Anticipation is building for GW Pharmaceuticals (NASDAQ:GWPH) as the biotech prepares to hopefully launch its first product in the U.S. in 2018.
Tag Archives: FDA
HOUSTON, Texas, Nov. 16, 2017 /Weed Wire/ – World Hemp Oil, LLC, a leading supplier and manufacturers of hemp-derived cannabidiol (CBD) oil since 2014, announces the availability of refined, distillate oil from the 2017 grow season at competitive prices.
The U.S. Food and Drug Administration has been keeping an eye of the growing popularity of hemp-derived cannabidiol, especially those CBD companies that have been making medical claims.
WASHINGTON, Nov. 1, 2017 /Weed Wire/ — As part of the U.S. Food and Drug Administration’s ongoing efforts to protect consumers from health fraud, the agency today issued warning letters to four companies illegally selling products online that claim to prevent, diagnose, treat, or cure cancer without evidence to support these outcomes.
The U.S. Food and Drug Administration may start cracking down on claims of marijuana health benefits that haven’t been proven, the agency’s commissioner said Tuesday.
Unlike GW Pharmaceuticals and Zynerba Pharmaceuticals, which rely on cannabinoid-based medicines to fill out the entirety of their drug-development pipelines, Arena Pharmaceuticals is one of the drug developers that have some of their pipelines devoted to cannabinoid-type therapeutics or CB agonists and other portions devoted to non-cannabinoid medicines.
BIRMINGHAM, Al., May 31, 2017 /Weed Wire/ — Alabama candidate for U.S. Senate, Dom Gentile, today announced his support for medical cannabis, and is adding this issue to his campaign platform.
First Trust Portfolios filed an S-6 on May 3oth with the Securities and Exchange Commission for a Medical Cannabis Portfolio Series – FT 6766 that is seeking above average capital appreciation.
On May 25, 2017, Sens. Dianne Feinstein, D-Calif., and Chuck Grassley, R-Iowa, announced that they had introduced the Cannabidiol Research Expansion Act, a bill that would ask the Attorney General to reconsider whether cannabidiol should be scheduled under the Controlled Substances Act and expand research opportunities as a means of determining the medical efficacy of cannabidiol and marijuana in the treatment of serious medical conditions.
A new cannabis study published in the New England Journal of Medicine saw a nearly 40 percent drop in seizures for participants who were using the marijuana derivative called cannabidiol.
Drug Enforcement Administration acting Chief Chuck Rosenberg reiterated an Obama-era stance Thursday that “marijuana is not medicine.”
In an interview with Yahoo News and Finance Anchor Bianna Golodryga, former Rep. Patrick Kennedy, D-R.I. claims lobbyists for marijuana legalization are attempting to sell Americans on a “Trojan horse.” Should members of the legal marijuana industry be concerned about Kennedy’s argument gaining momentum?
On April 6, 2017, both chambers of the Indiana Legislature approved measures loosening restrictions on a marijuana-derived oil used to treat epilepsy.
Insys Therapeutics’ stock rose on good news — but not tremendously so.
PHOENIX, March 17, 2017 /Weed Wire/ — As of March 15, 2017, five participants have received marijuana (cannabis) provided by the National Institute on Drug Abuse (NIDA) in an ongoing Phase 2 clinical trial sponsored by the non-profit Multidisciplinary Association for Psychedelic Studies (MAPS) at the Scottsdale Research Institute (SRI) in Phoenix, Ariz. MAPS is committed to sponsoring rigorous clinical research to develop cannabis into a prescription medicine through the Food and Drug Administration (FDA).
A Duke doctor has refused to continue seeing a nine-year-old North Carolina girl because her family gives her cannabidiol oil to cope with a rare illnes. The nine-year-old, Mia Morley, has a medical condition called Lennox Gastaut Syndrome. Her father, Dylan Morley, said Dr. Muhammad Mikati’s decision was based upon the federal status of CBD oil, which is not FDA approved.
Stephen Goldner, Senior Forensic Toxicologist at Quantum 9, learned early on how to work with the FDA, having developed the FDA-approved liquid dose form of methadone with his mentor John Broich. Hear Goldner discuss what role the FDA would likely play in life after medical cannabis legalization.
Investors in cannabis companies had an eventful 2016 with the approval of recreational marijuana usage in the states of California, Massachusetts, Maine, and Nevada providing a boost to all sorts of marijuana stocks. Of particular note, shares of Corbus Pharmaceuticals (NASDAQ: CRBP) posted a whopping 600% gain in 2016 following positive phase 2 data.
Sue Sisley, M.D., is leading the way in studying medical marijuana and post-traumatic stress disorder. In her talk, “Coping With PTSD,” hear Sisley discuss the first clinical trial to study the effects of medical marijuana in the treatment of post-traumatic stress disorder in military veterans.
The company announced Tuesday positive top-line results from a mid-stage placebo-controlled study of a proprietary combination of tetrahydrocannabinol, or THC, and cannabidiol, or CBD, for treating glioblastoma multiforme, or GBM.
LONDON, Feb. 7, 2017 /Weed Wire/ — GW Pharmaceuticals plc (Nasdaq:GWPH) (“GW,” “the Company” or “the Group”), a biopharmaceutical company focused on discovering, developing and commercializing novel therapeutics from its proprietary cannabinoid product platform, today announced positive top-line results from an exploratory Phase 2 placebo-controlled clinical study.
While non-food-contact surfaces are critical to the form and function of a facility for edibles, food-contact surfaces are at the frontline of food safety. Equipment purchases have to ensure hygienic design and permit efficient disassembly for cleaning, scrubbing, inspecting and sanitizing.
SAN DIEGO, Jan. 24, 2017/Weed Wire/ — Medical Marijuana, Inc. (OTC: MJNA) announced today that its subsidiary HempMeds Mexico® has received permission from Mexico’s health authority COFEPRIS to import their flagship product Real Scientific Hemp Oil-X™ (RSHO-X™) to treat a patient for their pain associated with cancer treatments and for their general well-being.
Marijuana stocks may be in for a bumpy ride this year.
A comprehensive study slams many of the alleged benefits of marijuana and points to serious negative effects. What will the impact of this study be for marijuana stocks?
Let’s take a look back on this past year and see what the future holds for marijuana stocks.
SAN DIEGO, Nov. 29, 2016 /Weed Wire/ — Medical Marijuana, Inc. (OTC PINK: MJNA), the first-ever publicly traded cannabis company in the United States, announced today that its major investment company AXIM® Biotechnologies, Inc. (AXIM® Biotech) (OTC PINK: AXIM) has filed an IP application with the World Intellectual Property Organization.
The Oregon Liquor Control Commission announced via email on Nov. 17 that it’s anticipating an influx of applications from prospective recreational marijuana businesses. If you hope to become a licensed recreational processor and want to avoid delays in having your application processed, compliance is critical.
Cannabinoids – what are they? How do they affect the human body? Are they really medicinal? On Nov. 16, 2016, Marijuana Investor Summit is bringing the Science and Medicine of Cannabis to the Palms Casino Resort in Las Vegas, Nevada, to answer these questions and more.
PHOENIX, Aug. 3, 2016 /Weed Wire/ — Insys Therapeutics, Inc. (NASDAQ:INSY) (“Insys” or “the Company”) today announced financial results for the three-month period ended June 30, 2016.
As the debate around medical marijuana rages on, the Food and Drug Administration has approved a synthetic version of the substance. The recently approved Syndros, manufactured by Insys Therapeutics, is a liquid form of dronabinol, a synthesized version of THC.
Shares of Insys Therapeutics Inc. (NASDAQ:INSYS) soared 19% in premarket trade Tuesday.
LONDON, June 21, 2016 /Weed Wire/ — GW Pharmaceuticals plc (Nasdaq: GWPH) (AIM: GWP) (“GW” or “the Company”) today announced that the Company has selected infantile spasms (IS) as the fourth target indication for its Epidiolex orphan pediatric epilepsy development program.
While the demand for edibles continues to rise, so too do the expectations for producers to follow good manufacturing practices and food safety plans consistent with federal requirements.
The U.S. Drug Enforcement Agency has given the green light to a clinical study of smoked marijuana’s effectiveness for treating Post Traumatic Stress Disorder in veterans, according to the Multidisciplinary Association for Psychedelic Studies. Seventy-six U.S. veterans will participate in the study.
On April 21, 2016, GW Pharmaceuticals (NASDAQ: GWPH), a biopharma company with two promising cannabis-based medications, announced it had received Orphan Drug Designation for cannabidiol in the treatment of Tuberous Sclerosis Complex.
According to a letter dated April 4, 2016, the Drug Enforcement Administration is currently assessing the Food and Drug Administration’s recommendation to reschedule marijuana.
BETHESDA, Md., March 22, 2016 /Weed Wire/ — Cannabics Pharmaceuticals Inc. (CNBX) today announced the start of a clinical study in Israel for cancer patients utilizing Cannabics’ SR Capsules.
When FDA barriers change, regulations deal fortune to some and hardship to others. On March 4, 2016, at the California Cannabis Business Expo in San Francisco, Stephen Goldner, Senior Forensic Toxicologist at Quantum 9, a cannabis consulting and technology firm, addressed the U.S. Food and Drug Administration’s role in regulating the cannabis industry in life after legalization.
A bill which would allow terminally ill patients to have access to medical marijuana has advanced in the Florida State Senate.
Does the consumer have a legally protected right to cannabis at a price and of a quality determined by free market forces? Will this idea play a role in shaping state licensing schemes?
Stephen Goldner, a forensic toxicologist at Quantum 9, a cannabis consulting and technology firm, will be discussing life after legalization at the California Cannabis Business Expo in San Francisco this March.
This snapshot of seven critical labeling events of 2015 captures the past as a means of illuminating the industry’s future.
Right before Christmas, on Dec. 23, 2015, the DEA released a press release quietly announcing a new federal advancement on cannabinoid research.
The pharmaceutical capsule as a medical cannabis delivery system has the greatest potential of propelling cannabis into mainstream medical treatment regimens.
There are many ways to continue the investment affair with cannabis. Many products beside the plant could be your go-betweens.
GW Pharma is reportedly ramping up production of Epidiolex in anticipation of FDA approval and the significant commercial demand for the drug that would follow.
Three days after presidential candidate and Vermont Sen. Bernie Sanders introduced the “Ending Federal Marijuana Prohibition Act” of 2015,” the grand dame of Democratic presidential politics finally changed her position on one of the most pressing political issues in America.
With legalization happening on a state-by-stay basis and no overarching regulatory agency to devise and implement national standards for labeling, the torch has to be picked up by manufacturers.
In Idaho, up to 25 children suffering from debilitating seizures will soon be able to enroll in a limited program that will provide them with Epidiolex, an experimental CBD-based drug derived from marijuana.