Feds Warn CBD Companies About Health Claims, Demand Response

LabRoots | November 22, 2019

The FTC and FDA sent out letters to several CDB companies deemed to be making false or unsubstantiated claims about their products’ health benefits and carrying out improper marketing and selling practices. The first round of letters went out in March and a second group in September. Three companies were alerted in each incidence; in the first, PotNetwork Holdings in Florida, Nutra Pure in Washington state, and Advanced Spine and Pain in New Jersey were contacted. The agencies did not reveal the names of the companies who received the second round of written alerts. The various businesses reportedly marketed their CBD products (like tinctures, capsules, oils, gummies and creams) as able to limit, treat or cure cancer, autoimmune diseases, neurodegenerative conditions and other maladies. The FTC expressed in a letter that it is illegal “to advertise that a product can prevent, treat or cure human disease unless you possess competent and reliable scientific evidence, including, when appropriate, well-controlled human clinical studies, substantiating that the claims are true at the time they are made.”

Spotlight

Chuck Stevens, Vice President and General Manager of Commercialization Strategy at PAREXEL, provides a brief introduction to his session, "Drug Development with Reimbursement in Mind: Obtaining the Input of Payers to Inform Clinical Trial Design" at the DIA 2014 50th Annual Meeting.

Spotlight

Chuck Stevens, Vice President and General Manager of Commercialization Strategy at PAREXEL, provides a brief introduction to his session, "Drug Development with Reimbursement in Mind: Obtaining the Input of Payers to Inform Clinical Trial Design" at the DIA 2014 50th Annual Meeting.

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PHARMA TECH

Overland Pharmaceuticals Partners with ArisGlobal to Accelerate Safety Capabilities

ArisGlobal | December 08, 2021

ArisGlobal, the leading provider of life sciences software that automates core drug development with its end-to-end drug development technology platform LifeSphere® announced its partnership with Overland Pharmaceuticals. Overland, a premier biopharmaceutical company bringing innovative medicines to underserved patients in Asia and worldwide, selected ArisGlobal's LifeSphere Multivigilance program to centralize pharmacovigilance activities and further develop and commercialize advances in medicine. "Pharmacovigilance is evolving, with greater demands to save time and cost, maintain compliance with shifting global regulations, and effectively aggregate large amounts of data, among other vital tasks, which is why we're excited that Overland has adopted ArisGlobal's LifeSphere Safety platform to manage those challenges. With LifeSphere Multivigilance, Overland will realize efficiency gains and obtain real-time insights into risk-benefit profiles across the product life cycle." Beena Wood, Vice President of Safety at ArisGlobal LifeSphere Multivigilance is an end-to-end, automated system that helps pharmacovigilance teams save time and effort, ensure future-proof compliance, and keep global teams collaboratively aligned. The LifeSphere product suite is used by over 60% of the top 50 biopharma companies worldwide. "Through formative partnerships, such as working with ArisGlobal, Overland will move forward with our mission to develop and commercialize the most promising advances in medicine across carefully selected therapeutic areas," said Roger Luo, Ph.D, Chief Development Officer of Overland. "Our goals are to build innovation for patients, achieve flexibility with business partners, and develop program efficiency by centralizing key operations. We feel that by bringing pharmacovigilance centrally with LifeSphere, we are one step closer to accomplishing that vision." "Safely and rapidly accelerating the development of new medicines is at the core of what we do," adds Rong Zhu, M.D, Ph.D., Head of Drug Safety & Pharmacovigilance at Overland. "Now, by utilizing LifeSphere Multivigilance, we will be able to centralize and scale our pharmacovigilance efforts, strengthen our data fabric, and further utilize effective R&D technology to assist in the development of patient-centric, life-changing therapies." Another key area that sparked alignment across ArisGlobal and Overland includes shared values of global collaboration, agility, and integrity. ArisGlobal's 30+ year tenure in the R&D technology industry will support Overland to architect differing partnership models and bring innovative drugs to underserved patients in Asia and around the world. This news comes on the heels of ArisGlobal's recent Breakthrough Conference, acknowledgment for requirement readiness in Gens & Associates' August 2021 "IDMP Software Vendor Readiness and Capability" report, and accolades by Frost & Sullivan for Customer Value Leadership for 2021. About ArisGlobal ArisGlobal is transforming the way today's most successful Life Sciences companies develop breakthroughs and bring new products to market. Our end-to-end drug development technology platform, LifeSphere®, integrates our proprietary cognitive computing engine to automate all core functions of the drug development lifecycle. Designed with deep expertise and a long-term perspective that spans more than 30 years, LifeSphere® is a unified platform that boosts efficiency, ensures compliance, delivers actionable insights, and lowers total cost of ownership through multi-tenant SaaS architecture. About Overland Pharmaceuticals Overland Pharmaceuticals is building a fully integrated biopharma company with a mission to bring innovative medicines to underserved patients in Asia and around the world. By leveraging our resources, global network, and local expertise across the biopharma ecosystem in Asia, Overland is establishing a portfolio of differentiated therapeutic candidates in a few carefully selected therapeutic areas. Through formative partnerships, Overland will move forward the development and commercialization of the most promising advances in medicine.

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PHARMA TECH

Tranquilmoney Releases PharmTracker for Independent Pharmacies, Small and Medium Pharmacy Chains

Tranquilmoney | December 28, 2020

Tranquilmoney, Inc., an organization that oversaw drug store outsider case compromise for Costco Pharmacy for more than 20 years, has delivered an electronic adaptation of its product. Any drug store would now be able to join to PharmTrackerTM and begin utilizing the framework to handle their cases. Tranquilmoney has overseen over $1 billion per year in drug store receivables compromise with 100% compromise and 99.9% assortments. Industry guidelines of assortment are about 92.5%. Dr. Karun Philip, Chairman and CEO, says "Drug store claims are moderately little with a normal of $40 from the protection plans. More than 20 years, we built up a framework that consolidated Artificial Intelligence, enormous information stockrooms, and area specialists, that in blend permit us to coordinate each installment to its relating guarantee. Thusly, all non-installments are recognized, and an underpayment of even one penny is identified and can be rebilled." PharmTrackerTM can be utilized as a self-administration programming on the web or as a reevaluated administration. Utilizing Tranquiilmoney's framework will help a Pharmacy gather as much as 99.9% from protection, more than the business standard of about 92.5%. Tranquilmoney expenses start at 45 pennies for every case for at least 3000 cases for each month going down to 2 pennies a case for bigger volumes. Here is the finished value list.

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PHARMACY MARKET

Evergreen Theragnostics Increases Alpha Radiopharmaceutical Production Capabilities

Evergreen Theragnostics, Inc. | July 17, 2021

Evergreen Theragnostics, Inc., a leading radiopharmaceutical Contract Development and Manufacturing Organization (CDMO) has started a major strategic expansion at its Springfield, NJ manufacturing facility. Evergreen has already started expanding to build a GMP state-of-the-art alpha emitter production center, incorporated into Evergreen's current facility, with the Evergreen Springfield Facility scheduled to open within the next two months. The expansion, which is scheduled to open in the first quarter of 2022, will strengthen Evergreen's capacity to serve alpha-based radiopharmaceutical projects from pre-clinical pharmaceutical research through commercial production and supply. Evergreen's new alpha program will research and manufacture novel radiopharmaceuticals, including Actinium-225 (Ac-225), Astatine-211 (At-211), Lead-212 (Pb-212), and Thorium-227 (Th-227). Targeted Alpha Therapy (TAT), which uses the radionuclides mentioned above, is a growing segment of therapeutic radiopharmaceuticals owing to its unprecedented promise of improving patient clinical outcomes in cancer. This new class of medicines, however, poses significant difficulties in both clinical development and manufacturing. The new facility was created by combining Evergreen's expertise in clinical production of TAT radiopharmaceuticals with a collaboration with Tema Sinergie, a leading supplier of radiopharmaceutical manufacturing equipment. This resulted in developing specifically made production equipment to meet the challenges associated with manufacturing alpha-emitting radiopharmaceuticals in a complete cGMP environment. About Evergreen Theragnostics, Inc. Evergreen Theragnostics, founded in 2019, is a leading radiopharmaceutical Contract Development and Manufacturing Organization (CDMO) headquartered in the United States. Evergreen will offer highly reliable manufacturing services for therapeutic and centrally distributed diagnostic radiopharmaceuticals from early development through commercialization, with a state-of-the-art global GMP facility opening in Q3'21. The company was founded by a team with extensive experience in radiopharmaceutical commercialization, manufacturing process development, and regulatory affairs management. About Tema Sinergie Tema Sinergie, founded in 1985, is a pioneer and global leader in the design and manufacture of shielded isolators for the nuclear medicine market, consistently working to extend its proven leadership onto the market of aseptic containment isolator systems to the pharmaceutical, biotech, and ATMP business branches. The company has obtained ISO 9001 and ISO 13485 certifications.

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