PharmaFocus Today – Page 318 – media

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
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- 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
- 117
- 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
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- 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
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- 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
AbbVie’s migraine medication Qulipta gets positive CHMP opinion

AbbVie announced the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion for its migraine medication Qulipta (atogepant). Once the CHMP has issued a positive opinion, the EMA will send a recommendation to the European Commission (EC) to approve it. While not a guarantee, a positive CHMP opinion is generally a good indication that a drug is likely to be approved. In a June 2023 statement, AbbVie claims that full approval from the European Commission (EC) would position Qulipta as the only daily oral calcitonin gene-related peptide (CGRP) receptor antagonist (gepant) treatment for episodic and chronic migraines available in the EU. Qulipta is approved for use in the US. In 2021, it managed to secure FDA approval to treat episodic migraine, receiving further approval this year to also treat chronic migraine. The positive opinion is based on Phase III trial results submitted ...
- Source: drugdu
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- June 25, 2023
Intercept winds down NASH programme after FDA pulls plug on Ocaliva

Following a negative Advisory Committee (AdCom) decision, the US Food and Drug Administration (FDA) has rejected Intercept’s Ocaliva (obeticholic acid) for the treatment of pre-cirrhotic fibrosis due to nonalcoholic steatohepatitis (NASH) in a complete response letter (CRL) to the company. In a 23 June conference call, the company announced that it would begin the process of shutting down the REGENERATE trial (NCT02548351), with an aim to complete this process by the end of 2023. Intercept will continue to collect study data until the trial is fully terminated. Furthermore, the biotech has already begun “winding down” its NASH-related investment into research and development, commercial, medical affairs and administrative function. The company will also cut down its workforce by a third to minimise operating expenses, beginning in the coming weeks with plans to complete this by the end of 2023. Intercept will pivot its focus to Ocaliva’s use for primary biliary cholangitis ...
- Source: drugdu
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- June 25, 2023
MSD extends peptide collaboration with IRBM

Contract research organisation IRBM has announced an extension to its collaboration with US-based Merck & Co. (MSD) to develop peptide therapeutics. IRBM began as part of MSD, in 2000, before being spun off in 2010. Following the separation, the companies continued to work together on drug discovery, with the collaboration being expanded in 2020 to develop peptide therapeutics for coronavirus. Advances in phage and mRNA display platforms have accelerated peptide development in recent years. In particular, IRBM claims it has made major progress with half-life extension strategies and utilising formulation enhancers to support oral route administrations. IRBM told Pharmaceutical Technology that AI is beginning to play a part in peptide discovery, and that radiotheranostics was a rapidly growing area of interest. Italy-based IRBM draws upon expertise in peptide drug development to bring new candidates to fruition. It utilises a platform that covers the entire range of activities required to discover ...
- Source: drugdu
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- June 25, 2023

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