Lupus

Provention Bio Resubmitting Biologics License Application for Delay of Clinical Type 1 Diabetes in At-Risk Individuals Following Type B Meeting with the FDA

Retrieved on: 
Thursday, January 27, 2022 - 9:05pm

In preliminary meeting comments,the FDA noted that the data package presented does not adequately support PK comparability because predicted primary PK parameters are indicative of a lower exposure.

Key Points: 
  • In preliminary meeting comments,the FDA noted that the data package presented does not adequately support PK comparability because predicted primary PK parameters are indicative of a lower exposure.
  • The Company believes it will be in a position to resubmit the BLA in the first quarter.
  • We look forward to re-submitting the BLA as soon as possible and facilitating the FDA's review and decision-making.
  • As with any pharmaceutical under development, there are significant risks in the development, regulatory approval and commercialization of new products.

Systemic Lupus Erythematosus (SLE)Market Spotlight Report 2021: 10-Year Disease Prevalence Forecast, Clinical Trials, Regulatory Events, Licensing and Acquisitions, and Drug-specific Revenue Forecasts - ResearchAndMarkets.com

Retrieved on: 
Thursday, January 27, 2022 - 6:24pm

This Market Spotlight report covers the Systemic Lupus Erythematosus (SLE) market, comprising key marketed and pipeline drugs, recent events and analyst opinion, clinical trials, upcoming and regulatory events, probability of success, epidemiology information, and licensing and acquisition deals, as well as presenting drug-specific revenue forecasts.

Key Points: 
  • This Market Spotlight report covers the Systemic Lupus Erythematosus (SLE) market, comprising key marketed and pipeline drugs, recent events and analyst opinion, clinical trials, upcoming and regulatory events, probability of success, epidemiology information, and licensing and acquisition deals, as well as presenting drug-specific revenue forecasts.
  • The approved drugs in the systemic lupus erythematosus (SLE) space target B-cell activating factor, glucocorticoid receptor, corticotropin releasing factor, and corticotropin releasing hormone.
  • The majority of industry-sponsored drugs in active clinical development for SLE are in Phase II, with only one drug in the NDA/BLA phase.
  • GlaxoSmithKline leads industry sponsors with the highest overall number of clinical trials for SLE, followed by AstraZeneca.

ChromaDex Announces Results of New Pilot Clinical Trial Showing Anti-Inflammatory Effects of Nicotinamide Riboside (NR) Supplementation

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Tuesday, January 25, 2022 - 11:32am

ChromaDex Corp. (NASDAQ:CDXC) today announced results of the 18th clinical trial on its flagship Niagen (patented nicotinamide riboside, or NR) ingredient with promising, peer-reviewed findings reported in the Journal of Clinical Investigation .

Key Points: 
  • ChromaDex Corp. (NASDAQ:CDXC) today announced results of the 18th clinical trial on its flagship Niagen (patented nicotinamide riboside, or NR) ingredient with promising, peer-reviewed findings reported in the Journal of Clinical Investigation .
  • The study was conducted as part of the ChromaDex External Research Program (CERP) and adds to a growing body of clinical evidence supporting the potential anti-inflammatory effects of NR supplementation.
  • The ChromaDex team, which includes world-renowned scientists, is pioneering research on nicotinamide adenine dinucleotide (NAD+), levels of which decline with age.
  • ChromaDex is the innovator behind NAD+ precursor nicotinamide riboside (NR), commercialized as the flagship ingredient Niagen.

Predicting Long COVID at Initial Point of COVID-19 Diagnosis: Institute for Systems Biology-Led Study Finds Several Warning Factors

Retrieved on: 
Tuesday, January 25, 2022 - 3:21pm

Key Points: 
  • View the full release here: https://www.businesswire.com/news/home/20220124005790/en/
    Now, researchers have identified several factors that can be measured at the initial point of COVID-19 diagnosis that anticipate if a patient is likely to develop long COVID.
  • Additionally, researchers found that mild cases of COVID-19, not just severe cases, are associated with long COVID.
  • Certain findings such as the low cortisol state in patients with long COVID have potential to translate rapidly to the clinic.
  • A key finding from the study deals with viral load, which can be measured near diagnosis to predict long COVID symptoms.

CareMetx and United Rheumatology Partner to Better Support Patients Who Suffer From Numerous Chronic Inflammatory Diseases

Retrieved on: 
Monday, January 24, 2022 - 5:44pm

Through this partnership, CareMetx will activate their intelligent prescription management solutions for both pharmacy and medical benefit products within United Rheumatologys network of Providers.

Key Points: 
  • Through this partnership, CareMetx will activate their intelligent prescription management solutions for both pharmacy and medical benefit products within United Rheumatologys network of Providers.
  • In addition to increased care awareness among rheumatology patients, the solution will help more effectively communicate with rheumatology patients who may need ongoing support services.
  • United Rheumatology is the preeminent rheumatology care management organization, empowering rheumatologists nationwide to advance the standard of care while leading in the development of value-based precision medicine.
  • Through this exciting partnership with United Rheumatology, CareMetx is able to improve patient access to life-changing therapies, says Brock Rush, SVP & GM of CareMetx.

Lupus Foundation of America Launches Online Self-Management Program, SELF, to Support People Living with Lupus

Retrieved on: 
Tuesday, January 18, 2022 - 3:00pm

"We're thrilled to provide people living with lupus with a convenient and personalized self-management program that allows them to be their best self," said Stevan W. Gibson, president and CEO, Lupus Foundation of America.

Key Points: 
  • "We're thrilled to provide people living with lupus with a convenient and personalized self-management program that allows them to be their best self," said Stevan W. Gibson, president and CEO, Lupus Foundation of America.
  • "In developing SELF, careful consideration and evaluation went into creating helpful tools, information, advice and support around four pillars of lupus management.
  • SELF is truly a one-stop resource for lupus self-management, and I encourage other people with lupus to take advantage of this helpful program."
  • The Lupus Foundation of America is the national force devoted to solving the mystery of lupus , one of the world's cruelest, most unpredictable and devastating diseases, while giving caring support to those who suffer from its brutal impact.

U.S. FDA Approves New MENTOR® MemoryGel BOOST™ Breast Implant

Retrieved on: 
Thursday, January 13, 2022 - 1:00pm

"The MemoryGel BOOST Breast Implant is truly a unique innovation that satisfies an unmet need and expands the MemoryGel product line."

Key Points: 
  • "The MemoryGel BOOST Breast Implant is truly a unique innovation that satisfies an unmet need and expands the MemoryGel product line."
  • This press release contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995 regarding MENTOR MemoryGel BOOST Breast Implant.
  • The MENTORCollection of Breast Implants are indicated for breast augmentation - in women who are at least 22 years old for MENTOR MemoryGel Breast Implants or MENTOR MemoryShape Breast Implants, and at least 18 years old for MENTOR Saline Breast Implants, and breast reconstruction.
  • For MemoryShape Implants: Patient Educational Brochure Breast Augmentation with MENTOR MemoryShape Breast Implants and Quick Facts about Breast Augmentation & Reconstruction with MENTOR MemoryShape Breast Implants.

BenevolentAI announces 3-year collaboration expansion with AstraZeneca focused on systemic lupus erythematosus and heart failure

Retrieved on: 
Thursday, January 13, 2022 - 9:16am

The expansion builds on the collaboration initiated in 2019 and adds systemic lupus erythematosus (SLE) and heart failure (HF) to ongoing work to identify multiple novel targets in chronic kidney disease (CKD) and idiopathic pulmonary fibrosis (IPF).

Key Points: 
  • The expansion builds on the collaboration initiated in 2019 and adds systemic lupus erythematosus (SLE) and heart failure (HF) to ongoing work to identify multiple novel targets in chronic kidney disease (CKD) and idiopathic pulmonary fibrosis (IPF).
  • The collaboration has already achieved two major milestones, with the first novel targets added to AstraZeneca's portfolio for both CKD and IPF.
  • Anne Phelan, Chief Science Officer at BenevolentAI, commented, "Our collaboration with AstraZeneca represents the future of drug discovery.
  • Mene Pangalos, Executive Vice President, BioPharmaceuticals R&D, AstraZeneca, commented, "Systemic lupus erythematosus and heart failure are debilitating diseases with high unmet patient needs.

BenevolentAI announces 3-year collaboration expansion with AstraZeneca focused on systemic lupus erythematosus and heart failure

Retrieved on: 
Thursday, January 13, 2022 - 9:17am

LONDON, Jan. 13, 2022 /PRNewswire/ -- BenevolentAI, a leading clinical-stage AI drug discovery company, has expanded its AI-driven drug discovery collaboration with AstraZeneca, doubling the number of disease areas being explored through the partnership. The three-year expansion includes an upfront payment, research funding, development milestone payments and tiered royalties on future revenues.

Key Points: 
  • The expansion builds on the collaboration initiated in 2019 and adds systemic lupus erythematosus (SLE) and heart failure (HF) to ongoing work to identify multiple novel targets in chronic kidney disease (CKD) and idiopathic pulmonary fibrosis (IPF).
  • The collaboration has already achieved two major milestones, with the first novel targets added to AstraZeneca's portfolio for both CKD and IPF.
  • Anne Phelan, Chief Science Officer at BenevolentAI, commented, "Our collaboration with AstraZeneca represents the future of drug discovery.
  • Mene Pangalos, Executive Vice President, BioPharmaceuticals R&D, AstraZeneca, commented, "Systemic lupus erythematosus and heart failure are debilitating diseases with high unmet patient needs.

Hemogenyx Pharmaceuticals and Selexis SA Will Advance Hemogenyx’s Acute Myeloid Leukemia (AML) CDX Bispecific Antibody to Human Trials

Retrieved on: 
Wednesday, January 12, 2022 - 12:00pm

Key Points: 
  • View the full release here: https://www.businesswire.com/news/home/20220112005112/en/
    The CDX bispecific is made using the Hemogenyxs proprietary humanised monoclonal antibody against a target on the surface of AML cells.
  • CDX was co-developed by Hemogenyx Pharmaceuticals and Eli Lilly and Company (Lilly).
  • Mr. Dirk Lange, CEO of Selexis, added, Theres an urgent need for effective treatments for AML, and we at Selexis are pleased to apply our technologies to help Hemogenyx advance the CDX bispecific antibody to the clinic.
  • Our global partners are utilizing Selexis technologies to advance more than 146 drug candidates in preclinical and clinical development and the manufacture of eight commercial products.