Digestive diseases

Evoke Pharma and EVERSANA Announce Support of The International Foundation for Gastrointestinal Disorders’ (IFFGD) August Gastroparesis Awareness Month

Retrieved on: 
Monday, August 2, 2021

Alongside IFFGD, Evoke and EVERSANA aim to increase community awareness about gastroparesis during this month-long campaign.

Key Points: 
  • Alongside IFFGD, Evoke and EVERSANA aim to increase community awareness about gastroparesis during this month-long campaign.
  • Employees from Evoke and EVERSANA are also encouraged to show their support throughout the walk.
  • Gastroparesis Awareness month is an essential time to emphasize the need for community education and involvement around gastroparesis.
  • Follow Evoke Pharma on Facebook: https://www.facebook.com/Evoke-Pharma-Inc-131313647029724
    Follow Evoke Pharma on LinkedIn: https://www.linkedin.com/company/evoke-pharma/
    EVERSANA is the leading provider of global services to the life sciences industry.

Gastroparesis Awareness Month: Putting the Patient First

Retrieved on: 
Thursday, July 1, 2021

Gastroparesis Awareness Month, established by IFFGD in 2016, takes place every year during the month of August, and IFFGD utilizes its platform to support the gastroparesis community by raising awareness to promote education and encourage research.

Key Points: 
  • Gastroparesis Awareness Month, established by IFFGD in 2016, takes place every year during the month of August, and IFFGD utilizes its platform to support the gastroparesis community by raising awareness to promote education and encourage research.
  • For three decades, IFFGD has been a leader in the fight for research to improve diagnostic and treatment options for GI disorders like gastroparesis.
  • This August, IFFGD will raise awareness to humanize this commonly misunderstood and often misdiagnosed condition by highlighting patient stories throughout the month.
  • #ThisIsGP the theme for Gastroparesis Awareness Month 2021, provides an opportunity for patients living with gastroparesis to share their stories and experiences with others worldwide.

Sense Relief Receives Grant From UCSF-Stanford Pediatric Device Consortium for Further Development and Study of the Treatment for Pregnancy Related Nausea and Vomiting

Retrieved on: 
Monday, June 28, 2021

SAN FRANCISCO, June 28, 2021 /PRNewswire/ --Sense Relief, Inc. received an innovation grant from the UCSF-Stanford Pediatric Device Consortium for the continued technical development and further clinical study of Sense Relief, an antiemetic digital therapeutic.

Key Points: 
  • SAN FRANCISCO, June 28, 2021 /PRNewswire/ --Sense Relief, Inc. received an innovation grant from the UCSF-Stanford Pediatric Device Consortium for the continued technical development and further clinical study of Sense Relief, an antiemetic digital therapeutic.
  • The study will help determine the efficacy of this novel health wearable treatment method, understand usage patterns, and classify the causes of nausea, such as medication-induced nausea, stress-related nausea, and vestibularneuritis.
  • The technical development of Sense Relief will integrate CardinalKit to support an ongoing consumer study of thousands of Sense Relief users.
  • The Sense Relief app is available for download to the Apple Watch to help ease symptoms of nausea.

Mirum Pharmaceuticals Showcases Maralixibat Transplant-Free Survival Data for Progressive Familial Intrahepatic Cholestasis and Long-Term Safety Analyses for Alagille Syndrome during WCPGHAN Annual Meeting

Retrieved on: 
Thursday, June 3, 2021

Mirum Pharmaceuticals, Inc. (Nasdaq: MIRM) presented analyses from its clinical studies evaluating maralixibat in patients with Alagille syndrome (ALGS) and progressive familial intrahepatic cholestasis type 2 (PFIC2), two rare liver diseases affecting children.

Key Points: 
  • Mirum Pharmaceuticals, Inc. (Nasdaq: MIRM) presented analyses from its clinical studies evaluating maralixibat in patients with Alagille syndrome (ALGS) and progressive familial intrahepatic cholestasis type 2 (PFIC2), two rare liver diseases affecting children.
  • These data demonstrated that patients with long-term maralixibat treatment who achieved serum bile acid (sBA) response had five-year transplant-free survival.
  • Mirums lead product candidate, maralixibat, is an investigational oral drug in development for Alagille syndrome (ALGS), progressive familial intrahepatic cholestasis (PFIC), and biliary atresia.
  • More than 1,600 individuals have received maralixibat, including more than 120 children who have received maralixibat as an investigational treatment for Alagille syndrome (ALGS) and progressive familial intrahepatic cholestasis (PFIC).

Evoke Pharma Announces Issuance of a New U.S. Patent Covering Methods of Use for Gimoti®

Retrieved on: 
Wednesday, June 2, 2021

Gimoti is Evokes nasal spray product for the relief of symptoms in acute and recurrent diabetic gastroparesis.

Key Points: 
  • Gimoti is Evokes nasal spray product for the relief of symptoms in acute and recurrent diabetic gastroparesis.
  • The U.S. Food and Drug Administration (FDA) approved the New Drug Application for Gimoti in June 2020.
  • We are pleased to announce the issuance of this new U.S. patent which further validates that Gimoti is innovative and novel.
  • The issuance of this patent strengthens the intellectual property protection for Gimoti and supports our commercial efforts to make Gimoti the treatment of choice in the gastroparesis market.

Mirum Pharmaceuticals to Present Maralixibat Data and Host Symposium at the 6th World Congress of Pediatric Gastroenterology, Hepatology and Nutrition (WCPGHAN) Annual Meeting 2021

Retrieved on: 
Wednesday, May 26, 2021

This abstract has been nominated for the prestigious Annual Alex Mowat Prize for best oral presentation in hepatology.

Key Points: 
  • This abstract has been nominated for the prestigious Annual Alex Mowat Prize for best oral presentation in hepatology.
  • Results to be announced during the congress closing ceremony on June 5, 2021 at 1:30 p.m. CEST.
  • Abstract number: H-ePwP-030: Gastrointestinal tolerability of maralixibat in patients with Alagille syndrome: An integrated analysis of short- and long-term treatment.
  • Maralixibat is a novel, minimally absorbed, orally administered investigational drug being evaluated in several rare cholestatic liver diseases.

Global Gastro-Esophageal Reflux Disease Markets, Epidemiology and Patient Flow Analysis Report 2020-2035 - ResearchAndMarkets.com

Retrieved on: 
Tuesday, May 25, 2021

The "Global Gastro-Esophageal Reflux Disease Epidemiology and Patient Flow - 2021" report has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • The "Global Gastro-Esophageal Reflux Disease Epidemiology and Patient Flow - 2021" report has been added to ResearchAndMarkets.com's offering.
  • Global Gastro-Esophageal Reflux Disease Epidemiology and Patient Flow Analysis - 2021, provides Gastro-Esophageal Reflux Disease epidemiology, demographics, and patient flow.
  • The research provides population data to characterize Gastro-Esophageal Reflux Disease patients, history of the disease at the population level (Gastro-Esophageal Reflux Disease prevalence, Gastro-Esophageal Reflux Disease incidence) and at the clinical level (from diagnosis to treated patients).
  • Gastro-Esophageal Reflux Disease patient flow: Gastro-Esophageal Reflux Disease prevalence, diagnosed, and drug-treated patients
    Demographics: Gastro-Esophageal Reflux Disease patients by age group, gender
    The data from this research will help executives:
    Establish basis for Gastro-Esophageal Reflux Disease market sizing, assessing market potential, and developing drug forecast models
    Identify Gastro-Esophageal Reflux Disease patients segments through age groups, gender, and disease sub-types
    Evaluate Gastro-Esophageal Reflux Disease market opportunities, identify target patient population
    View source version on businesswire.com: https://www.businesswire.com/news/home/20210525005752/en/

Albireo Receives Positive CHMP Opinion for Bylvay™ (odevixibat) for Treatment of Progressive Familial Intrahepatic Cholestasis (PFIC)

Retrieved on: 
Friday, May 21, 2021

b'Progressive familial intrahepatic cholestasis (PFIC) is a rare disorder that causes progressive, life-threatening liver disease.

Key Points: 
  • b'Progressive familial intrahepatic cholestasis (PFIC) is a rare disorder that causes progressive, life-threatening liver disease.
  • There are no drugs currently approved for PFIC, only surgical options that include partial external biliary diversion (PEBD) and liver transplantation.
  • Bylvay has also been granted Orphan Designation, as well as access to the PRIority MEdicines (PRIME) scheme for the treatment of PFIC.
  • In addition to PFIC, Bylvay has Orphan Drug Designations for the treatment of Alagille syndrome, biliary atresia and primary biliary cholangitis.

Processa Pharmaceuticals Announces First Patient Dosed in its Randomized Double-Blind, Placebo-Controlled Clinical Trial to Evaluate PCS499 in Treating Ulcerations in Patients Who Have Necrobiosis Lipoidica

Retrieved on: 
Thursday, May 20, 2021

NL is a rare, chronic, idiopathic, granulomatous disease of collagen degeneration caused by a number of very diverse pathophysiological changes in a patient.

Key Points: 
  • NL is a rare, chronic, idiopathic, granulomatous disease of collagen degeneration caused by a number of very diverse pathophysiological changes in a patient.
  • We are excited to have randomized the first patient in this Phase 2B trial.\xe2\x80\x9d\nThe Principal Investigator for the trial is Dr. Misha Rosenbach.
  • The Company uses these criteria for selection to further develop its pipeline programs to achieve high-value milestones effectively and efficiently.
  • Active clinical pipeline programs include: PCS6422 (metastatic colorectal cancer and breast cancer), PCS499 (ulcerative necrobiosis lipoidica) and PCS12852 (GI motility/gastroparesis).

Albireo to Showcase New Data at 6th World Congress of Pediatric Gastroenterology, Hepatology and Nutrition

Retrieved on: 
Wednesday, May 19, 2021

The FDA has granted Priority Review and set a PDUFA goal date of July 20, 2021.

Key Points: 
  • The FDA has granted Priority Review and set a PDUFA goal date of July 20, 2021.
  • The EMA\xe2\x80\x99s Pediatric Committee has agreed to Albireo\xe2\x80\x99s Bylvay Pediatric Investigation Plans for PFIC and biliary atresia.
  • In addition to PFIC, Bylvay has Orphan Drug Designations for the treatment of Alagille syndrome, biliary atresia and primary biliary cholangitis.
  • Albireo disclaims any obligation to update any forward-looking statement except as required by applicable law.\n'