National Institute for Health and Care Excellence

Microvi Awarded Over $1.1 Million to Scale its New Technology that Eliminates a Cancer-causing Chemical in Water

Retrieved on: 
Tuesday, November 15, 2022
Linda, Chromium, Drinking water, Cancer, Technology, Health, Working group, National Institute, Maintenance, Biology, Water, Biofuel, National Institute for Health and Care Excellence, Industry, Biophysical environment, San Francisco Bay Area, MNE, Water quality, Principal, CEO, NIH, Review, Oil, Renewable energy

Chromium in drinking water threatens the health of millions of people due to its link to cancers and reproductive effects.

Key Points: 
  • Chromium in drinking water threatens the health of millions of people due to its link to cancers and reproductive effects.
  • Chromium pollution is a widespread issue that affects Americans across all 50 states, according to the Environmental Working Group.
  • To address this challenge, the current Federal standard for total chromium in drinking water (100 parts per billion (ppb)) is under review.
  • Microvi developed a novel approach for chromium elimination based on its MicroNiche Engineering (MNE) platform technology.

Blue Earth Therapeutics Awarded UK MHRA Innovation Passport for Investigational 177Lu-rhPSMA-10.1 for Treatment of Metastatic Castrate-Resistant Prostate Cancer (mCRPC)

Retrieved on: 
Tuesday, November 8, 2022
Oncology, Health, Clinical Trials, Research, Science, Pharmaceutical, Biotechnology, PET, Acquisition, Magnetic resonance, Patient, Company, CEUS, Wales, Nuclear medicine, National Institute, Precision medicine, Health care, Google Images, Innovation, Biotechnology, Cancer, Isotope, Cardiac catheterization, Interventional radiology, Man, Therapeutic index, PSMA, Healthcare Improvement Scotland, SMC, Prostate cancer, Partnership, NICE, Institute of technology, 3D ultrasound, National Institute for Health and Care Excellence, MRI, Solution, MHRA, MAA, TDP, Magnetic resonance imaging, Therapy, Pharmaceutical industry, Medical imaging, Bracco

Blue Earth Therapeutics, a Bracco company and emerging leader in the development of innovative next generation therapeutic radiopharmaceuticals, today announced that its investigational therapeutic radiopharmaceutical, 177Lu-rhPSMA-10.1, has been awarded an Innovation Passport for the treatment of metastatic castrate-resistant prostate cancer.

Key Points: 
  • Blue Earth Therapeutics, a Bracco company and emerging leader in the development of innovative next generation therapeutic radiopharmaceuticals, today announced that its investigational therapeutic radiopharmaceutical, 177Lu-rhPSMA-10.1, has been awarded an Innovation Passport for the treatment of metastatic castrate-resistant prostate cancer.
  • Blue Earth Therapeutics and Blue Earth Diagnostics work closely on the development of 177Lu-rhPSMA-10.1.
  • Blue Earth Therapeutics has an emerging pipeline, initially focused on prostate cancer, and with plans to expand into additional disease areas in oncology.
  • In 2021, Bracco Imaging established Blue Earth Therapeutics as a separate, cutting-edge biotechnology vehicle to develop radiopharmaceutical therapies.

Aleta Biotherapeutics Receives Innovation Passport Designation for Biologic CAR T-Cell Therapy Engager ALETA-001

Retrieved on: 
Monday, November 7, 2022
Oncology, Health, Clinical Trials, Research, Science, Pharmaceutical, Biotechnology, Lymphoma, Ovarian cancer, BCMA, CD20, Edinburgh Cancer Research Centre, Queen Elizabeth Hospital, National Institute for Health and Care Excellence, Brain, Patient, NHL, Wales, Cancer, National Institute, Health care, Cancer Research UK, Innovation, ALL, Lymphoid leukemia, University Hospitals Birmingham NHS Foundation Trust, CAR, Entrepreneurship, CD19, Temozolomide, Healthcare Improvement Scotland, Neoplasm, Prostate cancer, SMC, CTE, Acute lymphoblastic leukemia, Lymphatic system, Antigen, NICE, Drug development, Medicine, Leukemia, Cancer research, MHRA, Therapy, The Queen Elizabeth Hospital, Adelaide, AML, B-cell maturation antigen, Pharmaceutical industry, Vaccine

Aleta Biotherapeutics (Aleta), a privately held immuno-oncology company with novel biologic CAR T engagers that work in synergy with cell therapies to improve outcomes for patients, announces that the U.K.

Key Points: 
  • Aleta Biotherapeutics (Aleta), a privately held immuno-oncology company with novel biologic CAR T engagers that work in synergy with cell therapies to improve outcomes for patients, announces that the U.K.
  • This designation for our biologic CAR T-cell therapy engager ALETA-001 marks an important step in addressing the high unmet need for patients who relapse or progress following CD19-targeted CAR T-cell therapy for blood cancers, such as lymphoma and leukemia, stated Paul Rennert, Co-Founder, Acting Chief Executive Officer and Chief Scientific Officer, Aleta Biotherapeutics.
  • ALETA-001 is an off-the-shelf preclinical biologic program developed to treat and prevent cell therapy relapse of existing CD19-targeted CAR T-cell therapies, termed CAR19 T cells.
  • Aleta Biotherapeutics is an immune-oncology company with a portfolio and platform of novel off-the-shelf biologic CAR T engagers (CTEs) that work in synergy with cell therapies to improve outcomes for patients.

Off-Label Avastin (Genentech) Dominates First-Line Biologic Use in Diabetic Retinopathy Despite Eylea's (Regeneron) Best Efforts to Secure Share in the Space, According to Spherix Global Insights

Retrieved on: 
Thursday, November 3, 2022
Genentech, FDA, Ophthalmology, Regeneron Pharmaceuticals, Bevacizumab, Diabetic retinopathy, National Institute for Health and Care Excellence, National Institute, Research, Ranibizumab, NASA RealWorld-InWorld Engineering Design Challenge, Insurance, NIH, Patient, Quality of life, Diabetes, DR, Traction, DME, Nephrology, Dermatology, Neurology, Gastroenterology, Medical device, Generic drug, Pharmaceutical industry

EXTON, Pa., Nov. 3, 2022 /PRNewswire/ -- Despite the availability of on-label products to treat diabetic retinopathy (DR), Genentech's off-label option, Avastin, is the predominant first-line treatment. 114 ophthalmologists provided data from 357 charts of DR patients recently prescribed their first biologic (fielded from August 15 to September 26, 2022). The inaugural chart audit included in Spherix's RealWorld Dynamix™: Biologic New Starts in Diabetic Retinopathy (US) service confirms Eylea falling short behind Genentech's off-label product.

Key Points: 
  • 114 ophthalmologists provided data from 357 charts of DR patients recently prescribed their first biologic (fielded from August 15 to September 26, 2022).
  • The inaugural chart audit included in Spherix's RealWorld Dynamix: Biologic New Starts in Diabetic Retinopathy (US) service confirms Eylea falling short behind Genentech's off-label product.
  • Genentech's Lucentis paved the way for biologics entering the space, receiving the first-to-market approval for treatment of DR back in April 2017.
  • To learn more about SPHERIX Global Insights, visit spherixglobalinsights.com or connect through LinkedIn and Twitter .

European Lupus Market Coverage Highlights Pipeline Perceptions and Country Differences in Patient Management, Spherix Reports

Retrieved on: 
Wednesday, October 26, 2022
Quality of life, SLE, Physician, National Institute, Time, AstraZeneca, Disease, Review, Ophthalmology, Dermatology, UCB, Lupus, Pfizer, Patient, Hydroxychloroquine, Rheumatology, Research, Gastroenterology, PGA, Lupus nephritis, Obinutuzumab, Neurology, GlaxoSmithKline, National Institute for Health and Care Excellence, Incidence, Health, NICE, Clinical trial, Flare, Bristol Myers Squibb, Belimumab, Anifrolumab, QOL, Pregnancy, Nephrology, JAK, Lists of people executed in the United States, Pharmaceutical industry, Biogen, LN, Aurinia, EU

EXTON, Pa., Oct. 26, 2022 /PRNewswire/ -- Rheumatologists have long struggled to effectively treat patients with systemic lupus erythematosus (SLE) given the wide heterogeneity of the disease and few effective treatment options. However, after nearly a decade of stagnant innovation for the treatment of SLE and lupus nephritis (LN), physicians now have three recently approved agents in their treatment armamentarium: GlaxoSmithKline's Benlysta (belimumab) in SLE and now LN, AstraZeneca's Saphnelo (anifrolumab) in SLE, and Aurinia's Lupkynis (voclosporin) in LN.

Key Points: 
  • Spherix Global Insights has been a leader in tracking the SLE and LN markets for several years, covering physician perspectives, treatment patterns, and pipeline assessments.
  • This coverage includes in-depth interviews with key opinion leaders (KOLs) and "in-the-trenches" physicians, along with large-scale attitudinal surveys and chart audits of more than 1000 patients.
  • Market-trending and future-looking reports, coupled with patient chart audits and launch trackers, enable subscribed clients to intelligently strategize as they strive towards optimal patient care and maximal market share.
  • RealWorld Dynamixis an independent, data-driven service unveiling real patient management patterns through rigorous analysis of large-scale patient chart audits.

Plus Therapeutics Presents Preliminary Safety and Feasibility Data from ReSPECT-LM Clinical Trial at the European Association of Nuclear Medicine Congress

Retrieved on: 
Wednesday, October 19, 2022
U.S. Securities and Exchange Commission, GBM, Therapy, CSF, Neoplasm, National Institute for Health and Care Excellence, CGMP, SubArachnoid Space, PSTV, Patient, Perception, EANM, Research, NIH, Nasdaq, Senior, Cancer, Company, Liposome, Plus, Cerebrospinal fluid, National, Association, Nuclear medicine, Adult, Safety, LM, CNS, Survival, Radiation, GLOBE, Grey, European Association for the Study of the Liver, Glioblastoma, Survival rate, Feasibility, Top-rated United States television programs by season, Pharmaceutical industry, Medical imaging

AUSTIN, Texas, Oct. 19, 2022 (GLOBE NEWSWIRE) --  Plus Therapeutics, Inc. (Nasdaq: PSTV) (the “Company”), a clinical-stage pharmaceutical company developing innovative, targeted radiotherapeutics for rare and difficult-to-treat cancers, presented data from two ongoing clinical trials evaluating the Company’s lead investigational targeted radiotherapeutic, Rhenium-186 NanoLiposome (186RNL), in leptomeningeal metastases (LM) and recurrent glioblastoma (GBM) at the 35th Annual Congress of the European Association of Nuclear Medicine (EANM). The Company’s ReSPECT-GBM presentation was selected for inclusion in the opening Plenary Highlights Lecture, signaling significant clinical interest in the field.

Key Points: 
  • The Companys ReSPECT-GBM presentation was selected for inclusion in the opening Plenary Highlights Lecture, signaling significant clinical interest in the field.
  • Combined with our Phase 1 data in recurrent glioblastoma, these presentations reinforce the tremendous potential of 186RNL as a versatile radiotherapeutic treatment option for multiple CNS cancers.
  • All patients showed a decreased CSF cell count by microfluidic chamber assay after treatment, ranging from 46% to 92%.
  • Cohort 2 in the ReSPECT-LM trial has commenced, with interim data from the first two patient cohorts expected by the end of 2022.

AVROBIO Granted ILAP Designation from U.K. MHRA for First-in-Class Gene Therapy for Gaucher Disease

Retrieved on: 
Tuesday, October 18, 2022
General Health, Health, Genetics, Stem Cells, Clinical Trials, LinkedIn, Data collection, AVRO, Mortality, Bone marrow, Innovation, Health, ERT, National Institute for Health and Care Excellence, Stem cell, Cystinosis, Phrase, Quality of life, Compte rendu, Risk assessment, Spleen, Twitter, Private Securities Litigation Reform Act, Industry, Enzyme replacement therapy, Healthcare Improvement Scotland, Clinical trial, Central nervous system, National Institute, NHS, Risk, Glycogen storage disease type II, Health care, Macrophage, MHRA, Growth, Glycogen storage disease, Frexit, Parkinson's disease, Security (finance), Cell, Hunter syndrome, Lists of diseases, Outline, Life expectancy, MAA, Marketing, Fatigue, SMC, Patient, Nasdaq, Gaucher's disease, Liver, Safety, NICE, National Health Service, COVID-19, Pharmaceutical industry, Gaucher

(Nasdaq: AVRO), a leading clinical-stage gene therapy company working to free people from a lifetime of genetic disease, today announced that the U.K.

Key Points: 
  • (Nasdaq: AVRO), a leading clinical-stage gene therapy company working to free people from a lifetime of genetic disease, today announced that the U.K.
  • Gaucher disease is a rare, inherited lysosomal disorder characterized by the toxic accumulation of glucosylceramide (GlcCer) and glucosylsphingosine (GlcSph) in macrophages.
  • Our first-in-class pipeline includes clinical programs for cystinosis and Gaucher disease type 1, as well as preclinical programs for Gaucher disease type 3, Hunter syndrome and Pompe disease.
  • Our proprietary plato gene therapy platform is designed to be scaled to support late-stage clinical development and commercialization globally.

Sonara Health Raises $3 Million to Fight the Opioid Crisis, Bringing Total Funding to Over $5 Million

Retrieved on: 
Tuesday, October 4, 2022
History, Technology, Blue Cross Blue Shield Association, Research, Opioid, National Institute, Stanford University, CEO, Methadone, NIH, FDA, Quality of life, National Institute for Health and Care Excellence, OHSU, Patient, Pharmaceutical industry

DALLAS, Oct. 4, 2022 /PRNewswire/ -- Sonara Health today announced $3 million in seed round funding led by First Trust Capital Partners and Blue Cross Blue Shield of Kansas. Sonara is a patented medication monitoring system that allows people to more safely consume methadone from home, eliminating daily clinic visits.

Key Points: 
  • Sonara is a patented medication monitoring system that allows people to more safely consume methadone from home, eliminating daily clinic visits.
  • Sonara Health's plans for the funds include further developing its platform and partnering with more opioid treatment programs to help more people on their path to recovery.
  • Sonara Health partners with opioid treatment programs to preserve the success of a proven delivery system and the patients' connection to their care teams.
  • According to the National Institute of Health (NIH) , methadone has the longest history of use for opioid disorder treatment, and significantly reduces opioid abuse.

United Kingdom National Institute for Health and Care Excellence (NICE) Publishes Interventional Procedure Guidance (IPG) for ReActiv8® Restorative Neurostimulation™

Retrieved on: 
Friday, September 23, 2022
Nursing, Medical Devices, Surgery, Hospitals, Fitness & Nutrition, Biotechnology, Alternative Medicine, Managed Care, General Health, Health, European Economic Area, Â, Time, National Health Service (England), NHS, Safety, Department, Risk, Clinical governance, Multifidus muscle, Leeds Teaching Hospitals NHS Trust, Forward-looking statement, Department of Health and Social Care, Patient, Physician, CEO, Technology, Pain, Pathology, Uncertainty, National Health Service, Consultant, National Institute for Health and Care Excellence, Research, NICE, Atraumatic Restorative Treatment (ART), National Institute, Pharmaceutical industry, Dentistry

ReActiv8 is currently the only technology offering restorative neurostimulation to the NHS for refractory mechanical chronic low back pain (CLBP).

Key Points: 
  • ReActiv8 is currently the only technology offering restorative neurostimulation to the NHS for refractory mechanical chronic low back pain (CLBP).
  • This new guidance will enable patients to have greater access to the therapy when previous treatment options have not proven successful.
  • This new guidance will allow more patients to gain access to ReActiv8 within the U.K. and further afield.
  • Mainstay Medical is a medical device company focused on commercializing its innovative implantable Restorative Neurostimulation system, ReActiv8, for people with disabling mechanical CLBP.

NICE Recommends BeiGene’s BRUKINSA® (zanubrutinib) for Patients with Waldenström’s Macroglobulinemia who have had at Least One Treatment

Retrieved on: 
Tuesday, September 20, 2022
Oncology, Health, Clinical Trials, General Health, Pharmaceutical, Biotechnology, Lymph, BTK, Safety, Blood, Lancet, National Institute for Health and Care Excellence, Patient, Jazz Pharmaceuticals, Lymphoid leukemia, Technology, FAD, National Health Service, NASDAQ, Research, Disease, National Institute, QALY, COVID-19, Food, Company, Intellectual property, B-cell lymphoma, Bone marrow, PARP, SSE, Man, Spleen, Food and Drug Administration, Woman, FDA, Review, Global health, Goal, Tislelizumab, Novartis, Tissue, NICE, Marketing, Half-life, Therapy, Twitter, WM, Form 10-Q, Rituximab, Cancer, Quality of life, Standard of care, Private Securities Litigation Reform Act, Pharmacokinetics, BLA, Bristol Myers Squibb, Union, Pharmaceutical industry, Hospital, BeiGene

This decision from NICE marks BRUKINSA as the first and only treatment for WM to be recommended for routine use in England and Wales.

Key Points: 
  • This decision from NICE marks BRUKINSA as the first and only treatment for WM to be recommended for routine use in England and Wales.
  • NICEs positive recommendation for zanubrutinib allows eligible patients in England and Wales to access an important new treatment option that may offer improved outcomes compared to the current standard of care.
  • Our expansive portfolio is directed predominantly by our internal colleagues supporting clinical trials in more than 45 countries and regions.
  • Treatment and outcome patterns in European patients with Waldenstrms macroglobulinaemia: a large, observational, retrospective chart review.