Exploring the Relationship Between Bowel Preparation Quality and Polyethylene Glycol Dosage in Diabetic Patients Using GLP-1 Receptor Agonists: A Prospective, Multicenter, Single-Blind, Randomized Controlled Trial.

Start Date17 Mar 2025

Sponsor / Collaborator-

NCT04199026

/ RecruitingEarly Phase 1IIT

Pilot Trial of an Implantable Microdevice for In Vivo Drug Sensitivity Testing in Patients With Sarcomas

This early phase I trial studies the side effects of implanting and removing a microdevice in patients with sarcomas that have spread to other places in the body (metastatic) or have come back (recurrent). Microdevices are rice-sized devices that are implanted into tumor tissue and are loaded with 10 different drugs that are delivered at very small doses, or "microdoses," which may only affect a very small, local area inside the tumor. The purpose of this study is to determine which drugs delivered in the microdevice affect tumor tissue in patients with sarcomas.

Start Date25 Feb 2025

Sponsor / Collaborator

The University of Texas MD Anderson Cancer Center

[+1]

NCT06393400

/ RecruitingPhase 1IIT

An Open-label, Single-arm, Phase 1 Study of the Combination of FMT and Gemcitabine with Nab-paclitaxel As First-line Therapy in Patients with Advanced Pancreatic Ductal Adenocarcinoma.

To confirm the safety of combining oral fecal microbiota transplantation (FMT) with gemcitabine and nab-paclitaxel chemotherapy as first line treatment in patients with unresectable or metastatic pancreatic ductal adenocarcinoma.

Start Date08 Jan 2025

Sponsor / Collaborator-

100 Clinical Results associated with Polyethylene glycol 3350

100 Translational Medicine associated with Polyethylene glycol 3350

100 Patents (Medical) associated with Polyethylene glycol 3350

83,542

Literatures (Medical) associated with Polyethylene glycol 3350

01 Dec 2025·Nano-Micro Letters

Dynamic Regulation of Hydrogen Bonding Networks and Solvation Structures for Synergistic Solar-Thermal Desalination of Seawater and Catalytic Degradation of Organic Pollutants

Article

Author: Jiao, Fan-Zhen ; Yu, Zhong-Zhen ; Yin, Guang ; Wu, Jing ; Qu, Jin ; Yu, Ming-Yuan

Abstract:

Although solar steam generation strategy is efficient in desalinating seawater, it is still challenging to achieve continuous solar-thermal desalination of seawater and catalytic degradation of organic pollutants. Herein, dynamic regulations of hydrogen bonding networks and solvation structures are realized by designing an asymmetric bilayer membrane consisting of a bacterial cellulose/carbon nanotube/Co2(OH)2CO3 nanorod top layer and a bacterial cellulose/Co2(OH)2CO3 nanorod (BCH) bottom layer. Crucially, the hydrogen bonding networks inside the membrane can be tuned by the rich surface –OH groups of the bacterial cellulose and Co2(OH)2CO3 as well as the ions and radicals in situ generated during the catalysis process. Moreover, both SO42− and HSO5− can regulate the solvation structure of Na+ and be adsorbed more preferentially on the evaporation surface than Cl−, thus hindering the de-solvation of the solvated Na+ and subsequent nucleation/growth of NaCl. Furthermore, the heat generated by the solar-thermal energy conversion can accelerate the reaction kinetics and enhance the catalytic degradation efficiency. This work provides a flow-bed water purification system with an asymmetric solar-thermal and catalytic membrane for synergistic solar thermal desalination of seawater/brine and catalytic degradation of organic pollutants.

01 Aug 2025·SEPARATION AND PURIFICATION TECHNOLOGY

A new clean and energy-saving process design of extractive distillation for ethyl propionate/n-propanol/H2O heterogeneous azeotrope system

Author: Zheng, Fengbin ; Wang, Yinglong ; Yang, Lili ; Hu, Quanyu ; Du, Xiaobin ; Sun, Chao ; Xue, Feng

The development of efficient wastewater treatment technologies is crucial for the sustainable advancement of the chem., pharmaceutical, and food industries.In this study, the azeotrope of Et propionate/n-propanol/water in liquor wastewater was successfully separated via extractive distillation and extractive pressure swing distillation technologies.Ethylene glycol was determined as the optimal entrainer based on relative volatility, and the interaction between azeotrope and entrainer was further explored through electrostatic potential and σ-profile anal.We employed the multi-objective optimization method to optimize different process flows, focusing on total annual cost and gas emissions as objective functions.The optimal solutions weighing economic and environmental factors were obtained.Addnl., heat-integrated technol. was used to explore energy-saving distillation processes to tackle the issue of excessive energy consumption.Finally, eight separation processes were discussed and analyzed from the perspective of economic, environmental, energy, and exergy.The findings indicated that the heat-integrated new four-column pressure swing-assisted extractive distillation process exhibited the most favorable environmental and economic performance.Compared with the extractive distillation process, the heat-integrated new four-column pressure swing-assisted extractive distillation scheme achieved a reduction of 28.14% in total annual cost and 47.47% in gas emissions.This study provides valuable insights for recycling Et propionate and n-propanol from industrial wastewater and has certain reference significance for future research.

01 Jul 2025·SEPARATION AND PURIFICATION TECHNOLOGY

Visible light-driven selective oxidation of multiple organic matters by photocatalysis of BiOX (X = I, Br): New insights into the role of oxygen vacancy generation and electron gain/loss properties of matter

Author: Yan, Jingyuan ; Liu, Kun ; Zhang, Hanbing ; Tong, Zhangfa ; Yu, Yingqi ; Wang, Yue ; Zhang, Jingwei ; Lv, Jianlin

Realizing better photocatalytic activity of materials by various strategies has always been a hot topic in the field of environmental catalysis.However, the complex heterogeneous composition and preparation process of catalysts undoubtedly limit their potential for practical pollution control.Therefore, clarifying the selective photocatalytic mechanism of pristine semiconductor oxide and the crucial relationship between catalysts structures and phys.-chem. characteristics of target pollutants become more necessary.In our study, based on the combination of d. functional theory (DFT) calculation and characterizations, the differences in photocatalytic degradation behavior and intrinsic mechanisms of common organic pollutants including ciprofloxacin (CIP), tetracycline (TC), Rhodamine B (RhB) and bisphenol-A (BPA) over the pristine BiOBr and BiOI were investigated, thereby clarifying the crucial relationship and synergistic effects between photocatalysts microstructure and pollutants characteristics.Under the same reaction conditions, 10 %-BiOBr (BiOBr obtained from the hydrothermal treatment in a 10 % ethylene glycol solution environment) exhibited better degradation performance of CIP (73 %), TC (67 %) and RhB (95 %) than that of BPA (28 %).While 10 %-BiOI (BiOI obtained from the hydrothermal treatment in a 10 % ethylene glycol solution environment) exhibited better degradation performance of BPA (88 %) than those of CIP (27 %), TC (60 %) and RhB (41 %).The obvious selective degradation difference of various target pollutants over the 10 %-BiOBr and 10 %-BiOI could be ascribed as follows: (i) Under the same synthesis condition, the differences in Bi-O bond lengths due to the halogen layers resulted in BiOI being more susceptible to generate oxygen vacancy than BiOBr, thereby boosting the non-radicalpathway degradation of electron-rich pollutants. (ii) The generation of radicals and non-radicals during photocatalysis were directly affected by the electronic characteristic discrepancies of the pollutants, thereby changing the main degradation pathways of organic matters.Results indicated that the electron-deficient pollutants including CIP, TC and RhB tended to be degraded by radical pathway.On the contrary electron-rich pollutant BPA was more susceptible to degradation via direct electrons transfer to oxygen vacancies of 10 %-BiOI.Our study supplied new insight into adopting pristine photocatalysts based on the difference of oxygen vacancy for selectively degrading various pollutants with different donating/losing electron ability, the corresponding mechanisms and degradation pathway could provide theor. reference for practical application of pristine photocatalysts.

News (Medical) associated with Polyethylene glycol 3350

02 Apr 2025

·www.prnewswire.com

BioMarin Announces Positive Pivotal Data for PALYNZIQ® (pegvaliase-pqpz) in Adolescents with Phenylketonuria

Company plans to submit for regulatory approval later this year SAN RAFAEL, Calif., April 2, 2025 /PRNewswire/ -- BioMarin Pharmaceutical Inc. (Nasdaq: BMRN) today announced that the Phase 3 PEGASUS trial evaluating PALYNZIQ® (pegvaliase-pqpz) met its primary efficacy endpoint, demonstrating a statistically significant lowering in blood Phe levels in adolescents aged 12-17 with phenylketonuria (PKU) compared to diet alone. Safety results were consistent with the known profile of the medicine. PALYNZIQ is the first and only enzyme therapy approved to treat adults with PKU. Detailed results from the PEGASUS study will be presented at an upcoming medical meeting and submitted to global health authorities starting later this year to request a label expansion for PALYNZIQ to include adolescents. "For more than two decades, BioMarin has made strides for people with PKU – pioneering the first treatment, bringing a meaningful new option in PALYNZIQ, and continuing to innovate as we advance our research pipeline. We are encouraged to see these positive data that build on that legacy and show how PALYNZIQ can make an impact for adolescents as they begin their transition to adult living," said Greg Friberg, M.D., executive vice president and chief research & development officer at BioMarin. "We look forward to sharing these data with the scientific community and to submitting them to global regulators with the goal of making PALYNZIQ available for younger people living with PKU." About PEGASUS PEGASUS is a Phase 3 multi-center open-label randomized controlled study evaluating the safety and efficacy of PALYNZIQ compared to diet alone in 55 adolescents aged 12-17 with phenylketonuria. The primary endpoints are change in blood Phe concentration and characterization of the safety profile in adolescents. Secondary endpoints include change in total dietary protein intake and pharmacokinetics. The study is being conducted in two parts: the primary treatment phase ranging from weeks 1-73 (Part 1), and the extension phase (Part 2), which lasts for up to an additional 80 weeks of monitoring for the PALYNZIQ arm and allows for crossover for those in the diet-only arm. For more information, please visit clinicaltrials.biomarin.com. About PALYNZIQ PALYNZIQ substitutes the deficient phenylalanine hydroxylase (PAH) enzyme in PKU with a PEGylated version of the enzyme phenylalanine ammonia lyase to break down Phe. PALYNZIQ is administered using a dosing regimen designed to facilitate tolerability; PALYNZIQ's safety profile consists primarily of immune-mediated responses, which can include anaphylaxis, for which robust risk management measures effective in clinical trials are in place. PALYNZIQ is approved to reduce blood Phe concentrations for adults in the U.S., for people 16 and older in the EU, Canada and Brazil, and for people 15 and older in Japan with PKU who have uncontrolled blood Phe concentrations greater than 600 micromol/L on existing management. Patient Support Accessing PALYNZIQ To reach a BioMarin RareConnections® Case Manager, please call, toll-free, 1-866-906-6100 or e-mail [email protected]. For more information about PALYNZIQ, please visit . For additional information regarding this product, please contact BioMarin Medical Information at [email protected]. About Phenylketonuria PKU, or phenylalanine hydroxylase (PAH) deficiency, is a genetic condition affecting approximately 70,000 people in the regions of the world where BioMarin operates. This enzyme is required for the metabolism of Phe, an essential amino acid found in most protein-containing foods. If functional enzyme is not present in sufficient quantities, Phe accumulates to abnormally high levels in the blood and becomes toxic to the brain, resulting in a variety of complications including severe intellectual disability, seizures, tremors, behavioral problems and psychiatric symptoms. As a result of newborn screening efforts implemented in the 1960s and early 1970s, virtually all individuals with PKU born after this period in countries with newborn screening programs are diagnosed at birth and treatment is implemented soon after. PKU can be managed with a severe Phe-restricted diet, which is supplemented by low-protein modified foods and Phe-free medical foods; however, it is difficult for most individuals to adhere to the lifelong strict diet to the extent needed to achieve adequate control of blood Phe levels. Dietary control of Phe in childhood can prevent major developmental neurological toxicities, but poor control of Phe in adolescence and adulthood is associated with a range of neurocognitive disabilities with significant functional impact. PALYNZIQ U.S. Indication and Important Safety Information PALYNZIQ® (pegvaliase-pqpz) is a phenylalanine (Phe)-metabolizing enzyme indicated to reduce blood Phe levels in adult patients with phenylketonuria who have uncontrolled blood Phe levels greater than 600 micromol/L on existing management. BOXED WARNING: RISK OF ANAPHYLAXIS Anaphylaxis has been reported after administration of PALYNZIQ and may occur at any time during treatment Administer the initial dose of PALYNZIQ under the supervision of a healthcare provider equipped to manage anaphylaxis, and closely observe patients for at least 60 minutes following injection. Prior to self-injection, confirm patient competency with self-administration, and patient's and observer's (if applicable) ability to recognize signs and symptoms of anaphylaxis and to administer auto-injectable epinephrine, if needed Consider having an adult observer for patients who may need assistance in recognizing and managing anaphylaxis during PALYNZIQ treatment. If an adult observer is needed, the observer should be present during and for at least 60 minutes after PALYNZIQ administration, should be able to administer auto-injectable epinephrine, and call for emergency medical support upon its use Prescribe auto-injectable epinephrine. Prior to the first dose, instruct the patient and observer (if applicable) on its appropriate use. Instruct the patient to seek immediate medical care upon its use. Instruct patients to carry auto-injectable epinephrine with them at all times during PALYNZIQ treatment PALYNZIQ is available only through a restricted program called PALYNZIQ REMS (Risk Evaluation and Mitigation Strategy). Further information, including a list of qualified pharmacies, is available at or by telephone at 1-855-758-REMS (1-855-758-7367) WARNINGS AND PRECAUTIONS Anaphylaxis Signs and symptoms of anaphylaxis reported include syncope, hypotension, hypoxia, dyspnea, wheezing, chest discomfort/chest tightness, tachycardia, angioedema (swelling of face, lips, eyes, tongue), throat tightness, skin flushing, rash, urticaria, pruritus, and gastrointestinal symptoms (vomiting, nausea, diarrhea) Anaphylaxis generally occurred within 1 hour after injection; however, delayed episodes occurred up to 48 hours after PALYNZIQ administration Consider having an adult observer for patients who may need assistance in recognizing and managing anaphylaxis during PALYNZIQ treatment. If an adult observer is needed, the observer should be present during and for at least 60 minutes after PALYNZIQ administration, should be able to administer auto-injectable epinephrine, and call for emergency medical support upon its use Anaphylaxis requires immediate treatment with auto-injectable epinephrine. Prescribe auto-injectable epinephrine to all patients receiving PALYNZIQ and instruct patients to carry auto-injectable epinephrine with them at all times during PALYNZIQ treatment. Prior to the first dose, instruct the patient and observer (if applicable) on how to recognize the signs and symptoms of anaphylaxis, how to properly administer auto-injectable epinephrine, and to seek immediate medical care upon its use. Consider the risks associated with auto-injectable epinephrine use when prescribing PALYNZIQ. Refer to the auto-injectable epinephrine prescribing information for complete information Consider the risks and benefits of readministering PALYNZIQ following an episode of anaphylaxis. If the decision is made to readminister PALYNZIQ, administer the first dose under the supervision of a healthcare provider equipped to manage anaphylaxis and closely observe the patient for at least 60 minutes following the dose. Subsequent PALYNZIQ dose titration should be based on patient tolerability and therapeutic response Consider premedication with an H1-receptor antagonist, H2-receptor antagonist, and/or antipyretic prior to PALYNZIQ administration based upon individual patient tolerability Other Hypersensitivity Reactions Hypersensitivity reactions other than anaphylaxis have been reported in 204 of 285 (72%) patients treated with PALYNZIQ in clinical trials Management of hypersensitivity reactions should be based on the severity of the reaction, recurrence of the reaction, and the clinical judgment of the healthcare provider, and may include dosage adjustment, temporary drug interruption, or treatment with antihistamines, antipyretics, and/or corticosteroids ADVERSE REACTIONS The most common adverse reactions (at least 20% of patients in either treatment phase) were injection site reactions, arthralgia, hypersensitivity reactions, headache, generalized skin reactions lasting at least 14 days, nausea, abdominal pain, vomiting, cough, oropharyngeal pain, pruritus, diarrhea, nasal congestion, fatigue, dizziness, and anxiety Of the 285 patients exposed to PALYNZIQ in an induction/titration/maintenance regimen in clinical trials, 44 (15%) patients discontinued treatment due to adverse reactions. The most common adverse reactions leading to treatment discontinuation were hypersensitivity reactions (6% of patients) including anaphylaxis (3% of patients), angioedema (1% of patients), arthralgia (4% of patients), generalized skin reactions lasting at least 14 days (2% of patients), and injection site reactions (1% of patients) The most common adverse reactions leading to dosage reduction were arthralgia (15% of patients), hypersensitivity reactions (9% of patients), injection site reactions (4% of patients), alopecia (3% of patients), and generalized skin reactions lasting at least 14 days (2% of patients) The most common adverse reactions leading to temporary drug interruption were hypersensitivity reactions (14% of patients), arthralgia (13% of patients), anaphylaxis (4% of patients), and injection site reactions (4% of patients) Angioedema and serum sickness: In clinical trials, 22 out of 285 (8%) patients experienced 45 episodes of angioedema (symptoms included: pharyngeal edema, swollen tongue, lip swelling, mouth swelling, eyelid edema, and face edema) occurring independent of anaphylaxis. In clinical trials, serum sickness was reported in 7 out of 285 (2%) patients Blood Phenylalanine Monitoring and Diet Obtain blood Phe levels every 4 weeks until a maintenance dosage is established. Periodically monitor blood Phe levels during maintenance therapy Counsel patients to monitor dietary protein and Phe intake, and adjust as directed by their healthcare provider DRUG INTERACTIONS Effect of PALYNZIQ on Other PEGylated Products In a single-dose study of PALYNZIQ in adult patients with PKU, two patients receiving concomitant injections of medroxyprogesterone acetate suspension (a formulation containing PEG 3350) experienced a hypersensitivity reaction. One of the two patients experienced anaphylaxis The clinical effects of concomitant treatment with different PEGylated products is unknown. Monitor patients treated with PALYNZIQ and concomitantly with other PEGylated products for hypersensitivity reactions including anaphylaxis USE IN SPECIFIC POPULATIONS Pregnancy and Lactation PALYNZIQ may cause fetal harm when administered to a pregnant woman Advise women who are exposed to PALYNZIQ during pregnancy or who become pregnant within one month following the last dose of PALYNZIQ that there is a pregnancy surveillance program that monitors pregnancy outcomes. Healthcare providers should report PALYNZIQ exposure and encourage these patients to report their pregnancy to BioMarin (1-866-906-6100) Monitor blood Phe levels in breastfeeding women treated with PALYNZIQ Pediatric Use The safety and effectiveness of PALYNZIQ in pediatric patients have not been established Geriatric Use Clinical studies of PALYNZIQ did not include patients aged 65 years and older You are encouraged to report suspected adverse reactions to BioMarin at 1-866-906-6100, or to FDA at 1-800-FDA-1088 or . Please see accompanying full Prescribing Information, including Boxed Warning. About BioMarin BioMarin is a global biotechnology company dedicated to translating the promise of genetic discovery into medicines that make a profound impact on the life of each patient. The San Rafael, California-based company, founded in 1997, has a proven track record of innovation with eight commercial therapies and a strong clinical and preclinical pipeline. Using a distinctive approach to drug discovery and development, BioMarin seeks to unleash the full potential of genetic science by pursuing category-defining medicines that offer new possibilities for people living with genetically defined conditions around the world. To learn more, please visit . Forward-Looking Statements This press release contains forward-looking statements about the business prospects of BioMarin Pharmaceutical Inc. (BioMarin), including without limitation, statements about: the Phase 3 PEGASUS trial evaluating PALYNZIQ, including plans to present results at an upcoming medical conference; the safety profile and potential benefit of PALYNZIQ for adolescents, including ability to lower blood Phe levels in adolescents aged 12-17 with phenylketonuria (PKU) compared to diet alone; the development of BioMarin's PALYNZIQ program generally, including plans to submit detailed results to global health authorities later this year to request a label expansion for PALYNZIQ to include adolescents with the goal of making PALYNZIQ available to younger people living with PKU; and the continued clinical development of PALYNZIQ. These forward-looking statements are predictions and involve risks and uncertainties such that actual results may differ materially from these statements. These risks and uncertainties include, among others: results and timing of current and planned preclinical studies and clinical trials of PALYNZIQ; any potential adverse events observed in the continuing monitoring of the patients in the clinical trials; the content and timing of decisions by the U.S. Food and Drug Administration, the European Medicines Agency, the European Commission and other regulatory authorities; and those factors detailed in BioMarin's filings with the Securities and Exchange Commission, including, without limitation, the factors contained under the caption "Risk Factors" in BioMarin's Annual Report on Form 10-K for the year ended December 31, 2024, as such factors may be updated by any subsequent reports. Stockholders are urged not to place undue reliance on forward-looking statements, which speak only as of the date hereof. BioMarin is under no obligation, and expressly disclaims any obligation to update or alter any forward-looking statement, whether as a result of new information, future events or otherwise. BioMarin®, BioMarin RareConnections® and PALYNZIQ® are registered trademarks of BioMarin Pharmaceutical Inc. SOURCE BioMarin Pharmaceutical Inc. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Clinical ResultPhase 3Drug Approval

28 Oct 2024

·ir.bauschhealth.com

ACG Presidential Plenary to Highlight Analysis of Xifaxan® (rifaximin) Risk Reduction of Overt Hepatic Encephalopathy (OHE) Recurrence

Additional ACG presentation to focus on impact of Xifaxan on OHE rehospitalizations LAVAL, QC / ACCESSWIRE / October 27, 2024 / Bausch Health Companies Inc. (NYSE:BHC)(TSX:BHC) and its gastroenterology (GI) business, Salix Pharmaceuticals ("Salix"), announced that results of an analysis of Xifaxan® (rifaximin) monotherapy will be presented during a Presidential Plenary Session of The American College of Gastroenterology® 2024 Annual Scientific Meeting taking place October 25-30 in Philadelphia, PA. This post hoc analysis of data from two randomized trials evaluated the efficacy of Xifaxan monotherapy compared to lactulose monotherapy for risk reduction of overt hepatic encephalopathy (OHE) recurrence and all-cause mortality. During ACG, Salix will also present new data on the impact of Xifaxan use on rehospitalizations following an OHE hospitalization discharge in both commercially insured and Medicare patient populations. Two posters to be presented at the ACG meeting will also share findings for Plenvu® (polyethylene glycol 3350, sodium ascorbate, sodium sulfate, ascorbic acid, sodium chloride, and potassium chloride for oral solution) as a bowel preparation medication, including efficacy findings from colonoscopy patients who have either comorbid conditions or are taking concomitant medications that are known to impact bowel prep quality. "These presentations at ACG 2024 can give healthcare professionals confidence that treatments from Salix have potential to improve outcomes for their patients" said Aimee Lenar, Executive Vice President, US Pharma at Bausch Health. "Bausch Health remains dedicated to pursuing life-changing solutions and continues to invest in expanding the body of evidence for our medicines today and in the future." The complete list of Salix research and analyses to be presented at ACG 2024 is as follows: XIFAXAN Bajaj, Jasmohan S. et.al. Rifaximin Monotherapy Is More Effective Than Lactulose Monotherapy for Reducing the Risk of Overt Hepatic Encephalopathy (OHE) Recurrence and All-Cause Mortality: An Analysis of Two Randomized Trials Presidential Plenary Session 2; Presentation #9 Monday, October 28, 10:06 - 10:18 AM ET Jesudian, Arun B. et.al. Impact of Rifaximin Use on Overt Hepatic Encephalopathy (OHE) Rehospitalizations Post Discharge from an OHE Hospitalization in Commercially and Medicare Insured Patients Poster #P1162 Sunday, October 27, 3:30 PM - 7:00 PM ET Bajaj, Jasmohan S. et.al. Rifaximin Monotherapy Is More Effective Than Lactulose Monotherapy for Reducing the Risk of Overt Hepatic Encephalopathy (OHE) Recurrence and All-Cause Mortality: An Analysis of Two Randomized Trials Presidential Plenary Session 2; Presentation #9 Monday, October 28, 10:06 - 10:18 AM ET Presidential Plenary Session 2; Presentation #9 Monday, October 28, 10:06 - 10:18 AM ET Jesudian, Arun B. et.al. Impact of Rifaximin Use on Overt Hepatic Encephalopathy (OHE) Rehospitalizations Post Discharge from an OHE Hospitalization in Commercially and Medicare Insured Patients Poster #P1162 Sunday, October 27, 3:30 PM - 7:00 PM ET Poster #P1162 Sunday, October 27, 3:30 PM - 7:00 PM ET PLENVU Cash, Brooks D. et.al. Efficacy and Safety of the 1 Liter NER1006 Bowel Preparation for Colonoscopy in Adults With Comorbid Conditions That May Impact Prep Quality Poster #P3667 Tuesday, October 29, 10:30 AM - 4:00 PM ET Poppers, David. et.al. One-Liter NER1006 Is Efficacious as a Bowel Preparation for Colonoscopy in Patients Taking Concomitant Medications Known to Impact Prep Quality Poster #P3657 Tuesday, October 29, 10:30 AM - 4:00 PM ET Cash, Brooks D. et.al. Efficacy and Safety of the 1 Liter NER1006 Bowel Preparation for Colonoscopy in Adults With Comorbid Conditions That May Impact Prep Quality Poster #P3667 Tuesday, October 29, 10:30 AM - 4:00 PM ET Poster #P3667 Tuesday, October 29, 10:30 AM - 4:00 PM ET Poppers, David. et.al. One-Liter NER1006 Is Efficacious as a Bowel Preparation for Colonoscopy in Patients Taking Concomitant Medications Known to Impact Prep Quality Poster #P3657 Tuesday, October 29, 10:30 AM - 4:00 PM ET Poster #P3657 Tuesday, October 29, 10:30 AM - 4:00 PM ET About XIFAXAN INDICATION XIFAXAN® (rifaximin) 550 mg tablets are indicated for the reduction in risk of overt hepatic encephalopathy (HE) recurrence in adults and for the treatment of irritable bowel syndrome with diarrhea (IBS-D) in adults. IMPORTANT SAFETY INFORMATION XIFAXAN is contraindicated in patients with a hypersensitivity to rifaximin, rifamycin antimicrobial agents, or any of the components in XIFAXAN. Hypersensitivity reactions have included exfoliative dermatitis, angioneurotic edema, and anaphylaxis. Clostridium difficile-associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including XIFAXAN, and may range in severity from mild diarrhea to fatal colitis. If CDAD is suspected or confirmed, ongoing antibiotic use not directed against C. difficile may need to be discontinued. There is an increased systemic exposure in patients with severe (Child-Pugh Class C) hepatic impairment. Caution should be exercised when administering XIFAXAN to these patients. Caution should be exercised when concomitant use of XIFAXAN and P-glycoprotein (P-gp) and/or OATPs inhibitors is needed. Concomitant administration of cyclosporine, an inhibitor of P-gp and OATPs, significantly increased the systemic exposure of rifaximin. In patients with hepatic impairment, a potential additive effect of reduced metabolism and concomitant P-gp inhibitors may further increase the systemic exposure to rifaximin. In clinical studies, the most common adverse reactions for XIFAXAN (alone or in combination with lactulose) were: HE (≥10%): Peripheral edema (17%), constipation (16%), nausea (15%), fatigue (14%), insomnia (14%), ascites (13%), dizziness (13%), urinary tract infection (12%), anemia (10%), and pruritus (10%) IBS-D (≥2%): Nausea (3%), ALT increased (2%) INR changes have been reported in patients receiving rifaximin and warfarin concomitantly. Monitor INR and prothrombin time. Dose adjustment of warfarin may be required. XIFAXAN may cause fetal harm. Advise pregnant women of the potential risk to a fetus. XIFAXAN is contraindicated in patients with a hypersensitivity to rifaximin, rifamycin antimicrobial agents, or any of the components in XIFAXAN. Hypersensitivity reactions have included exfoliative dermatitis, angioneurotic edema, and anaphylaxis. Clostridium difficile-associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including XIFAXAN, and may range in severity from mild diarrhea to fatal colitis. If CDAD is suspected or confirmed, ongoing antibiotic use not directed against C. difficile may need to be discontinued. There is an increased systemic exposure in patients with severe (Child-Pugh Class C) hepatic impairment. Caution should be exercised when administering XIFAXAN to these patients. Caution should be exercised when concomitant use of XIFAXAN and P-glycoprotein (P-gp) and/or OATPs inhibitors is needed. Concomitant administration of cyclosporine, an inhibitor of P-gp and OATPs, significantly increased the systemic exposure of rifaximin. In patients with hepatic impairment, a potential additive effect of reduced metabolism and concomitant P-gp inhibitors may further increase the systemic exposure to rifaximin. In clinical studies, the most common adverse reactions for XIFAXAN (alone or in combination with lactulose) were: HE (≥10%): Peripheral edema (17%), constipation (16%), nausea (15%), fatigue (14%), insomnia (14%), ascites (13%), dizziness (13%), urinary tract infection (12%), anemia (10%), and pruritus (10%) IBS-D (≥2%): Nausea (3%), ALT increased (2%) INR changes have been reported in patients receiving rifaximin and warfarin concomitantly. Monitor INR and prothrombin time. Dose adjustment of warfarin may be required. XIFAXAN may cause fetal harm. Advise pregnant women of the potential risk to a fetus. To report SUSPECTED ADVERSE REACTIONS, contact Salix Pharmaceuticals at 1-800-321-4576 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. Please click here for full Prescribing Information. About PLENVU INDICATION PLENVU® (polyethylene glycol 3350, sodium ascorbate, sodium sulfate, ascorbic acid, sodium chloride, and potassium chloride for oral solution) is a prescription medication used by adults to clean the colon before a colonoscopy. IMPORTANT SAFETY INFORMATION Do not take PLENVU® if you have a blockage in your intestine (bowel obstruction), an opening in the wall of your stomach or intestine (bowel perforation), problems with food or fluid emptying from your stomach (gastric retention), a problem with food moving too slowly through your intestines (ileus), a very dilated large intestine, or an allergy to any of the ingredients in PLENVU®. PLENVU® and other bowel preparations can cause serious side effects including loss of body fluid (dehydration) and changes in blood salts (electrolytes) in your blood. These changes can cause abnormal heartbeats that may result in death, seizures (even if you have never had a seizure), or kidney problems. Your chance of having fluid loss and changes in body salts with PLENVU® is higher if you have heart problems, kidney problems, or take water pills, high blood pressure medicine, or non-steroidal anti-inflammatory drugs (NSAIDS). Your healthcare provider may do blood tests after you take PLENVU® to check your blood for changes. Tell your healthcare provider right away if you have any symptoms of too much fluid loss (dehydration) including vomiting, dizziness, heart problems, kidney problems, seizures, dry mouth, urinating less often than normal; headache, or feel faint, weak, or lightheaded, especially when you stand up. PLENVU® can cause ulcers of the bowel or bowel problems (ischemic colitis). Tell your healthcare provider right away if you have severe stomach-area (abdomen) pain or rectal bleeding. PLENVU® can cause serious allergic reactions that may include skin rash, itching, raised red patches on your skin (hives); swelling of the face, lips, tongue, and throat; and kidney problems. The most common side effects in patients taking PLENVU® were nausea, vomiting, dehydration, and stomach pain or discomfort. Tell your healthcare provider about all of your medical conditions and medicines you take, including prescription, nonprescription medicines, vitamins, and herbal supplements before you take PLENVU® Do not take PLENVU® if you have a blockage in your intestine (bowel obstruction), an opening in the wall of your stomach or intestine (bowel perforation), problems with food or fluid emptying from your stomach (gastric retention), a problem with food moving too slowly through your intestines (ileus), a very dilated large intestine, or an allergy to any of the ingredients in PLENVU®. PLENVU® and other bowel preparations can cause serious side effects including loss of body fluid (dehydration) and changes in blood salts (electrolytes) in your blood. These changes can cause abnormal heartbeats that may result in death, seizures (even if you have never had a seizure), or kidney problems. Your chance of having fluid loss and changes in body salts with PLENVU® is higher if you have heart problems, kidney problems, or take water pills, high blood pressure medicine, or non-steroidal anti-inflammatory drugs (NSAIDS). Your healthcare provider may do blood tests after you take PLENVU® to check your blood for changes. Tell your healthcare provider right away if you have any symptoms of too much fluid loss (dehydration) including vomiting, dizziness, heart problems, kidney problems, seizures, dry mouth, urinating less often than normal; headache, or feel faint, weak, or lightheaded, especially when you stand up. PLENVU® can cause ulcers of the bowel or bowel problems (ischemic colitis). Tell your healthcare provider right away if you have severe stomach-area (abdomen) pain or rectal bleeding. PLENVU® can cause serious allergic reactions that may include skin rash, itching, raised red patches on your skin (hives); swelling of the face, lips, tongue, and throat; and kidney problems. The most common side effects in patients taking PLENVU® were nausea, vomiting, dehydration, and stomach pain or discomfort. Tell your healthcare provider about all of your medical conditions and medicines you take, including prescription, nonprescription medicines, vitamins, and herbal supplements before you take PLENVU® These are not all the possible side effects of PLENVU®. Ask your healthcare provider for more information. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088. Please click here for full Prescribing Information. About Bausch Health Bausch Health Companies Inc. (NYSE:BHC)(TSX:BHC) is a global diversified pharmaceutical company enriching lives through our relentless drive to deliver better health care outcomes. We develop, manufacture and market a range of products primarily in gastroenterology, hepatology, neurology, dermatology, international pharmaceuticals and eye health, through our controlling interest in Bausch + Lomb Corporation. Our ambition is to be a globally integrated healthcare company, trusted and valued by patients, HCPs, employees and investors. Our gastroenterology business, Salix Pharmaceuticals, is one of the largest specialty pharmaceutical businesses in the world and has licensed, developed and marketed innovative products for the treatment of gastrointestinal diseases for more than 30 years. For more information about Salix, visit www.Salix.com and connect with us on Twitter and LinkedIn. For more information about Bausch Health, visit www.bauschhealth.com and connect with us on LinkedIn.

Drug Approval

09 Oct 2024

·isogenica.com

Tackling the challenge of short half-life for biological therapeutics

With more than 180 therapeutic proteins and peptides approved by the US Food and Drug Administration (FDA), the market for biological therapeutics, also called biologics, is booming. But many small biologics, including VHH-based therapies, have one significant challenge that must be overcome: their short half-life. The short half-life of many promising biologics is attributed to their small size of less than 70 kDa, which makes it easy for the kidney to filter them out. Because of this limitation, have gruelling dosing schedules that require in-person visits to the hospital/clinic so patients can continuously receive infusions. At Isogenica, half-life extension for our VHHs was always top of our list. Improving half-life is essential to realise the potential of smaller biotherapeutics, like VHH-based drugs, by reducing dosing frequency and healthcare costs and, ultimately, improving the quality of life for patients. In this article, we look at some ways in which the half-life of biological therapeutics can be extended to deliver on this promise, and why we chose an anti-albumin approach – ISOXTEND®. Over the years, several strategies have gained momentum in improving the half-life of biologics. While some of them improve the half-life by simply increasing the size of the therapeutic agent, others modify the structure of the drug to reduce the rate at which it is cleared. Many strategies also involve ‘tying’ the biologic to biomolecules that have a better half-life, such as antibodies, transferrin, or human serum albumin (HSA). Here are some of the common techniques that can be used to increase the half-life of small biologics. PEGylation was the first successful technology used to extend the half-life of biologics and has been applied to clinical medicine for more than 25 years. Through this process, polyethylene glycol (PEG) molecules are covalently attached to the biologic, increasing its molecular weight and effective size, which prevents the kidneys from quickly filtering the biologic based on size. Additionally, PEGs prevent access to proteases and peptidases that can degrade protein-based drugs, playing a further role in extending the half-life of these therapeutics. Despite the efficacy of PEGylation, there are several disadvantages to this technology. For instance, research suggests that PEGs are not 100% safe – they are immunogenic and cells treated with PEGylated biologics can develop PEG-containing vacuoles. Additionally, because PEGs change the physicochemical properties of the biological therapeutic, they can also greatly reduce its potency. Repeating amino acid chains, which work in similar ways to PEG, can also be attached to biologics. Like PEG, they increase the effective size of the biological therapeutic to reduce direct filtration by the kidneys, improving the overall half-life of the biologic. There are two leading amino acid half-life extension technologies – XTEN and ELPylation – although the use of other amino acid chains like PASylation and HAPylation is also being researched. XTEN is a protein polymer developed by Amunix. It comprises a library of amino acid sequences expressed by E. coli that coil randomly around a small biological therapeutic. Depending on the length of the XTEN sequence used, the half-life of a biologic can be tuned to fit its clinical indication. ELPylation, a technology developed by PhaseBio, also uses repeating amino acid chains to increase the size of biologics and thereby improve their half-life. Unlike PEGs, these repeating amino acid technologies are biodegradable and non-toxic. But despite this, they have similar drawbacks to PEGs, including the potential for immunogenicity of the polypeptide repeat units. Additionally, these kinds of half-life extenders can raise a series of potential manufacturing and dosing challenges, including developability, stability, solubility, immunogenicity and loss of activity in comparison with the unmodified drug. Small proteins in the blood are normally cleared out of the body by being broken down by cells in the liver or filtered out by the kidneys. But some proteins – such as human IgG antibodies and human serum albumin (HSA) – escape this fate by binding to cell surface receptors (FcRn) that enable them to be taken up by cells and ‘recycled’, prolonging their persistence in the body. Fusing biologics with HSA or fragments from IgG is a commonly used technique for improving the half-life of many small biologics that would otherwise be lost by filtration or metabolism. Fusing a biological therapeutic with IgG enables it to bind to the FcRn receptor and be recycled through cells, bypassing degradation or filtration. Although this is an effective way to improve the half-life of biologics, Fc domains on IgG can cause toxicity in the liver and have unwanted side effects through interactions with immune cells. There are also limitations in applying this across preclinical species. HSA is the most abundant plasma protein. It is highly soluble, extremely stable, and has a long circulatory half-life as a result of the FcRn-mediated recycling pathway. Direct or indirect binding of biologics to Human Serum Albumin (HSA) also recruits the FcRn-mediated recycling pathway, protecting biologics from degradation by recycling them through cells and significantly extending half-life. Early attempts to exploit the long half-life of HSA involved building fusion proteins combining biologics with serum albumin. However, HSA is a large protein and can exert significant effects on the biophysical properties of the drug, as well as its efficacy being limited to human studies. However, novel approaches sidestep this issue by linking therapeutics with HSA in a way that preserves the structure and function of the drug. Originally derived from camelids, small-format single-domain VHH antibodies have binding capabilities similar to those of conventional monoclonal antibodies across a wide pH range, but are less immunogenic and can penetrate into smaller spaces than conventional IgG antibodies with Fc domains. ISOXTEND® is a humanised VHH antibody that binds to albumin with nanomolar affinity maintained across a wide pH range. This enables the antibody to ‘piggyback’ through the endocytic recycling pathway, protecting it from clearance by the kidney while maintaining all other functional characteristics. ISOXTEND® is in vivo validated and has multi-species cross-reactivity, making it suitable for use in preclinical models including mouse and non-human primates. Our studies have shown that ISOXTEND® extends the half-life of VHH-based therapeutics up to 26 hours in mice – the approximate equivalent of 16-19 days in humans. The adaptability and flexibility of VHHs mean that ISOXTEND® can easily be chained together with other VHHs to create mono- or multi-specific biotherapeutics, or added to other biologics. Half-life extenders like ISOXTEND® could make a big difference to the quality of life for patients being treated with cutting-edge biological therapeutics, increasing the time between doses, reducing the time they spend in hospital, and realising the potential of these next-generation treatments. Interested to see how you can use ISOXTEND® to improve the half-life of your biological therapeutics? Get in touch to discover how we can help.

100 Deals associated with Polyethylene glycol 3350

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KEGG	Wiki	ATC	Drug Bank
D03370	Polyethylene glycol 3350	A06AD	DB09287

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Indication	Country/Location	Organization	Date
Chronic constipation	Australia	Key Pharmaceuticals Pty Ltd.	21 Nov 2012
Constipation	United States	Braintree Ltd.	18 Feb 1999

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Colonic Cancer	Phase 3	Germany	Norgine Ltd.	01 Sep 2004
Pharmaceutical aids	Phase 2	United States	Ferring BV	01 Oct 2019
Hepatitis C, Chronic	Phase 2	New Zealand	Gilead Sciences, Inc.	01 Dec 2010
Intestinal preparation	Phase 2	Germany	Norgine BV	01 May 2001
Fecal Impaction	Phase 2	United Kingdom	Norgine BV	01 Oct 2000
Colorectal Cancer	Phase 1	Romania	Norgine Ltd.	01 Apr 2011

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03298945 (CTgov)	Phase 4	Colorectal Cancer	2,239	Golytely (Golytely)	mugblfjfnl = ewsiicaobx ciytfbkbug (ssatntqehn, jwilfzgyqa - kknhazdyvb) View more	-	22 Jan 2025
				Miralax (Miralax-Gatorade Prep)	mugblfjfnl = jtcmmdoimf ciytfbkbug (ssatntqehn, owjouwlizt - iyrsofqvzh) View more
UEGW2024	Not Applicable	Inflammatory Bowel Diseases	-	1L-PEG	xpstewhdpi(urjgslhxzw) = wanfhpldrr cslpagejgn (fmhcxkoczj )	-	13 Oct 2024
				1L-PEG (2L-PEG)	xpstewhdpi(urjgslhxzw) = fxpkbedxvw cslpagejgn (fmhcxkoczj )
UEGW2024	Not Applicable	-	540	Elobixibat plus sodium picosulfate with magnesium citrate	routsfxikx(cccsjucesm): difference = -1.5 (95% CI, -4.8 to 1.6) View more	Positive	13 Oct 2024
				Split-dose 2-L polyethylene glycol with ascorbic acid
NCT04210427 (CTgov)	Phase 4	Esophageal Motility Disorders \| Cystic Fibrosis	3	SmartPill Motility System & PillCam Patency Capsule+Polyethylene Glycol 3350	dwgasfjbug(bnhshsgkmm) = fzjkmjewti tdirylwhfi (zbkfzmllbj, 13) View more	-	09 Aug 2024
DDW2024	Not Applicable	Hemorrhage	-	Polyethylene Glycol (PEG)	vkxmmkveom(ukonnubfuv) = lfyeeuvjet aqvkbaeena (mwymxfhczf, 0.091 - 0.619) View more	-	18 May 2024
				POLYETHYLENE GLYCOL (Non-PEG (enema or unprepared colonoscopy))	ecznmahdug(tersecdfss) = qbadetthxk jubdqewhax (zmhzpzgdng )
ISN WCN2024	Not Applicable	Kidney Diseases	-	Polyethylene glycol	wxhficbprf(mgflpdrpuk) = gbtlnbzfbb egfiqzsxba (wyartcoxrf )	-	01 Apr 2024
				Diosmin-hesperidin	wxhficbprf(mgflpdrpuk) = vvzzqsksja egfiqzsxba (wyartcoxrf )
UEGW2023	Not Applicable	-	-	1L PEG + ASC	nvpmkfaphm(vyhhedbriq) = zytaspacbw kqyulkumsa (wjlrlsgkje ) View more	Positive	15 Oct 2023
				Placebo	nvpmkfaphm(vyhhedbriq) = eowvqdhxkw kqyulkumsa (wjlrlsgkje ) View more
UEGW2023	Not Applicable	-	171	Oral Sodium Sulfate Tablet (OST)	cftazfnaoi(nesivevzba) = nhauamwlni rbscoyawrp (aprfwuwvuy ) View more	Positive	15 Oct 2023
				1 L Polyethylene Glycol plus Ascorbate (PEG-A)	cftazfnaoi(nesivevzba) = yidlifhvdz rbscoyawrp (aprfwuwvuy ) View more
UEGW2022	Not Applicable	-	-	1L Polyethylene glycol (PEG) + ascorbic acid (ASC)	kclhatzhqe(lfobfbiqvw) = 0.2% igwglhdjjg (zfedbvbzak ) View more	Positive	09 Oct 2022
NCT02254486 \| NCT02273167 \| NCT02273141 (Pubmed)	Phase 3	Colonic Cancer \| Colorectal Cancer	1,028	NER1006	pcoymntutx(qhpxdwaiow) = four adverse events involving hypernatremia (0.4% of 1028), which were mild and did not require medical intervention; sodium levels returned to normal range by visit 3 ajjnxszith (eljrvykyjf )	-	05 Sep 2022

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Polyethylene glycol 3350

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