PharmaFocus Today – Page 345 – media

Mirroring Senate counterparts, House committee advances PBM reforms

The House Energy & Commerce Committee advanced multiple bills to the House floor in a seven-hour hearing Wednesday, some of which included measures to address drug pricing transparency and PBMs. The highlights included two bills, among other healthcare measures, that would advance accountability around PBMs and on drug pricing, including the embattled 340B program. One bill, also known as the “Promoting Access to Treatments and Increasing Extremely Needed Transparency,” or PATIENT Act, would ban spread pricing where PBMs can charge that state more than they reimburse pharmacies. That same ban was included in a Senate bill that also recently advanced out of committee. The House bill, introduced by bipartisan sponsors Cathy McMorris Rodgers (R-WA), committee chair, and Frank Pallone (D-NJ), passed unanimously at 49-0. Both the House and Senate bills would also add new transparency measures around PBMs. Rodgers said during the committee meeting that the bill is “the product ...
- Source: https://endpts.com/
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- May 28, 2023
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
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
First UK death linked to ‘zombie’ drug xylazine

The death of a 43-year-old man is the first in the UK to be linked to the “zombie” drug xylazine, which is prompting overdose warnings in the US. Normally used as a large-animal tranquiliser but now being found in heroin, it can cause a dangerously low heart rate and large open skin wounds. UK experts are calling it “a really concerning drug”. They say drug users should be warned it is now present in the UK but there is no safe dose in humans. ‘Bought heroin’ Karl Warburton, form Solihull, West Midlands, died in May 2022 at home and had a history of illicit drug use, according to the coroner’s report. He had been referred to addiction services on a number of occasions. An examination of his body detected heroin, fentanyl and cocaine in his system, as well as xylazine. A report on his death in the Journal of Forensic and ...
- Source: BBC news
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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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