LSM

Pharma Two B Announces Publication of Positive Phase 3 Study Results of P2B001, an Investigational Treatment for Early Parkinson’s Disease, in Movement Disorders

Retrieved on: 
Thursday, November 9, 2023
UPDRS, Incidence, PD, III, Neurology, University of South Florida, Physician, Emeritus, Pramipexole, Epworth Sleepiness Scale, FRCPC, LSM, ESS, Somnolence, University, Department of Neurology, Xuanwu hospital, Mount Sinai School, NDA, Safety, Patient, PPX, Movement disorder, Dietary supplement, Pharmaceutical industry, Surveying

The study included 544 untreated patients with Parkinson’s disease who were randomized (2:2:2:1) to treatment with P2B001, its individual components (pramipexole-ER 0.6 mg or rasagiline-ER 0.75 mg), or marketed PramiER individually titrated to optimal dose (1.5-4.5 mg).

Key Points: 
  • The study included 544 untreated patients with Parkinson’s disease who were randomized (2:2:2:1) to treatment with P2B001, its individual components (pramipexole-ER 0.6 mg or rasagiline-ER 0.75 mg), or marketed PramiER individually titrated to optimal dose (1.5-4.5 mg).
  • Further, he stated that “P2B001 is a once-a-day treatment that requires no titration.
  • P2B001 was generally well tolerated and showed fewer sleep-related and dopaminergic adverse events in comparison to commercially used doses of pramipexole ER.
  • “We look forward to moving P2B001 forward towards an NDA submission to make this potential treatment option available to patients.”

E-Scopics announces commercial launch of Hepatoscope in the US and opens its subsidiary in the USA

Retrieved on: 
Thursday, November 9, 2023
Other Health, Software, General Health, Radiology, Apps, Applications, Medical Devices, Technology, Health Technology, Biotechnology, Other Technology, Health, Diabetes, Chronic liver disease, Physician, SOS, Liver, Speed of sound, Medtech, LSM, Steatosis, Risk, U.S. FDA, Nutritionist, ATT, GLP1, Patient, BSC, UAA Films, Medical imaging

This will enable its nomad use at the point of care, by various clinicians ranging from diabetologists, nutritionists, primary care physicians and beyond.

Key Points: 
  • This will enable its nomad use at the point of care, by various clinicians ranging from diabetologists, nutritionists, primary care physicians and beyond.
  • This new concept of Ultrasound-as-a-Service (UaaS) allows an agile adaptation to specific ultrasound applications to democratize their use to non-expert users.
  • The platform provides ultra-low power ultrasound and ultrafast imaging capability, which can support premium ultrasound modalities in an ultra-portable form factor.
  • “Following our clinical evaluation of Hepatoscope, it becomes clear to me that the device is ideally positioned for screening of MASLD-MASH.

Lumos Pharma Announces Topline Data from Phase 2 OraGrowtH210 and OraGrowtH212 Trials of LUM-201 in PGHD Met All Primary and Secondary Endpoints

Retrieved on: 
Tuesday, November 7, 2023
Research, ECG, PD, Injection, Injection (medicine), Comparable, Classification, AHV, Child, Transgender hormone therapy, PEM, KOL, University, Safety, Patient, LUMO, Unique, MD, Growth, Standard error, GH, Growth hormone, Coronavirus Scientific Advisory Board, FDA, Șaeș, Aes, Pediatric endocrinology, City of Hope National Medical Center, Mother, LSM, SDS, University of Chile, Political moderate, Silviculture, Vaccine, Pharmaceutical industry, Birth control, Wood drying, Online shopping, Endocrinology

AUSTIN, Texas, Nov. 07, 2023 (GLOBE NEWSWIRE) -- Lumos Pharma, Inc. (NASDAQ:LUMO) today announced that topline results from its Phase 2 OraGrowtH210 dose-finding trial and its Phase 2 OraGrowtH212 Pharmacokinetic/Pharmacodynamic (PK/PD) trial met all primary and secondary endpoints. Data from the OraGrowtH210 Trial demonstrated annualized height velocity (AHV) on the 1.6 mg/kg dose of orally administered LUM-201 of 8.2 cm/yr at six months and 8.0 cm/yr at 12 months on treatment,* in line with historical data in moderate pediatric growth hormone deficiency (PGHD) patients and within the targeted 2 cm/yr margin of the comparator injectable recombinant growth hormone (rhGH) arm. Data also provided preliminary validation of the predictive enrichment marker (PEM) strategy, with prespecified primary and secondary outcomes met, de-risking our patient selection for our Phase 3 program. Data from the OraGrowtH212 Trial confirmed that LUM-201’s unique pulsatile mechanism produces an increase in growth rates while restoring growth hormone secretion and IGF-1 to within normal ranges †, with levels substantially below those produced by exogenous injectable rhGH.†† Additionally, data from a small subset of 10 subjects combined 1.6 and 3.2 mg/kg dosage of LUM-201 in both OraGrowtH210 and OraGrowtH212 trials demonstrated the sustained effectiveness of AHV up to 24 months. Furthermore, the safety profile for LUM-201 remained clean throughout both Phase 2 studies, with no safety concerns identified in either of our Phase 2 trials conducted thus far.

Key Points: 
  • Data also provided preliminary validation of the predictive enrichment marker (PEM) strategy, with prespecified primary and secondary outcomes met, de-risking our patient selection for our Phase 3 program.
  • The OraGrowtH210 trial met its primary objective, with 6-month AHV data of 8.2 cm/yr supporting the 1.6 mg/kg as the optimal dose for a Phase 3 clinical trial.
  • Eighteen and 24-month growth data were available for 10 subjects from the OraGrowtH210 and OraGrowtH212 Trials who met AHV criteria per protocol at 12 months.
  • Every participant in the OraGrowtH212 Trial met the criteria for Patient PEM positivity, ensuring their potential responsiveness to LUM-201.

Press Release: TZIELD® Phase 3 data presented at ISPAD shows potential to slow the progression of Stage 3 type 1 diabetes in newly diagnosed children and adolescents; full data simultaneously published in The NEJM

Retrieved on: 
Wednesday, October 18, 2023
Medical Affairs Bureau, AUC, Ageing, Yale School of Medicine, Endocrinology, Conference, Diabetes, Acquisition, General Medicine Faculty of RostGMU (Rostov State Medical University), PROTECT, LSM, Numerical, Growth, Disease, Clinical trial, The New England Journal of Medicine, C-peptide, Sanofi, Safety, T1D, ISPAD, Patient, Pharmaceutical industry, Medical imaging, Management, Medicine

New data from TZIELD’s (teplizumab-mzwv) PROTECT Phase 3 trial were presented today at the 49th Annual ISPAD Conference, in Rotterdam, The Netherlands.

Key Points: 
  • New data from TZIELD’s (teplizumab-mzwv) PROTECT Phase 3 trial were presented today at the 49th Annual ISPAD Conference, in Rotterdam, The Netherlands.
  • The full data set has been simultaneously published in The New England Journal of Medicine .
  • This significant difference indicates the potential of TZIELD to slow the progression of Stage 3 type 1 diabetes in this population.
  • While the study’s key secondary endpoints did not meet statistical significance, numerical trends favoring TZIELD were seen in relevant clinical parameters.

Anavex’s Phase 2b/3 Trial of Blarcamesine (ANAVEX®2-73) in Patients with Alzheimer’s Disease Shows Robust Clinical Efficacy and Slows Neurodegeneration

Retrieved on: 
Thursday, September 14, 2023
Cognition, Maintenance, Blarcamesine, Magnetic resonance, University, Therapy, Alzheimer's disease, Disease, Radiology, Coronavirus Scientific Advisory Board, Medical imaging, Biomarker, Doctor of Philosophy, Dementia, Science, Plasma, MRI, DSM-IV codes, LSM, Dizziness, Amyloid, MD, UCSF, ADNI, Patient, Neurology, ADAS, Principal, Safety, Pharmaceutical industry, Medicine, Psychiatry

The trial was a Multicenter (52 medical research centers/hospitals in 5 countries), randomized, double-blind, placebo-controlled, 48-week phase 2b/3 trial that enrolled 508 participants with early symptomatic Alzheimer disease (mild cognitive impairment/mild dementia).

Key Points: 
  • The trial was a Multicenter (52 medical research centers/hospitals in 5 countries), randomized, double-blind, placebo-controlled, 48-week phase 2b/3 trial that enrolled 508 participants with early symptomatic Alzheimer disease (mild cognitive impairment/mild dementia).
  • Participants were randomized to receive blarcamesine (n = 338) or placebo (n = 170) oral capsules once daily for 48 weeks.
  • All prespecified clinical endpoints were analyzed using a mixed model for repeated measures (MMRM).
  • The MMRM analysis method is the convention used for regulatory filings and discussions with regulatory authorities are in preparation.

Avalon’s Laboratory Services MSO Acquires California-Based Medical Supply Company and Proprietary FDA-Registered External Male Catheter Device

Retrieved on: 
Wednesday, September 13, 2023
Insurance, Male, Medi-Cal, Blue Cross Blue Shield Association, Aetna, MMS, National Health Laboratory Service, Durable medical equipment, LSM, CCS, Home medical equipment, MSO, FDA, Urinary incontinence, Health insurance, Medicaid, UnitedHealth Group, Humana, Medicare

Leading Edge Innovations owns the GeeWhiz External Condom Catheter, a patented, FDA-registered, in-market, male incontinence device.

Key Points: 
  • Leading Edge Innovations owns the GeeWhiz External Condom Catheter, a patented, FDA-registered, in-market, male incontinence device.
  • Notably, LSM also acquired a proprietary, FDA-registered, external male catheter device - GeeWhiz.
  • The GeeWhiz External Condom Catheter is approved for reimbursement by Medicare and a number of high-profile private insurance providers.
  • The GeeWhiz catheter device system is designed to help men with urinary incontinence and bladder control.

YugabyteDB 2.19: Bridging an Application’s Journey from Lift-and-Shift Migration to Massive Scale

Retrieved on: 
Tuesday, September 12, 2023
Networks, Data Management, Apps, Applications, Technology, Software, Aurora, Cloud, Database, SQL, Table, Spanner (database), PostgreSQL, Datadog, Amazon Aurora, Organization, LSM, Cost, CBO, Google Cloud, Connection, AWS, Cryptocurrency, Video game, YugabyteDB, Oracle, Azure

Together, these capabilities expand the reach of distributed PostgreSQL to applications at every scale while simplifying application architecture and migration.

Key Points: 
  • Together, these capabilities expand the reach of distributed PostgreSQL to applications at every scale while simplifying application architecture and migration.
  • Semi-distributed databases offer a simple lift-and-shift migration without the need to re-architect applications, but are limited in scale, eventually forcing another migration when needs grow.
  • And as the app grows, YugabyteDB seamlessly shifts to a fully-distributed mode to provide the massive scaling benefits of distributed SQL.
  • The latest release of Yugabyte’s open source end-to-end migration tool, YugabyteDB Voyager 1.5, introduces live, non-disruptive migration from Oracle.

Avalon’s Laboratory Services MSO Launches Innovative Laboratory Test for Tuberculosis

Retrieved on: 
Wednesday, August 30, 2023
Infection, Culture, TB, Brain, National Health Laboratory Service, LSM, Collection, Polymerase chain reaction, Lymph, Patient, MSO, PCR, Mycobacterium tuberculosis, Disease, Vaccine, Tuberculosis, MTB

FREEHOLD, N.J., Aug. 30, 2023 (GLOBE NEWSWIRE) -- Avalon GloboCare Corp. (“Avalon” or the “Company”) (NASDAQ: ALBT), a developer of innovative precision diagnostics and provider of clinical laboratory services, today announced that Laboratory Services MSO, LLC (“LSM”) is now offering an in-house laboratory developed test (“LDT”) to detect Tuberculosis (“TB”) using a patient’s sputum sample. Avalon owns a 40% interest in LSM.

Key Points: 
  • FREEHOLD, N.J., Aug. 30, 2023 (GLOBE NEWSWIRE) -- Avalon GloboCare Corp. (“Avalon” or the “Company”) (NASDAQ: ALBT), a developer of innovative precision diagnostics and provider of clinical laboratory services, today announced that Laboratory Services MSO, LLC (“LSM”) is now offering an in-house laboratory developed test (“LDT”) to detect Tuberculosis (“TB”) using a patient’s sputum sample.
  • LSM’s new polymerase chain reaction (“PCR”) test allows for accurate and rapid identification of Mycobacterium tuberculosis (“Mtb”) from samples.
  • The most frequently used diagnostic methods for tuberculosis are the tuberculin skin test, acid-fast stain, culture, and polymerase chain reaction.
  • This test also has a significantly higher throughput and much lower cost per test as compared to the standard diagnostic tests.

Avalon’s Laboratory Services MSO Announces Expansion into Arizona

Retrieved on: 
Monday, August 21, 2023
Member of Congress, Barry Goldwater, Genetics, Politics, COVID-19, General Revenue Corporation, Second Continental Congress, National Health Laboratory Service, Congress, LSM, Toxicology, Republican, Genetic testing, MSO, COLA, Family, Pharmaceutical industry, Veritas

FREEHOLD, N.J., Aug. 21, 2023 (GLOBE NEWSWIRE) -- Avalon GloboCare Corp. (“Avalon” or the “Company”) (NASDAQ: ALBT), a developer of innovative precision diagnostics and provider of clinical laboratory services, today announced Laboratory Services MSO, LLC (“LSM”) is opening a new laboratory, Veritas Laboratories LLC (“Veritas”), in Scottsdale, Arizona. Avalon owns a 40% interest in LSM. Veritas is a CLIA-certified and COLA-accredited laboratory that offers a wide range of high-quality testing, including drug testing, genetic testing, urinary testing and COVID-19 PCR testing.

Key Points: 
  • New Wholly Owned Lab “Veritas Laboratory” of Arizona, Anticipated to Generate Revenue in 2023
    Engages Former Congressman Barry M. Goldwater Jr. To Expand Insurance Coverage and Grow Lab Footprint
    FREEHOLD, N.J., Aug. 21, 2023 (GLOBE NEWSWIRE) -- Avalon GloboCare Corp. (“Avalon” or the “Company”) (NASDAQ: ALBT), a developer of innovative precision diagnostics and provider of clinical laboratory services, today announced Laboratory Services MSO, LLC (“LSM”) is opening a new laboratory, Veritas Laboratories LLC (“Veritas”), in Scottsdale, Arizona.
  • Veritas is a CLIA-certified and COLA-accredited laboratory that offers a wide range of high-quality testing, including drug testing, genetic testing, urinary testing and COVID-19 PCR testing.
  • Additionally, LSM has engaged former Congressman Barry M. Goldwater to expand coverage with in-network providers and grow laboratory footprint in Arizona.
  • Congressman Barry M. Goldwater, Jr. stated, “We welcome LSM to Arizona as they open a new facility in Scottsdale.

Neurocrine Biosciences Announces FDA Approval of INGREZZA® (valbenazine) Capsules for the Treatment of Chorea Associated With Huntington's Disease

Retrieved on: 
Friday, August 18, 2023
Huntington's disease, Maintenance, VMAT2, Chorea, Depression, Pharmacy, Somnolence, Disease, Huntington's Disease Society of America, Neurocrine Biosciences, Quality of life, Medicine, NMS, Hives, Behavior, Rash, HSG, Insomnia, Capsule, LSM, TMC, Patient, McGovern Medical School, Neuroleptic malignant syndrome, SAN, FANA, Suicidal ideation, FDA, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, FAAN, Food, Caregiver, Safety, Pharmaceutical industry, Birth control, HD, Neurology

"We are thankful for those in the HD community who helped contribute to this important milestone, and we remain committed to bringing medicines to patients with unmet medical needs for debilitating neurological disorders."

Key Points: 
  • "We are thankful for those in the HD community who helped contribute to this important milestone, and we remain committed to bringing medicines to patients with unmet medical needs for debilitating neurological disorders."
  • In clinical studies in Huntington's disease, treatment-emergent adverse events included somnolence and sedation, urticaria, rash and insomnia.
  • "Data also demonstrated INGREZZA was generally well tolerated and showed clinically meaningful improvement in adults with chorea associated with HD."
  • "The approval of INGREZZA for HD chorea means that people living with HD have a new treatment option to help manage their chorea symptoms, which is a welcomed milestone in efforts to improve care for families affected by HD."