National Institute for Health and Care Excellence

FSD Pharma Announces Its Australian Entity Receives Approval to Proceed With Phase 1 Clinical Trial of Lucid-201, a Candidate for the Potential Treatment of Major Depressive Disorder

Retrieved on: 
Wednesday, March 22, 2023
Science, Neurology, Biotechnology, Research, Pharmaceutical, Health, Mental Health, Clinical Trials, CSE, Depression, Therapy, FSD, DSM-IV codes, Grammatical mood, Seasonal affective disorder, SAD, Multiple sclerosis, FRA, Sadness, Anhedonia, MDD, Season, Machine learning, Melancholic depression, Algorithm, Psychotic depression, Motivation, Ageing, United, National Institute for Health and Care Excellence, Major depressive disorder, Pharmaceutical industry

Hundreds of millions of people globally need new, safer, accessible and more effective options to redefine the front-line approach by getting to the root of the disorder and how it is currently treated.

Key Points: 
  • Hundreds of millions of people globally need new, safer, accessible and more effective options to redefine the front-line approach by getting to the root of the disorder and how it is currently treated.
  • MDD can be a chronic condition with multiple periods of regression and relapse over a lifetime.
  • Different types of MDD include Seasonal Affective Disorder (SAD), Postpartum depression, psychotic depression, melancholic depression, and catatonic depression.
  • According to Allied Market Research, the global antidepressant drugs market size was valued at $15.65 billion in 2020 and is projected to reach $21.0 billion by 2030.2

argenx Announces UK MHRA Approval of VYVGART for the Treatment of Generalized Myasthenia Gravis

Retrieved on: 
Wednesday, March 15, 2023
Alfa Romeo, SMC, Lancet Neurology, NICE, ADAPT, Healthcare Improvement Scotland, Euronext, Patient, MHRA, National Institute for Health and Care Excellence, Acetylcholine receptor, The Lancet, Health care, GMG, Pharmaceutical industry

“We are pleased to announce this latest regulatory approval of VYVGART, another exciting advancement toward our vision of making our innovation available to as many patients as possible," said Tim Van Hauwermeiren, Chief Executive Officer of argenx.

Key Points: 
  • “We are pleased to announce this latest regulatory approval of VYVGART, another exciting advancement toward our vision of making our innovation available to as many patients as possible," said Tim Van Hauwermeiren, Chief Executive Officer of argenx.
  • Responders were defined as having at least a two-point reduction on the MG-ADL scale sustained for four or more consecutive weeks during the first treatment cycle2.
  • There were also significantly more responders on the Quantitative Myasthenia Gravis (QMG) scale following treatment with efgartigimod compared with placebo (63% vs. 14%; p
  • Responders were defined as having at least a three-point reduction on the QMG scale sustained for four or more consecutive weeks during the first treatment cycle.

Kanabo Group Launches ‘Treat It’ - UK’s First Online Medicinal Cannabis Clinic For Chronic Pain Management

Retrieved on: 
Monday, March 13, 2023
Managed Care, Alternative Medicine, Health, NHS, Care Quality Commission, General Medical Council, Chronic pain, Migraine, Pain management, Multiple sclerosis, National Institute for Health and Care Excellence, Certification, Patient, Pain, Human back, Neck pain, GP, Prescription, Pharmaceutical industry, Nursing, Poultry farming, Dentistry, Cancer, Peripheral neuropathy, Sciatica

Kanabo Group today announced the launch of Treat It the UK’s first online medical cannabis clinic for pain management.

Key Points: 
  • Kanabo Group today announced the launch of Treat It the UK’s first online medical cannabis clinic for pain management.
  • Treat It, powered by the GP Service - a Kanabo Group company, provides secure online access to an experienced doctor, usually within less than 24hrs.
  • Where conventional treatments have not worked, the specialist doctor can prescribe medicinal cannabis, which has been shown to relieve pain for a range of common chronic pain conditions .
  • Treat It aims to address the issue of limited access to pain management treatments for the approximately 8 million chronic pain sufferers in the UK.

DiCello Levitt’s “Fu” Zimmermann Appointed to Lead Litigation Against L’Oréal and Others Over Cancer-Causing Hair Relaxer Products Marketed to Minority Women

Retrieved on: 
Friday, March 3, 2023
Legal, Women, Professional Services, Other Health, Health, Cosmetics, Consumer, Retail, Oncology, Lawyer, Woman, Formaldehyde, Metal, Douglas, National Cancer Institute, Kayla DiCello, Hearing, Risk, Paraben, National Institute for Health and Care Excellence, Douglas v. U.S. District Court ex rel Talk America, MDL, Abrasion, Uterine cancer, District court, Black

DiCello Levitt partner Diandra “Fu” Debrosse Zimmermann today was appointed Plaintiffs’ Co-Lead Counsel in a multidistrict litigation against L’Oréal and other makers of hair relaxer products marketed primarily to Black and Latin women, alleging that such products are directly linked to uterine and ovarian cancer.

Key Points: 
  • DiCello Levitt partner Diandra “Fu” Debrosse Zimmermann today was appointed Plaintiffs’ Co-Lead Counsel in a multidistrict litigation against L’Oréal and other makers of hair relaxer products marketed primarily to Black and Latin women, alleging that such products are directly linked to uterine and ovarian cancer.
  • Similar lawsuits followed before their transfer and centralization into the MDL, In Re: Hair Relaxer Marketing Sales Practices and Products Liability Litigation.
  • That finding was particularly alarming for Black women, who report using hair straightening products more than other populations.
  • Zimmermann and Crump founded the organization, Shades of Mass, in 2022 to combat the lack of diverse attorney leadership in MDLs.

Global SYK Inhibitors Market & Clinical Trials Outlook to 2028: by Company, Country, Indication and Phase - ResearchAndMarkets.com

Retrieved on: 
Monday, February 27, 2023
Pharmaceutical, Health, Clinical Trials, Clinical trial, Immunotherapy, Grifols, SYK, Disorder, CIS, Drug development, National Institute for Health and Care Excellence, Research, United Kingdom, ITP, Investment, Patient, Therapy, Government, Indication, Cancer, NMPA, Prevalence, NICE, Pharmaceutical industry, Fostamatinib

One such novel target that is emerging to have some possible promising potential for drug development in several disorders including cancers is SYK.

Key Points: 
  • One such novel target that is emerging to have some possible promising potential for drug development in several disorders including cancers is SYK.
  • Spleen tyrosine kinase (SYK) is a cytoplasmic non-receptor kinase that is known to have oncogenic properties and has been extensively investigated.
  • Its therapeutic potential has been noticed by pharmaceutical companies and drugs against SYK have started their initial clinical trial phases.
  • This emerging target has resulted in several pharmaceutical industries trying to develop novel therapies and testing them under clinical trials.

AMO Pharma Announces MHRA Confirmation of CDM1-RS as Approvable Primary Outcome Measure in Myotonic Dystrophy

Retrieved on: 
Monday, February 27, 2023
Medicine, Innovation, Therapy, University, Choking, Wales, Myotonic dystrophy, National Institute for Health and Care Excellence, Phenotype, DM, SMC, FDA, NHS, Regulation of tobacco by the U.S. Food and Drug Administration, AMO, MHRA, DM1, National Health Service, Birth defect, Muscular dystrophy, Healthcare Improvement Scotland, Professor, Caregiver, Tideglusib, Food, TDP, Health care, NICE, Pharmaceutical industry

LONDON, Feb. 27, 2023 /PRNewswire/ -- AMO Pharma Limited ("AMO Pharma"), a privately held biopharmaceutical company focusing on rare childhood-onset neurogenetic disorders with limited or no treatment options, today announced that the UK Medicines and Healthcare products Regulatory Agency (MHRA) has confirmed that the Congenital DM1 Rating Scale (CDM1-RS) can be considered an approvable primary outcome measure in clinical trials to develop a treatment for congenital myotonic dystrophy type 1 (CDM1). 

Key Points: 
  • Following advice from the U.S. Food and Drug Administration (FDA), the scale was incorporated by AMO Pharma into the REACH-CDM pivotal study in CDM1.
  • The MHRA reviewed data from AMO Pharma on how the scale was developed using information from natural history studies, consultation with therapeutic area experts and feedback from patient advocates.
  • The MHRA concluded the measure could be considered an approvable primary outcome measure in the event of a positive result in the REACH-CDM study of AMO-02 in CDM1.
  • In December 2022 AMO Pharma announced completion of patient enrollment in the company's REACH-CDM study of the investigational therapy AMO-02 (tideglusib) for the treatment of congenital myotonic dystrophy.

AMO Pharma Announces MHRA Confirmation of CDM1-RS as Approvable Primary Outcome Measure in Myotonic Dystrophy

Retrieved on: 
Monday, February 27, 2023
Medicine, Innovation, Therapy, University, Choking, Wales, Myotonic dystrophy, National Institute for Health and Care Excellence, Phenotype, DM, SMC, FDA, NHS, Regulation of tobacco by the U.S. Food and Drug Administration, AMO, MHRA, DM1, National Health Service, Birth defect, Muscular dystrophy, Healthcare Improvement Scotland, Professor, Caregiver, Tideglusib, Food, TDP, Health care, NICE, Pharmaceutical industry

LONDON, Feb. 27, 2023 /PRNewswire/ -- AMO Pharma Limited ("AMO Pharma"), a privately held biopharmaceutical company focusing on rare childhood-onset neurogenetic disorders with limited or no treatment options, today announced that the UK Medicines and Healthcare products Regulatory Agency (MHRA) has confirmed that the Congenital DM1 Rating Scale (CDM1-RS) can be considered an approvable primary outcome measure in clinical trials to develop a treatment for congenital myotonic dystrophy type 1 (CDM1). 

Key Points: 
  • Following advice from the U.S. Food and Drug Administration (FDA), the scale was incorporated by AMO Pharma into the REACH-CDM pivotal study in CDM1.
  • The MHRA reviewed data from AMO Pharma on how the scale was developed using information from natural history studies, consultation with therapeutic area experts and feedback from patient advocates.
  • The MHRA concluded the measure could be considered an approvable primary outcome measure in the event of a positive result in the REACH-CDM study of AMO-02 in CDM1.
  • In December 2022 AMO Pharma announced completion of patient enrollment in the company's REACH-CDM study of the investigational therapy AMO-02 (tideglusib) for the treatment of congenital myotonic dystrophy.

SPORTGAIT'S BKG (trademarked) PATENTED GAIT TECHNOLOGY PREDICTIVE CAPABILITIES VETTED AND PUBLISHED

Retrieved on: 
Thursday, February 23, 2023
Newton, Parkinson's disease, Stroke, MD, BKG, Athlete, Health status of Asian Americans, Disease, Biomarker, Research, Algorithm, Journal, Patient, EKG, National Institute for Health and Care Excellence, Concussion, BESS, Gait, Parent, Medical device

The study found that SportGait's BKG gait method and algorithms are superior in accuracy and usability for measuring and managing concussion outcomes.

Key Points: 
  • The study found that SportGait's BKG gait method and algorithms are superior in accuracy and usability for measuring and managing concussion outcomes.
  • The BKG can be used as a biomarker of disease because each condition has a characteristic biokinetic signature," said Dr. Mark Williams, MD and BKG Innovator.
  • "Physical, and in this case gait, biomarkers are becoming a critical component for healthcare," commented SportGait President and CEO Chris Newton.
  • The research article was published in the Journal of Concussion in February 2023, and appears in Volume 7: 1-11.

Worldwide SYK Inhibitors Industry to 2028: Dosage, Patent, Price & Sales Insights on Fostamatinib

Retrieved on: 
Friday, February 24, 2023
Clinical trial, Immunotherapy, Grifols, SYK, Disorder, CIS, Drug development, National Institute for Health and Care Excellence, Research, United Kingdom, ITP, Investment, Patient, Therapy, Government, Indication, Cancer, NMPA, Prevalence, NICE, Pharmaceutical industry, Fostamatinib

This report contains a thorough analysis of the recent trend and shifts towards SYK inhibitors and provides detailed information about the possible opportunities that have opened up since the introduction of SYK inhibitors in the market.

Key Points: 
  • This report contains a thorough analysis of the recent trend and shifts towards SYK inhibitors and provides detailed information about the possible opportunities that have opened up since the introduction of SYK inhibitors in the market.
  • One such novel target that is emerging to have some possible promising potential for drug development in several disorders including cancers is SYK.
  • Spleen tyrosine kinase (SYK) is a cytoplasmic non-receptor kinase that is known to have oncogenic properties and has been extensively investigated.
  • Its therapeutic potential has been noticed by pharmaceutical companies and drugs against SYK have started their initial clinical trial phases.

Areteia Therapeutics Granted ILAP Designation from UK MHRA for Oral Dexpramipexole for Eosinophilic Asthma

Retrieved on: 
Thursday, February 23, 2023
Biotechnology, Pharmaceutical, Health, Innovation, Therapy, National Institute for Health and Care Excellence, SMC, NHS, Patient, MHRA, National Health Service, Healthcare Improvement Scotland, Health care, NICE, Pharmaceutical industry

Areteia Therapeutics today announced that the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has granted an Innovation Passport under the Innovative Licensing and Access Pathway (ILAP) to dexpramipexole, an eosinophil lowering small molecule, that has recently entered Phase III clinical development.

Key Points: 
  • Areteia Therapeutics today announced that the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has granted an Innovation Passport under the Innovative Licensing and Access Pathway (ILAP) to dexpramipexole, an eosinophil lowering small molecule, that has recently entered Phase III clinical development.
  • The Innovation Passport is the first step in the ILAP process, triggering the MHRA and its partner agencies, including the National Institute for Health and Care Excellence (NICE), the Scottish Medicines Consortium (SMC) and National Health Service (NHS) England, to chart a roadmap for regulatory and development milestones with the goal of early patient access in the U.K.
    “It is great to see that in granting an Innovation Passport, the MHRA is as excited as we are about the potential for dexpramipexole,” said Jorge Bartolome, Chief Executive Officer of Areteia Therapeutics.
  • He added, “If approved, dexpramipexole would represent the first oral drug for eosinophilic asthma patients, offering an alternative to injectable biologics.”