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Clinical Trial News

Symbiosis Pharmaceutical Services Achieves Manufacturing Milestone with 1,000th Sterile Injectable Batch

Monoclonal Antibody
  • Symbiosis Pharmaceutical Services, a global contract manufacturing organization, has successfully completed its 1,000th sterile drug product batch since its founding in 2011.
  • The Scottish-based company has manufactured complex injectable products including monoclonal antibodies, antibody-drug conjugates, viral vectors, and advanced therapy medicinal products across clinical and commercial stages.
  • Symbiosis played a crucial role in COVID-19 vaccine development by manufacturing nearly one million doses of the Oxford University/AstraZeneca vaccine at its Stirling facility to support clinical trials.
  • The milestone reflects the company's growth from a startup to an internationally recognized sterile manufacturer supporting global pharmaceutical development and commercial supply chains.

AbbVie's Rinvoq Achieves Breakthrough Results in Alopecia Areata Phase III Trial

  • AbbVie's Rinvoq demonstrated significant efficacy in a Phase III trial for alopecia areata, with 47.1% of patients achieving 90% or more scalp hair coverage on the 30mg dose versus 1.4% on placebo.
  • The UP-AA study represents the first pivotal clinical program to meet the rigorous standard of complete scalp hair regrowth (SALT=0) in patients with severe alopecia areata.
  • Guggenheim analysts called the results "impressive" and estimate the indication could add several hundred million to over $1 billion in annual sales for Rinvoq by the early 2030s.
  • The JAK inhibitor showed consistent safety profile with no major adverse cardiovascular events, malignancies, or deaths reported in the study.

A Study of Baricitinib (LY3009104) in Adults With Severe or Very Severe Alopecia Areata

NCT03899259CompletedPhase 3
Eli Lilly and Company
Posted 7/8/2019

A Study to Evaluate the Safety and Effectiveness of Upadacitinib Tablets in Adult and Adolescent Participants With Severe Alopecia Areata

NCT06012240Active, Not RecruitingPhase 3
AbbVie
Posted 10/11/2023

A Study of Baricitinib (LY3009104) in Participants With Severe or Very Severe Alopecia Areata

NCT03570749CompletedPhase 2
Eli Lilly and Company
Posted 9/24/2018

FDA Approves Expanded Biktarvy Indication for HIV Treatment-Experienced Patients Restarting Therapy

Drug Approval
  • The FDA has approved a new indication for Biktarvy to treat HIV patients with treatment history who are not virologically suppressed and are restarting antiretroviral therapy.
  • The approval addresses a critical unmet need, as only 65% of people with HIV in the US are virally suppressed and gaps in care account for nearly 80% of new HIV diagnoses.
  • The expanded indication is based on evidence from treatment-naïve studies 1489 and 1490, which demonstrated rapid viral suppression and zero treatment-emergent resistance cases through five years.
  • Healthcare providers can now more confidently support a broader range of HIV patients, including those who have interrupted treatment and need to restart therapy.

Study to Evaluate the Safety and Efficacy of Bictegravir/Emtricitabine/Tenofovir Alafenamide Versus Abacavir/Dolutegravir/Lamivudine in Human Immunodeficiency Virus-1 (HIV-1) Infected, Antiretroviral Treatment-Naive Adults

NCT02607930CompletedPhase 3
Gilead Sciences
Posted 11/13/2015

Study to Evaluate the Safety and Efficacy of Bictegravir/Emtricitabine/Tenofovir Alafenamide Versus Dolutegravir + Emtricitabine/Tenofovir Alafenamide in Human Immunodeficiency Virus (HIV-1) Infected, Antiretroviral Treatment-Naive Adults

NCT02607956CompletedPhase 3
Gilead Sciences
Posted 11/11/2015

Psyence BioMed Partner PsyLabs Achieves GMP-Grade Ibogaine Production Milestone

  • PsyLabs, a strategic partner of Psyence BioMed, successfully produced GMP-aligned Ibogaine Total Alkaloid extract that met all microbial safety standards for food-grade consumption.
  • The high-purity extract was verified by an accredited third-party laboratory, marking a significant advancement in scalable psychedelic API production.
  • PsyLabs is expanding its chemistry production area to meet growing demand for Ibogaine HCL, Psilocybin Isolate, and other 90% purity compounds derived from natural sources.
  • The achievement reflects Psyence BioMed's ongoing investment in PsyLabs since acquiring an equity stake in 2024, supporting development of compliant psychedelic therapeutics.

China Establishes Initial Pricing Mechanism for New Drugs to Boost Innovation Returns

  • China's National Healthcare Security Administration has officially established an initial pricing mechanism for newly launched drugs, marking a shift from cost-control to innovation-encouraging healthcare policies.
  • The mechanism allows high-quality innovative drugs to achieve "returns commensurate with high investment and high risk" with satisfactory price levels and five-year price stability periods.
  • Over 100 new price items for medical technologies including brain-computer interfaces have been added, facilitating faster clinical adoption and revenue generation for breakthrough technologies.
  • The policy addresses the long-standing challenge where innovative drugs faced significant price reductions to enter medical insurance coverage, severely dampening pharmaceutical innovation enthusiasm.

FDA Approves First Neuroimmune Modulation Device for Rheumatoid Arthritis Treatment

Drug Approval
  • The FDA has approved SetPoint Medical's SetPoint System, the first implantable neuroimmune modulation device for adults with moderate-to-severe rheumatoid arthritis who cannot tolerate or are inadequately managed by existing biologic therapies.
  • The approval was supported by the 242-patient RESET-RA trial, which met its primary efficacy endpoint with statistically significant ACR20 improvement at 3 months and sustained benefits through 12 months.
  • The device delivers daily electrical stimulation to the vagus nerve to activate the body's natural anti-inflammatory pathways, with 75% of patients remaining free of biologic DMARDs at 12 months.
  • SetPoint Medical plans a targeted U.S. launch in 2025, followed by national expansion in early 2026, with future evaluation planned for multiple sclerosis and Crohn's disease.

Vagus Nerve Stimulation for Moderate to Severe Rheumatoid Arthritis

NCT04539964Active, Not RecruitingPhase 3
SetPoint Medical Corporation
Posted 1/11/2021

UK CDMO Eramol Advances Sterile Manufacturing Facility for 2026 Launch

  • Eramol, a UK-based pharmaceutical CDMO, is developing an 11,000 square foot sterile manufacturing facility in Sevenoaks, Kent, scheduled to open in early 2026.
  • The facility features a 1,900 square foot GMP Grade A/C cleanroom suite designed for small to medium batch production of sterile injectable products.
  • The site incorporates cutting-edge equipment including Fedegari autoclave and high-performance isolator technology for aseptic filling into 2ml and 10ml vials.
  • MHRA inspection is anticipated by end of 2025, with the facility built to meet stringent 2023 EU GMP Annex 1 requirements.

Soligenix's SGX945 Matches Efficacy of FDA-Approved Therapy in Behçet's Disease Phase 2a Trial

Rare Disease
  • Soligenix's SGX945 demonstrated biological efficacy in a Phase 2a trial for Behçet's disease, achieving a 40% improvement in oral ulcer outcomes compared to 37% for FDA-approved apremilast.
  • The treatment showed sustained benefits through an 8-week follow-up period despite stopping therapy at week 4, with 7 of 8 patients reporting perceived clinical benefit.
  • SGX945 was well-tolerated with no treatment-related adverse events, contrasting with apremilast's common side effects including diarrhea, nausea, and headache.
  • The company plans to reformulate SGX945 for home-based subcutaneous administration and advance to a placebo-controlled Phase 2 study targeting this rare inflammatory disease affecting up to 1 million people worldwide.

Tirzepatide Demonstrates Cardiovascular Benefits in Type 2 Diabetes Patients with ASCVD and OSA

  • Tirzepatide showed noninferiority to dulaglutide for major adverse cardiovascular events in the SURPASS-CVOT trial, while reducing all-cause mortality by 16% in patients with type 2 diabetes and established atherosclerotic cardiovascular disease.
  • The GIP/GLP-1 dual agonist provided superior kidney protection and greater improvements in HbA1c and body weight compared to dulaglutide over a median 4-year follow-up period.
  • In patients with obstructive sleep apnea and type 2 diabetes, tirzepatide significantly reduced cardiovascular event risk by 42% compared to liraglutide and 14% compared to semaglutide in real-world data analysis.
  • The cardiovascular benefits were observed across multiple patient subgroups, supporting tirzepatide's potential as a front-line treatment for high-risk diabetes patients.

Ultromics Secures $55M Series C to Scale AI-Powered Heart Failure Diagnostics Across US Hospitals

AI
  • Ultromics raised $55 million in Series C funding to expand its FDA-cleared EchoGo platform for detecting heart failure with preserved ejection fraction (HFpEF) and cardiac amyloidosis across US hospitals.
  • The AI-powered diagnostic tool improved HFpEF detection by 73.6% compared to traditional methods and has analyzed over 430,000 echocardiograms to date.
  • With Medicare reimbursement secured and partnerships with major health systems including UChicago Medicine and Mayo Clinic, the platform addresses a critical diagnostic gap where up to 64% of heart failure cases go undetected.
  • Heart failure drives over $30 billion in annual US healthcare costs, projected to exceed $70 billion by 2030, highlighting the urgent need for improved diagnostic capabilities.

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