trading on the Tel Aviv Stock Exchange (TASE). Under Israeli law and the TASE rules, the delisting of Redhill's ordinary shares from trading on the TASE will take place at least 90 days after the date of this announcement, which is expected to be on or about Feb. 13, 2020. Redhill's American depositary shares, each of which represents 10 ordinary shares, will continue to trade on Nasdaq under the symbol RDHL.
U.S. bankruptcy court for the District of Delaware has approved Sienna Biopharmaceuticals Inc.'s proposed bidding procedures and chapter 11 sale process timeline. Bids to acquire all or substantially all of the company's assets are now due to Cowen and Co. on or before Dec. 2, by 5 p.m. ET. The bidding procedures also set an auction of the company's assets for Dec. 5 and a hearing to consider sales approvals for Dec. 10 at 10:30 a.m. ET. In the interim, the Westlake Village, Calif.-based company will manage and operate its business under the jurisdiction of the court and applicable provisions of the bankruptcy code.