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Acurable prepares to challenge ResMed for sleep apnea diagnosis market

Dive Brief Acurable is preparing to challenge ResMed and Resonea for the sleep apnea diagnosis market in the U.S. Having received 510(k) clearance in February, Acurable plans to start selling its AcuPebble Ox100 device in the U.S. this summer. The device records the sounds of the patient’s respiratory and cardiac functions and monitors blood oxygen levels to assess suspected obstructive sleep apnea. ResMed acquired a rival device, now sold as onesleeptest, through its 2021 Ectosense takeover and Resonea offers some of the same capabilities through its Drowzle Pro mobile application. Dive Insight AcuPebble Ox100 builds on an older Acurable device, AcuPebble SA100, that received 510(k) clearance in the summer of 2021. Like the older device, AcuPebble Ox100 features a sensor that the patient sticks to their neck to record respiratory and heart sounds. The acoustic signals are processed and analyzed by algorithms to detect sleep apnea. The new device combines ...
- Source: https://www.medtechdive.com/news/acurable-launch-sleep-apnea-diagnosis/651232/
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- May 28, 2023
Groundbreaking study targets ‘jumping genes’ in the entire genomes of the human large intestine

The Korea Advanced Institute of Science and Technology (KAIST) and their collaborators have conducted a groundbreaking study targeting ‘jumping genes’ in the entire genomes of the human large intestine. Published in Nature on May 18 2023, the research unveils the surprising activity of ‘Long interspersed nuclear element-1 (L1),’ a type of jumping gene previously thought to be mostly dormant in human genomes. The study shows that L1 genes can become activated and disrupt genomic functions throughout an individual’s lifetime, particularly in the colorectal epithelium. (Paper Title: Widespread somatic L1 retrotransposition in normal colorectal epithelium, https://www.nature.com/articles/s41586-023-06046-z) With approximately 500,000 L1 jumping genes, accounting for 17% of the human genome, they have long been recognized for their contribution to the evolution of the human species by introducing ‘disruptive innovation’ to genome sequences. Until now, it was believed that most L1 elements had lost their ability to jump in normal tissues of modern ...
- Source: https://www.news-medical.net/news/20230525/Groundbreaking-study-targets-jumping-genes-in-the-entire-genomes-of-the-human-large-intestine.aspx
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- May 28, 2023
【EXPERT Q&A】What aspects should be considered when sending samples to clients? How can we create opportunities for sales techniques, generate chances for client visits, and encourage clients to sign contracts promptly?

When sending samples, it is important to select the right customers with potential demand, pay attention to the details of customized samples, ensure the quality, and provide secure packaging. Including a company catalog and sample list can help customers understand your company and products better. Following up after sending the samples and maintaining regular communication with the customer can help improve the order conversion rate.
- Source: drugdu
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- May 28, 2023
customized sample details order conversion rate sample packaging sample quality samples
【EXPERT Q&A】Could someone explain the WC certification documents for exporting Active Pharmaceutical Ingredients (APIs) to the European Union?

Drugdu.com expert’s response: Active pharmaceutical ingredients (APIs) intended for export to the European Union need to obtain the Good Manufacturing Practice (GMP) certification and Written Confirmation (WC) document issued by the European Medicines Agency (EMA). GMP certification for pharmaceuticals involves rigorous auditing of the manufacturer’s quality management system, production processes, equipment, and personnel, ensuring the produced pharmaceuticals meet the quality and safety requirements of the EU. GMP certification is a prerequisite for obtaining the WC document; only businesses that have passed GMP certification can obtain the WC document and export APIs to the EU market. The WC document is one of the required export documents for APIs to the EU, aiming to ensure that APIs exported to the EU meet the EU’s quality and safety requirements. To apply for the WC document, the API manufacturing company needs to submit the following information to the EMA: 1.Name of the API and its ...
- Source: drugdu
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- May 28, 2023
Researchers identify potential new treatment for those who act out their dreams while sleeping

Mount Sinai researchers have published what they say is the first study to identify a new form of treatment for rapid eye movement (REM) sleep behavior disorder. This condition affects more than 3 million Americans, mostly adults over the age of 50, who often unknowingly physically act out their dreams with vocal sounds or sudden, violent arm and leg movements during slumber, leading to significant injury to themselves or bed partners. The new study, published in the Journal of Neuroscience, outlines a novel model to better characterize how REM sleep behavior disorder develops due to neurodegeneration—when brain cells lose function over time—which is associated with the accumulation of tau protein. This model provides an early-life biomarker of impending deterioration of the brain, which could guide future prevention and treatment. The paper also demonstrates for the first time that sleep medications known as dual orexin receptor antagonists—commonly used to treat insomnia, or difficulty falling ...
- Source: Journal of Neuroscience
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- May 27, 2023
Bipartisan lawmakers pressure FDA on common chemotherapies now in shortage

The US House of Representatives has turned a sharp eye to drug shortages over the past few months, with hearings and new caucuses to try and dampen the situation, but another bipartisan letter sent yesterday to FDA aims to keep the pressure up on cancer drug shortages. Reps. Debbie Dingell (D-MI) and Tim Walberg (R-MI) penned the letter to FDA Commissioner Rob Califf, expressing concerns around the shortages of two commonly used chemotherapies used to treat cancer, known as cisplatin and carboplatin, which are used for lung, gynecologic and breast cancers, as well as methotrexate, which is used in treating other forms of cancer. “These chemotherapy drug shortages come amid a shortage of other critical cancer medications. Taken together, they are straining the ability of doctors to provide the best course of treatment for their patients. We are hearing directly from impacted hospitals urging immediate action to address ...
- Source: https://endpts.com/
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- May 27, 2023
Most Medicaid Enrollees Are Unaware About the Return to Eligibility Renewals

About 65% of Medicaid enrollees are unsure if states are allowed to now disenroll people from Medicaid if they aren’t eligible anymore or didn’t renew coverage, and 7% incorrectly believe that states can’t do this, a new analysis showed. During the Covid-19 pandemic and under the continuous enrollment provision, states were barred from disenrolling people on Medicaid. However, this provision ended March 31, meaning the normal renewal process for Medicaid has resumed and states will disenroll those who are no longer eligible or don’t renew coverage (many states are completing this process over the course of a year). As many as 18 million people could lose Medicaid coverage during this period. The new analysis, published Wednesday by the Kaiser Family Foundation, was based on the organizations’ Survey of Health Insurance Consumers. The survey was conducted prior to the end of the continuous enrollment provision between February 21 and ...
- Source: https://medcitynews.com/2023/05/medicaid-eligibility-renewal-redetermination/
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- May 27, 2023
BMS pitches Breyanzi as the first CAR-T for CLL. But will a single-arm trial persuade the FDA?

CAR-T therapies have been around for six years, but it was only in January that Bristol Myers Squibb unveiled the first positive readout for such a personalized immunotherapy in chronic lymphocytic leukemia (CLL), the most common form of leukemia, from a pivotal multicenter study. In new data released Thursday, Bristol Myers Squibb said that Breyanzi eradicated signs of cancer in 18.4% of patients with heavily pretreated CLL or small lymphocytic lymphoma (SLL). The phase 1/2 trial coded TRANSCEND CLL 004 has therefore met its primary endpoint. Among those who achieved a complete response, the median duration of response wasn’t reached after a median follow-up of 21.1 months. No patients in that group experienced disease progression or deaths by the data cutoff. The results will be presented during the 2023 American Society of Clinical Oncology annual meeting on June 6. Bristol released the findings ahead of the meeting Thursday. Breyanzi’s complete response data “are remarkable and ...
- Source: drugdu
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- May 27, 2023
Celadon secures medicinal cannabis contract

Celadon will sell a minimum of £3m worth of the high-THC product over the next three years Celadon Pharmaceuticals – a company focused on researching cannabis-based medicines – has announced that it has secured a contract for the commercial supply of its pharmaceutical-grade cannabis product with a UK medicinal cannabis company. As part of the agreement, Celadon will sell a minimum of £3m worth of the high-THC product over the next three years. The initial shipment is expected to be made towards the end of 2023, while the contract could be extended for a further two years with the mutual agreement of the parties. The milestone contract follows the company’s Good Manufacturing Practices registration in January and the update to its Home Office licence, also from earlier this year. Directors at Celadon believe that it is one of a limited number of companies globally with the approvals in place to ...
- Source: drugdu
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- May 27, 2023
Mirati’s long wait for next lung cancer med ends in phase 3 failure

After a five and a half month wait, Mirati Therapeutics finally has the answer it’s been waiting for on a lung cancer med called sitravatinib: The therapy did not improve survival in a phase 3 study. Back in December 2022, Mirati said that the SAPPHIRE trial would continue to its final analysis instead of getting an interim readout as planned. The company had hoped to use the early data to support an FDA application for approval in second- and third-line non-small cell lung cancer (NSCLC). Mirati was looking for a 3.5-month overall survival benefit, but, according to a brief update Wednesday afternoon, that measure was not successful at the final analysis. The company is not releasing the data set at this time but promised to do so “at a future date.” Patients who are experiencing clinical benefit may continue on treatment at the discretion of the principal investigators. The failure ...
- Source: drugdu
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- May 27, 2023

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