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Clinical Trial News

Cadila Pharmaceuticals Launches Biscado (Bisoprolol) to Address India's Cardiovascular Disease Burden

  • Cadila Pharmaceuticals has launched Biscado (Bisoprolol), a highly cardioselective beta-1 adrenergic blocker, marking its entry into the beta-blocker therapy segment for cardiovascular disease management.
  • The launch is particularly significant for India, where individuals are predisposed to higher sympathetic activity and elevated resting heart rates, with studies showing a 10 beats per minute increase in resting heart rate associated with a 20% increase in cardiovascular death risk.
  • Clinical evidence from the landmark CIBIS-II study demonstrates Biscado's efficacy with a 34% reduction in all-cause mortality, 44% reduction in sudden cardiac death, and 36% reduction in heart failure hospitalizations.
  • The drug will be available in both monotherapy and fixed-dose combinations with other antihypertensive agents, providing comprehensive cardiovascular management options for physicians.

Hemab Therapeutics Advances Bleeding Disorder Pipeline with Promising Clinical Data at ISTH 2025

Monoclonal AntibodyOrphan Drug
  • Sutacimig (formerly HMB-001) demonstrates promising interim Phase 2 safety and efficacy results for Glanzmann thrombasthenia, receiving WHO International Non-Proprietary Name designation.
  • HMB-002 shows initial proof of mechanism clinical data in Von Willebrand disease patients through the ongoing VELORA Pioneer study, supported by comprehensive preclinical data.
  • Natural history studies reveal significant disease burden, with 88% of Glanzmann thrombasthenia patients reporting at least one bleed weekly and 34% requiring medical treatment.
  • Hemab will present 11 abstracts across multiple bleeding disorder programs at the International Society on Thrombosis and Haemostasis Congress in Washington, DC.

A Study of Bleeding and Treatment in Participants With Von Willebrand Disease

NCT06610201Recruiting
Hemab ApS
Posted 8/30/2024

A Phase 1/2 Study to Investigate Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of HMB-001 in Glanzmann Thrombasthenia

NCT06211634Active, Not RecruitingPhase 1
Hemab ApS
Posted 12/13/2022

A Study Assessing HMB-002 in Participants With Von Willebrand Disease

NCT06754852RecruitingPhase 1
Hemab ApS
Posted 2/6/2025

XL-protein Grants Worldwide License to Grifols for PASylation-Enhanced Biopharmaceutical Development

  • XL-protein has entered into a worldwide licensing agreement with Grifols to develop long-acting biopharmaceuticals using proprietary PASylation technology.
  • The collaboration will leverage XL-protein's clinical-stage PASylation technology to extend circulation time of Grifols therapeutics for more effective treatments.
  • Under the agreement, XL-protein will receive upfront payments plus milestone payments and tiered royalties, while Grifols gains worldwide exclusive marketing rights.

XPro™ Shows Promise in Reducing Alzheimer's Pathology Following Traumatic Brain Injury in Preclinical Study

  • INmune Bio's XPro™ (XPro1595, pegipanermin) significantly reduced amyloid formation and improved brain function in transgenic mice following traumatic brain injury.
  • The study demonstrated that XPro™ treatment administered 30 minutes post-injury prevented elevations in key Alzheimer's disease markers including TNFR1, BACE1, and Aβ42 levels.
  • Research findings support XPro™ as a promising therapeutic approach to reduce Alzheimer's disease pathology risk in patients who experience traumatic brain injury.
  • The drug works by selectively neutralizing soluble TNF without affecting transmembrane TNF or TNF receptors, targeting neuroinflammation linked to neurodegeneration.

Femasys Partners with Carolinas Fertility Institute to Expand FemaSeed Access Across North Carolina Network

  • Femasys Inc. announced a partnership with Carolinas Fertility Institute to offer FemaSeed intratubal insemination across CFI's network of more than 8 locations in North Carolina.
  • FemaSeed achieved over double the pregnancy rates of traditional intrauterine insemination (IUI) in cases of low male sperm count according to pivotal clinical trial data.
  • The partnership expands access to FemaSeed as a less invasive and cost-effective first-line fertility treatment option before patients consider IVF.
  • Carolinas Fertility Institute serves patients across North Carolina and the Southeast with locations in Winston-Salem, Greensboro, and Charlotte.

Prospective Multi-Center Trial for FemBloc Permanent Birth Control

NCT05977751RecruitingNot Applicable
Femasys Inc.
Posted 10/31/2023

Weekly Oral Risperidone Shows Promise for Schizophrenia Treatment in Phase 3 Trial

  • LYN-005, a once-weekly oral formulation of risperidone, demonstrated therapeutic drug levels comparable to daily dosing in the first successful Phase 3 trial of long-acting oral technology for psychiatric disorders.
  • The STARLYNG-1 trial showed that weekly dosing maintained stable drug concentrations throughout the week with efficacy and safety profiles similar to immediate-release risperidone.
  • Despite promising results, the study faced significant limitations including a 43% dropout rate, short duration of five weeks, and occurrence primarily in structured inpatient settings.
  • This breakthrough could address medication adherence challenges in schizophrenia treatment by offering an alternative to daily pills or monthly injections for patients who struggle with current dosing regimens.

OneSource Specialty Pharma Partners with Xbrane Biopharma for Commercial Biosimilar Manufacturing

  • OneSource Specialty Pharma Limited has entered a strategic manufacturing partnership with Sweden-based Xbrane Biopharma AB to support commercial production of biosimilar products targeting EUR 23 billion in annual peak sales.
  • Xbrane's lead biosimilar candidate Ximluci, a ranibizumab biosimilar, has received European market authorization and launched in 2023, with U.S. approval currently under review.
  • The collaboration will involve technology transfer to OneSource's integrated biologics facility in Bangalore, India, while enabling regulatory approvals from the U.S. FDA and EMA for OneSource's manufacturing capabilities.
  • OneSource has also invested in Xbrane's recent funding round, demonstrating long-term strategic commitment between the two companies to expand global access to affordable biologics.

Cyclopharm Secures Maximum 5-Year US Patent Extension for Technegas Lung Imaging Agent Through 2031

  • Cyclopharm received the maximum allowable five-year patent extension from the USPTO, extending Technegas exclusivity in the US market until 2031.
  • The nuclear medicine ventilation imaging agent is used for diagnosing pulmonary embolism and provides superior lung periphery visualization compared to conventional methods.
  • The patent extension ensures uninterrupted US market exclusivity without risk of generic competition, supporting commercialization efforts in the world's largest healthcare market.
  • FDA's thorough regulatory review and continued support during the patent process reinforces Technegas' position as the leading nuclear medicine agent for functional lung ventilation imaging.

Modified DASH Diet Shows Significant Blood Pressure Benefits in Type 2 Diabetes Patients

  • A modified DASH diet tailored for diabetes (DASH4D) significantly reduced systolic blood pressure by 4.6 mm Hg and diastolic pressure by 2.3 mm Hg in type 2 diabetes patients.
  • The blood pressure reduction was achieved even in patients already taking multiple antihypertensive medications, with 66% of participants on two or more blood pressure drugs.
  • The DASH4D diet combines traditional DASH principles with diabetes-specific modifications including lower carbohydrates, higher unsaturated fats, and reduced potassium intake.
  • Sodium reduction appeared to have a stronger impact on lowering blood pressure than the DASH4D diet alone, highlighting the importance of dietary sodium restriction in diabetes management.

ANGLE's Parsortix System Enables Breakthrough Cancer Research Revealing CTC Clusters as Key Metastatic Drivers

  • ANGLE's Parsortix system has enabled multiple breakthrough studies published in high-impact journals, revealing novel insights into circulating tumor cell biology and cancer metastasis mechanisms.
  • Research published in Nature Genetics demonstrates that CTC clusters exhibit significant genetic diversity and are up to 100 times more metastatic than individual CTCs, making them critical targets for preventing cancer spread.
  • Additional studies using the Parsortix platform have uncovered substantial tumor cell release during prostate and ovarian cancer surgeries, opening new avenues for understanding surgical risks and developing protective strategies.
  • The mechanical conditioning research in breast cancer patients revealed progressive increases in metastatic potential through the cancer cascade, potentially guiding treatment selection with anti-fibrotic drugs.

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