Investigational Studies

By Winona LaDuke Tribal hemp growers have planted the seeds of a new economy and an innovative and holistic approach to many challenges in our territories. This spring, gathering first on the White Earth reservation and then in Colorado, tribal “hempsters” have joined an international renaissance of the plant which once clothed much of Europe […]

Announces Meeting with FDA to Obtain Consent for Start of Phase 3 Pivotal Registration Study in Treatment of Acute GVHDAndProvides Corporate Update and Outlook for 2018 SAN FRANCISCO and TEL AVIV, Israel, April 26, 2018 (GLOBE NEWSWIRE) — Kalytera Therapeutics, Inc. (TSX VENTURE:KALY) (OTCQB:KALTF) (the “Company” or “Kalytera“) today issued the following letter to shareholders […]

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Announces Meeting with FDA to Obtain Consent for Start of Phase 3 Pivotal Registration Study in Treatment of Acute GVHDAndProvides Corporate Update and Outlook for 2018 SAN FRANCISCO and TEL AVIV, Israel, April 26, 2018 (GLOBE NEWSWIRE) — Kalytera Therapeutics, Inc. (TSX VENTURE:KALY) (OTCQB:KALTF) (the “Company” or “Kalytera“) today issued the following letter to shareholders […]

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Analysis focus: Abeona Therapeutics Today we will discuss Abeona Therapeutics (NASDAQ:ABEO), which is up more than 5% in early trading after announcing that the European Medicines Agency (NYSEMKT:EMA) has granted its gene therapy ABO-202 an Orphan Drug designation for the treatment of neuronal ceroid lipofuscinosis or Batten disease. This has been another solid year for […]

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The Pharma Letter provides subscribers with daily, up-to-date news, business intelligence, comment and analysis for the pharmaceutical, biotechnology and generics sectors of the health care industry, backed by a team of respected writers with many years of experience in the field. … read more at: https://www.thepharmaletter.com/article/cannabinoid-based-tourette-syndrome-and-epilepsy-treatments-on-the-horizon

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An advisory panel from the United States Food and Drug Administration (FDA) has recommended the approval of a novel epilepsy drug that is made up of ingredients from marijuana. The agency normally follows the recommendations of the advisory panels regarding approvals and rejections of applications of new drugs. The recommendation statement came yesterday (19th April […]

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This spring, after gathering on the White Earth Indian Reservation in northwestern Minnesota and then in Colorado, tribal “hempsters” are working toward a renaissance of the plant that once clothed much of Europe and North America. Tribal hemp growers from the Meskwaki, Lakota, Menominee, Mandan, Hidatsa, Colville and other Native nations are planting the seeds […]

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Advocates for development of marijuana-based treatments, and those pushing for better treatments of epilepsy, were pleased with the panel’s recommendation. “This is a very good development, and it basically underscores that there are medicinal properties to some of the cannabinoids,” said Dr. Igor Grant, director of the Center for Medicinal Cannabis Research at the University […]

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The Pharma Letter provides subscribers with daily, up-to-date news, business intelligence, comment and analysis for the pharmaceutical, biotechnology and generics sectors of the health care industry, backed by a team of respected writers with many years of experience in the field. … read more at: https://www.thepharmaletter.com/article/first-fda-approval-for-cannabidiol-based-drug-moves-closer

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The analysts wrote, “Epilepsy remains a challenging indication to treat, with over a third of patients (750k patients in the U.S.) who are inadequately controlled despite several antiepileptic drugs (market of $5B) taken concurrently. GW’s lead product, Epidiolex, an orphan drug designated oral CBD (cannabidiol), showed positive results in three P3 trials for Dravet (DS) […]

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The Pharma Letter provides subscribers with daily, up-to-date news, business intelligence, comment and analysis for the pharmaceutical, biotechnology and generics sectors of the health care industry, backed by a team of respected writers with many years of experience in the field. … read more at: https://www.thepharmaletter.com/article/fda-report-backs-approval-of-cannabis-derived-drug

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LONDON, April 12, 2018 (GLOBE NEWSWIRE) — GW Pharmaceuticals plc (GWPH) “GW,” “the Company” or “the Group”), a biopharmaceutical company focused on discovering, developing and commercializing novel therapeutics from its proprietary cannabinoid product platform, along with its U.S. subsidiary Greenwich Biosciences, today announced that the Company will present data from the pivotal Phase 3 trials […]

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