PWS

Genasys Partners in European Union-Funded Project to Revolutionize Public Warning

Retrieved on: 
Tuesday, March 26, 2024
Civil service commission, Grant, Galileo Galilei, Republic, Disaster, Genasys, Satellite navigation, SAN, EWSS, University, European Commission, JCDecaux, CNES, Telecommunications, FDC, European, PWS, GNSS, Mobile phone

101082555) that goes beyond smartphone-based alerting by developing a solution that will extend the reception and processing of Galileo Emergency Warning Satellite Service (EWSS) public safety warnings into display panels, indoor warning systems, and acoustic devices.

Key Points: 
  • 101082555) that goes beyond smartphone-based alerting by developing a solution that will extend the reception and processing of Galileo Emergency Warning Satellite Service (EWSS) public safety warnings into display panels, indoor warning systems, and acoustic devices.
  • Genasys’ experience in innovating satellite-connected speaker systems that broadcast audible voice messages with exceptional clarity qualified us to partner in this consortium.
  • Genasys Protect ALERT will be used to conduct an end-to-end Project AWARE demonstration with the Republic of Slovenia Administration for Civil Protection and Disaster Relief, a customer and consortium member.
  • The Republic of Slovenia Administration for Civil Protection and Disaster Relief will host one of the demonstrations planned at the end of the project.

Tonix Pharmaceuticals Receives Rare Pediatric Disease Designation from the FDA for TNX-2900 for the Treatment of Prader-Willi Syndrome

Retrieved on: 
Monday, March 25, 2024
Eating, Prader–Willi syndrome, Obesity, Orphan drug, Appetite, Ageing, Tonix Pharmaceuticals, IND, Polyphagia, Priority review, Oxytocin, Marketing, FDA, Genetic disorder, PWS, Food, Pharmaceutical industry

CHATHAM, N.J., March 25, 2024 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company), a biopharmaceutical company with marketed products and a pipeline of development candidates, today announced the U.S. Food and Drug Administration (FDA) has granted Rare Pediatric Disease Designation to TNX-2900* (intranasal potentiated oxytocin), a proprietary magnesium (Mg2+)-potentiated formulation of intranasal oxytocin, to treat Prader-Willi syndrome (PWS) in children and adolescents. TNX-2900 was previously granted Orphan Drug designation by the FDA in 2022 for the treatment of PWS and the investigational new drug (IND) application was cleared by the FDA in 2023. The Company may be eligible to receive a transferable Priority Review Voucher if TNX-2900 for PWS is approved for marketing. Recently, vouchers have sold for approximately $100 million.

Key Points: 
  • TNX-2900 was previously granted Orphan Drug designation by the FDA in 2022 for the treatment of PWS and the investigational new drug (IND) application was cleared by the FDA in 2023.
  • The Company may be eligible to receive a transferable Priority Review Voucher if TNX-2900 for PWS is approved for marketing.
  • Recently, vouchers have sold for approximately $100 million.
  • “The Rare Pediatric Disease Designation is an important regulatory milestone in the development of TNX-2900.

HARMONY BIOSCIENCES INITIATES GLOBAL PHASE 3 REGISTRATIONAL TRIAL (TEMPO STUDY) OF PITOLISANT IN PATIENTS WITH PRADER-WILLI SYNDROME

Retrieved on: 
Wednesday, April 3, 2024
ODD, Narcolepsy, Prader–Willi syndrome, TEMPO, Cataplexy, Patient, Ageing, EDS, Safety, Harmony, Plasma protein binding, FDA, PWS, Pitolisant, Pharmaceutical industry

Approximately 15,000 – 20,000 people in the U.S. are living with PWS, the majority experiencing behavioral symptoms and more than half with EDS.

Key Points: 
  • Approximately 15,000 – 20,000 people in the U.S. are living with PWS, the majority experiencing behavioral symptoms and more than half with EDS.
  • "Our progress in expanding the clinical applications of pitolisant in PWS and in other rare diseases, remains promising.
  • Pitolisant is marketed as WAKIX® in the U.S. and is FDA approved to treat EDS or cataplexy in adult patients with narcolepsy.
  • Pitolisant is not approved for use in patients with PWS and is currently being evaluated as an investigational agent in this patient population.

3M Settlement with Public Water Suppliers to Address PFAS in Drinking Water Receives Final Court Approval

Retrieved on: 
Monday, April 1, 2024
Insurance, Risk, District court, Uncertainty, Drinking water, PFAS, PWS, Pharmaceutical industry

The now-finalized agreement will support PWS that detect PFAS at any level or may do so in the future and will benefit U.S.-based PWS that provide drinking water to Americans across the country.

Key Points: 
  • The now-finalized agreement will support PWS that detect PFAS at any level or may do so in the future and will benefit U.S.-based PWS that provide drinking water to Americans across the country.
  • The agreement received overwhelming support and participation from U.S. PWS, and the court resolved the small number of objections that were raised in favor of the settlement.
  • Payments under the agreement are scheduled to begin in the third quarter of 2024, provided there are no pending appeals of the final approval order.
  • The table below sets forth the expected pre-tax payments that 3M would make assuming the nominal $12.5B settlement cap is reached.

Soleno Therapeutics Provides Corporate Update and Reports Fourth Quarter and Full-Year 2023 Financial Results

Retrieved on: 
Wednesday, March 6, 2024
Therapy, Quarter, Research, FDA, Food, HQ, Sale, Prader–Willi syndrome, Exercise, PWS, Human resources, Patient, NDA, Pharmaceutical industry

REDWOOD CITY, Calif., March 06, 2024 (GLOBE NEWSWIRE) -- Soleno Therapeutics, Inc. (Soleno) (NASDAQ: SLNO), a clinical-stage biopharmaceutical company developing novel therapeutics for the treatment of rare diseases, today provided a corporate update, and reported financial results for the fourth quarter and full-year ended December 31, 2023.

Key Points: 
  • REDWOOD CITY, Calif., March 06, 2024 (GLOBE NEWSWIRE) -- Soleno Therapeutics, Inc. (Soleno) (NASDAQ: SLNO), a clinical-stage biopharmaceutical company developing novel therapeutics for the treatment of rare diseases, today provided a corporate update, and reported financial results for the fourth quarter and full-year ended December 31, 2023.
  • DCCR continued to be generally well-tolerated in the randomized withdrawal period with no new or unexpected safety signals.
  • “Following recent feedback from the FDA, Soleno remains focused on preparing an NDA submission for DCCR in PWS mid-2024,” said Anish Bhatnagar, M.D., Chief Executive Officer of Soleno Therapeutics.
  • Total other income (expense), net, was $2.6 million for the quarter ended December 31, 2023, and $0.1 million in the same period of 2022.

PRISM MarketView Highlights Work of Emerging Companies on Rare Disease Day

Retrieved on: 
Thursday, February 29, 2024
Rare disease, Therapy, Regenerative Medicine Advanced Therapy, FAP, Concha bullosa, Sulindac, Chemistry, Fast track (FDA), Muscular dystrophy, FDA, Sensation, News, Eflornithine, DMD, Prader–Willi syndrome, BLA, Chromosome, RDEB, PDUFA, Skin, Voyager, PRISM, Duchenne muscular dystrophy, Safety, Neurocrine Biosciences, Rare Disease Day, Genetics, Fatigue, Walking, PWS, Patient, DSM-IV codes, Medicine, Disease, Exosome, FA, CMC, Priority review, Pharmaceutical industry

All areas of medicine, and all organs and body systems, are impacted by rare diseases, including rare neurological and neuromuscular diseases, metabolic, skin and bone diseases, and chromosomal disorders.

Key Points: 
  • All areas of medicine, and all organs and body systems, are impacted by rare diseases, including rare neurological and neuromuscular diseases, metabolic, skin and bone diseases, and chromosomal disorders.
  • Today on Rare Disease Day, PRISM MarketView highlights emerging companies working to deliver life changing treatments for those living with rare diseases.
  • RDEB is a severe rare disease characterized by extremely fragile, and extensive blistering and wounds.
  • Capricor is a biotechnology company dedicated to advancing transformative cell and exosome-based therapeutics to redefine the treatment landscape for rare diseases.

Tonix Pharmaceuticals to Participate in the 2024 BIO CEO & Investor Conference

Retrieved on: 
Tuesday, February 20, 2024
Infection, Therapy, Fibromyalgia, TNX-102, Tonix Pharmaceuticals, Orphan drug, Smallpox, NIAID, Research, Annual report, NIH, CD40L, FDA, BIO, Prader–Willi syndrome, Sumatriptan, Government, Upsher-Smith Laboratories, Conference, Disease, Autoimmunity, University, COVID-19, PWS, Patient, Acute stress disorder, Security (finance), Long, Breakthrough therapy, Risk, IND, NDA, Failure, Long COVID, Cancer, Pharmaceutical industry

CHATHAM, N.J., Feb. 20, 2024 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company), a biopharmaceutical company with marketed products and a pipeline of development candidates, today announced that Seth Lederman, M.D., President and Chief Executive Officer of Tonix Pharmaceuticals, will present at the BIO CEO & Investor Conference on February 26, 2024 at 1:30 p.m.

Key Points: 
  • CHATHAM, N.J., Feb. 20, 2024 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company), a biopharmaceutical company with marketed products and a pipeline of development candidates, today announced that Seth Lederman, M.D., President and Chief Executive Officer of Tonix Pharmaceuticals, will present at the BIO CEO & Investor Conference on February 26, 2024 at 1:30 p.m.
  • Tonix is a biopharmaceutical company focused on commercializing, developing, discovering and licensing therapeutics to treat and prevent human disease and alleviate suffering.
  • Tonix intends to meet with the FDA in the first half of 2024 and submit an NDA for the approval of Tonmya for the management of fibromyalgia in the second half of 2024.
  • A Phase 2 study of TNX-1300 is expected to be initiated in the first quarter of 2024.

Southern Glazer’s Wine & Spirits Promotes Lewis Kenrick to President, West Region

Retrieved on: 
Friday, March 1, 2024
Food, Beverage, Other Retail, Wine & Spirits, Retail, Specialty, Chain, Retirement, National accounts, PWS, Château, Management

Southern Glazer's Wine & Spirits (Southern Glazer's)—the world’s preeminent distributor of beverage alcohol—today announced that it has promoted Lewis Kenrick to the role of President, West Region, effective March 1, 2024.

Key Points: 
  • Southern Glazer's Wine & Spirits (Southern Glazer's)—the world’s preeminent distributor of beverage alcohol—today announced that it has promoted Lewis Kenrick to the role of President, West Region, effective March 1, 2024.
  • In his most recent role, Kenrick served as Executive Vice President, General Manager of California.
  • As President, West Region, Kenrick will be responsible for leading all business activities in Alaska, Idaho, Oregon, Washington, Arizona, New Mexico, California, Nevada, and Hawaii.
  • “Lewis’ commercial leadership experience in California, our largest market, helps make him the ideal successor for our sizeable West Region,” said Wittig.

HARMONY BIOSCIENCES RECEIVES U.S. FOOD AND DRUG ADMINISTRATION ORPHAN DRUG DESIGNATION FOR PITOLISANT IN PRADER-WILLI SYNDROME

Retrieved on: 
Tuesday, February 20, 2024
Caregiver, Orphan drug, Narcolepsy, FDA, Food, TEMPO, Prader–Willi syndrome, Phase 3, Safety, PWS, EDS, Patient, Science, Plasma protein binding, Pharmaceutical industry

PLYMOUTH MEETING, Pa., Feb. 20, 2024 /PRNewswire/ -- Harmony Biosciences Holdings, Inc. (Nasdaq: HRMY), announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug designation to pitolisant for the treatment of Prader-Willi syndrome (PWS).

Key Points: 
  • PLYMOUTH MEETING, Pa., Feb. 20, 2024 /PRNewswire/ -- Harmony Biosciences Holdings, Inc. (Nasdaq: HRMY), announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug designation to pitolisant for the treatment of Prader-Willi syndrome (PWS).
  • "The decision to grant Orphan Drug designation to pitolisant indicates that it could be a promising treatment option for people living with Prader-Willi syndrome," said Kumar Budur, M.D., M.S., Chief Medical Officer at Harmony Biosciences.
  • FDA Orphan Drug designation incentivizes the advancement of promising therapies for rare diseases by providing tax credits for clinical development, waivers for user fees, and seven years of market exclusivity following drug approval.
  • In the upcoming Phase 3 registrational TEMPO study, Harmony will assess the safety and efficacy of pitolisant in treating EDS and behavioral disturbances in PWS.

Southern Glazer’s Wine & Spirits Announces Retirement of Patrick Daul, President, West Region

Retrieved on: 
Friday, February 9, 2024
Retail, Restaurant, Bar, Convenience Store, Wine & Spirits, Supermarket, Specialty, Food, Beverage, Landing slot, Marketing, Retirement, Wine, PWS, Senior, Diageo, Management

Southern Glazer's Wine & Spirits (Southern Glazer's)—the world’s preeminent distributor of beverage alcohol—today announced the retirement of Patrick Daul, President, West Region effective July 2024.

Key Points: 
  • Southern Glazer's Wine & Spirits (Southern Glazer's)—the world’s preeminent distributor of beverage alcohol—today announced the retirement of Patrick Daul, President, West Region effective July 2024.
  • “I’ve had the privilege of working alongside Patrick for many years, whose journey at Southern Glazer’s reflects not only his deep industry expertise, but also his unwavering dedication,” said John Wittig, Chief Commercial Officer, Southern Glazer’s.
  • Currently, Daul serves as President, West Region, marking the latest milestone in his accomplished career at Southern Glazer’s.
  • “Patrick’s retirement is a significant occasion, and we express our deepest gratitude for his exemplary leadership at Southern Glazer’s,” said Wayne E. Chaplin, Chief Executive Officer, Southern Glazer’s.