FRCPC

Agios Presents Positive Results from Phase 3 ENERGIZE Study of Mitapivat in Non-Transfusion-Dependent Thalassemia in Plenary Session at the European Hematology Association 2024 Hybrid Congress

Retrieved on: 
Sabato, Giugno 15, 2024
Head, American University, Iron overload, Patient, Fatigue, Agios Pharmaceuticals, Thalassemia, NTD, Disease, University of Toronto, AGIO, Congress, Hemolysis, University, Master of Science, S104, Pyruvate kinase, Central European, Anemia, American University of Beirut, Arm, Quality of life, BID, FRCPC, Medical device

CAMBRIDGE, Mass., June 15, 2024 (GLOBE NEWSWIRE) -- Agios Pharmaceuticals, Inc. (Nasdaq: AGIO), a leader in cellular metabolism and pyruvate kinase (PK) activation pioneering therapies for rare diseases, today presented detailed results from the global Phase 3 ENERGIZE study of mitapivat in adults with non-transfusion-dependent (NTD) alpha- or beta-thalassemia in a plenary session (abstract #S104) at the European Hematology Association 2024 (EHA2024) Hybrid Congress, which is being held June 13-16, 2024, in Madrid, Spain. In a related poster presentation (abstract #P1529), the company presented additional data from the ENERGIZE study highlighting clinically meaningful improvements in health-related quality of life measures and patient-reported outcomes among patients in the mitapivat arm compared to those in the placebo arm.

Key Points: 
  • The ENERGIZE study achieved its primary endpoint, with mitapivat demonstrating a statistically significant increase in hemoglobin response rate compared to placebo.
  • 122 (93.8%) in the mitapivat arm and 62 (96.9%) in the placebo arm completed the 24-week double-blind period of the study.
  • Baseline demographics and characteristics were balanced between mitapivat and placebo arms, and representative of a population of non-transfusion dependent thalassemia patients.
  • Agios will host a virtual investor breakout session tomorrow, June 16, 2024, at 10:00 a.m.

Dianthus Therapeutics Announces FDA Clearance to Initiate Phase 2 Trial of DNTH103 in Multifocal Motor Neuropathy (MMN)

Retrieved on: 
Mercoledì, Giugno 12, 2024
PD, Patient, Dianthus, MMN, IND, Complement component 1s, Therapy, Safety, University of Toronto, University, Master of Science, Associate, Pathology, Infection, Neuromuscular disease, Momentum, Immunoglobulin therapy, FDA, Food, Food and Drug Administration, Multifocal motor neuropathy, FRCPC, Pharmaceutical industry

NEW YORK and WALTHAM, Mass., June 12, 2024 (GLOBE NEWSWIRE) -- Dianthus Therapeutics, Inc. (Nasdaq: DNTH), a clinical-stage biotechnology company dedicated to advancing the next generation of antibody complement therapeutics to treat severe autoimmune diseases, today announced U.S. Food and Drug Administration (FDA) clearance of its Phase 2 Investigational New Drug (IND) application for the MoMeNtum trial of DNTH103 in patients with Multifocal Motor Neuropathy (MMN).

Key Points: 
  • “Pre-clinical and clinical evidence support the classical pathway’s role in the pathology seen in MMN,” said Simrat Randhawa, MD, Chief Medical Officer of Dianthus Therapeutics.
  • Following determination of Ig dependency and responsiveness, patients will be randomized to receive placebo or DNTH103 administered subcutaneously (S.C.) every two weeks (Q2W).
  • Initial top-line results from this trial are anticipated to be available in the second half of 2026.
  • Treating MMN with an active C1s inhibitor, like DNTH103, has the potential to transform the lives of these patients.”

Arcutis Announces New Long-Term Data of Roflumilast Cream 0.15% for the Treatment of Mild to Moderate Atopic Dermatitis (AD) in Adults and Children Down to Age Six Presented at Revolutionizing Alopecia Areata, Vitiligo, and Eczema Conference

Retrieved on: 
Lunedì, Giugno 10, 2024
Irritant, Mount Sinai Health System, Flare, Incidence, Patient, Child, Dermatitis, Doctor of Philosophy, Propylene glycol, Skin condition, Laboratory, Week, Immunology, Headache, FAAD, Safety, Allergen, Skin, Common, Alopecia areata, COVID-19, Master of Science, Ethanol, Itch, MD, Mount, Conference, Ageing, FRCPC

In the study, roflumilast cream was well-tolerated, with no new safety signals observed over 56 weeks of treatment.

Key Points: 
  • In the study, roflumilast cream was well-tolerated, with no new safety signals observed over 56 weeks of treatment.
  • In addition, 57.7% of these participants maintained disease control on the twice weekly schedule through their final study day.
  • “Based on these positive results, individuals can expect long-term efficacy and improvement in the signs and symptoms of AD, including itch, from roflumilast cream.
  • In addition, roflumilast cream does not include sensitizing excipients or irritants, such as propylene glycol, polyethylene glycol, isopropyl alcohol, ethanol, or fragrances.

The American Diabetes Association Kicks Off the 84th Scientific Sessions with Breakthrough Diabetes Research

Retrieved on: 
Giovedì, Giugno 13, 2024
AID, Ageing, Cancer, Food and Drug Administration, FRCPC, Orange County Convention Center, Innovation, Obesity, Sleep apnea, Himawari (satellites), News, Abstract, Health, Weight gain, Doctor of Philosophy, Food, Death, FDA, Symposium, Physician, Research

ORLANDO, Fla., June 13, 2024 /PRNewswire/ -- From June 21–24, the American Diabetes Association® (ADA) will host the 84th Scientific Sessions in Orlando, FL. The ADA's Scientific Sessions is the world's largest diabetes meeting, convening more than 11,000 leading physicians, scientists, researchers and health care professionals from around the globe. The hybrid meeting will feature the latest scientific findings in diabetes, including more than 200 sessions and 2,000 original research presentations at the Orange County Convention Center.

Key Points: 
  • Leading Diabetes Scientific Sessions Meeting Will Present Groundbreaking Data on Key Topics Including: Obesity, Technology, AI Health and the Latest in Diabetes Innovation
    ORLANDO, Fla., June 13, 2024 /PRNewswire/ -- From June 21–24, the American Diabetes Association® (ADA) will host the 84th Scientific Sessions in Orlando, FL.
  • The hybrid meeting will feature the latest scientific findings in diabetes, including more than 200 sessions and 2,000 original research presentations at the Orange County Convention Center.
  • During the annual meeting, the ADA is highlighting the latest cutting-edge advances in diabetes research and care.
  • "This year's Scientific Sessions is set to highlight the latest and greatest advances in diabetes research with an exceptional, data-driven program," said Alice Y.Y.

Electronic Health Records to Electronic Data Capture: Enhancing the Data Journey in Oncology Clinical Trials, Upcoming Webinar Hosted by Xtalks

Retrieved on: 
Mercoledì, Aprile 17, 2024
FRCPC, Clinical research, EHR, Electronic health record, MD, Doctor of Philosophy, Research, EDC, Senior, Health information management, Drug development, Clinical trial, FACP, Medical imaging

TORONTO, April 17, 2024 /PRNewswire-PRWeb/ -- The choices made in clinical trial setup — from patient recruitment strategies to data collection methods — directly impact the success and cost of a trial. Efficiency and data quality are crucial at every point in the drug development process.

Key Points: 
  • In this free webinar, learn what electronic health record (EHR) to electronic data capture (EDC) is and the benefits of EHR to EDC connectivity for both the site and sponsor (time, cost and data quality).
  • TORONTO, April 17, 2024 /PRNewswire-PRWeb/ -- The choices made in clinical trial setup — from patient recruitment strategies to data collection methods — directly impact the success and cost of a trial.
  • The drug development industry has moved from paper-based data collection methods to the use of electronic data capture (EDC) systems over the past two decades.
  • For more information, or to register for this event, visit Electronic Health Records to Electronic Data Capture: Enhancing the Data Journey in Oncology Clinical Trials [Electronic Health Records to Electronic Data Capture: Enhancing the Data Journey in Oncology Clinical Trials __title__ live webinar].

ASDS/A Board of Directors Appoints Tara Azzano as Executive Director

Retrieved on: 
Lunedì, Aprile 8, 2024
Research, Diagnosis, Executive, Patient, Association management, FRCPC, Society, Interim, Meeting, ASDS, Medicine, Management

Schaumburg, IL, April 08, 2024 (GLOBE NEWSWIRE) -- Tara L. Azzano was recently named Executive Director of the American Society for Dermatologic Surgery (ASDS), the largest specialty organization in the U.S. exclusively representing dermatologic surgeons.

Key Points: 
  • Schaumburg, IL, April 08, 2024 (GLOBE NEWSWIRE) -- Tara L. Azzano was recently named Executive Director of the American Society for Dermatologic Surgery (ASDS), the largest specialty organization in the U.S. exclusively representing dermatologic surgeons.
  • She joined the organization in 2002 as the Director of Education, Research and Meetings.
  • Azzano has almost a quarter of a century’s worth of experience with ASDS/A, and her institutional knowledge of our Society is unprecedented.
  • “I am truly thrilled to have been chosen as the next Executive Director and to continue to share my passion for dermatologic surgery.

The START Center for Cancer Research Takes a Major Step Forward in its Mission to Bring the Hope of Cancer Research to Communities Globally

Retrieved on: 
Lunedì, Aprile 8, 2024
Oncology, Health, General Health, Clinical Trials, Research, Science, Pharmaceutical, ChromeOS, FJD, MBE, Growth, Environment, Patient, Pi, Cancer, EMA, MD, FRCPC, START, PDX, Clinical trial, Safety, Multimedia, Principal investigator, FDA, Physician, Pharmaceutical industry

The START Center for Cancer Research, the world's largest global site network of early phase oncology clinical trials, sets its sights on expanding access to breakthrough research to all communities globally.

Key Points: 
  • The START Center for Cancer Research, the world's largest global site network of early phase oncology clinical trials, sets its sights on expanding access to breakthrough research to all communities globally.
  • Slack, a respected leader in the clinical research industry, brings nearly 20 years of experience to grow START's mission of revolutionizing cancer clinical research.
  • With a global network spanning eight locations, including START San Antonio, START Midwest, START Mountain Region, START Madrid (FJD and CIOCC), START Barcelona, START Dublin, and START Lisbon, START is at the forefront of advancing cancer research.
  • Co-founders of The START Center for Cancer Research, Amita Patnaik, MD, FRCPC, and Kyriakos P. Papadopoulos, MD, will continue their pivotal roles as Co-directors of Clinical Research at START San Antonio.

Cara Therapeutics to Host Notalgia Paresthetica (NP) Virtual KOL Event on Wednesday, March 27, 2024

Retrieved on: 
Giovedì, Marzo 7, 2024
EDT, Master of Science, MD, Diabetic neuropathy, Notalgia paresthetica, FRCPC, Therapy, Webcast, Patient, Diagnosis, Itch, Epidemiology, KOL

The event will feature a panel of leaders in the field of neuropathic pruritus who will discuss the epidemiology, diagnosis, treatment landscape, and significant unmet medical need in notalgia paresthetica (NP).

Key Points: 
  • The event will feature a panel of leaders in the field of neuropathic pruritus who will discuss the epidemiology, diagnosis, treatment landscape, and significant unmet medical need in notalgia paresthetica (NP).
  • The live panel discussion will be moderated by Joana Goncalves, MD, Chief Medical Officer of Cara Therapeutics.
  • The event will also highlight oral difelikefalin in NP and its potential in this underserved neuropathy.
  • A live webcast of the event will be accessible under “Events & Presentations” in the Investors section of the Company’s website at www.CaraTherapeutics.com .

Sandoz receives Health Canada approval for Jubbonti®, first and only denosumab biosimilar for treatment of osteoporosis

Retrieved on: 
Martedì, Febbraio 20, 2024
Health Canada, Denosumab, RANK, Biosimilar, Safety, FRCPC, Novartis, Patient, Osteoporosis, Generic drug

Sandoz continues to expand access for patients in Canada, offering denosumab biosimilar to treat osteoporosis and increase bone mass.

Key Points: 
  • Sandoz continues to expand access for patients in Canada, offering denosumab biosimilar to treat osteoporosis and increase bone mass.
  • Health Canada approval based on robust Phase I and Phase III clinical studies.
  • BOUCHERVILLE, Quebec, Feb. 20, 2024 (GLOBE NEWSWIRE) -- Sandoz Canada is pleased to announce that Health Canada has provided authorization to market Jubbonti® (denosumab subcutaneous injection, reference medicine: Prolia*).
  • Jubbonti® is the first and only Health Canada-approved denosumab biosimilar for osteoporosis and increasing bone mass.

AMGEN PRESENTS NEW RESEARCH ON OTEZLA® (APREMILAST) AT AAD 2024

Retrieved on: 
Sabato, Marzo 9, 2024
Pustulosis palmaris et plantaris, Psoriasis, CPU socket, Aes, Headache, Diarrhea, Amgen, Pain, Pediatrics, DLQI, Skin, Nausea, Vomiting, Queen's University, AMGN, AAD, Safety, University, FRCPC, University of Alberta, PASI, Dermatology Life Quality Index, Patient, PST, Scalp, Ageing, Abdominal pain, Poster, American Academy, Pharmaceutical industry

THOUSAND OAKS, Calif., March 9, 2024 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced new, 52-week results from the Phase 3 SPROUT study examining the use of Otezla® (apremilast) in children and adolescents aged 6 to 17 years with moderate to severe plaque psoriasis. These data, along with findings from a Phase 3 late-breaking study on Otezla in palmoplantar pustulosis, will be presented at the 2024 American Academy of Dermatology (AAD) Annual Meeting, March 8-12 in San Diego.                                     

Key Points: 
  • These data, along with findings from a Phase 3 late-breaking study on Otezla in palmoplantar pustulosis, will be presented at the 2024 American Academy of Dermatology (AAD) Annual Meeting, March 8-12 in San Diego.
  • "These data reflect Amgen's commitment to exploring new ways to treat inflammatory skin disease," said Ponda Motsepe-Ditshego, vice president, Global Medical, at Amgen.
  • Continued Otezla use resulted in sustained improvements in psoriasis severity and skin involvement in patients for up to one year.
  • Findings will be presented as a late-breaking oral presentation on Saturday, March 9 at 9:20 a.m. PST.