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

What’s next for the healthcare industry? Explore some of the groundbreaking developments that are leading to more individualized therapies and personalized medicine.

Spotlight

What’s next for the healthcare industry? Explore some of the groundbreaking developments that are leading to more individualized therapies and personalized medicine.

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BUSINESS INSIGHTS, PHARMACY MARKET

Massive Bio and NeoGenomics Announce Collaboration to Accelerate Oncology Drug Discovery and Improve Patient Care

Businesswire | March 27, 2023

Massive Bio, Inc., a private AI-enabled oncology startup that provides virtual and in-person concierge services for cancer patients, and NeoGenomics, Inc. a leading provider of cancer-focused genetic testing services and global oncology contract research services, today announced a collaboration with the goal of accelerating the development of new cancer therapies and ultimately improving the lives of millions of cancer patients around the world. NeoGenomics will identify patients in real time who may be eligible for clinical trials based on biomarker status. Following initial contact and outreach provided directly from NeoGenomics to the treating physician, Massive Bio will help obtain patient consent and expediate additional screening and potential enrollment. This partnership will help to quickly identify patients eligible for clinical trials and help patients and providers make an informed decision regarding their potential treatment avenue. By combining their respective strengths in biomarker testing, data analysis, machine learning, and biomarker and genomic profiling, the collaboration between NeoGenomics and Massive Bio have achieved a significant milestone in the oncology industry. "Our mission at Massive Bio is to provide cancer patients with the best possible care and treatment options,” said Selin Kurnaz, PhD, CEO and co-founder of Massive Bio. “By partnering with NeoGenomics, a leading player in the cancer diagnostics industry that shares Massive Bio’s commitment to advancing cancer research and improving patient outcomes, we can leverage their expertise in oncology diagnostics to accelerate the identification of patients who may be eligible for clinical trials." “NeoGenomics’ advanced diagnostic tools and U.S. footprint, combined with Massive Bio's AI capabilities and concierge services in oncology, will enable us to match patients to clinical trials faster and more efficiently, resulting in improved outcomes and reduced costs,” said Vishal Sikri, President of the Advanced Diagnostics Division of NeoGenomics. “We are thrilled to partner with Massive Bio to advance precision medicine and improve the delivery of healthcare services to patients, pharmaceutical partners, and healthcare providers." Dr. Arturo Loaiza-Bonilla, MD, co-founder and Chief Medical Officer of Massive Bio, added, "This collaboration between NeoGenomics and Massive Bio will enable us to provide patients with personalized care and support throughout their cancer journey, and move the needle forward in precision oncology and research." AboutMassive Bio Massive Bio empowers cancer patients to find their best treatment options, using artificial intelligence to improve equitable access and precision targeting for clinical trial matching, drug matching, and drug development. Massive Bio combines its best-in-class AI platform with technology-enabled services to remove barriers in clinical trial enrollment, value-based oncology decisions, and data-driven cancer treatment. The company serves more than two dozen pharmaceutical companies, contract research organizations, and hospital networks, and has been awarded an SBIR contract by the National Cancer Institute. Massive Bio was founded in 2015 by clinical, technology, and M&A executives, and has a global presence with nearly 100 people in 12 countries.

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BUSINESS INSIGHTS, PHARMA TECH

Cambrex Announces the Acquisition of Snapdragon Chemistry

Cambrex | January 24, 2023

Cambrex, a renowned global contract development and manufacturing organization (CDMO) offering drug substance, product, and analytical services throughout the drug lifecycle, recently announced the completion of its acquisition of Snapdragon Chemistry, a US-based provider of chemical process development services to a diverse range of emerging and established biopharma customers. Snapdragon Chemistry specializes in the development of active pharmaceutical ingredient (API) batch and continuous flow processes, employing cutting-edge automated technology and proprietary equipment to address complicated process and analytical development challenges. With its headquarters for R&D and manufacturing in Waltham, Massachusetts, Snapdragon's 70+ employees, including 31 Ph.D. scientists, have strong ties to the local scientific community. Cambrex's CEO Tom Loewald commented, "Today, we welcome our new colleagues from Snapdragon to Cambrex." He added, "With Snapdragon's depth of scientific expertise in API process development, I'm certain our customers will see the benefits of this combination and be delighted to work with Snapdragon's team." (Source – PR Newswire) Cambrex's portfolio of specialized pharmaceutical development and manufacturing solutions continues to grow, with Snapdragon reinforcing its experience in continuous flow production in addition to augmenting the recent investments in continuous flow process development capabilities at its North Carolina facility in High Point. Snapdragon's CEO Matt Bio said, "I am extremely proud of what our team at Snapdragon has built over the years." He further added, "With Cambrex, we have found an ideal home for our customers and employees, and I look forward to continued success as part of Cambrex." (Source – PR Newswire) About Cambrex Founded in 1981, Cambrex is a contract development and manufacturing organization (CDMO) that offers drug substances, products, and analytical services throughout the drug lifecycle. It provides a variety of specialized medicinal substance technologies and capabilities, such as controlled substances, biocatalysis, continuous flow, material characterization, solid-state science, stability storage and testing, and potent APIs. Cambrex is a trusted partner in the branded and generic markets for the development and manufacturing of API and finished dosage forms. With over 40 years of experience, it has a growing workforce of over 2,300 specialists serving global clients from North America and Europe.

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BUSINESS INSIGHTS, PHARMACY MARKET

Harrow Introduces Next-Gen Compounded Atropine Formulations

Harrow | February 16, 2023

On February 15, 2023, Harrow, a renowned pharmaceutical firm specializing in eyecare in the United States, announced the launch of its next-generation, patent-pending compounded Atropine formulations. These formulations are now accessible through ImprimisRx, a mail-order pharmacy subsidiary wholly owned by Harrow. The following are the key features of ImprimisRx's next-generation Atropine formulations Thoroughly validated analytical tests are conducted to ensure potency, consistency, and stability. The formulations are free of preservatives and boric acid. They possess a physiologic pH of 5.5. They can be stored at room temperature for up to 180 days. Eyecare professionals can purchase these compounded Atropine formulations for as less as $39 per 5mL bottle through various channels, such as online via atropine.com or by contacting ImprimisRx Customer Service at 615-437-4690 via call or text. Compounded formulations are recommended for patients with clinical requirements that are not met by FDA-approved medications. It is essential to note that compounded medications are not reviewed by FDA for their safety and effectiveness. ImprimisRx does not manufacture copies of products that are already available in the market. Harrow's Chairman and Chief Executive Officer, Mark L. Baum, commented, "Our mission has always been to help our eyecare professionals address their patients' unmet needs and to make ophthalmic medications both accessible and affordable. The availability of these innovative compounded atropine formulations is in keeping with our mission. We believe ophthalmologists, optometrists, and the millions of Americans who may benefit from topical atropine therapy, will appreciate the tremendous value these patent-pending formulations offer." (Source – Business Wire) About Harrow Founded in 2012, Harrow is a leading ophthalmic pharmaceutical firm in the United States focused on discovering, developing, and introducing accessible, innovative, and affordable prescription therapies. It holds commercial rights for ten FDA-approved eyecare pharmaceutical products. In addition, the company also operates ImprimisRx, a leading U.S. compounding business that specializes in ophthalmic medications and is licensed to ship prescription drugs in all 50 states. The success of its efforts is reflected in its remarkable financial performance, with a 72% compound annual growth rate achieved during our first eight years in operation. This phenomenal growth rate has established Harrow as one of the fastest-growing ophthalmic pharmaceutical companies in the United States.

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