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Clinical Trial News

Global Breast Cancer Therapeutics Market Expected to Reach $78.61 Billion by 2033

OncologyTargeted TherapyMonoclonal AntibodyAIPrecision MedicineDrug Approval
• The global breast cancer therapeutics market, valued at $32.93 billion in 2023, is projected to reach $78.61 billion by 2033, growing at a CAGR of 9.09% over the next decade.
• North America dominates the market with a 38.61% revenue share, driven by high breast cancer prevalence and presence of key pharmaceutical companies including Pfizer, Roche, and Novartis.
• Targeted therapies hold the largest market segment at 64.85%, with hormone receptor-positive treatments accounting for 66.97% of the market as precision medicine approaches gain traction.

China Dominates AI-Driven Drug Discovery Patent Landscape, Reshaping Pharmaceutical R&D

AIDrug Discovery
  • China has filed over 38,000 generative AI patent applications between 2014-2023, with a significant portion focused on drug discovery and compound screening technologies.
  • The surge in Chinese AI pharmaceutical patents is fueled by government investment, tech giant participation, pharmaceutical market growth, and access to vast healthcare data resources.
  • AI-driven drug discovery systems being patented can analyze chemical compounds, predict properties, and identify drug candidates more efficiently, potentially reducing development timelines and costs.

CNIPA Upholds Vortioxetine Crystal Form Patent in Landmark Decision for Pharmaceutical IP in China

  • China's National Intellectual Property Administration (CNIPA) has made landmark decisions upholding the validity of a crystal form patent for the antidepressant Vortioxetine (Brintellix®), establishing important precedents for pharmaceutical patents in China.
  • The CNIPA ruled that the β-type crystal form of Vortioxetine hydrobromide demonstrated unexpected technical effects with its optimal balance of high melting point, low hygroscopicity, and appropriate solubility, confirming its inventiveness.
  • This decision highlights the growing importance of crystal form patents in China's pharmaceutical landscape, especially as they remain outside the country's patent linkage system, creating potential market barriers for generic manufacturers.

FDA Approves Vabysmo Prefilled Syringe for Key Causes of Vision Loss

  • The FDA has approved Genentech's Vabysmo prefilled syringe (PFS) for treating wet AMD, DME, and macular edema following RVO, impacting nearly three million people in the U.S.
  • Vabysmo is the first bispecific antibody for the eye, targeting Ang-2 and VEGF-A, offering rapid vision improvement and retinal drying in approved conditions.
  • The Vabysmo PFS provides the same medicine as the vial form in a ready-to-use format, simplifying administration for retina specialists and enhancing patient experience.
  • Over four million doses of Vabysmo have been distributed globally since its initial approval in 2022, with ongoing reviews by health authorities worldwide.

GSK's Dostarlimab Expands Development Portfolio to Target Multiple Advanced Cancers

  • Dostarlimab (Jemperli), GSK's humanized monoclonal antibody, is currently approved for dMMR/MSI-H endometrial cancer and is expanding into multiple solid tumor indications through clinical development.
  • The PD-1 inhibitor, administered intravenously, works by activating anti-tumor immunity and is being investigated for over 20 different cancer types, including head and neck, lung, and colorectal cancers.
  • Originally approved for endometrial cancer treatment, Dostarlimab represents a significant advancement in immunotherapy, particularly for patients who have progressed after platinum-based chemotherapy.

UK Survey Reveals 8-Year Treatment Delay and Severe Impact of Chronic Hand Eczema on Daily Life

  • A UK survey commissioned by LEO Pharma reveals chronic hand eczema (CHE) patients wait an average of 8 years before seeking medical help, despite severe impact on quality of life.
  • Seven out of ten CHE patients report significant interference with relationships and work/education, with 75% agreeing hand eczema is more challenging than eczema on other body parts.
  • Only 14% of patients discuss emotional impact with healthcare providers, highlighting a critical gap in care, while current treatment options remain limited with significant side effects.

Semaglutide Drugs Ozempic and Wegovy Linked to Increased Risk of Blinding Eye Condition in New Study

  • A Harvard-led study found patients prescribed semaglutide (Ozempic/Wegovy) were 4-7 times more likely to develop NAION, a rare eye condition causing permanent vision loss.
  • The research analyzed over 16,000 patients and found 8.9% of diabetic patients on semaglutide developed NAION compared to 1.8% on other diabetes drugs over three years.
  • NAION affects 10 out of 100,000 people and causes sudden, painless vision loss in one eye with no current effective treatments available.
  • Researchers emphasize the findings are significant but tentative, requiring larger studies to confirm the association between semaglutide use and vision complications.

Annovis Bio's Buntanetap Shows Cognitive Improvement in Parkinson's Subgroup

• Annovis Bio's buntanetap demonstrated significant cognitive improvements in Parkinson's patients diagnosed more than three years ago, according to Phase III trial subgroup analysis. • The study highlighted improvements in MDS-UPDRS Part II, Part III, and Phase II+III scores with the 20mg dose of buntanetap compared to placebo. • A separate subgroup analysis showed significant improvements in patients with postural instability and gait difficulty (PIGD), a subset linked to faster disease progression. • Annovis plans to advance buntanetap into a longer study to verify symptomatic improvements and explore its potential disease-modifying properties.

A Double-blind Study to Investigate Efficacy and Safety of Buntanetap Compared With Placebo in Participants With Early PD

NCT05357989CompletedPhase 3
Annovis Bio Inc.
Posted 8/3/2022

A Dose-ranging Study to Investigate Efficacy of Buntanetap in Mild to Moderate AD

NCT05686044CompletedPhase 2
Annovis Bio Inc.
Posted 4/1/2023

Twice-Yearly Lenacapavir Injections Show 100% Efficacy in Preventing HIV in Women

  • A clinical trial in South Africa and Uganda demonstrated that lenacapavir, administered via injection every six months, provided complete protection against HIV infection in young women.
  • The Purpose 1 trial compared lenacapavir to daily oral PrEP medications, Truvada (F/TDF) and Descovy (F/TAF), with lenacapavir showing significantly higher efficacy.
  • The trial's independent data safety monitoring board recommended halting the blinded phase due to the clear benefit of lenacapavir, offering all participants a choice of PrEP.
  • Gilead Sciences, the drug developer, plans to submit the trial results to regulatory bodies and the WHO, with hopes of incorporating lenacapavir into HIV prevention guidelines.

FDA Approves Lilly's Kisunla (donanemab-azbt) for Early Symptomatic Alzheimer's Disease

  • The FDA has approved Kisunla (donanemab-azbt) for treating early symptomatic Alzheimer's disease, including mild cognitive impairment and mild dementia stages.
  • Kisunla is the first amyloid plaque-targeting therapy allowing treatment cessation upon plaque removal, potentially reducing costs and infusion frequency.
  • Clinical trials showed Kisunla significantly slowed cognitive decline by 35% in early-stage patients and reduced amyloid plaques by up to 84% over 18 months.
  • Treatment with Kisunla carries potential side effects, including amyloid-related imaging abnormalities (ARIA) and infusion-related reactions, requiring careful monitoring.

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