Cystinuria

New tiopronin delayed-release tablets launch with patient support for the treatment of cystinuria in the US

Retrieved on: 
Lundi, mai 13, 2024
FDA, Health, Research, Pharmaceutical, Science, Biotechnology, Partnership, Incidence, Patient, Rash, Lymphadenopathy, Full, Diarrhea, Birth, Milk, Label, Generic, Risk, Tiopronin, Food, Pregnancy, Education, Nausea, Glomerulonephritis, Fever, Arthralgia, SVP, Vomiting, Tablet, Cystinuria, Torrent, Kidney stone disease, Kidney, Breastfeeding, Miscarriage, Proteinuria, Fatigue, Hyperthermia, Child, Lactation, Cycle, Use, Nephrotic syndrome, Birth control

In addition, a Patient Nutrition Program* will be available to reinforce the clinic’s nutrition plan,” says Chikai Lai, SVP & Chief Commercial Officer, Cycle.

Key Points: 
  • In addition, a Patient Nutrition Program* will be available to reinforce the clinic’s nutrition plan,” says Chikai Lai, SVP & Chief Commercial Officer, Cycle.
  • Alcohol: Tiopronin is released faster from tiopronin delayed-release tablets in the presence of alcohol and the risk for adverse events associated with tiopronin delayed-release tablets when taken with alcohol is unknown.
  • Because of the potential for serious adverse reactions, including nephrotic syndrome, advise patients that breastfeeding is not recommended during treatment with tiopronin delayed-release tablets.
  • Tiopronin delayed-release tablets are not approved for use in pediatric patients weighing less than 20 kg or in pediatric patients unable to swallow tablets.

Revive Therapeutics Provides Update of Phase 3 Clinical Study for Bucillamine in the Treatment of COVID-19

Retrieved on: 
Mardi, mai 30, 2023
Long COVID, Institutional review board, CSE, Drug development, Therapy, Cystinuria, Fever, COVID-19, Coronavirus, SARS, Injury, Research, COVID, Disorder, Cough, RVV, Patient, IRB, Polymerase chain reaction, Hematology, Evaluation, Viral load, Heart rate, FDA, Study, Long, Safety, Pharmaceutical industry, Bucillamine

The Company plans to complete its initial evaluation of the Study’s data with an independent biostatistician team by the end of June.

Key Points: 
  • The Company plans to complete its initial evaluation of the Study’s data with an independent biostatistician team by the end of June.
  • At this time, the Company will only provide regular updates via press releases as information becomes available.
  • The Company is not making any express or implied claims that its product has the ability to eliminate or cure COVID-19 (SARS-2 Coronavirus) at this time.
  • There can be no assurance that the Company will proceed with the clinical development and regulatory approvals of Bucillamine for COVID-19 in the U.S. and internationally.

Revive Therapeutics Provides Update of Phase 3 Clinical Study for Bucillamine in the Treatment of COVID-19

Retrieved on: 
Vendredi, mai 12, 2023
Long COVID, CSE, Therapy, DSMB, Hospital, Cystinuria, Fever, COVID-19, Coronavirus, Injury, Research, COVID, Disorder, Cough, Data monitoring committee, RVV, Patient, Heart rate, FDA, Death, Study, Long, Safety, Pharmaceutical industry, Bucillamine

The DSMB recommended that the Study be halted early due to statistical significance of the primary endpoint likely not going to be met should the Study continue towards completion.

Key Points: 
  • The DSMB recommended that the Study be halted early due to statistical significance of the primary endpoint likely not going to be met should the Study continue towards completion.
  • Based on the recommendation from the DSMB, the Company has halted the Study and will now proceed to unblind and seek an evaluation of the Study’s data, including the COVID-19 clinical symptoms data (i.e.
  • cough, fever, heart rate, and oxygen saturation) to determine the potential next clinical and regulatory steps for Bucillamine.
  • There can be no assurance that the Company will proceed with the clinical development and regulatory approvals of Bucillamine for COVID-19 in the U.S. and internationally.

Revive Therapeutics Provides Update of Phase 3 Clinical Study for Bucillamine in the Treatment of COVID-19

Retrieved on: 
Mardi, avril 18, 2023
Long COVID, CSE, Therapy, DSMB, Hospital, Cystinuria, Fever, COVID-19, Coronavirus, Injury, Research, COVID, Type, Disorder, Cough, CDC, Data monitoring committee, RVV, Patient, Heart rate, FDA, Death, Environment, Long, Safety, Pharmaceutical industry, Bucillamine, Study

After further regulatory discussions with various groups, the Company has now decided that it will have the Data Safety Monitoring Board (“DSMB”) review the Study’s Post-Dose selection data of approximately 500 subjects for efficacy.

Key Points: 
  • After further regulatory discussions with various groups, the Company has now decided that it will have the Data Safety Monitoring Board (“DSMB”) review the Study’s Post-Dose selection data of approximately 500 subjects for efficacy.
  • In the latter case, the Company would request a meeting with the FDA to determine the appropriate next steps toward obtaining potential regulatory approval.
  • At this time, the Company will only provide regular updates via press releases as information becomes available.
  • The Company is not making any express or implied claims that its product has the ability to eliminate or cure COVID-19 (SARS-2 Coronavirus) at this time.

Revive Therapeutics Provides Update of Phase 3 Clinical Study for Bucillamine in the Treatment of COVID-19

Retrieved on: 
Lundi, mars 20, 2023
Long COVID, CSE, Therapy, DSMB, Hospital, Cystinuria, Fever, COVID-19, Secure, Coronavirus, Injury, Research, COVID, Type, Disorder, Cough, Data monitoring committee, RVV, Patient, Risk, Heart rate, FDA, Death, Study, Long, Safety, Pharmaceutical industry, Medical imaging

On March 8th, 2023, the Company announced that it had received the Type C meeting written responses from the FDA to obtain agreement on the proposed protocol endpoints for the Company’s Study.

Key Points: 
  • On March 8th, 2023, the Company announced that it had received the Type C meeting written responses from the FDA to obtain agreement on the proposed protocol endpoints for the Company’s Study.
  • Although the Study was originally designed for a ‘hospitalization or death’ primary endpoint, and it completed enrollment of almost three-quarters of the Study’s recruitment goal and recorded specific clinical symptoms (i.e.
  • ischemia-reperfusion injury , cystinuria ), fast track, and breakthrough therapy designations; and
    Secure alliances with strategic partners, including pharmaceutical companies, to achieve Bucillamine’s full commercial potential.
  • The Company is not making any express or implied claims that its product has the ability to eliminate or cure COVID-19 (SARS-2 Coronavirus) at this time.

Aeglea BioTherapeutics Reports Fourth Quarter and Full Year 2022 Financial Results and Provides Program Updates

Retrieved on: 
Jeudi, mars 2, 2023
Linda, Patient, MBA, License, DSM-IV codes, FDA, European Medicines Agency, Clinical trial, Marketing, OLE, Arginase, Homocystinuria, Safety, MD, Research, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, BLA, Therapy, LTE, EMA, Food, Investigational New Drug, Pharmaceutical industry, Management, Cryptocurrency, Cystinuria

AUSTIN, Texas, March 2, 2023 /PRNewswire/ -- Aeglea BioTherapeutics, Inc. (NASDAQ: AGLE), a clinical-stage biotechnology company developing a new generation of human enzyme therapeutics as innovative solutions for rare metabolic diseases, today announced financial results for the fourth quarter and full year 2022, and provided program updates.

Key Points: 
  • Research and development expenses totaled $14.3 million for the fourth quarter of 2022 and $16.8 million for the fourth quarter of 2021.
  • General and administrative expenses totaled $5.0 million for the fourth quarter of 2022 and $7.3 million for the fourth quarter of 2021.
  • Net loss totaled $18.8 million and $20.4 million for the fourth quarter of 2022 and 2021, respectively, which includes non-cash stock compensation expense of $1.4 million and $2.1 million for the fourth quarter of 2022 and 2021, respectively.
  • As of December 31, 2022, Aeglea had available cash, cash equivalents, marketable securities and restricted cash of $57.3 million.

Aeglea BioTherapeutics Announces Update to Corporate Structure to Increase Operational Efficiency

Retrieved on: 
Vendredi, janvier 6, 2023
Fordham University, Samsung Biologics, Biotechnology, Knowledge, Journal of Global Drug Policy and Practice, Workforce, Homocystinuria, United, Patient, University, M.B.A, Therapy, University of Texas at Austin, Cystinuria, Vetter Pharma, Management, Psychology, Genentech, Biology

AUSTIN, Texas, Jan. 6, 2023 /PRNewswire/ -- Aeglea BioTherapeutics, Inc. (NASDAQ:AGLE), a clinical-stage biotechnology company developing a new generation of human enzyme therapeutics as innovative solutions for rare metabolic diseases, today announced an update to its corporate structure. These changes are in addition to the restructuring process that was initiated in August 2022 and are intended to further streamline the organization, create operational efficiencies to support near- and long-term objectives and maximize the value of the company's two clinical programs.

Key Points: 
  • AUSTIN, Texas, Jan. 6, 2023 /PRNewswire/ -- Aeglea BioTherapeutics, Inc. (NASDAQ:AGLE), a clinical-stage biotechnology company developing a new generation of human enzyme therapeutics as innovative solutions for rare metabolic diseases, today announced an update to its corporate structure.
  • As part of these additional changes, the workforce of the company has been further reduced by approximately 15%.
  • Aeglea is also halting the preclinical work on the Cystinuria and other unnamed pipeline programs.
  • Ms. Caudill joined Aeglea in 2019 and has served as a valued leader of the company's manufacturing, technical operations and pegtarviliase program teams.

Empty Gelatin Capsule Market Report 2022-2028: Increasing Prevalence of Chronic Diseases Fuels 8.1% Annual Growth - ResearchAndMarkets.com

Retrieved on: 
Jeudi, décembre 15, 2022
Chemicals, Plastics, Pharmaceutical, Health, Manufacturing, Lyfe, Wickham Laboratories Ltd, Penicillamine, Capsule, Cystinuria, Food industry, Wilson's disease, ACG Group, Prevalence, Degenerative disease, Cancer, Gelatin, Conditional sentence, Diabetes, HPMC, CVD, Growth, Wilson, USFDA, Dietary supplement, Fine chemical

The global empty gelatin capsule market is anticipated to grow at a significant CAGR around 8.1% during the forecast period (2022-2028).

Key Points: 
  • The global empty gelatin capsule market is anticipated to grow at a significant CAGR around 8.1% during the forecast period (2022-2028).
  • The major factor for the growth of the market is the increasing prevalence of chronic diseases such as CVD, cancer, diabetes, and gastrointestinal diseases coupled with the rising demand for gelatin capsules.
  • The global empty gelatin capsule market is segmented based on the type and based on end-user.
  • Also, the rise in prevalence of chronic diseases such as cardiovascular diseases and cancer, and advancement in capsule drug delivery technology in the region are some of the factors that are driving the global empty gelatin capsule market.

Protect The Kidneys From Overindulgence During The Holidays

Retrieved on: 
Lundi, novembre 14, 2022
People, University, Growth, Recurrence, Kidney, Calcium, Urine, Chronic kidney disease, Stomach, New York University Grossman School of Medicine, Amazon, Physiology, Nephrology, Medicine, Urology, CVS, Holiday, Patient, University School, Life, NYU Langone Hospital — Long Island, Hospital, Sugar, Moonstone, Capsule, Cystinuria, Phosphorus

PITTSBURGH, Penn. , Nov. 14, 2022  /PRNewswire-PRWeb/ -- During the holidays, with special gatherings, parties, dinners, and cookie swaps, it's easy to overindulge. While it's OK to enjoy splurges here and there, it's important to keep the body and organs in balance, especially for those who may be prone to kidney stones. Moonstone Stone Stopper™ is a simple supplement to help prevent kidney stones, keeping the body hydrated and healthier without adding extra sugars or calories to individuals' diets.

Key Points: 
  • PITTSBURGH, Penn., Nov. 14, 2022 /PRNewswire-PRWeb/ -- During the holidays, with special gatherings, parties, dinners, and cookie swaps, it's easy to overindulge.
  • Moonstone Stone Stopper is a simple supplement to help prevent kidney stones, keeping the body hydrated and healthier without adding extra sugars or calories to individuals' diets.
  • Alkali citrate supplementation has been shown to reduce growth and recurrence of calcium-based stones, uric acid stones, and cystine stones.
  • Alkali citrate binds with calcium, which helps prevent the calcium from binding with other molecules to form kidney stones.

Travere Therapeutics Reports First Quarter 2022 Financial Results

Retrieved on: 
Jeudi, mai 5, 2022
GAAP, SIMD, HCU, Safety, Caregiver, Irbesartan, Travers Tool, Life, Annual general meeting, Risk, Investor, EGFR, CMA, Mission statement, NASDAQ, Company, Kidney, Patient, FDA, SG, Regulation of tobacco by the U.S. Food and Drug Administration, New Drug Application, PROTECT, Disease, SAN, Therapy, Heart Protection Study, U.S. Securities and Exchange Commission, Society, Private Securities Litigation Reform Act, Immunoglobulin A, Union, Proteinuria, NDA, Research, Security (finance), Cystinuria, International, R, MAA, Vifor Pharma, Acquisition, COVID-19, Table, Maintenance, GLOBE, Food, Trial of the century, Review, Webcast, Income tax, Patent, Cystine, Form 10-K, Pharmaceutical industry, Fine chemical, Lithium, Bank, FSGS, IgA nephropathy

SAN DIEGO, May 05, 2022 (GLOBE NEWSWIRE) -- Travere Therapeutics, Inc. (NASDAQ: TVTX) today reported its first quarter 2022 financial results and provided a corporate update.

Key Points: 
  • SAN DIEGO, May 05, 2022 (GLOBE NEWSWIRE) -- Travere Therapeutics, Inc. (NASDAQ: TVTX) today reported its first quarter 2022 financial results and provided a corporate update.
  • Total other expense, net, for the first quarter of 2022 was $9.8 million, compared to $6.0 million for the same period in 2021.
  • ET to discuss company updates as well as first quarter 2022 financial results.
  • The Company believes that these non-GAAP financial measures are helpful in understanding its past financial performance and potential future results.