FDA Adverse Event Reporting System

Scilex Holding Company Presented Oral and Poster Presentations on ZTlido (lidocaine topical system) at the 2023 Annual PAINWeek Conference Held in Las Vegas, NV

Retrieved on: 
Tuesday, September 12, 2023
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PALO ALTO, Calif., Sept. 12, 2023 (GLOBE NEWSWIRE) -- Scilex Holding Company (Nasdaq: SCLX, “Scilex” or “Company”), a majority-owned subsidiary of Sorrento Therapeutics, Inc. (OTC: SRNEQ), an innovative revenue-generating company focused on acquiring, developing and commercializing non-opioid pain management products for the treatment of acute and chronic pain, announced that it presented oral and poster presentations at the 2023 Annual PAINWeek Conference on the benefits of ZTlido (lidocaine topical system).

Key Points: 
  • PALO ALTO, Calif., Sept. 12, 2023 (GLOBE NEWSWIRE) -- Scilex Holding Company (Nasdaq: SCLX, “Scilex” or “Company”), a majority-owned subsidiary of Sorrento Therapeutics, Inc. (OTC: SRNEQ), an innovative revenue-generating company focused on acquiring, developing and commercializing non-opioid pain management products for the treatment of acute and chronic pain, announced that it presented oral and poster presentations at the 2023 Annual PAINWeek Conference on the benefits of ZTlido (lidocaine topical system).
  • The conference was held from September 5-8, 2023 in Las Vegas, NV.
  • Impact of Adhesion on Patient Satisfaction, Medication Switching and Discontinuation with Lidocaine Topical Patches Based on FDA Adverse Event Reporting and Patient Surveys.
  • “More new data presented to support superior adhesion qualities of ZTLido, as well as decreased healthcare resource utilization compared to Lidocaine 5% patch demonstrating significant reduction in outpatient visits and ER/Urgent Care visits.

Data Presented at the 2023 SLEEP Annual Meeting Strengthens Evidence for ProSomnus Precision Oral Appliance Therapy for the Treatment of Obstructive Sleep Apnea

Retrieved on: 
Thursday, June 8, 2023
Oat, Abstract, HNS, SRS, Medicine, Database, AASM, CPAP, Obstructive sleep apnea, OAT, Sleep Research Society, American Academy, Research, OSA, Precision, American Academy of Sleep Medicine, MD, Patient, Risk, FDA Adverse Event Reporting System, Annual general meeting, AHI, Associated, Mortality, FDA, VI, Safety, Pharmaceutical industry, Dietary supplement, Cryptocurrency

Prior research importantly demonstrates that SASHB is predictive of mortality, cardiovascular events, and overall health outcomes, whereas the frequency-based index (apnea hypopnea index “AHI”) is not.

Key Points: 
  • Prior research importantly demonstrates that SASHB is predictive of mortality, cardiovascular events, and overall health outcomes, whereas the frequency-based index (apnea hypopnea index “AHI”) is not.
  • In this retrospective analysis of 48 patients, precision OAT demonstrated 90% therapeutic efficacy using the risk based SASHB index.
  • “As the CPAP recall persists, two abstracts investigate FDA adverse event reports and the safety of precision OAT.
  • This research further establishes ProSomnus precision OAT as a safe and efficacious treatment for OSA.”

Data Presented at the 2023 American Academy of Dental Sleep Medicine and the American Thoracic Society Meetings Further Validate ProSomnus Precision Oral Appliance Therapy for the Treatment of Obstructive Sleep Apnea

Retrieved on: 
Tuesday, May 30, 2023
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100% of patients adhered to OAT, while 83% of patients adhered to CPAP.

Key Points: 
  • 100% of patients adhered to OAT, while 83% of patients adhered to CPAP.
  • Liners: 98.5% of AERs involved lab-formed OATs with and without liners, while just 1.5% of AERs involved precision-engineered liner-less devices.
  • “Precision oral appliance therapy consists of intraoral medical devices that precisely track to the healthcare provider’s treatment plan and the patient’s anatomy,” said Len Liptak, Chief Executive Officer of ProSomnus.
  • “This data further validates that our non-invasive, patient-preferred, precision oral appliance therapy is associated with excellent outcomes for patients with OSA.”

Avadel Pharmaceuticals Provides Corporate Update and Reports Fourth Quarter and Full Year 2022 Financial Results

Retrieved on: 
Thursday, March 30, 2023
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ET

Key Points: 
  • ET
    DUBLIN, Ireland, March 30, 2023 (GLOBE NEWSWIRE) -- Avadel Pharmaceuticals plc (Nasdaq: AVDL), a biopharmaceutical company focused on transforming medicines to transform lives, today provided a corporate update and announced its financial results for the fourth quarter ended December 31, 2022.
  • Collectively, these milestones move us closer to the potential commercialization of LUMRYZ,” said Greg Divis, Chief Executive Officer of Avadel Pharmaceuticals.
  • I want to thank all stakeholders including patients, healthcare practitioners, and our investors for their strong support during this process.
  • Avadel will host a conference all and live audio webcast to discuss its fourth quarter and full year quarter 2022 financial results and provide a corporate update today at 8:30 a.m.

Prolacta Clinical Advisory Board Members Present Webinar on Improved Growth Metrics for Preterm Infants Fed an Exclusive Human Milk Diet

Retrieved on: 
Thursday, December 1, 2022
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DUARTE, Calif., Dec. 1, 2022 /PRNewswire/ -- Prolacta Bioscience®, the world's leading hospital provider of 100% human milk-based nutritional products for critically ill, premature infants, announced today that two members of the Prolacta Clinical Advisory Board (PCAB) will present a webinar for clinicians who care for preterm infants titled "Improved Growth Metrics for Preterm Infants Supported With a Human Milk Diet" on Thursday, Dec. 1, at 9 a.m. PT.

Key Points: 
  • Stacia Pegram, MA, RDN, LD, and Patti Perks, MS, RDN, CNSC, will present "Improved Growth Metrics for Preterm Infants Supported With a Human Milk Diet" on Dec. 1
    DUARTE, Calif., Dec. 1, 2022 /PRNewswire/ -- Prolacta Bioscience , the world's leading hospital provider of 100% human milk-based nutritional products for critically ill, premature infants, announced today that two members of the Prolacta Clinical Advisory Board (PCAB) will present a webinar for clinicians who care for preterm infants titled "Improved Growth Metrics for Preterm Infants Supported With a Human Milk Diet" on Thursday, Dec. 1, at 9 a.m. PT.
  • Perks and Pegram are members of the Prolacta Clinical Advisory Board (PCAB), a group of neonatologists, neonatal nursing leaders, and neonatal dietitians with broadly recognized clinical expertise.
  • Prolacta's 100% human milk-based nutritional products have been evaluated in more than 20 clinical studies published in peer-reviewed journals.
  • Prolacta maintains the industry's strictest quality and safety standards for screening, testing, and processing donor human milk.

Breaking Data on the Efficacy and Cost-Effectiveness of an Exclusive Human Milk Diet for Premature Infants To Be Presented at the American Academy of Pediatrics 2022 National Conference

Retrieved on: 
Friday, October 7, 2022
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One study based on real-world data from seven U.S. hospitalsdemonstrates the efficacy and cost-effectiveness of an EHMD for premature infants.

Key Points: 
  • One study based on real-world data from seven U.S. hospitalsdemonstrates the efficacy and cost-effectiveness of an EHMD for premature infants.
  • "These collaborative data fill gaps in evidence-based medicine for NICU leaders and provide support for implementing an EHMD for very preterm infants," Dr. Fox said.
  • The major difference between cow milk-based and human milk-based products is the composition notably, the bioactive components that are unique to human milk.
  • Prolacta maintains the industry's strictest quality and safety standards for screening, testing, and processing donor human milk.

Prolacta Bioscience Recognizes Nurses Caring for Fragile Infants Every Day Throughout Neonatal Nurses Week and NICU Awareness Month

Retrieved on: 
Monday, September 12, 2022
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DUARTE, Calif., Sept. 12, 2022 /PRNewswire/ -- Prolacta Bioscience®, the world's leading hospital provider of 100% human milk-based nutritional products for critically ill, premature infants, is celebrating National Neonatal Nurse's Week and NICU Awareness Month by recognizing the dedication of the neonatal intensive care unit (NICU) nurses who work tirelessly to care for the most fragile patients: premature infants.

Key Points: 
  • Established by the National Association of Neonatal Nurses (NANN) two decades ago, Neonatal Nurses Week 2022 is observed September 12-18 to celebrate the nurses who care for the medically fragile babies in the NICU.
  • The week falls during NICU Awareness Month, which honors families with infants experiencing a stay in the NICU and the health professionals who care for them.
  • Throughout Neonatal Nurses Week, Prolacta is recognizing NICU nurses with free educational offerings, such as CE-credited webinars to support the growth and health of premature infants in their care.
  • Each day, Prolacta will provide a new resource to support NICU nurses in meeting the health and nutritional needs of premature infants.

Multiple Peer-Reviewed Studies Show Prolacta's 100% Human Milk-Based Nutritional Fortifiers Reduce Risk of Life-Threatening Comorbidities in Premature Infants, Compared to Cow Milk-Based Nutrition

Retrieved on: 
Wednesday, July 27, 2022
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DUARTE, Calif., July 27, 2022 /PRNewswire/ -- Prolacta Bioscience®, the world's leading hospital provider of 100% human milk-based nutritional products for critically ill, premature infants, reports that data from a growing body of peer-reviewed clinical studies show a reduced risk of several comorbidities among premature infants who received Prolacta's 100% human milk-based fortifiers as part of Exclusive Human Milk Diet (Prolacta's EHMD), compared to premature infants fed cow milk-based fortifiers.1-13                                                                                                                          

Key Points: 
  • "1-13
    Neonatal intensive care units (NICUs) worldwide are working to reduce complications in premature infants.
  • "Addressing premature infant complications through nutrition in the NICU means getting these babies home sooner and healthier, and ultimately reducing hospital costs.
  • Prolacta's 100% human milk-based nutritional products have been evaluated in more than 20 clinical studies published in peer-reviewed journals.
  • *Estimated number of premature infants fed Prolacta's products from January 2007 to December 2021; data on file.

Prolacta Bioscience Introduces Its First Evidence-Based Feeding Protocol for an Exclusive Human Milk Diet in the NICU

Retrieved on: 
Tuesday, June 14, 2022
Science, Health maintenance organization, Milk, Neonatology, Flavored fortified wine, FAAP, Safety, Food, LinkedIn, Lactoferrin, Immunity, UHT, Pasteurization, Nursing, Nutritional science, Method, FDA, Growth, Division, Hospital, Risk, Diabetes, Antibody, Health, Jean-Louis Vincent, Incidence, Research, Diet, Twitter, FDA Adverse Event Reporting System, Pediatrics, Population, Obesity, Instagram, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Uncertainty, Medical Center, NICU, Medical imaging, Feed manufacturing, Dietary supplement, Facebook, MD

DUARTE, Calif., June 14, 2022 /PRNewswire/ -- Prolacta Bioscience®, the world's leading hospital provider of 100% human milk-based nutritional products for critically ill, premature infants, today announced the introduction of the first evidence-based feeding protocol for the use of an Exclusive Human Milk Diet including Prolacta's products (Prolacta's EHMD) in the neonatal intensive care unit (NICU). Prolacta's EHMD ProtocolTM addresses the nutritional risks of late and inadequate nutrition facing low birth weight premature infants and is the first nutritional guidance issued for the use of the company's human milk-based nutritional products.

Key Points: 
  • The major difference between cow milk-based and human milk-based products is the composition notably, the bioactive components that are unique to human milk.
  • Early fortification of enteral feedings for infants
  • 2020;15(5):297-303. doi:10.1089/bfm.2019.013
    4 Delaney Manthe E, Perks PH, Swanson JR. Team-based implementation of an exclusive human milk diet.
  • Composition and variation of macronutrients, immune proteins, and human milk oligosaccharides in human milk from nonprofit and commercial milk banks.

Leaderboard Branding Adds to Expert Drug Safety Division With Influential Hire: Former FDA DMEPA Evaluator

Retrieved on: 
Tuesday, June 7, 2022
Approximation error, Arbutus Biopharma, Leaderboard, Lymphatic system, LinkedIn, Fingerpaint, Doctor of Pharmacy, Nephrology, Creativity, Solution, FDA Adverse Event Reporting System, FDA, Division, Review, B2B, Twitter, Clinical trial, Drug development, Cardiology, Health, Institute, Hematology, Safety, Medical device, Facebook, United States Pharmacopeia

CHARLOTTE, N.C., June 7, 2022 /PRNewswire/ -- Leaderboard Branding, a Fingerpaint company, the fast-growing global naming and branding firm that delivers strategic insights and world-class creativity to biopharma and healthcare companies as early as clinical phase 1, announced the hiring of Max Straka, PharmD, FISMP, a former FDA Division of Medication Error Prevention and Analysis (DMEPA) safety evaluator. As a Director of Leaderboard Branding's Drug Safety Division, Dr. Straka adds to the broad experience of global leaders and innovators in this important area of drug development.

Key Points: 
  • As a Director of Leaderboard Branding's Drug Safety Division, Dr. Straka adds to the broad experience of global leaders and innovators in this important area of drug development.
  • "Max brings a unique end-to-end perspective of drug safety, as well as an insider's understanding of the FDA," said Brannon Cashion, Managing Partner of Leaderboard Branding.
  • About Leaderboard Branding: Leaderboard Branding, a Fingerpaint company, is a global naming and branding firm that delivers strategic insights and world-class creativity to every client, on every engagement.
  • The expert strategists at Leaderboard Branding have a unique ability to optimize a brand's commercial potential while mitigating safety concerns and aligning to regulatory guidelines.