USWM

Norgine B.V. submits Marketing Authorisation Application via Project Orbis for eflornithine (difluoromethylornithine [DFMO]) in high-risk neuroblastoma

Retrieved on: 
Monday, April 15, 2024
Orbis, FDA, Risk, SOC, DFMO, Patient, USWM, Standard of care, Eflornithine, Pharmaceutical industry

AMSTERDAM, April 15, 2024 /PRNewswire/ -- Norgine B.V. today announced its first marketing authorisation application submissions on 10 April 2024, seeking approval for eflornithine in high-risk neuroblastoma (HRNB), via Project Orbis in Australia, Switzerland and the United Kingdom.

Key Points: 
  • AMSTERDAM, April 15, 2024 /PRNewswire/ -- Norgine B.V. today announced its first marketing authorisation application submissions on 10 April 2024, seeking approval for eflornithine in high-risk neuroblastoma (HRNB), via Project Orbis in Australia, Switzerland and the United Kingdom.
  • This milestone supports Norgine's efforts to deliver patient access to eflornithine and bring a further treatment option in the field of paediatric oncology.
  • Norgine and USWM, LLC (dba US WorldMeds), a Kentucky-based specialty pharmaceutical company, have an exclusive licensing agreement by which Norgine will register and commercialise eflornithine, also referred to as DFMO, in Europe, Australia and New Zealand.
  • On 13 December 2023, the US Food and Drug Administration (FDA) approved eflornithine as the first oral maintenance therapy for high-risk neuroblastoma (HRNB), indicated to reduce the risk of relapse in adult and paediatric patients who have received certain prior therapies.1 The approval decision was based on findings from a trial comparing outcomes from Study 3b (NCT02395666; investigational arm)2,4 and Study ANBL0032 (NCT00026312; clinical-trial-derived external control arm)3,4, where use of eflornithine resulted in improved event-free survival and overall survival when compared to outcomes for  patients with high-risk neuroblastoma treated with the standard of care (SoC) without the drug.1
    Dr David Gillen, Chief Medical Officer at Norgine, added, "These submissions via Project Orbis represent an important first step in the regulatory process for eflornithine and re-emphasise Norgine's passion and commitment in attempting to secure additional treatment options for patients living with HRNB, a condition with a high level of unmet medical need."

Panbela Therapeutics Announces US WorldMeds NDA Approval for Eflornithine (DFMO) in Pediatric Neuroblastoma

Retrieved on: 
Monday, December 18, 2023
Lung cancer, National Cancer Institute, Partnership, Neuroblastoma, Research, FDA, Colorectal cancer, Polyamine, PBLA, Multiple myeloma, NDA, Prostate cancer, MSN, Doctor of Philosophy, Therapy, COG, USWM, Eflornithine, Cancer, New Drug Application, Patient, NCI, Pharmaceutical industry

The approval of USWM’s NDA for the use of eflornithine for the treatment of patients with high-risk neuroblastoma marks the first FDA approval of an NDA for any polyamine targeted therapy in a cancer indication.

Key Points: 
  • The approval of USWM’s NDA for the use of eflornithine for the treatment of patients with high-risk neuroblastoma marks the first FDA approval of an NDA for any polyamine targeted therapy in a cancer indication.
  • In July 2023, Panbela divested its pediatric neuroblastoma program to USWM in an arrangement entitling Panbela to up to approximately $9.5 million of non-dilutive funding, including payments upon USWM’s successful completion of milestones related to eflornithine's clinical development, regulatory approval, and commercial sales.
  • “The FDA’s approval of USWM’s eflornithine NDA for high-risk neuroblastoma is an exciting milestone in our partnership.
  • This demonstrates the potential for polyamine targeted therapies in cancer,” said Jennifer K. Simpson, PhD, MSN, CRNP, President & Chief Executive Officer of Panbela.

DMK Pharmaceuticals Regains Full Rights from US WorldMeds for SYMJEPI® and Provides Corporate Update

Retrieved on: 
Tuesday, November 28, 2023
Marketing, Adrenaline, SAN, USWM, Growth, DMK, Naloxone

US WorldMeds previously held exclusive distribution and commercialization rights for SYMJEPI® and ZIMHI® (naloxone) products in the United States, and was responsible for marketing, promotion and distribution efforts.

Key Points: 
  • US WorldMeds previously held exclusive distribution and commercialization rights for SYMJEPI® and ZIMHI® (naloxone) products in the United States, and was responsible for marketing, promotion and distribution efforts.
  • The Company is now actively seeking out-license opportunities for SYMJEPI® in the US and globally, in addition to exploring other options with a focus on maximizing value for shareholders.
  • “Given our renewed focus on our core business, we are taking decisive actions that we believe will remove obstacles and improve our ability to drive long-term growth,” said Eboo Versi, M.D., Ph.D., CEO of DMK Pharmaceuticals.
  • “This represents an important step in DMK’s ongoing transformation journey as we continue to execute against our operating plan and review our existing business relationships to ensure maximal benefit to DMK’s stakeholders and patients.”

US WorldMeds Announces FDA Approval of IWILFIN™ (eflornithine) to Strengthen Fight Against Aggressive Childhood Cancer

Retrieved on: 
Thursday, December 14, 2023
Children, FDA, Health, General Health, Pharmaceutical, Oncology, Research, Family, Consumer, Science, Parenting, Neuroblastoma, Tenderness, Urine, Pneumonia, Huber loss, Somatic symptom disorder, Patient, Otitis media, Diagnosis, Tiffany Aching, Bruise, Liver, Chills, Hospital, Hearing loss, Vomiting, Food, Chair, American Cancer Society, EFS, Nose, Mortality, Multimedia, Division, Hematology, Pennsylvania State University, Blood, Diarrhea, Kool-Aid, Bleeding, Nausea, Development, Skin infection, Shivering, Urinary tract infection, Cough, Consortium, Risk, Sinusitis, Humble, Texas, Pain, Skin, Eflornithine, Hope, Upper respiratory tract infection, Disease, Abdomen, Tablet, Pediatric Hematology and Oncology, Sneeze, MD, Death, Immunotherapy, Pharmaceutical industry, Medical device, Nursing, Birth control, Phosphorus, Fever, USWM

High-risk neuroblastoma is a challenging disease, with a high mortality rate driven primarily by the risk of relapse after achieving remission.

Key Points: 
  • High-risk neuroblastoma is a challenging disease, with a high mortality rate driven primarily by the risk of relapse after achieving remission.
  • US WorldMeds partnered with the Beat Childhood Cancer Research Consortium at Penn State University, which conducted the preclinical and clinical research to help advance this vital therapy.
  • The Consortium represents a group of over 50 hospitals that offer collaboration through a network of childhood cancer clinical trials.
  • “We are thankful for the dedication of our partners, specifically the Beat Childhood Cancer Research Consortium, who work tirelessly to improve treatment outcomes for pediatric cancer patients.

Panbela Therapeutics to Receive a Total Up to $9.5 Million for Divestiture of Assets within Eflornithine (DFMO) Pediatric Neuroblastoma Program to US WorldMeds

Retrieved on: 
Wednesday, July 19, 2023
Therapy, MSN, USWM, Polyamine, Eflornithine, New Drug Application, Cancer, COG, PBLA, Research, Doctor of Philosophy, Sale, National Cancer Institute, Patient, The News & Advance, DFMO, FDA, NCI, Pharmaceutical industry, Neuroblastoma

Neuroblastoma, a rare cancer originating from immature nerve cells, contributes to nearly 15% of pediatric cancer deaths.

Key Points: 
  • Neuroblastoma, a rare cancer originating from immature nerve cells, contributes to nearly 15% of pediatric cancer deaths.
  • Under the terms of the agreement, Panbela is entitled to receive up to approximately $9.5 million non-dilutive funding in exchange for the sale of certain assets within its pediatric neuroblastoma program for eflornithine.
  • Panbela will receive payments upon USWM’s successful completion of milestones related to eflornithine's clinical development, regulatory approval, and commercial sales.
  • “Divesting eflornithine assets for pediatric neuroblastoma is another milestone in executing our business plan to generate long-term value for our shareholders.

Adamis Pharmaceuticals Reports Second Quarter 2022 Financial Results and Provides Corporate Update

Retrieved on: 
Wednesday, August 10, 2022
FDA, CEO, Emergency, GLOBE, Failure, Private Securities Litigation Reform Act, SEC, Clinical trial, Sale, Patent, USWM, Government, Allergy, Patient, Syringe, Review, Data monitoring committee, COVID-19, Company, Twitter, SAN, DSMB, Martin PBM Mariner, Form 10-K, Safety, Awareness, NASDAQ, Research, Opioid overdose, Goal, Anaphylaxis, Employment, ADMP, Adrenaline, LinkedIn, Pharmacy, Naloxone, Degenerative disease, Annual report, USC, Pharmaceutical industry, 4-Hydroxy-TEMPO, Fagron, Eddie Fenech Adami

SAN DIEGO, Aug. 10, 2022 (GLOBE NEWSWIRE) -- Adamis Pharmaceuticals Corporation (NASDAQ: ADMP), a commercial-stage biopharmaceutical company primarily focused on developing and commercializing products in various therapeutic areas, including allergy, opioid overdose, respiratory and inflammatory disease, today reported financial results for the second quarter of 2022 and provided an update on recent corporate developments.

Key Points: 
  • SAN DIEGO, Aug. 10, 2022 (GLOBE NEWSWIRE) -- Adamis Pharmaceuticals Corporation (NASDAQ: ADMP), a commercial-stage biopharmaceutical company primarily focused on developing and commercializing products in various therapeutic areas, including allergy, opioid overdose, respiratory and inflammatory disease, today reported financial results for the second quarter of 2022 and provided an update on recent corporate developments.
  • I committed to the CEO role in May because I could see beyond Adamis current position to where it could go.
  • Many customers feel ZIMHIs combination of a higher dose with intramuscular delivery provides an advantage and significantly differentiates it from the leading competitors.
  • ET / 1:30 p.m. PT, during which Company executives will review financial information for the second quarter of 2022 and provide a corporate update.

US WorldMeds Launches ZIMHIDirect.com

Retrieved on: 
Tuesday, July 5, 2022
FDA, Death, Fever, Current Medical Research and Opinion, Patient, Injection, Blood pressure, Opioid overdose, Caregiver, CEO, Adult, Allergy, Morphine, GLOBE, Nervous, Cardiopulmonary resuscitation, Center, Shivering, Nausea, Law enforcement, Central nervous system, Sneeze, Common, Emergency medical services, History, Irritability, Vomiting, Tramadol, HCL, Perspiration, Yawn, Risk, LLC, Heroin, Weakness, Malignant hyperthermia, Naloxone, EMS, Organization, Dizziness, Centers for Disease Control and Prevention timeline, Seizure, Connecticut Department of Emergency Services and Public Protection, Tremor, Fentanyl, CPR, Diarrhea, Medicine, Emergency, Government, USWM, Restless, Heart rate, Oxycodone, Hydrocodone, CDC, Pharmaceutical industry

It will significantly simplify and streamline the ordering process to ensure our partner organizations can stay focused on their essential roles helping patients facing opioid overdoses, said Breck Jones Sr., CEO of US WorldMeds.

Key Points: 
  • It will significantly simplify and streamline the ordering process to ensure our partner organizations can stay focused on their essential roles helping patients facing opioid overdoses, said Breck Jones Sr., CEO of US WorldMeds.
  • US WorldMeds is a privately held specialty pharmaceutical company that develops, licenses, and markets unique healthcare products designed to improve the lives of patients with challenging conditions and unmet medical needs.
  • US WorldMeds has built a branded product portfolio in the therapeutic areas of opioid withdrawal and malignant hyperthermia.
  • More information on US WorldMeds can be found at www.usworldmeds.com .

US WorldMeds to Deploy StayinFront TouchRx CRM

Retrieved on: 
Tuesday, June 28, 2022
Efficiency, Patient, List of life sciences, Event management, HCPS, Research, GLOBE, Pharma, Associate Director of National Intelligence and Chief Information Officer, PDMA, Goal, Compliance, CLM, United Kingdom, Partnership, Information technology, Technology, Licensure, Federal, Solution, Time, USWM, Mobile, CRM, Fine chemical, Biotechnology

StayinFront will provide its advanced mobile solution, StayinFront TouchRx , to US WorldMeds field representatives to maximize their efficiency and effectiveness.

Key Points: 
  • StayinFront will provide its advanced mobile solution, StayinFront TouchRx , to US WorldMeds field representatives to maximize their efficiency and effectiveness.
  • StayinFront TouchRx is supported by a highly experienced team that has worked with Life Science companies for over 20 years.
  • StayinFront TouchRx, delivers an intuitive interface that empowers field teams and mangers, said Ken Arbadji, Vice President Sales, North America at StayinFront.
  • Pharma and Biotech companies rely on StayinFront to optimize field team performance and streamline sales operations by reducing the complexity, time, and costs of CRM.

US WorldMeds and Adamis Pharmaceuticals Announce U.S. Launch of ZIMHI™ Naloxone Product

Retrieved on: 
Thursday, March 31, 2022
Private Securities Litigation Reform Act, Blood pressure, Perspiration, Heroin, Diarrhea, CDC, Caregiver, Adult, Malignant hyperthermia, SEC, Medicine, CEO, Oxycodone, USWM, Naloxone, Twitter, Goal, GLOBE, Haemophilia, Irritability, Emergency, Fentanyl, Pharmacy, Seizure, Central nervous system, Dizziness, Tremor, ADMP, Death, Adrenaline, 4-Hydroxy-TEMPO, Nausea, Injection, LLC, Opioid overdose, Cardiopulmonary resuscitation, Vomiting, Shivering, NASDAQ, Anaphylaxis, Restless, Somnolence, Morphine, Yawn, Annual report, Nervous, Tramadol, Common, Allergy, Program, Drug, Center, Weakness, SAN, FDA, Patient, LinkedIn, Form 10-K, Hydrocodone, Korea Disease Control and Prevention Agency, USP, Fever, Sneeze, Heart rate, COVID-19, CPR, Pharmaceutical industry, Vaccine, Health insurance, Eddie Fenech Adami

LOUISVILLE, Ky.andSAN DIEGO, March 31, 2022 (GLOBE NEWSWIRE) -- USWM, LLC (US WorldMeds), and Adamis Pharmaceuticals Corporation (NASDAQ: ADMP), today announced the U.S. launch and availability of ZIMHI (naloxone HCL Injection, USP) 5 mg/0.5 mL.

Key Points: 
  • LOUISVILLE, Ky.andSAN DIEGO, March 31, 2022 (GLOBE NEWSWIRE) -- USWM, LLC (US WorldMeds), and Adamis Pharmaceuticals Corporation (NASDAQ: ADMP), today announced the U.S. launch and availability of ZIMHI (naloxone HCL Injection, USP) 5 mg/0.5 mL.
  • Dr. Dennis J. Carlo, President and CEO of Adamis, stated, ZIMHI provides the highest intramuscular dose of naloxone among naloxone injection devices currently available.
  • We are very excited to once again partner with US WorldMeds to launch ZIMHI.
  • Do not use ZIMHI if you are allergic to naloxone hydrochloride or any of the ingredients in ZIMHI.

US WorldMeds Reaches Agreement With Walgreens To Make Immediately Available LUCEMYRA® (lofexidine) In Pharmacies Across The Nation

Retrieved on: 
Tuesday, August 31, 2021
Center, Centers for Disease Control and Prevention, Prescription, Liver, Opioid use disorder, LLC, Malignant hyperthermia, Breast milk, Blood pressure, Consciousness, Heart rate, National Center for Health Statistics, Somnolence, Long QT syndrome, Drug, Walgreens Boots Alliance, Insurance, Lightheadedness, Medical statistics, Pharmacy, Hope, Nasdaq, Addiction medicine, Medicare, Degenerative disease, Health, Death, Norepinephrine, Pharmacist, Tablet, WBA, Allergy, Dizziness, Risk, Patient, Benzodiazepine, Barbiturate, Xerostomia, Respiration, FDA, USWM, Classic (Better Than I've Ever Been), Brain, Technology, Centers for Disease Control and Prevention timeline, Health insurance, Pharmaceutical industry, Cereal

LOUISVILLE, Ky., Aug. 31, 2021 /PRNewswire/ -- US WorldMeds, a Kentucky-based specialty pharmaceutical company, announced Walgreens will stock LUCEMYRA (lofexidine) tablets in Walgreens pharmacies across the U.S., effective September 1.

Key Points: 
  • LOUISVILLE, Ky., Aug. 31, 2021 /PRNewswire/ -- US WorldMeds, a Kentucky-based specialty pharmaceutical company, announced Walgreens will stock LUCEMYRA (lofexidine) tablets in Walgreens pharmacies across the U.S., effective September 1.
  • Patients without insurance coverage for LUCEMYRA may be eligible to pay $300 for a LUCEMYRA prescription.
  • We are extremely proud to be partnering with Walgreens, a premier national pharmacy retailer, in support of this vitally important issue."
  • The actual savings on out-of-pocket costs for LUCEMYRA will vary according to refill quantity, personal healthcare insurance coverage, and adherence to FDA dosing guidelines.