Medicare’s physician fee schedule includes billing codes for digital therapeutics for the first time. Stakeholders say these codes could help turn around reimbursement challenges weighing on the entire digital medicines sector. By Frank VinluanWhen the FDA approves a drug, passing that regulatory bar of safety and efficacy puts it on the path toward likely reimbursement by government and commercial payers. The same has not been true for digital therapeutics. A proposal from the Centers for Medicare and Medicaid Services signals a change in federal thinking about such technologies, which could pave the way for broader coverage of novel digital medicines. For the first time, CMS’s proposed physician fee schedule, a comprehensive annual listing of the fees that Medicare uses to pay doctors, now includes digital therapeutics. The proposal does not cover all digital therapeutics under multiple benefit categories, as the Digital Therapeutics Alliance (DTA) had asked nearly a year ago. ...
Sound Pharmaceuticals wishes to maintain its relationship with the WuXi AppTec for manufacturing its lead Meniere’s disease drug SPI-1005, amidst increasing scrutiny on Chinese companies in the US, says CEO Jonathan Kil. In an exclusive interview with Pharmaceutical Technology Kil stated the company is “actively supporting WuXi”. The Biden administration set its sights on several Chinese firms with the introduction of the BIOSECURE Act, including WuXi AppTec. The BIOSECURE Act will withhold federal funding and contracts to companies should the biotech equipment or services used be sourced from ‘companies of concern’. These include several Chinese firms including WuXi. Under the Act, existing corporate ties will be permitted until 2032. According to Reuters, information stating the company transferred US intellectual property to Beijing without consent was shared with US senators driving this bill. Last month, Sound Pharmaceuticals completed a Phase III trial for its drug SPI-1005. Interim results from the study ...
The US Food and Drug Administration (FDA) has approved ARS Pharmaceuticals‘ neffy (epinephrine nasal spray) 2mg for the emergency treatment of allergic reactions (type I). The indications include life-threatening anaphylaxis in adults and children weighing a minimum of 30kg. Previously, only injectable epinephrine was available for such patients. Anaphylaxis is a severe allergic reaction that can quickly become fatal, necessitating immediate medical intervention. Common triggers include certain foods, medications and insect stings, with symptoms such as hives, swelling, and difficulty breathing typically manifesting within minutes of exposure. The approval of neffy is supported by data from four clinical studies involving 175 healthy adults. These studies compared the blood concentration levels of epinephrine after administering neffy or traditional epinephrine injections. The findings indicated that neffy delivers comparable epinephrine levels to those of injectable products. In addition to matching the epinephrine blood concentrations, neffy demonstrated similar increases in blood pressure and heart ...
Sable Therapeutics has entered into an exclusive global licensing agreement with Columbia University to develop new polycation nanomedicines aimed at treating obesity. This partnership will focus on progressing a portfolio of compounds, SBL-001 and SBL-002, targeting both visceral and subcutaneous adiposity. Sable will hold sole rights for the development and commercialisation of the intellectual property created by Columbia University’s Dr Kam Leong, biomedical engineering professor Samuel Sheng, and Sable Therapeutics scientific co-founder Dr Li Qiang. SBL-001 and SBL-002 are designed to significantly diminish fat cell volume and have been uniquely engineered for selective uptake by adipose cells. Key features of the compounds include the ability to reduce fat cell targeted uptake volume by up to 70%. They can also act as a discrete drug delivery system for other agents, such as GLP-1s, which reduce fat. Sable Therapeutics focuses on creating assets for fat reduction, targeting conditions such as visceral obesity ...
Recently, Hengrui Pharmaceuticals’ subsidiary, Suzhou Shengdia Bio-pharmaceutical Co., Ltd. has received a Notice of Approval for Clinical Trial of Drugs issued by the State Drug Administration, agreeing to conduct a clinical trial for the treatment of moderate-to-severe plaque psoriasis in children and adolescents aged 6 to less than 18 years old, who are suitable for systemic therapy or phototherapy. Psoriasis is a chronic, relapsing, immune-mediated inflammatory skin disease that most often involves the scalp, knees, elbows, hands and feet. The prevalence of psoriasis ranges from 0.09% to 11.4% of the global population [1][2], and the prevalence of psoriasis in our country is about 0.5% [3]. About 80%-90% of psoriasis cases are of the common type of psoriasis (plaque psoriasis) and 10%-20% of cases are of moderate to severe psoriasis involving more than 5% of the body surface area (BSA) [4]. It is estimated that approximately 1/3 of adults with psoriasis ...
Recently, Hengrui Pharmaceuticals’ subsidiary, Guangdong Hengrui Pharmaceuticals Co., Ltd. received a Notice of Approval for Clinical Trial of Drugs approved by the State Drug Administration, agreeing to conduct a clinical trial of SHR-1819 Injection for patients with Prutigo nodularis (PN). PN is a chronic, inflammatory skin disease clinically characterized by episodes of intense itching and multiple nodular lesions. The main clinical symptom is intense, recurrent itching accompanied by uncontrollable scratching, which leads to hyperkeratosis of the skin to the point of forming dome-shaped nodules.1 PN leads to the development of psychological disorders in patients who face a significant reduction in quality of life, reduced sleep quality, and anxiety and depression. According to Frost & Sullivan, the number of PN patients in China will be approximately 2 million in 2022 and is expected to reach 2.1 million in 2030. To date, there is no standard diagnosis and treatment program for PN, ...
Aurelle Health, a D2C Nutraceutical brand aimed to prioritise women’s hormonal health, has been launched in India. Taking its lineage from Balaxi Pharmaceuticals, the inception of the brand is based on the statistics that 1 out of every 5 Indian women suffer from hormonal issues like Polycystic Ovary Syndrome (PCOS). The brand further aims to educate women about their hormone health. As part of the launch phase, the company has introduced products across four categories – hair health, skin health, gut health and weight management. The novel products namely Clear Canvas, Mane and Maintain, Gut Health and Tone it Down, claim to be non-GMO, clinically proven, sugar-free and vegan. Paridhi Maheshwari, Founder, Aurelle Health explains that the brand incorporates her journey through PCOS, along with her experience in the pharmaceutical industry. Aurelle products are currently available on their website, Amazon and in select skin/hair clinics. The products are slated to ...
Motor neuron disease (MND), also referred to as amyotrophic lateral sclerosis (ALS), is a debilitating condition where messages from the brain’s motor neurons fail to reach the muscles, resulting in muscle weakening. At present, there is no cure for MND. Now, researchers have developed a new imaging technique to detect pathological abnormalities linked to MND, which could enhance the understanding of brain changes responsible for the disease and potentially aid in developing new treatments. This advancement was highlighted in a study published in Nature Communications, a collaborative effort between the University of Birmingham (Birmingham, UK) and the University of Sheffield (Sheffield, UK). Researchers at the University of Birmingham developed the new method called native ambient mass spectrometry (NAMS), allowing them to analyze proteins in their natural state directly from brain and spinal cord tissue samples. This technique provides unprecedented detail in studying protein structures in relation to their location within ...
Parkinson’s disease is identified by the buildup of misfolded alpha-synuclein proteins, which are crucial to the function of neural cells in the brain. This condition impacts millions globally, creating substantial hurdles in both early detection and treatment. Typically, Parkinson’s is diagnosed in later stages through clinical observation of physical symptoms, which often delays the application of potential treatments. Early diagnosis currently depends on sophisticated, costly equipment that is not widely accessible, particularly in less developed regions. Researchers have now introduced a novel visual diagnostic approach aimed at improving early detection capabilities for neurodegenerative diseases like Parkinson’s. Named Cap-QuIC (Capillary-enhanced Quaking-Induced Conversion), the techniques developed by researchers at the University of Minnesota (Minneapolis, MN, USA), allows clinicians to visually identify infected samples, enhancing both the affordability and accessibility of testing. Building on their earlier diagnostic advancements, Cap-QuIC employs a simple technique to visually detect misfolded alpha-synuclein proteins. In their research published ...
By Don Tracy, Associate Editor Regulatory action marks the first engineered cell therapy approved for a solid tumor cancer in the United States.The FDA has granted accelerated approval to Adaptimmune Therapeutics’ Tecelra (afamitresgene autoleucel), an engineered cell therapy that targets resectable or metastatic synovial sarcoma in adults who have undergone prior chemotherapy and are HLA-A*02 positive with MAGE-A4 antigen expression. The treatment, which was approved based on results from the SPEARHEAD-1 trial, marks the first engineered cell therapy for a solid tumor cancer to be approved in the United States, according to the company.1 “The approval of Tecelra is a momentous step in Adaptimmune’s journey to redefine the way cancer is treated and the culmination of a decade of groundbreaking R&D. I want to thank the patients, caregivers, investigators, and clinical teams as well as everyone at Adaptimmune and our partners who made possible this watershed moment for cell therapy ...
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