Patient Information Advisory Group

Acer Therapeutics Reacquires Worldwide Development, Commercialization and Economic Rights to OLPRUVA™ from Relief Therapeutics, Excluding the Geographical Europe

Retrieved on: 
Wednesday, August 30, 2023
Heart, Principality, Maple syrup urine disease, Fatigue, BSA, Diet, Relief Therapeutics, CLA, Edema, UCD, Probenecid, Appetite, Valproate, Vomiting, Patient Information Advisory Group, Relief, UCD School of Medicine, Acquisition, Metabolism, Patient, Ammonia, Swelling, CPS, Blood, Child, Hypokalemia, European, ELA, OTC, Somnolence, ACER, Nausea, Confusion, Liver, FDA, Therapy, Lightheadedness, Headache, Potassium, Sodium, Neurotoxicity, Haloperidol, Pharmaceutical industry, Maple syrup, Acer

OLPRUVA™ is approved in the U.S. for the treatment of certain urea cycle disorders (UCDs).

Key Points: 
  • OLPRUVA™ is approved in the U.S. for the treatment of certain urea cycle disorders (UCDs).
  • Acer and Relief have now agreed to terminate the CLA, where Acer is no longer required to pay Relief 60% of OLPRUVA™ net profits in the Acer territories and have regained all development and commercialization rights in rest of the world, excluding the Geographical Europe.
  • Additionally, Acer and Relief have entered into a new Exclusive License Agreement (ELA) in which Relief will retain development and commercialization rights for OLPRUVA™ in the Geographical Europe, where Acer will have the right to receive a royalty of up to 10% of the net sales of OLPRUVA™.
  • For additional Important Safety Information, see full Prescribing Information , Patient Package Insert and discuss with your doctor.

Acer Therapeutics Announces OLPRUVA™ Commercial Launch Progressing Ahead of Schedule

Retrieved on: 
Monday, May 1, 2023
Society, BSA, Diet, Education, SIMD, UCD, Medicare Part D, Prescription, Government, Medicare, Patient Information Advisory Group, WAC, UCD Boat Club, Acquisition, Patient, Practitioner, Physician, CPS, OTC, PBM, ACER, GPO, FDA, Therapy, Body surface area, Pharmaceutical industry, Medicaid, Acer

NEWTON, Mass., May 01, 2023 (GLOBE NEWSWIRE) -- Acer Therapeutics Inc. (Nasdaq: ACER), a pharmaceutical company focused on the acquisition, development and commercialization of therapies for serious, rare and life-threatening diseases with significant unmet medical needs, today announced an update on progress in support of its commercial launch of OLPRUVA™ (sodium phenylbutyrate) for oral suspension, including drug availability now expected earlier than anticipated in mid-June 2023, subject to additional capital.

Key Points: 
  • “As a result of these efforts, I am pleased to report we are ahead of our anticipated launch schedule and now expect drug availability beginning in mid-June 2023.
  • We have also made significant progress in our ongoing discussions with payers regarding reimbursement, increased physician awareness and interest, and built out our patient support and fulfillment program.
  • Acer expects to publish OLPRUVA™’s list price, or wholesale acquisition cost (WAC), in mid-to-late May.
  • Acer has also made significant progress in support of its objective to raise awareness for OLPRUVA™ as a new, alternative treatment option for certain UCD patients.

UroGen Pharma Reports Third Quarter 2022 Financial Results and Recent Corporate Developments

Retrieved on: 
Thursday, November 10, 2022
Medical Devices, Medical Supplies, Hospitals, Clinical Trials, Other Health, Biotechnology, General Health, Pharmaceutical, Health, Oncology, Adult, Clothing, Risk, Transitional epithelium, Patient Information Advisory Group, Stomach, Company, Pharmakon—Danish College of Pharmacy Practice, Kidney, Recurrence, Blood, Ureter, Swelling, Birth, Urination, Urinary tract infection, SEC, NMIBC, Water, Time, Cancer, Orphan drug, Neoplasm, Patient, UTUC, Urine, COVID-19, Vomiting, Private Securities Litigation Reform Act, Sodium bicarbonate, Bone marrow, Medicine, Clinical trial, Breast milk, Fatigue, Skin, Growth, Abdomen, Nausea, Perforation, NDA, FDA, Trial of the century, Urinary bladder, Fever, Technology, View, Man, Safety, Female, Pain, Transitional cell carcinoma, Nephrectomy, Pharmaceutical industry, Medical imaging, Health insurance, Birth control, Tanning (leather), Phosphorus, Generic drug, Mitomycins, Mitomycin C

The U.S. FDA previously granted Orphan Drug, Fast Track, and Breakthrough Therapy Designations to Jelmyto for the treatment of LG-UTUC.

Key Points: 
  • The U.S. FDA previously granted Orphan Drug, Fast Track, and Breakthrough Therapy Designations to Jelmyto for the treatment of LG-UTUC.
  • You should not receive JELMYTO if you have a hole or tear (perforation) of your bladder or upper urinary tract.
  • Tell your healthcare provider right away if you become pregnant or think you may be pregnant during treatment with JELMYTO.
  • JELMYTO and UroGen are registered trademarks of UroGen Pharma Ltd.
    View source version on businesswire.com: https://www.businesswire.com/news/home/20221110005284/en/

FDA Authorizes an Extension of the In-Use Period for UroGen Pharma’s JELMYTO® Admixture to 96 Hours Following Reconstitution

Retrieved on: 
Wednesday, September 28, 2022
Biotechnology, FDA, Health, Pharmaceutical, Oncology, Adult, LG, Risk, Time-invariant system, Birth, Safety, Urinary bladder, COVID-19, Twitter, FDA, Food, Clothing, Urinary tract infection, Blood, Vomiting, Perforation, Neoplasm, Breast milk, Growth, Urination, Thermoregulation, University of Maryland Baltimore Washington Medical Center, Private Securities Litigation Reform Act, UTUC, UM, Patient Information Advisory Group, Patient, Swelling, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Physician, Abdomen, Disease, Technology, Pain, Pharmacist, Female, Bone marrow, Nasdaq, Sodium bicarbonate, Urine, Water, Medicine, Fever, SEC, Hospital, Skin, Nausea, Kidney, University, Fatigue, Recurrence, Stomach, Pharmaceutical industry, Medical imaging, Health insurance, Birth control, Tanning (leather), Phosphorus, Urology, Mitomycins

This extension expands access to JELMYTO and gives our customers greater flexibility in choosing when to mix and schedule instillations.

Key Points: 
  • This extension expands access to JELMYTO and gives our customers greater flexibility in choosing when to mix and schedule instillations.
  • UroGen encourages healthcare providers to consult the new Prescribing Information and speak to their UroGen representative about this extended in-use period to optimize flexibility when treating patients with JELMYTO.
  • You should not receive JELMYTO if you have a hole or tear (perforation) of your bladder or upper urinary tract.
  • Your healthcare provider may need to temporarily or permanently stop JELMYTO if you develop bone marrow problems during treatment with JELMYTO.

Benitec Biopharma Releases Full Year 2022 Financial Results and Provides Operational Update

Retrieved on: 
Friday, September 2, 2022
Muscle, Safety, Research, Oculopharyngeal muscular dystrophy, Dispute board, Disclosure, Dysphagia, Principal investigator, U.S. Securities and Exchange Commission, GMP, GLOBE, Company, Patient, ICF, Patient Information Advisory Group, FIH, Institutional review board, REB, Phenotype, Argonaute, Annual report, Clinical, Trial of the century, Investigational New Drug, RNA, Form 10-K, NASDAQ, CTA, Oropharyngeal dysphagia, Animal, HDL-Atherosclerosis Treatment Study, Benitec Biopharma, Child development stages, Review, IRB, HIV disease progression rates, CEC, IND, Achievement, Natural history, Validation, Sales, Pharmaceutical industry, Medicine, Medical imaging, Mineral wool, Cryptocurrency, OPMD

HAYWARD, Calif., Sept. 02, 2022 (GLOBE NEWSWIRE) -- Benitec Biopharma Inc. (NASDAQ: BNTC) (Benitec or the Company), a development-stage, gene therapy-focused, biotechnology company developing novel genetic medicines based on its proprietary DNA-directed RNA interference ("ddRNAi") platform, today announced financial results for its Fiscal Year ended June 30, 2022.

Key Points: 
  • HAYWARD, Calif., Sept. 02, 2022 (GLOBE NEWSWIRE) -- Benitec Biopharma Inc. (NASDAQ: BNTC) (Benitec or the Company), a development-stage, gene therapy-focused, biotechnology company developing novel genetic medicines based on its proprietary DNA-directed RNA interference ("ddRNAi") platform, today announced financial results for its Fiscal Year ended June 30, 2022.
  • The Company has filed its annual report on Form 10-K for the quarter ended June 30, 2022, with the U.S. Securities and Exchange Commission.
  • Banks, M.D., Ph.D., Executive Chairman and Chief Executive Officer of Benitec Biopharma.
  • 52-weeks of post-dosing follow-up for conclusive evaluation of the primary and secondary endpoints of the Phase 1b/2a BB-301 treatment study.

UroGen Pharma Reports Second Quarter 2022 Financial Results and Recent Corporate Developments

Retrieved on: 
Thursday, August 11, 2022
Oncology, Health, Clinical Trials, Research, Science, Pharmaceutical, Biotechnology, Nausea, Trial of the century, Female, SEC, Cancer, Clinical trial, Urine, Pain, Blood, Fever, Patient, Swelling, Skin, Clothing, Sodium bicarbonate, Perforation, Breast milk, Disease, Risk, NDA, Technology, Private Securities Litigation Reform Act, UTUC, Patient Information Advisory Group, Recurrence, Ureter, Safety, Water, Birth, Growth, Neoplasm, Man, Fatigue, NMIBC, Bladder cancer, Bone marrow, COVID-19, Stomach, Urinary bladder, Urination, Kidney, Time, Orphan drug, Transitional cell carcinoma, FDA, Vomiting, Abdomen, Nephrectomy, Company, Twitter, View, TURBT, Urinary tract infection, Transitional epithelium, Medicine, Adult, Pharmaceutical industry, Medical imaging, Health insurance, Birth control, Tanning (leather), Phosphorus, Generic drug, Pharmakon—Danish College of Pharmacy Practice, Mitomycin C, Mitomycins

The U.S. FDA previously granted Orphan Drug, Fast Track, and Breakthrough Therapy Designations to Jelmyto for the treatment of LG-UTUC.

Key Points: 
  • The U.S. FDA previously granted Orphan Drug, Fast Track, and Breakthrough Therapy Designations to Jelmyto for the treatment of LG-UTUC.
  • You should not receive JELMYTO if you have a hole or tear (perforation) of your bladder or upper urinary tract.
  • Tell your healthcare provider right away if you become pregnant or think you may be pregnant during treatment with JELMYTO.
  • UroGen are registered trademarks of UroGen Pharma Ltd.
    View source version on businesswire.com: https://www.businesswire.com/news/home/20220811005112/en/

UroGen Pharma Highlights Data Presentations at the 2022 American Urological Association Annual Meeting

Retrieved on: 
Friday, May 13, 2022
Biotechnology, Pharmaceutical, Health, Oncology, Urination, Clothing, Fever, Pain, Nausea, Blood, LG, Swelling, Medicine, Neoplasm, Regulation of tobacco by the U.S. Food and Drug Administration, Urine, Food, Sodium bicarbonate, UNC, Thermoregulation, Time-invariant system, Breast milk, Patient, Bone marrow, Patient Information Advisory Group, Associate, Stomach, Ernest, University of North Carolina at Charlotte, Abdomen, Kidney, Birth, UTUC, Female, AUA, University, Technology, Vomiting, Skin, H. Lee Moffitt Cancer Center & Research Institute, Urinary tract infection, Fatigue, Twitter, Water, Perforation, Medical imaging, Health insurance, Birth control, Tanning (leather), Pharmaceutical industry, Phosphorus, Urology, Mitomycins

It is approved for administration in a retrograde manner via ureteral catheter or antegrade through nephrostomy tube.

Key Points: 
  • It is approved for administration in a retrograde manner via ureteral catheter or antegrade through nephrostomy tube.
  • You should not receive JELMYTO if you have a hole or tear (perforation) of your bladder or upper urinary tract.
  • Before receiving JELMYTO, tell your healthcare provider about all your medical conditions, including if you:
    are pregnant or plan to become pregnant.
  • Tell your healthcare provider right away if you become pregnant or think you may be pregnant during treatment with JELMYTO.

UroGen Pharma Reports First Quarter 2022 Financial Results and Recent Corporate Developments

Retrieved on: 
Tuesday, May 10, 2022
Oncology, Health, Clinical Trials, Research, Science, Pharmaceutical, Biotechnology, Ureter, Birth, Swelling, Kidney, Safety, Urination, Patient Information Advisory Group, Risk, Skin, Female, NMIBC, View, SEC, Trial of the century, Technology, Nausea, Stomach, Pain, Twitter, Water, Perforation, Company, Probability, Patient, Urine, Clinical trial, FDA, Nephrectomy, Sodium bicarbonate, Vomiting, Private Securities Litigation Reform Act, Bone marrow, Medicine, Neoplasm, NDA, Time, Fatigue, UTUC, Clothing, Growth, Man, COVID-19, Transitional cell carcinoma, Abdomen, Fever, Cancer, Blood, Orphan drug, Urinary bladder, Urinary tract infection, Adult, Breast milk, Transitional epithelium, Recurrence, Pharmaceutical industry, Medical imaging, Health insurance, Birth control, Tanning (leather), Phosphorus, Generic drug, Mitomycins, Mitomycin C, Pharmakon—Danish College of Pharmacy Practice

The U.S. FDA previously granted Orphan Drug, Fast Track, and Breakthrough Therapy Designations to Jelmyto for the treatment of LG-UTUC.

Key Points: 
  • The U.S. FDA previously granted Orphan Drug, Fast Track, and Breakthrough Therapy Designations to Jelmyto for the treatment of LG-UTUC.
  • You should not receive JELMYTO if you have a hole or tear (perforation) of your bladder or upper urinary tract.
  • Tell your healthcare provider right away if you become pregnant or think you may be pregnant during treatment with JELMYTO.
  • JELMYTO and UroGen are registered trademarks of UroGen Pharma Ltd.
    View source version on businesswire.com: https://www.businesswire.com/news/home/20220510005510/en/

UroGen Pharma Reports Fourth Quarter and Full-year 2021 Financial Results and Recent Corporate Developments

Retrieved on: 
Monday, March 21, 2022
Biotechnology, Health, Pharmaceutical, Clinical Trials, Oncology, Private Securities Litigation Reform Act, Risk, Adult, Fatigue, SEC, Urination, Cancer, Medicine, Neoplasm, Breast milk, Sodium bicarbonate, Technology, Twitter, UTUC, Patient Information Advisory Group, Trial of the century, Time, NDA, Ureter, Urine, Recurrence, Transitional cell carcinoma, Kidney, Nausea, Pain, View, Clothing, Perforation, Swelling, Female, Nephrectomy, Vomiting, NMIBC, Clinical trial, Growth, Urinary tract infection, Man, Urinary bladder, FDA, Patient, Birth, Abdomen, Company, Stomach, ATLAS, Skin, Bone marrow, Fever, Safety, Orphan drug, COVID-19, Arm, Transitional epithelium, Blood, TURBT, Water, Pharmaceutical industry, Medical imaging, Health insurance, Birth control, Tanning (leather), Phosphorus, Generic drug, Mitomycin C, Mitomycins, JELMYTO®, UPPER TRACT UROTHELIAL CANCER (UTUC), UGN-102, THE PHASE 3 ENVISION TRIAL, THE PHASE 3 ATLAS TRIAL, UROGEN PHARMA LTD., JELMYTO®, UPPER TRACT UROTHELIAL CANCER (UTUC), UGN-102, THE PHASE 3 ENVISION TRIAL, THE PHASE 3 ATLAS TRIAL, UROGEN PHARMA LTD.

The U.S. FDA previously granted Orphan Drug, Fast Track, and Breakthrough Therapy Designations to Jelmyto for the treatment of LG-UTUC.

Key Points: 
  • The U.S. FDA previously granted Orphan Drug, Fast Track, and Breakthrough Therapy Designations to Jelmyto for the treatment of LG-UTUC.
  • You should not receive JELMYTO if you have a hole or tear (perforation) of your bladder or upper urinary tract.
  • Tell your healthcare provider right away if you become pregnant or think you may be pregnant during treatment with JELMYTO.
  • JELMYTO and UroGen are registered trademarks of UroGen Pharma Ltd.
    View source version on businesswire.com: https://www.businesswire.com/news/home/20220321005260/en/

UroGen Pharma Reports Third Quarter 2021 Financial Results and Recent Corporate Developments

Retrieved on: 
Monday, November 15, 2021
Biotechnology, Pharmaceutical, Health, TURBT, Urine, Bone marrow, Cancer, Female, Clinical trial, Swelling, Nephrectomy, Growth, COVID-19, Urinary tract infection, Perforation, Pain, Solution, Transitional epithelium, ATLAS, Safety, Abdomen, Kidney, Recurrence, Patient Information Advisory Group, Technology, Blood, Transitional cell carcinoma, Probability, Ureter, Vomiting, Fever, Fatigue, Clothing, Patient, FDA, Adult, Bladder cancer, View, Private Securities Litigation Reform Act, Medicine, Orphan drug, Breast milk, Risk, Twitter, UTUC, Urinary bladder, SEC, Urination, Man, Nausea, Sodium bicarbonate, Arm, Water, Birth, Stomach, Neoplasm, Company, Skin, Pharmaceutical industry, Medical imaging, Health insurance, Birth control, Tanning (leather), Phosphorus, Generic drug, Jelmyto®, Upper Tract Urothelial Cancer (UTUC), UGN-102, the Phase 3 ATLAS Trial, UroGen Pharma Ltd., JELMYTO®, UPPER TRACT UROTHELIAL CANCER (UTUC), UGN-102, THE PHASE 3 ATLAS TRIAL, UROGEN PHARMA LTD.

The U.S. FDA previously granted Orphan Drug, Fast Track, and Breakthrough Therapy Designations to Jelmyto for the treatment of LG-UTUC.

Key Points: 
  • The U.S. FDA previously granted Orphan Drug, Fast Track, and Breakthrough Therapy Designations to Jelmyto for the treatment of LG-UTUC.
  • You should not receive JELMYTO if you have a hole or tear (perforation) of your bladder or upper urinary tract.
  • Tell your healthcare provider right away if you become pregnant or think you may be pregnant during treatment with JELMYTO.
  • JELMYTO and UroGen are registered trademarks of UroGen Pharma Ltd.
    View source version on businesswire.com: https://www.businesswire.com/news/home/20211115005427/en/