Fatigue

Catalyst Pharmaceuticals Receives U.S. FDA Approval For Increased Maximum Daily Dose For FIRDAPSE®

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четверг, мая 30, 2024

The increased maximum daily dose offers healthcare providers and patients greater flexibility in treatment regimens for the management of LEMS.

Key Points: 
  • The increased maximum daily dose offers healthcare providers and patients greater flexibility in treatment regimens for the management of LEMS.
  • FIRDAPSE is currently the only U.S. approved treatment for LEMS and this approval broadens the approved dosing options for prescribers treating LEMS.
  • “We are pleased to receive the approval for the increased maximum daily dose of FIRDAPSE,” said Richard J. Daly, President and CEO of Catalyst.
  • “This pivotal achievement further underscores our dedication to meeting the evolving needs of LEMS patients and their healthcare providers.

NextCure Presents Phase 1b Data on NC410 and Pembrolizumab Combination at ASCO 2024

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четверг, мая 30, 2024

The poster presentation highlights the safety and tolerability of doses between 30-200 mg of NC410 in combination with 400 mg of pembrolizumab.

Key Points: 
  • The poster presentation highlights the safety and tolerability of doses between 30-200 mg of NC410 in combination with 400 mg of pembrolizumab.
  • The combination resulted in partial responses (PR) and stable disease in both CRC and ovarian cancer.
  • “While MSS/MSI-L CRC and ovarian cancer are difficult to treat and recalcitrant to immunotherapy, the combination of NC410 and pembrolizumab demonstrated clinical activity against both tumor types.
  • Details of the presentation are as follows:
    Title: A Phase 1b study of NC410 in combination with pembrolizumab in immune checkpoint inhibitor (ICI) naïve, and refractory microsatellite stable (MSS)/microsatellite instability-low (MSI-L) colorectal cancer (CRC) and ovarian cancer

Tonix Pharmaceuticals Announces Two Poster Presentations of TNX-102 SL (Sublingual Cyclobenzaprine HCl) at the ASCP Annual Meeting

Retrieved on: 
четверг, мая 30, 2024

CHATHAM, N.J., May 30, 2024 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company), a fully-integrated biopharmaceutical company with marketed products and a pipeline of development candidates, today announced two poster presentations at the American Society of Clinical Psychopharmacology (ASCP) Annual Meeting being held May 28-31, 2024 in Miami Beach, Fla. Copies of the presentations are available under the Scientific Presentations tab of the Tonix website at www.tonixpharma.com.

Key Points: 
  • Copies of the presentations are available under the Scientific Presentations tab of the Tonix website at www.tonixpharma.com .
  • TNX-102 SL was well tolerated with an adverse event profile comparable to prior studies and no new safety signals observed.
  • Previous trials of TNX-102 SL showed that it reduced military PTSD symptoms in as early as two weeks with favorable tolerability.
  • Randomized clinical trial of bedtime sublingual cyclobenzaprine (TNX-102 SL) in military-related PTSD and the role of sleep quality in treatment response.

Tiziana Life Sciences Scientific Board Chairman to Receive Prestigious Award for Multiple Sclerosis Research

Retrieved on: 
четверг, мая 30, 2024

The award ceremony will take place on May 30, 2024 at the Consortium of Multiple Sclerosis Centers annual meeting being held in Nashville, Tennessee.

Key Points: 
  • The award ceremony will take place on May 30, 2024 at the Consortium of Multiple Sclerosis Centers annual meeting being held in Nashville, Tennessee.
  • “We are thrilled to see Dr. Howard Weiner recognized with the ‘Giants of MS’ award for his exceptional achievements in MS research,” said Gabriele Cerrone, Chairman, acting CEO, and founder of Tiziana Life Sciences.
  • Weiner's relentless pursuit of scientific excellence and commitment to improving patient outcomes also exemplifies the values we uphold at Tiziana.
  • This award acknowledges individuals who have demonstrated extraordinary leadership and innovation in the field of MS research.

Mika Health and Cancer Support Community Aim to Close Gaps in Mental Health Care with United States’ First AI-Enabled “Precision Support” Digital Therapeutic That is Free for Cancer Patients

Retrieved on: 
пятница, мая 31, 2024

The organizations will debut the only AI-enabled evidence-based oncologic digital therapeutic that is completely free to patients and caregivers in the United States.

Key Points: 
  • The organizations will debut the only AI-enabled evidence-based oncologic digital therapeutic that is completely free to patients and caregivers in the United States.
  • “Many patients have unidentified mental health challenges or are unable to access the support they seek.
  • Mika is continuously co-developed and trusted by patients and their families, as well as clinicians all over the world.
  • “We are thrilled to work alongside an innovative leader in digital therapeutics whose commitment to improving cancer patients’ access to care aligns so strongly with ours.”

Hope Biosciences Research Foundation Announces Topline Results of Cell Therapy Clinical Trial in Long COVID

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пятница, мая 31, 2024

Houston-area clinical research organization Hope Biosciences Research Foundation (HBRF) today shares topline results of a randomized, placebo-controlled Phase II study ( NCT05126563 ) to evaluate Hope Biosciences’ adipose‑derived allogeneic mesenchymal stem cell therapy (HB-adMSCs) for patients with Post‑COVID‑19 syndrome.

Key Points: 
  • Houston-area clinical research organization Hope Biosciences Research Foundation (HBRF) today shares topline results of a randomized, placebo-controlled Phase II study ( NCT05126563 ) to evaluate Hope Biosciences’ adipose‑derived allogeneic mesenchymal stem cell therapy (HB-adMSCs) for patients with Post‑COVID‑19 syndrome.
  • The trial enrolled 79 participants, with 39 subjects in the treatment group and 40 in the placebo group; 34 participants completed the study from the treatment group, and 30 from the placebo group.
  • The 26-week study mandated four infusions of 200 million stem cells, for a total of 800 million cells.
  • The study announced in this release is made possible in part due to support from The John S. Dunn Foundation.

EVOKE-01 Study Results in Metastatic NSCLC to Be Presented at an Oral Session at ASCO 2024

Retrieved on: 
пятница, мая 31, 2024

Gilead Sciences, Inc. (Nasdaq: GILD) today announced detailed results from the Phase 3 EVOKE-01 study that will be presented during an oral session (Abstract #LBA8500) today (2:45-5:45pm CT) at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting.

Key Points: 
  • Gilead Sciences, Inc. (Nasdaq: GILD) today announced detailed results from the Phase 3 EVOKE-01 study that will be presented during an oral session (Abstract #LBA8500) today (2:45-5:45pm CT) at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting.
  • The company previously announced that the study did not meet the primary endpoint of overall survival (OS) in previously treated metastatic non-small cell lung cancer (NSCLC).
  • “Treating patients with metastatic NSCLC who have progressed on available treatments continues to be a challenge.
  • Longer-term results from Cohort A of the Phase 2 EVOKE-02 study of Trodelvy in combination with KEYTRUDA® (pembrolizumab) in first-line metastatic PD-L1 ≥50% NSCLC will also be presented in a poster session (Abstract #8592) on June 3, 2024.

Xeris Biopharma Announces Positive Topline Phase 2 Clinical Data of Its Investigational XeriSol™-Formulated Once-Weekly Subcutaneous (SC) Levothyroxine (XP-8121)

Retrieved on: 
четверг, мая 30, 2024

XP-8121 employs the Company’s XeriSol™ formulation technology to enable a novel once-weekly SC injection of levothyroxine.

Key Points: 
  • XP-8121 employs the Company’s XeriSol™ formulation technology to enable a novel once-weekly SC injection of levothyroxine.
  • The Phase 2 study included the following periods: Screening, Titration Period (2 to 8 weeks), and Maintenance Period (4 weeks).
  • Participants entered the study on a stable oral dose (≥ 3 months) with normal TSH and free T4 laboratory values.
  • Participants were receiving a daily oral levothyroxine dose of 83.7 ± 31.14 mcg (mean ± SD) at study entry.

Aviv Clinics Spotlights New Study Using Hyperbaric Oxygen Therapy for Adults Suffering from Fibromyalgia Related to Childhood Sexual Abuse

Retrieved on: 
вторник, мая 28, 2024

The report, Hyperbaric oxygen therapy vs. pharmacological intervention in adults with fibromyalgia related to childhood sexual abuse: prospective, randomized clinical trial , was conducted by the Sagol Center for Hyperbaric Medicine and Research at Shamir Medical Center and published in the peer-reviewed journal of Nature’s Scientific Reports.

Key Points: 
  • The report, Hyperbaric oxygen therapy vs. pharmacological intervention in adults with fibromyalgia related to childhood sexual abuse: prospective, randomized clinical trial , was conducted by the Sagol Center for Hyperbaric Medicine and Research at Shamir Medical Center and published in the peer-reviewed journal of Nature’s Scientific Reports.
  • Fibromyalgia syndrome (FMS) is a debilitating condition characterized by chronic widespread pain, along with symptoms of fatigue, disrupted sleep, and cognitive dysfunction.
  • Among these triggers, traumatic experiences, including childhood sexual, emotional, or physical abuse, have been suggested as predisposing factors in a substantial number of FMS patients.
  • The Aviv Medical Program includes an in-depth assessment of the patient’s physical and neurological condition to assess their overall health.

Kolmar BNH Expands Its Global Market by Launching HemoHIM G in Taiwan

Retrieved on: 
вторник, мая 28, 2024

Kolmar BNH (KRX: 200130), a prominent Korean health functional food Original Development Manufacturing (ODM) firm, announced that it has unveiled its latest offering, HemoHIM G, in Taiwan.

Key Points: 
  • Kolmar BNH (KRX: 200130), a prominent Korean health functional food Original Development Manufacturing (ODM) firm, announced that it has unveiled its latest offering, HemoHIM G, in Taiwan.
  • View the full release here: https://www.businesswire.com/news/home/20240527924165/en/
    Manufactured by Kolmar BNH and distributed by Atomy, HemoHIM G, containing Angelica sinensis, Ligusticum chuanxiong, and Paeonia lactiflora, is now available in Taiwan.
  • (Photo: Kolmar BNH)
    HemoHIM G represents an enhanced iteration of HemoHIM, tailored to meet the distinctive tastes of consumers in Taiwan and Europe.
  • Kolmar BNH plans to expedite its market expansion in Asia by launching HemoHIM G in the Taiwan market on May 15.