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Clinical Trial News

FDA Rejects Accelerated Approval for Moderna and Merck's AI-Driven Melanoma Vaccine

  • The FDA has denied accelerated approval for Moderna and Merck's mRNA-4157 melanoma vaccine, which uses AI to personalize the formulation.
  • The decision follows concerns from FDA officials regarding the review of drugs developed using artificial intelligence technologies.
  • Moderna views the denial as a step in ongoing discussions with regulators regarding the innovative vaccine candidate.
  • The melanoma vaccine is currently undergoing Phase 3 trials to assess its efficacy and safety profile.

Moderna Scales Back RSV Ambitions, Cuts Pipeline Programs Amid Market Challenges

  • Moderna acknowledges slower-than-expected uptake of its RSV vaccine mResvia, facing stiff competition from established players GSK and Pfizer in the U.S. market.
  • The company announces significant restructuring, including $1.1 billion reduction in annual R&D spending by 2027 and discontinuation of five pipeline programs including cancer treatments and RSV infant vaccine.
  • Despite setbacks, Moderna outlines strategic shift focusing on oncology development while maintaining respiratory disease programs, targeting five new product launches by 2027.

FDA Approves Genentech's Tecentriq Hybreza, First Subcutaneous Anti-PD-(L)1 Immunotherapy

  • The FDA has approved Tecentriq Hybreza, a subcutaneous formulation of atezolizumab, marking the first subcutaneous anti-PD-(L)1 cancer immunotherapy in the U.S.
  • Tecentriq Hybreza reduces treatment time to approximately 7 minutes via subcutaneous injection, compared to 30-60 minutes for intravenous infusion.
  • Approval was based on the IMscin001 study, demonstrating comparable efficacy, safety, and blood concentration levels to intravenous Tecentriq.
  • A patient preference study showed that 71% of patients preferred Tecentriq Hybreza due to reduced clinic time and increased comfort.

A Study to Investigate Atezolizumab Subcutaneous in Patients With Previously Treated Locally Advanced or Metastatic Non-Small Cell Lung Cancer

NCT03735121CompletedPhase 3
Hoffmann-La Roche
Posted 12/14/2018

EQBMED Partners with Amgen and Merck to Enhance Diversity in Clinical Trials

  • Equitable Breakthroughs in Medicine Development (EQBMED) collaborates with Amgen and Merck to increase diversity in clinical trials, focusing on oncology and cardiovascular disease.
  • The partnership aims to co-design strategies that foster closer collaborations with local EQBMED trial sites and communities to engage underrepresented patients.
  • Amgen plans to enhance infrastructure at community-facing sites, while Merck will develop a clinical trial site assessment model and provide patient navigation support.
  • EQBMED's initiative reflects a growing effort to address health equity gaps by tailoring clinical trials to community priorities and increasing clinical trial representation.

FDA Approves Lilly's Ebglyss (lebrikizumab) for Moderate-to-Severe Atopic Dermatitis

  • The FDA has approved Ebglyss (lebrikizumab) for adults and children 12 years and older with moderate-to-severe atopic dermatitis not well controlled by topical treatments.
  • Clinical trials showed Ebglyss significantly cleared skin in patients as early as four weeks and provided meaningful itch relief as early as two weeks.
  • Ebglyss offers long-lasting efficacy with a monthly maintenance dose after an initial treatment phase, providing sustained relief for up to one year.
  • Ebglyss, a targeted IL-13 inhibitor, can be used with or without topical corticosteroids, offering a new first-line biologic treatment option.

AI Technology Revolutionizes Pharmaceutical Supply Chain Management to Combat Drug Shortages

  • Advanced AI algorithms are transforming pharmaceutical supply chains by providing real-time insights and predictive analytics, with 41% of pharmaceutical companies reporting supply chain disruptions as of June 2022.
  • AI-driven inventory management systems have demonstrated the ability to reduce pharmaceutical waste by up to 30% through improved forecasting and distribution optimization.
  • Integration of AI with IoT and blockchain technologies is enabling enhanced supply chain visibility, optimized logistics, and proactive disruption management across the pharmaceutical industry.

FDA Approves Subcutaneous Atezolizumab (Tecentriq Hybreza) for Multiple Cancer Types

  • The FDA has approved a subcutaneous formulation of atezolizumab and hyaluronidase-tqjs (Tecentriq Hybreza) for all indications of intravenous atezolizumab.
  • This includes non-small cell lung cancer, small cell lung cancer, hepatocellular carcinoma, melanoma, and alveolar soft part sarcoma.
  • The approval was based on the IMscin001 trial, which demonstrated comparable drug levels and similar safety and efficacy profiles to IV administration.
  • The subcutaneous injection offers a faster, more convenient administration route, taking approximately 7 minutes compared to 30-60 minutes for IV infusion.

A Study to Investigate Atezolizumab Subcutaneous in Patients With Previously Treated Locally Advanced or Metastatic Non-Small Cell Lung Cancer

NCT03735121CompletedPhase 3
Hoffmann-La Roche
Posted 12/14/2018

Gilead's Lenacapavir Shows Promise in HIV Prevention and Treatment

  • Gilead's twice-yearly injectable lenacapavir reduced HIV infections by 96% in a Phase 3 trial, demonstrating superiority to daily oral Truvada for PrEP.
  • The PURPOSE 2 trial included cisgender men, transgender individuals, and gender non-binary people, showing broad efficacy across diverse populations.
  • Gilead plans to begin regulatory filings for lenacapavir for PrEP by the end of 2024, with potential launch in 2025, prioritizing access in high-incidence, resource-limited countries.
  • A Phase 2 trial of once-weekly oral islatravir and lenacapavir maintained viral suppression in adults with HIV, paving the way for Phase 3 trials.

Study to Compare an Oral Weekly Islatravir/Lenacapavir Regimen With Bictegravir/Emtricitabine/Tenofovir Alafenamide in Virologically Suppressed People With HIV-1

NCT06630286Active, Not RecruitingPhase 3
Gilead Sciences
Posted 10/9/2024

Pre-Exposure Prophylaxis Study of Lenacapavir and Emtricitabine/Tenofovir Alafenamide in Adolescent Girls and Young Women at Risk of HIV Infection

NCT04994509Active, Not RecruitingPhase 3
Gilead Sciences
Posted 8/30/2021

Study of Lenacapavir and Emtricitabine/Tenofovir Disoproxil Fumarate (F/TDF) for Prevention of HIV in People Who Inject Drugs (HPTN 103)

NCT06101342Active, Not RecruitingPhase 2
Gilead Sciences
Posted 12/13/2023

Study of Lenacapavir and Emtricitabine/Tenofovir Disoproxil Fumarate (F/TDF) in Prevention of HIV in Cisgender Women in the United States (HPTN 102)

NCT06101329Active, Not RecruitingPhase 2
Gilead Sciences
Posted 11/17/2023

Study of Lenacapavir for HIV Pre-Exposure Prophylaxis in People Who Are at Risk for HIV Infection

NCT04925752Active, Not RecruitingPhase 3
Gilead Sciences
Posted 6/28/2021

Study to Compare an Oral Weekly Islatravir/Lenacapavir Regimen With Standard of Care in Virologically Suppressed People With HIV-1

NCT06630299Active, Not RecruitingPhase 3
Gilead Sciences
Posted 10/8/2024

Study Evaluating the Safety and Efficacy of Islatravir in Combination With Lenacapavir in Virologically Suppressed People With HIV

NCT05052996Active, Not RecruitingPhase 2
Gilead Sciences
Posted 10/5/2021

CVRx's Barostim Device Shows Durable Benefits in Heart Failure Patients Over Two Years

• CVRx reported that its Barostim device provides sustained improvements in heart failure patients over 24 months, enhancing their physical and psychosocial well-being. • The Barostim device, which uses baroreflex activation therapy, electrically stimulates baroreceptors to restore balance to the autonomic nervous system. • The study, published in the Journal of the American College of Cardiology: Heart Failure, builds on earlier data demonstrating long-term symptomatic benefits. • Barostim received FDA approval in 2019 for advanced heart failure and expanded its label in 2023 for broader use in heart failure patients.

Baroreflex Activation Therapy for Heart Failure

NCT02627196Active, Not RecruitingNot Applicable
CVRx, Inc.
Posted 4/19/2016

Neurocrine's Luvadaxistat Fails Phase II Trial for Cognitive Impairment in Schizophrenia

  • Neurocrine Biosciences' ERUDITE Phase 2 trial of luvadaxistat did not meet its primary endpoint for improving cognitive impairment in schizophrenia patients.
  • The trial's failure contrasts with positive results from the earlier INTERACT study, attributed to variability in cognitive measures and baseline imbalances.
  • Neurocrine will halt luvadaxistat development and focus on Phase 3 trials of NBI-1117568 for schizophrenia and NBI-1065845 for major depressive disorder.

Study to Evaluate the Efficacy, Safety, and Tolerability of Luvadaxistat in Participants With Cognitive Impairment Associated With Schizophrenia

NCT05182476TerminatedPhase 2
Neurocrine Biosciences
Posted 12/7/2021

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