Daily Top News – July 29, 2020

July 29, 2020

llllllllll Nucala (mepolizumab) / GSK
GSK Second quarter 2020 (GSK Press Release) – Jul 29, 2020 – “Nucala granted priority review by FDA for hypereosinophilic syndrome (HES). Decision expected H1 2021….Total Respiratory sales were up 17% AER, 16% CER, with strong growth from…Nucala in all regions. International Respiratory sales grew 17% AER, 17% CER, including Nucala, up 42% AER, 31% CER…Sales of Nucala were £241 million in the quarter and grew 24% AER, 21% CER, with US sales up 28% AER, 26% CER to £150 million. Europe sales of £54 million grew 4% AER, 6% CER and International sales of £37 million grew 42% AER, 31% CER including growth of the at-home use application.”


llllllllll GSK2881078 / GSK
GSK delivers Q2 sales of £7.6 billion -2% AER, -3% CER (Pro-forma -10% CER*) (GSK Press Release) – Jul 29, 2020 – “GSK’078 for COPD muscle weakness was terminated as data did not support progression in this indication….Initial data of the proof-of-concept study on the COPD candidate vaccine showed it did not meet the primary endpoint. Work is ongoing to better understand the data; no progression to Phase III is planned.”


llllllllll Ajovy (fremanezumab) / Otsuka, Teva
Teva Announces New Drug Application Filing in Japan for AJOVY (fremanezumab) Injection (Teva Press Release) – Jul 29, 2020 – “Teva Pharmaceutical Industries Ltd….today announced Otsuka Pharmaceutical Co., Ltd. has submitted an application to the Pharmaceuticals and Medical Devices Agency of Japan to obtain manufacturing and marketing approval in Japan for AJOVY® (fremanezumab) injection for the preventive treatment of migraine.”


llllllllll Jay Pharma to File IND Applications to FDA for a clinical study of proprietary formulations in Radiodermatitis and a combination Therapy in Glioblastoma (PRNewswire) – Jul 29, 2020 – “AMERI Holdings, Inc…announced that its proposed amalgamation partner Jay Pharma Inc…has announced the addition of new senior staff as the Company prepares to file two new investigational new drug (IND) applications for the treatment of radiodermatitis and glioblastoma multiforme (GBM)…’We recently announced Investigational Review Board (IRB) approval for a GBM study at the Rabin Institute in Israel’….Phase I/II human clinical trials in Israel will administer the Company’s proprietary synthetic CBD formula to 40 enrollees: half of whom will be treated with the CBD formula, and the other half will be treated with the formula in combination with clomiphene, an estrogen binding site inhibitor.”


llllllllll MK-6482 / Merck (MSD)
FDA Grants Breakthrough Therapy Designation to Merck’s Novel HIF-2α Inhibitor MK-6482 for Treatment of Certain Patients With Von Hippel-Lindau Disease- Associated Renal Cell Carcinoma (Businesswire) – Jul 29, 2020 – “Merck…announced today that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to the hypoxia-inducible factor-2 alpha (HIF-2α) inhibitor MK-6482, a novel investigational candidate in Merck’s oncology pipeline, for the treatment of patients with von Hippel-Lindau (VHL) disease-associated renal cell carcinoma (RCC) with nonmetastatic RCC tumors less than three centimeters in size, unless immediate surgery is required. The FDA also granted orphan drug designation to MK-6482 for VHL disease. These designations are based on data from a Phase 2 trial evaluating MK-6482 in patients with VHL-associated clear cell RCC, which were presented at the 2020 American Society of Clinical Oncology Annual Meeting.”

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