PHARMA TECH

Sebela Pharmaceuticals Announces U.S. Launch of SUTAB® Tablets, An Alternative to Liquid Colonoscopy Preparation

Sebela Pharmaceuticals | January 06, 2021

Sebela Pharmaceuticals® today announced that SUTAB® (sodium sulfate, magnesium sulfate, and potassium chloride) tablets, the first tablet colonoscopy preparation to receive approval from the U.S. Food and Drug Administration (FDA) in over 10 years, is now available in the United States.
SUTAB is a sulfate-based tablet colonoscopy preparation that is taken orally in a split-dose administration starting the evening before a colonoscopy. The tablets offer a safe and effective alternative to liquid colonoscopy preparations, which traditionally require consuming large volumes of poor-tasting solution and can often be a barrier to patients' willingness to undergo colonoscopy screening for colorectal cancer. 1 

The American Cancer Society and the U.S. Preventive Services Task Force recommend adults undergo screening for colorectal cancer beginning at age 45.2 Colonoscopy is the gold standard detection method for colorectal cancer, a leading cause of cancer-related deaths that can be more effectively treated if caught early through screening.3 Within the last decade, the rate of colonoscopy procedures has increased significantly with approximately 18 million people now screened annually for colorectal cancer.

"Alternative colonoscopy preparations, like SUTAB, can play an important role in encouraging more patients to get screened for colorectal cancer," said Alan Cooke, President and CEO of Sebela Pharmaceuticals. "With the introduction of SUTAB tablets, we hope to take yet another important step toward removing some of the burden often associated with the preparation process – allowing more patients to feel confident in their choice to undergo a colonoscopy."

The FDA approved SUTAB on November 10, 2020. The approval was based on positive Phase 3 clinical trials, which evaluated the safety and efficacy of SUTAB compared to FDA-approved preparations in 941 patients, including a traditional polyethylene glycol and ascorbate preparation (PEG-EA) for bowel cleansing prior to a colonoscopy.4

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Learn how Janssen Pharmaceuticals is leveraging technology to transform the pharmaceutical industry and work towards their mission of eradicating cancer.

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BUSINESS INSIGHTS, PHARMACY MARKET

Innovation Pharmaceuticals Announces BT BeaMedical Technologies Receives FDA Clearance for New Surgical Laser Family

Innovation Pharmaceuticals Inc | November 29, 2022

BT BeaMedical Technologies a private company developing a next-generation laser-based platform for epilepsy and cancer surgery, has notified Innovation Pharmaceuticals that it has received U.S. Food and Drug Administration clearance for its MANTA surgical laser family. The clearance is an important milestone for BeaMed in its development of an advanced laser technology with respect to shaping energy and matching it to patient specific anatomy, a novel concept that BeaMed is proving a reality. Innovation Pharmaceuticals made a strategic investment to acquire a minority stake in BeaMed in June 2022. BeaMed is the inventor and developer of the StingRay Laser System a novel laser-based thermal ablation technology designed for treatment of previously inoperable cases of epilepsy and for improvement of outcomes and enablement of new treatment options for oncology procedures, including those treating brain, prostate, liver, breast, and lung cancers. The StingRay Laser System will utilize the MANTA laser family as its core energy generation devices coupled to new fiber optic technology, allowing a perfect match between the exact structure of tumors and epileptic focal points and the energy delivery, while protecting vital functional areas against thermal damage. The MANTA surgical laser family was cleared by the FDA including five different wavelengths and soft tissue use in a very wide set of clinical specialties, including Neurosurgery, Spinal Surgery, Urology, Thoracic Surgery, Pulmonary Surgery, Gynecology, General Surgery, ENT/Head and Neck, Plastic Surgery, Orthopedics, Arthroscopy, Ophthalmology, Radiology, and Oral Surgery. BeaMed expects to soon make requisite submissions to the FDA for clearance of its fiber optics for use in multiple medical indications. “We are excited with the speed of progress BeaMed is making towards introduction of its new platform product with the potential to help millions of patients globally suffering from epilepsy and cancer in multiple specialties. The execution of this submission and the speed of clearance speaks volumes to the commercialization strategy and the exceptional capabilities of the regulatory team at BeaMed,” Leo Ehrlich, Chief Executive Officer at Innovation Pharmaceuticals “This is an exciting and important milestone for our company. This clearance gives us two key achievements. First, U.S. market access to a wide range of potential laser energy sources, each allowing us different and unique tissue interaction, an achievement which will have wide clinical implications. The second is a very wide set of intended uses covering many key potential markets for our technology. This underscores the clear regulatory strategy of BeaMed, which goes hand in hand with our broad impact business vision of revolutionizing key treatments, including brain tumors, epilepsy, lung cancer, prostate cancer, breast cancer and more,” said Gil Shapira, co-founder of BeaMed. BeaMed was founded by Moshe Eshkol and Gil Shapira, both highly experienced specialists in surgical lasers and medical devices. BeaMed and the development of the StingRay system are also supported by a special prestigious grant from the BIRD Foundation a bi-national organization supporting Israel-US collaboration. Gil Shapira brings forward 26+ years of engineering and product development and management experience, with over 17 years in the surgical laser industry. Gil owns and manages neoLaser, a company he founded in 2012, and led to revenue growth and profitability, with a 43% CAGR on its way to more than 1200 global installations and performing 50,000+ surgeries annually in over 30 countries. Previously, Gil led product development and marketing at OmniGuide, a successful high-growth laser-based medical device spin-off out of the Massachusetts Institute of Technology. About Innovation Pharmaceuticals Innovation Pharmaceuticals Inc. is a clinical stage biopharmaceutical company developing a portfolio of innovative therapies addressing multiple areas of unmet medical need, including inflammatory diseases, cancer, and infectious diseases. The Company is also active in evaluating other potential investment opportunities that can add value and diversify its portfolio.

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PHARMA TECH

Sirona Biochem Signs International Partnership Agreement with Wanbang Biopharmaceuticals

Sirona Biochem Corp. | November 28, 2022

Sirona Biochem Corp. announces that, subsequent to the LOI, Sirona and Wanbang Biopharmaceuticals have signed an expanded, international partnership agreement to collaborate on licencing Sirona’s SGLT2 inhibitor, TFC-039, as a pharmaceutical treatment in both animal and human health. The agreement adds human health to the partnership as a result of new licencing opportunities currently in due diligence. Wanbang and Sirona initially signed a licensing agreement for TFC-039, whereby Wanbang obtained the rights to develop the compound as a diabetes treatment in China and Sirona retained the global rights. Sirona has since been in discussions with animal health companies to advance TFC-039 as a treatment for diabetes and chronic kidney disease in companion animals. SGLT2 inhibitors provide an opportunity to treat inflicted animals with an oral medication as opposed to the traditional method of daily insulin injections. More recently, Sirona has entered into due diligence with a large pharmaceutical company with a regional interest in developing the compound for human diabetes. Together, Sirona and Wanbang share extensive knowledge and scientific results of TFC-039. Partnering will significantly increase the speed to third-party partnerships and commercialization. The shared data spans over 12 years of research and development, and includes in vitro and in vivo preclinical work, multiple clinical studies, advanced manufacturing process development and the ability to commercially manufacture TFC-039. “We have a long-standing relationship with Wanbang and are excited to combine our two companies’ expertise to license TFC-039. Wanbang has invested millions of dollars into the clinical stage research and development of the manufacturing processes for TFC-039. These pieces of data are critical to large organizations and will greatly increase the opportunities to move forward. The probability of a successful licensing agreement has been made much stronger by leveraging our alliance with Wanbang. We have had a successful year building Sirona’s pipeline, with positive movement on all projects and we’re looking forward to continuing this success with our SGLT2 inhibitor as well as our antiviral and anti-aging projects in 2023.” Dr. Howard Verrico, CEO About Wanbang Biopharmaceuticals and Fosun Pharmaceuticals Wanbang Biopharmaceuticals develops, manufactures, and markets drugs with indications for chronic disease treatment, antibiotics, and other endocrine diseases in China. Founded in 1981, the company is headquartered in Xuzhou, China, and is a subsidiary of Shanghai Fosun Pharmaceutical Group. Fosun is a leader in the pharmaceutical industry and is regarded as one of the top five domestic pharmaceutical companies in China. About Sirona Biochem Corp. Sirona Biochem is a cosmetic ingredient and drug discovery company with a proprietary platform technology. Sirona specializes in stabilizing carbohydrate molecules with the goal of improving efficacy and safety. New compounds are patented for maximum revenue potential. Sirona’s compounds are licensed to leading companies around the world in return for licensing fees, milestone fees and ongoing royalty payments. Sirona’s laboratory, TFChem, is located in France and is the recipient of multiple French national scientific awards and European Union and French government grants.

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VIEWS AND ANALYSIS, PHARMACY MARKET

MedRhythms Recognized for Advancements in Prescription Digital Therapeutics from CB Insights, Reuters Events Pharma and Fast Company

MedRhythms | December 12, 2022

CB Insights today announced that, for the second year in a row, MedRhythms has been named to its annual Digital Health 150, a list that showcases the 150 most promising private digital health companies. This recognition comes a week after MedRhythms received the Most Valuable Digital Therapy award at the Reuters Events Pharma Awards ceremony and less than a month after MedRhythms was named a Fast Company Next Big Things in Tech honoree for the progress that the company has made on its products and their potential to improve access to high quality care. "From reimagining clinical care, to leveraging tech like AR/VR to improve surgical training, this year's Digital Health 150 winners are transforming the future of healthcare with digital technology. This increasingly global cohort, representing more than 18 countries across five continents, is not only driving better patient outcomes, but making healthcare more accessible. We are excited to follow the meaningful impact and continued success of this year's winners." Brian Lee, SVP of CB Insights' Intelligence Unit "Being recognized as a leader in the industry by CB Insights, Reuters Events Pharma and Fast Company is an incredible honor and is a testament to our entire team's commitment to our mission to positively impact the lives of those living with neurologic injury and disease," said Brian Harris, CEO and Co-Founder of MedRhythms. "These recognitions serve as validation of our team's progress to date and, more importantly, as motivation to keep advancing as we push the envelope in healthcare by building next-generation neurotherapeutics that leverage the power of music to bring important interventions to patients around the world." Utilizing the CB Insights platform, the research team selected these 150 winners from a pool of over 13,000 private companies, including applicants and nominees. They were chosen based on factors including R&D activity, proprietary Mosaic scores, market potential, business relationships, investor profile, news sentiment analysis, competitive landscape, team strength, and tech novelty. The research team also reviewed over 3,000 Analyst Briefings submitted by applicants. MedRhythms is pioneering the development of next-generation neurotherapeutics designed to improve walking, mobility and related functional outcomes via a proprietary, patented technology platform. The company's platform combines sensors, software, and music with advanced neuroscience to target neural circuitry. The company is developing a pipeline of digital therapeutics across a range of neurological conditions, including stroke, multiple sclerosis and Parkinson's disease. In 2021, MedRhythms announced an oversubscribed Series B financing round of $27M co-led by Morningside Ventures and Advantage Capital. Since raising the Series B financing, MedRhythms has announced that the company has entered into collaborations with Universal Music Group (UMG), the world's largest record label for music content and data, and Biogen, one of the first global biotechnology companies. MedRhythms' most advanced product, which addresses gait impairment in chronic stroke, received Breakthrough Device designation from the U.S. Food and Drug Administration. Earlier this year, MedRhythms finalized a worldwide licensing agreement worth up to $120M with Biogen for the company's second product, which targets gait impairment in multiple sclerosis. In addition to these two assets, the company has a strong pipeline in large markets with high unmet needs and is conducting feasibility studies in collaboration with some of the world's leading clinicians and researchers. About Fast Company Fast Company is the only media brand fully dedicated to the vital intersection of business, innovation, and design, engaging the most influential leaders, companies, and thinkers on the future of business. The editor-in-chief is Brendan Vaughan. Headquartered in New York City, Fast Company is published by Mansueto Ventures LLC. About Reuters Events Pharma More open so that the strongest ideas and insights are brought to the fore in a transparent, trustworthy manner. More valued by having an authentic approach to building products and services that matter to patients. About MedRhythms MedRhythms is pioneering the development of next-generation neurotherapeutics designed to improve walking, mobility and related functional outcomes via a proprietary, patented technology platform. The company's platform combines sensors, software, and music with advanced neuroscience to target neural circuitry. The company is developing a pipeline of digital therapeutics across a range of neurological conditions, including stroke, multiple sclerosis and Parkinson's disease. The company's pipeline product for chronic stroke walking deficits received Breakthrough Device designation in 2020 and the company raised a Series B financing round in 2021 led by Morningside Ventures and Advantage Capital. MedRhythms is headquartered in Portland, Maine.

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