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After delays, Sarepta’s DMD gene therapy Elevidys finally crosses FDA finish line at $3.2M

After several delays and a narrow advisory committee vote, Sarepta’s Duchenne muscular dystrophy (DMD) gene therapy has finally won an accelerated approval. The FDA’s approval for Elevidys comes one month behind the agency’s prior schedule and in a restricted patient population. But a win is a win for Sarepta. Specifically, the drug is approved to treat ambulatory patients ages 4 to 5 years with a confirmed mutation in the DMD gene. Sarepta is charging Elevidys, a one-time gene therapy, at a list price of $3.2 million, CEO Douglas Ingram told investors during a call Thursday. He pointed to an analysis suggesting the drug could be cost-effective at $5 million. Ingram expects the launch to take a few months to pick up, based on logistical and policy issues to address, he told investors. As opposed to an treatment outcome-based payment approach that has been adopted by other existing gene therapies to ...
- Source: drugdu
- 111
- June 26, 2023
World Health Organization publishes research agenda for antimicrobial resistance

The World Health Organization (WHO) has published its first global research agenda for scientists to address the ‘most urgent’ human health priorities to tackle antimicrobial resistance (AMR), which has been declared by the organisation as one of the top ten threats to global public health. Associated with the deaths of 4.95 million people in 2019, AMR occurs when bacteria, viruses, fungi and parasites change and adapt to antibiotics over time. As a result, infections become harder to treat, and the risk of disease spread, severe illness and death increases. The WHO Global Research Agenda for AMR in human health outlines 40 research topics on drug-resistant bacteria, fungi and Mycobacterium tuberculosis that the organisation said “must be answered by 2030”. WHO said the aim of the agenda is to guide key stakeholders, including policymakers, researchers and funders, in generating new evidence to inform AMR policies and interventions as part of efforts ...
- Source: drugdu
- 110
- June 26, 2023
Gilead’s chronic hepatitis D antiviral shows long-term efficacy in late-stage trial

Gilead Sciences has shared positive results from a late-stage study of its chronic hepatitis D virus (HDV) treatment, Hepcludex (bulevirtide). Gilead said the new 96-week data from the phase 3 MYR301 trial, which was presented at this year’s European Association for the Study of the Liver Congress, “reinforces the role of Hepcludex as an efficacious and well-tolerated treatment for the management of chronic HDV”. Data shows that the combined virological and biochemical response rates continued to increase through week 96, with response rates of 55% and 56% at the 2mg and 10mg dose levels, respectively. An additional analysis from the trial, presented in a late-breaker, also showed that study participants who appeared to not respond or only partially respond to the antiviral at week 24 went on to achieve a virological response at 96 weeks. The safety profile at week 96 was consistent with what was observed at week 48, ...
- Source: drugdu
- 112
- June 26, 2023
FDA orders stores to stop selling Elf Bar disposable Vapes

The U.S. Food and Drug Administration said Thursday it has sent warning letters to 189 retailers, telling them to stop selling unauthorized tobacco products such as Elf Bar and Esco Bars. Both brands are disposable e-cigarettes sold in flavors known to appeal to kids, including bubblegum and cotton candy. A federal ban on flavored vapes that was issued in early 2020 does not cover disposable vapes. “The FDA is prepared to use all of its authorities to ensure these, and other illegal and youth-appealing products, stay out of the hands of kids,” FDA Commissioner Dr. Robert Califf said in an agency news release. “We are committed to a multi-pronged approach using regulation, compliance and enforcement action and education to protect our nation’s youth.” The warning letters were sent following a nationwide inspection blitz conducted over several weeks. In addition, two studies published in Morbidity & Mortality Weekly Report highlight concerns ...
- Source: drugdu
- 118
- June 26, 2023
Study explores the use of deep learning algorithm to detect occlusal caries

A diagnostic study on the detection of occlusal caries from a clinical photograph using a deep learning algorithm will be presented at the 101st General Session of the IADR, which will be held in conjunction with the 9th Meeting of the Latin American Region and the 12th World Congress on Preventive Dentistry on June 21-24, 2023, in Bogotá, Colombia. The Interactive Talk presentation, “Automated Detection of Occlusal Caries Using Deep Learning Algorithm,” will take place on Saturday, June 24 at 4:25 p.m. Colombia Time (UTC-05:00) during the “Prevalence of Health Conditions and Risk Factors” session. The study by Chukwuebuka Elozona Ogwo of Temple University, Philadelphia, PA, U.S. sought to determine the accuracy, precision, and sensitivity of the YOLOv7 object detection algorithm in occlusal caries detection from clinical photographs and (2) develop software for occlusal caries detection. Only consenting adults (>=18 years old) with permanent dentition receiving care at the Temple ...
- Source: drugdu
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- June 26, 2023
analysts

Dive Brief Intuitive Surgical’s minimally invasive bronchoscopy platform Ion may provide “some of the most exciting advancements in robotic technology” in the coming years, according to analysts at BTIG. While Ion contributed an estimated $115 million of the company’s $6.2 billion in revenue last year, the analysts see scope for Intuitive to grow sales by capturing more of the lung biopsy market and expanding into the ablation of tumors. Intuitive competes for the bronchoscopy market with Johnson & Johnson’s Monarch platform. The analysts estimate there are about twice as many Ion systems as Monarch devices in use. Dive Insight Intuitive’s success rests on its da Vinci robotic platform and discussions of the future of the company focus on whether J&J and Medtronic can challenge the dominance of that device, the BTIG analysts said. “Intuitive’s push into robotic bronchoscopy is purposeful, not just simply for the bronchoscopy opportunity, but for its ...
- Source: drugdu
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- June 26, 2023
FDA Approves Sarepta’s Gene Therapy for Duchenne Muscular Dystrophy

By Heather McKenzie https://www.biospace.com/ Pictured: FDA sign in front of a brown brick building/Adobe Stock, Grandbrothers Sarepta’s Elevidys, approved Thursday as the first gene therapy for Duchenne muscular dystrophy, has been priced at $3.2 million per patient, making it one of the world’s most expensive medicines. The price, announced Thursday following the FDA’s decision, is second in the U.S. only to that of uniQure and CSL Behring’s hemophilia B therapy Hemgenix, approved late last year, which costs $3.5 million per patient, according to BioPharma Dive. On a conference call, Sarepta CEO Doug Ingram said the price reflected a “conservative” approach to valuing the therapy’s benefits to patients and their families, BioPharma Dive reported. Sarepta expects that discounts through Medicaid or a 340B program will make the net price of Elevidys about 20% lower than its gross cost. Original story published June 22 Sarepta’s Elevidys, approved Thursday, is now one of ...
- Source: drugdu
- 120
- June 25, 2023
States Back FTC in Lawsuit Seeking to Block Amgen-Horizon Deal

Pictured: FTC sign on a wall/iStock Six U.S. states are joining the Federal Trade Commission’s lawsuit seeking to block Amgen’s $27.8 billion buyout of rare disease biotech Horizon Therapeutics, Reuters reported on Thursday. The acquisition “would allow Amgen to monopolize the market for certain crucial medications,” which would make these treatments less affordable and accessible to patients, Illinois Attorney General Kwame Raoul said in a statement. Illinois is one of the states joining the FTC’s lawsuit, along with California, Minnesota, New York, Washington and Wisconsin. In the amended lawsuit, the six states and the FTC are asking the District Court of the Northern District of Illinois to issue a preliminary injunction against the Amgen-Horizon deal while the Commission prepares an administrative complaint, and until decisions have been made about the complaint. The plaintiffs are also seeking a temporary restraining order against the acquisition and any other related transactions. “When drug ...
- Source: drugdu
- 120
- June 25, 2023
Sterigenics moves closer to end of ethylene oxide lawsuit as most claimants accept $408M deal

Dive Brief Almost all the claimants in a lawsuit against Sterigenics over damage allegedly caused by ethylene oxide (EtO) — used to sterilize reusable medical devices — have opted to participate in the settlement. Early this year, contract device sterilizer Sterigenics and its parent company Sotera Health agreed to pay $408 million to resolve hundreds of ethylene oxide cases without admitting liability. The latest update shows that all but three of the 882 claimants have accepted the settlement. The suits of the claimants who opted out will proceed to pretrial discovery and the “immaterial fraction” of the settlement they represent will revert to Sterigenics at the end of the year. Dive Insight The settlement relates to Sterigenics’ former facility in Willowbrook, Illinois. In September, a jury ruled in favor of cancer survivor Susan Kamuda and awarded her $358.7 million. Months later, the company agreed to settle with another 882 people ...
- Source: drugdu
- 127
- June 25, 2023
New white paper on challenges and opportunities in theranostics education

Leaders from 12 nuclear medicine organizations around the world have issued a white paper about the challenges and opportunities in theranostics education. Published in the June issue of The Journal of Nuclear Medicine, the report outlines the current theranostic educational and accreditation offerings across the globe. It also provides guidelines to assist countries in developing educational and training curriculums that enable physicians to confidently and safely perform nuclear theranostics procedures. The concept of theranostics refers to the integration of therapeutics and diagnostics into a single management approach. Through their high sensitivity and specificity, theranostic radiopharmaceuticals have started to play a major role in precision medicine by significantly improving patient disease management, particularly in oncology. “As exciting as it sounds, the clinical implementation of theranostics radiopharmaceuticals in nuclear medicine faces significant challenges. The practice of a fully integrated diagnostic and therapeutic nuclear medicine specialty requires an in-depth knowledge in many different ...
- Source: drugdu
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- June 25, 2023

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