National Institute for Health and Care Excellence

Verve Therapeutics Announces VERVE-101 Awarded Innovation Passport by the UK MHRA for the Treatment of Heterozygous Familial Hypercholesterolemia

Retrieved on: 
Tuesday, February 14, 2023
National Institute for Health and Care Excellence, Medication, NICE, Blood, United Kingdom, Innovation, SMC, TDP, Medicine, MHRA, Safety, PCSK9, Patient, Wales, Liver, Therapy, Healthcare Improvement Scotland, Health care, Partnership, Injection, Cardiovascular disease, Pharmacokinetics, Pharmaceutical industry, Verve

The ILAP aims to accelerate time to market and facilitate patient access to innovative medicines.

Key Points: 
  • The ILAP aims to accelerate time to market and facilitate patient access to innovative medicines.
  • VERVE-101 is a novel, investigational gene editing medicine designed to be a single-course treatment that permanently turns off the PCSK9 gene in the liver to durably lower disease-driving low-density lipoprotein cholesterol (LDL-C).
  • ILAP was launched by the MHRA in January 2021 with an aim to accelerate the development of and facilitate patient access to medicines.
  • The Innovation Passport is granted by the UK's ILAP Steering Group, which consists of representatives from MHRA, the National Institute for Health and Care Excellence (NICE), the Scottish Medicines Consortium (SMC), and the All Wales Therapeutics and Toxicology Centre (AWTTC).

Gold Rabbit Sports Announces Strategic Partnership With Bio-Tech Start-Up Prothegen To Accelerate The Development Of Revolutionary Concussion Treatment

Retrieved on: 
Wednesday, February 8, 2023
Health, Sports, Neurology, Other Sports, Other Health, General Sports, Biotechnology, MBA, Gold, Injury, Woman, Concussion, National Institute for Health and Care Excellence, Stroke, Brain damage, TBI, Safety, PhD-MBA, Ferroptosis, Research, Cell death, Stanford University, Ottawa University, Sport, Partnership, Trauma, Doctor of Philosophy, Management

“We want to leverage our collective networks to inspire the sports world to think differently about athlete safety,” said André Schunk , Gold Rabbit CEO and founder.

Key Points: 
  • “We want to leverage our collective networks to inspire the sports world to think differently about athlete safety,” said André Schunk , Gold Rabbit CEO and founder.
  • “When a traumatic injury – like a concussion – occurs, a type of cell death called ferroptosis, takes place.
  • Our scientifically proven, peer-reviewed treatment arrests ferroptosis, keeps cells functioning, and significantly diminishes the damage created by the trauma.
  • Essentially, we’ve developed a potentially transformational treatment for concussions, strokes, Parkinson’s, and even Alzheimer’s disease,” said Zanchi.

UK Focused Ultrasound Foundation Announces Launch

Retrieved on: 
Monday, January 30, 2023
Health Technology, Telemedicine, Virtual Medicine, Radiology, Pharmaceutical, Surgery, Oncology, Philanthropy, Medical Devices, Clinical Trials, Foundation, Biotechnology, Science, Other Science, Nursing, Research, Health, Prostate, National Health Service (England), Brain, House, NICE, Attention, Guys, MP, Institute of Cancer Research, Focused Ultrasound Foundation, National Institute for Health and Care Excellence, Myenteric plexus, Patient, Essential tremor, Hospital, Liver, Prostate cancer, Radiation, NHS, Civil service commission, Charity Commission for England and Wales, Pancreas, University of Oxford, HMRC, University, Neoplasm, Pancreatic cancer, Medical imaging

The UK Focused Ultrasound Foundation (UK FUSF), dedicated to advancing the development and adoption of focused ultrasound in the UK, today announced its formal launch.

Key Points: 
  • The UK Focused Ultrasound Foundation (UK FUSF), dedicated to advancing the development and adoption of focused ultrasound in the UK, today announced its formal launch.
  • “Our vision at the Foundation is for focused ultrasound to be used in the UK to improve the lives of millions of people afflicted with a wide variety of serious medical disorders in the shortest time possible,” said Foundation Chairman Philip Keevil.
  • It works closely with, but is independent of, the US-based Focused Ultrasound Foundation, aligning on goals and resources to advance focused ultrasound to treat millions worldwide.
  • UK FUSF is already partnering with the prostate cancer charity Prost8 UK and focused ultrasound device manufacturer Sonablate to increase access of focused ultrasound treatment for patients diagnosed with prostate cancer by co-funding the deployment early this year of a new prostate cancer treatment device at Guys & St Thomas' Hospital in London.

Jazz Pharmaceuticals receives NICE recommendation for the reimbursement of Epidyolex® (cannabidiol) for the treatment of seizures associated with tuberous sclerosis complex in England

Retrieved on: 
Tuesday, January 31, 2023
Newton, Dravet syndrome, Tuberous sclerosis, TSA, Heart, Jazz Pharmaceuticals, EMA, GW, Strategic planning, Medicines and Healthcare products Regulatory Agency, Seizure, NHS, Medicine, Skin, TSC, Epilepsy, Lennox–Gastaut syndrome, Cannabidiol, NICE, Wales, GW Pharmaceuticals, Brain, MHRA, Patient, National Institute for Health and Care Excellence, Ann Mercy Hunt, Clobazam, Healthcare Improvement Scotland, European Medicines Agency, Pharmaceutical industry

TSC can be diagnosed in infancy but many children are not diagnosed until later in childhood when their seizures begin and other symptoms appear.

Key Points: 
  • TSC can be diagnosed in infancy but many children are not diagnosed until later in childhood when their seizures begin and other symptoms appear.
  • [4] It is estimated that between 3,700 and 11,000 people in the UK live with TSC.
  • TSC is a very difficult to manage condition, with common issues including epilepsy in eight out of ten people.
  • Please note that, in relation to this Jazz media announcement, no honorarium was provided to the Tuberous Sclerosis Association.

BRUKINSA® (zanubrutinib) Receives Marketing Authorization for Chronic Lymphocytic Leukemia (CLL) and Marginal Zone Lymphoma (MZL) in Great Britain by MHRA

Retrieved on: 
Thursday, January 19, 2023
Biotechnology, Pharmaceutical, Health, Oncology, National Institute for Health and Care Excellence, MHRA, Union, Lymphatic system, Healthcare Improvement Scotland, BTK, Rituximab, NICE, CLL, SSE, SEQUOIA, Health care, Chronic lymphocytic leukemia, Patient, Physician, Medication, Pharmaceutical industry, BeiGene, Hematology

BeiGene (NASDAQ: BGNE; HKEX: 06160; SSE: 688235), a global biotechnology company, today announced that the Medicines and Healthcare products Regulatory Agency (MHRA) has granted marketing authorizations for BRUKINSA (zanubrutinib) in Great Britain for both the treatment of adult patients with chronic lymphocytic leukemia (CLL) and the treatment of adult patients with marginal zone lymphoma (MZL) who have received at least one prior anti-CD20-based therapy.

Key Points: 
  • BeiGene (NASDAQ: BGNE; HKEX: 06160; SSE: 688235), a global biotechnology company, today announced that the Medicines and Healthcare products Regulatory Agency (MHRA) has granted marketing authorizations for BRUKINSA (zanubrutinib) in Great Britain for both the treatment of adult patients with chronic lymphocytic leukemia (CLL) and the treatment of adult patients with marginal zone lymphoma (MZL) who have received at least one prior anti-CD20-based therapy.
  • “BRUKINSA is a highly selective BTK inhibitor that has demonstrated clinically meaningful improvements over the first generation of BTK inhibitor in relapsed CLL,” said Dr Renata Walewska, Department of Hematology, University Hospitals Dorset, Bournemouth, UK.
  • The MHRA authorization for MZL is based on results from the multicenter, global, single-arm, open-label, Phase 2 MAGNOLIA3 trial in patients with R/R MZL who received at least one anti-CD-20 based regimen.
  • BRUKINSA has also been recommended by the Scottish Medicines Consortium for the treatment of adult patients with WM who have received at least one prior therapy, or in first-line treatment for patients unsuitable for chemoimmunotherapy.

Intellia Therapeutics Awarded Innovation Passport in the United Kingdom for NTLA-2002, an Investigational Genome Editing Treatment for Hereditary Angioedema

Retrieved on: 
Wednesday, January 11, 2023
CRISPR, National Institute for Health and Care Excellence, Genome, MHRA, Therapy, Intellia Therapeutics, Healthcare Improvement Scotland, SMC, NICE, HAE, Partnership, Health care, Patient, NTLA, Hereditary angioedema, Wales, Medication, Pharmaceutical industry

CAMBRIDGE, Mass., Jan. 11, 2023 (GLOBE NEWSWIRE) -- Intellia Therapeutics, Inc. (NASDAQ:NTLA), a leading clinical-stage genome editing company focused on developing potentially curative therapies leveraging CRISPR-based technologies, today announced the U.K.

Key Points: 
  • CAMBRIDGE, Mass., Jan. 11, 2023 (GLOBE NEWSWIRE) -- Intellia Therapeutics, Inc. (NASDAQ:NTLA), a leading clinical-stage genome editing company focused on developing potentially curative therapies leveraging CRISPR-based technologies, today announced the U.K.
  • Medicines and Healthcare products Regulatory Agency (MHRA) has awarded the Innovation Passport for NTLA-2002, an in vivo genome editing candidate being developed for the treatment of hereditary angioedema (HAE).
  • The Innovation Passport is the point of entry into the U.K.’s Innovative Licensing and Access Pathway (ILAP), which is designed to accelerate time to market and facilitate patient access to innovative medicines.
  • “With the high treatment burden of currently available chronic therapies for hereditary angioedema, we are pleased to receive the ILAP designation, which will enable Intellia to further accelerate the clinical development of NTLA-2002,” said Intellia President and Chief Executive Officer John Leonard, M.D.

Sustained Acoustic Medicine Enables Student-Athletes to Recover in the Classroom While Meeting Their Academic Obligations

Retrieved on: 
Monday, January 9, 2023
U.S. Department of Defense Strategy for Operating in Cyberspace, Swelling, Injury, National Institute for Health and Care Excellence, History of Sufism, Bursitis, Tendinopathy, Research, Narcotic, Inflammation, Athlete, Pain, Medical imaging

AUSTIN, Texas, Jan. 09, 2023 (GLOBE NEWSWIRE) -- A Texas collegiate football program is taking advantage of sustained acoustic medicine (sam®), a low-intensity, long-duration ultrasound treatment developed by ZetrOZ Systems .

Key Points: 
  • AUSTIN, Texas, Jan. 09, 2023 (GLOBE NEWSWIRE) -- A Texas collegiate football program is taking advantage of sustained acoustic medicine (sam®), a low-intensity, long-duration ultrasound treatment developed by ZetrOZ Systems .
  • Injured athletes are utilizing the device while in class, allowing them to recover from injury and get the full benefit of the recommended one-hour treatment time without sacrificing attendance.
  • A representative from the ZetrOZ Systems sports medicine team visited the organization to discuss the sam® device.
  • In addition to its anti-inflammatory effects, long-duration ultrasound therapy has also been found to reduce pain, improve mobility, and accelerate tissue repair.

FibroGen/Astellas' EVRENZO (roxadustat) Gaining Traction in the United Kingdom and Germany, according to Spherix Global Insights

Retrieved on: 
Tuesday, December 6, 2022
EGFR, Dialysis, United Kingdom, Endpoint security, EMA, Patient, AstraZeneca, CKD, National Institute for Health and Care Excellence, European Medicines Agency, Chronic kidney disease, NICE, Pharmaceutical industry, Roxadustat

EXTON, Pa., Dec. 6, 2022 /PRNewswire/ -- After a regulatory debacle in the United States which ended with FibroGen and AstraZeneca receiving a Complete Response Letter in August 2021 for Roxadustat, FibroGen found success with partner Astellas in Europe.

Key Points: 
  • Only a fraction of the patients were treated with EVRENZO, with the highest use in the United Kingdom and most use originating in ESA-nave patients.
  • Spherix Global Insights is a leading provider of market research, business intelligence and advisory services to the global life sciences industry.
  • A trusted advisor and industry thought leader, Spherix Global Insights provides specialized market expertise in six (6) focused therapeutic areas including: dermatology, gastroenterology, nephrology, neurology, rheumatology and ophthalmology.
  • To learn more about Spherix Global Insights, visit spherixglobalinsights.com or connect through LinkedIn and Twitter .

The Worldwide Narcolepsy Therapeutics Industry is Expected to Reach $5 Billion by 2028 at a 10.5% CAGR - ResearchAndMarkets.com

Retrieved on: 
Wednesday, November 16, 2022
General Health, Pharmaceutical, Health, Investment, Sodium oxybate, Gamma-Hydroxybutyric acid, Narcolepsy, Hypersomnia, Economic development, Excessive daytime sleepiness, Insomnia, Modafinil, Life, Pharmacokinetics, Dopamine, Person, Emotion, Stimulant, NIH, Hypnagogia, EDS, National Institute for Health and Care Excellence, Cataplexy, Union, Restless legs syndrome, Sleep apnea, Norepinephrine, Sleep paralysis, GABAB, Diagnosis, Health, Patient, Pharmaceutical industry

The Global Narcolepsy Therapeutics Market size is expected to reach $5 billion by 2028, rising at a market growth of 10.5% CAGR during the forecast period.

Key Points: 
  • The Global Narcolepsy Therapeutics Market size is expected to reach $5 billion by 2028, rising at a market growth of 10.5% CAGR during the forecast period.
  • Modafinil, armodafinil, and stimulants are only a few of the medications used to treat narcolepsy.
  • Others include sodium oxybate and venlafaxine, which are used to treat the symptoms of sleep paralysis and sleep-related hallucinations (e.g.
  • One of the main factors holding back the narcolepsy market is the high cost of narcolepsy diagnosis and treatment.

Healthcare Leader Jennifer Carvalho Named President of Substance Use Division, Discovery Behavioral Health

Retrieved on: 
Thursday, November 24, 2022
Patient, Addiction, Hospital, National Institute for Health and Care Excellence, Disease, Happiness, DBH, Legislation, Mental health, National Association, Death, Eating disorder, Research, Parity, SUD, Psychiatry, Multimedia, Addiction medicine, Policy, TMS, Education, Pharmaceutical industry, Drug, Management, Medicine, Discovery

LOS ANGELES, Nov. 23, 2022 /PRNewswire/ -- Discovery Behavioral Health, Inc., an expanding network of evidence-based mental health, substance use and eating disorder treatment centers, is pleased to announce the appointment of seasoned industry executive Jennifer Carvalho as President of Substance Use Division. Carvalho reports directly to DBH COO James Bailey.

Key Points: 
  • LOS ANGELES, Nov. 23, 2022 /PRNewswire/ -- Discovery Behavioral Health, Inc ., an expanding network of evidence-based mental health, substance use and eating disorder treatment centers, is pleased to announce the appointment of seasoned industry executive Jennifer Carvalho as President of Substance Use Division.
  • "Our ability to navigate the shifting landscape of behavioral health is key to addressing the expanding national mental health crisis.
  • "At Discovery Behavioral Health the goals for my team are operational.
  • That's why Discovery Behavioral Health has made evidence-based, outcome-driven healthcare accessible and affordable since inception.