Regulatory Affairs Editorial

  1. Mitsubishi Tanabe Tweaks Study Design For ALS Success

    A new treatment for adult patients with ALS, also known as Lou Gehrig’s disease, is now available to patients in the U.S. Produced by Mitsubishi Tanabe Pharma America, Inc. (MTPA),RADICAVA is the first ALS treatment to be approved by the FDA in more than 20 years. While it will not reverse the effects of ALS, a recent clinical trial found it slowed the decline in physical function of patients by 33 percent.

  2. Novartis: Pragmatic Clinical Trials & RWE Gain Traction

    In this Q&A, Sameer Tandon, head of strategic alliances and customer transactions in U.S. medical affairs for Novartis, shares some of the challenges of his job and what trends will shape the future of the medical affairs group. Tandon discusses real-world evidence, FDA, payers, working with CROs, procurement costs, and more.

  3. Pharma “Not Prepared” For New EU Data Protection Regulation

    Pharmaceutical companies, CROs, and software/application vendors with operations in the European Union (EU) may be at serious risk from the new EU General Data Protection Regulation (GDPR). Violations of the regulation, which is set to go into effect in 2018, can result in penalties of €20 million or 4 percent of worldwide revenue.

  4. Senate Revises Right-To-Try, CUPA Still Gives Thumbs Down

    In August, the Senate passed, via unanimous consent, a bill that claims to improve access to experimental drugs for patients. While the Senate made numerous changes to the original Right-To-Try (RTT) bill, the New York University School of Medicine Working Group on Compassionate Use and Pre-Approval Access (CUPA), which came out against the bill advanced by the House, remains steadfast in its opposition to the legislation.

  5. Clinical News Roundup: FDA Says Three-Parent Baby Technique is Illegal

    Clinical News Roundup for the week of August 6, 2017 with information on mitochondrial replacement technology, PRA acquiring Symphony Health, and startup monARC building patient networks for next-generation clinical trials.

  6. DIA Trends: Technology, Trial Design, & Regulators

    In his role as SVP and managing director, Americas for DIA Global, Sudip Parikh has the opportunity to look across the pharmaceutical industry at what companies are doing in regard to clinical trials. In this article, he shares his insights into what the industry can do to make trials more efficient and speed up the entire trial process.

  7. Clinical News Roundup: LabCorp To Acquire Chiltern

    Clinical News Roundup for the week of July 30, 2017 with information on LabCorp acquisition of Chiltern, merger of INC Research and inVentiv Health, FDA Reauthorization Act, Right-To-Try legislation, and more.

  8. Should We Rethink Randomized Clinical Trials?

    If we want to accelerate the drug development process, is it time to reconsider randomized clinical trials? That was the main question asked at a recent colloquium that included industry leaders from pharma networks, academia, patient groups, major medical centers, and the FDA.

  9. Clinical News Roundup: FDA Sets Inaugural Meeting Of Patient Engagement Advisory Committee

    Clinical News Roundup for the week of July 23, 2017 with information on FDA’s Patient Engagement Advisory Committee, FDA guidance of IRB waivers, FDAnews joining WIRB-Copernicus Group, Right-To-Try legislation, Type 1 diabetes vaccine headed for trials, and more.

  10. Cell Therapy Trial Targets Type 1 Diabetes In Children

    Getting adult patients to take part in a clinical trial is difficult. When developing a treatment for a childhood disease, that recruitment challenge becomes even more difficult. The combination of patient age and the experimental nature of a treatment can cause concern amongst both parents and the FDA. Caladrius Biosciences is a company dealing with that challenge. The company is developing a cell therapy technology based on a patient’s own T-cells.