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Clinical Trial News

Dr. Reddy's Rituximab Biosimilar Receives Positive CHMP Opinion for EU Launch

  • Dr. Reddy's Laboratories has received a positive opinion from the EMA's CHMP for its proposed rituximab biosimilar, DRL_RI (ITUXREDI), paving the way for its launch in European markets.
  • The CHMP's positive opinion will be reviewed by the European Commission for marketing authorization in EU member countries and EEA states.
  • DRL_RI is developed as a biosimilar of MabThera (rituximab), a CD20-directed cytolytic antibody, targeting indications like NHL, CLL, RA, GPA/MPA, and PV.
  • A separate Marketing Authorisation Application (MAA) will be submitted to the UK MHRA following the reliance route under the International Recognition Procedure (IRP).

Kailera Bio Obtains $400M to Fast-Track Obesity Drug into Phase 3 Trials

  • Kailera Bio, led by Ron Renaud, secures $400 million in funding to expedite the development of a novel obesity treatment.
  • The funding will enable Kailera to bypass Phase 2 trials and proceed directly to Phase 3 clinical studies, accelerating the drug's path to market.
  • This investment reflects significant interest in innovative obesity therapies and the potential for Kailera's drug to address a critical unmet need.
  • Kailera aims to become a significant player in the obesity treatment landscape by rapidly advancing its drug through clinical development.

Children's of Alabama Advances Pediatric Cancer Treatment Through Clinical Trials

  • Children's of Alabama is pioneering advanced cancer treatments for pediatric patients through its robust clinical trials program.
  • The hospital collaborates with institutions nationwide, providing access to cutting-edge therapies for children with cancer in Alabama.
  • Clinical trials at Children's of Alabama offer hope for children with relapsed or treatment-resistant cancers, improving their chances of survival.
  • A young leukemia survivor, Will Hicks, exemplifies the success of these trials, highlighting the potential for life-saving outcomes.

Sagimet's Denifanstat Receives FDA Breakthrough Therapy Designation for MASH

• Sagimet Biosciences' denifanstat has been granted Breakthrough Therapy Designation by the FDA for treating noncirrhotic MASH with moderate to advanced liver fibrosis. • The designation was based on clinical data demonstrating denifanstat's potential to address the underlying metabolic dysfunction in MASH patients. • Sagimet is actively preparing to initiate a Phase 3 clinical program for denifanstat by the end of 2024, aiming to confirm its efficacy and safety. • Denifanstat, a fatty acid synthase (FASN) inhibitor, represents a novel approach to treating MASH by targeting dysfunctional metabolic pathways.

WHO Declares Mpox a Global Health Emergency Amidst Rising Cases of More Virulent Strain

  • The WHO has declared mpox a Public Health Emergency of International Concern due to a surge in cases, particularly of the more virulent clade IB strain.
  • The declaration aims to accelerate access to testing, vaccines, and therapeutic drugs in affected regions, with the WHO releasing $1.5 million for containment efforts.
  • Currently, mpox treatment relies on supportive care and antivirals like cidofovir or tecovirimat, while a specific vaccine is urgently needed, with China leading vaccine development.
  • Despite an increase in mpox trials in 2022, global research efforts need to be intensified to address the deadly disease effectively.

Targeted Therapy Improves Outcomes in Pretreated Metastatic Solid Tumors: ROME Trial

  • The phase 2 ROME trial demonstrated that targeted treatment, guided by genomic profiling, significantly improved overall response rate (ORR) in pretreated metastatic solid tumor patients.
  • Progression-free survival (PFS) was also significantly longer in the targeted treatment arm compared to standard of care (SOC), with a hazard ratio of 0.64 (p < 0.001).
  • Exploratory analysis in patients with high tumor mutational burden (hTMB) and microsatellite stability (MSS) showed improved PFS with targeted immunotherapy versus SOC.
  • The rate of grade 3 or higher adverse events was lower in the targeted treatment arm, suggesting a better safety profile compared to standard of care.

The Rome Trial From Histology to Target: the Road to Personalize Target Therapy and Immunotherapy

NCT04591431Active, Not RecruitingPhase 2
Fondazione per la Medicina Personalizzata
Posted 10/7/2020

Imeglimin's Metabolic Action Investigated in New Study Using Advanced Glucose Clamp Technology

  • A study investigates imeglimin's impact on metabolic function using a two-step hyperinsulinemic-euglycemic glucose clamp, employing an artificial endocrine pancreas to maintain glucose levels.
  • Researchers monitor participants' diet and physical activity meticulously before and during the clamp test to ensure accurate measurement of imeglimin's effects.
  • The study assesses hepatic, muscle, and adipose tissue insulin sensitivity, along with insulin clearance and feedback inhibition of insulin secretion, providing a comprehensive metabolic profile.
  • This research aims to elucidate imeglimin's mechanisms of action, potentially enhancing diabetes treatment strategies by improving insulin sensitivity in key tissues.

Teva Pharmaceuticals Launches Generic Octreotide Acetate for Injectable Suspension

  • Teva Pharmaceuticals has launched the first generic version of Sandostatin LAR Depot in the U.S., offering a new treatment option.
  • The generic octreotide acetate is indicated for treating acromegaly and severe diarrhea associated with carcinoid syndrome.
  • Sandostatin LAR Depot, the branded version, recorded annual sales of $826 million as of July 2024, indicating a substantial market.
  • This launch provides a more accessible alternative for patients requiring this important medication, according to Teva.

Ascelia Pharma's Orviglance Phase III Data to Be Presented at RSNA Conference

  • Ascelia Pharma's Phase III SPARKLE study results for Orviglance will be presented at the Radiological Society of North America (RSNA) annual conference in December.
  • The SPARKLE study investigated Orviglance as a liver-specific MRI contrast agent for patients with severe kidney disease.
  • The presentation highlights the potential clinical value of Orviglance as a new manganese-based MRI contrast option.
  • The study's acceptance as an oral presentation at RSNA underscores the significance of its findings in radiology.

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