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Clinical Trial News

Global Economic Pressures Force Pharmaceutical Industry to Confront Radical Transformation

  • The pharmaceutical industry faces unprecedented challenges due to patent cliffs, pricing pressures, and a shift from blockbuster drugs to niche products, necessitating fundamental industry restructuring.
  • Healthcare systems, particularly in the UK and US, are implementing severe cost-cutting measures, with the NHS targeting £20bn in annual savings and US healthcare requiring $80bn reduction over 10 years.
  • Industry experts call for urgent reform of regulatory frameworks, including Good Clinical Practice guidelines and EU Clinical Trials directive, to maintain pharmaceutical innovation while managing rising development costs.

FDA Expands Access to Investigational Drugs for Treatment Use

The FDA has finalized a rule to expand access to investigational drugs for patients with serious or immediately life-threatening diseases or conditions who have no comparable or satisfactory alternative therapy. This rule aims to increase awareness and knowledge of expanded access programs, detailing criteria, submission requirements, and safeguards for different types of expanded access.

FDA Approves Sanofi's Multaq for Atrial Fibrillation Patients, Marking First New Treatment in Two Decades

Drug Approval
  • The FDA has approved Sanofi's Multaq (dronedarone) to reduce cardiovascular hospitalization risk in patients with atrial fibrillation or atrial flutter, representing the first new treatment option in this therapeutic area in twenty years.
  • The approval is based on five clinical studies involving 6,300 patients, with the landmark ATHENA trial demonstrating a 24% reduction in cardiovascular hospitalization or death from any cause compared to placebo.
  • Multaq showed significant clinical benefits including a 28% reduction in total hospital days and 35% decrease in heart-related hospitalization time in atrial fibrillation patients.
  • The drug is contraindicated in patients with severe heart failure, following results from the ANDROMEDA trial that showed increased mortality risk in this population.

NZ Scientist's Gene Research Offers Hope Against Obesity Epidemic

A New Zealand researcher, Professor Matthew During, is pioneering gene therapy to combat obesity, following successful animal trials. The therapy targets the brain's hypothalamus to regulate weight and could enter human clinical trials within a year.

FDA Issues Guidance for Cardiovascular Risk Assessment of Novel Antidiabetic Agents

The FDA has released final guidance for assessing cardiovascular risks in new type 2 diabetes treatments, emphasizing the importance of clinical trials to ensure these therapies do not increase cardiovascular event risks. The guidance mandates detailed safety information from Phase II and III trials, including the establishment of a cardiovascular end-point committee and the inclusion of high-risk individuals. A meta-analysis of trial data is required post-trial to evaluate drug safety comprehensively.

WuXi PharmaTech Strengthens Board with Strategic Appointments of Industry Veterans

• WuXi PharmaTech has appointed several key executives to its Board of Directors, including Ying Han, Stewart Hen, and co-founder Ning Zhao, bringing valuable financial and pharmaceutical expertise to the company.
• The strategic board appointments aim to enhance WuXi's business operations and financial systems as the company continues to expand its pharmaceutical R&D outsourcing services in China and the United States.
• Co-founder Tao Lin has stepped down from his position on the board and as Vice President of Internal Operations, marking a significant leadership transition for the growing pharmaceutical services organization.

New Cancer Treatment Successes Identified in Phase 3 Trials

A comprehensive evaluation of phase 3 randomized controlled trials (RCTs) conducted by the NCI-funded COG program from 1955 to 2000 reveals that new cancer treatments were statistically superior in 24% of comparisons, with a 5% relative reduction in the death rate. The study highlights the importance of the ethical principle of equipoise in clinical research and suggests that the current system of RCTs in cancer is efficient within certain limits, with a consistent pattern of treatment successes over time.

KU Team Announces Breakthrough in Leishmaniasis Treatment

Scientists at Karachi University's H.E.J. Research Institute of Chemistry have developed a herbal ointment for treating cutaneous leishmaniasis, showing high success rates in clinical trials without side effects. The disease, a significant public health concern in Pakistan, has seen a 90% treatment success rate in trials.

Study on Adherence to Glaucoma Medication Regimens

A study utilizing electronic monitoring to objectively measure adherence to glaucoma medication regimens found good adherence rates among patients using once-daily prostaglandin analogs, whether as sole therapy or with an adjunctive medicine.

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