• Regulatory NewsRegulatory News

    Senators Call for 15 Years of Marketing Exclusivity for Some New Drugs

    • 12 December 2014
    Two US senators have proposed new legislation that would grant an unprecedented 15 years of marketing exclusivity to certain types of pharmaceutical and biopharmaceutical products. Background The bill, known as the Dormant Therapies Act of 2014, is the second piece of legislation introduced in as many days by Sens. Orrin Hatch and Michael Bennet (D-CO). The duo introduced the Promise for Antibiotics and Therapeutics for Health (PATH) Act on 10 December 2014. R...
  • Regulatory NewsRegulatory News

    After New Drugs Delayed by DEA, Legislators Seek Overhaul of Drug Scheduling Process

    For most pharmaceutical products in the US, obtaining approval from the US Food and Drug Administration (FDA) to market a product means a company can begin selling its product as soon as it wants. But for a subset of products subject to the Controlled Substances Act (CSA ) , the Drug Enforcement Administration (DEA)—not FDA—is the ultimate arbiter of when market access occurs and the extent to which it occurs. Now new legislation wants to make the process by which DEA ...
  • Woodcock Lauds First Submission of 'Breakthrough' Product

    The US Food and Drug Administration (FDA) has already accepted its first product under its new "Breakthrough" therapies designation, and more are soon to be on the way, a high-ranking agency official said recently. In a 3 December 2012 announcement posted on FDA's Voice blog, Janet Woodcock, director of FDA's Center for Drug Evaluation and Research (CDER), sought to explain the law, calling it an exciting development for an agency that has long searched for effective...
  • Feature ArticlesFeature Articles

    Perspective: Advancing Breakthrough Therapies for Patients

    Advances in science and medicine are leading to exciting possibilities for the treatment of serious or life-threatening conditions, such as cancer. Growing knowledge of disease biology and molecular targets has shifted drug development from a traditional "shotgun" approach to targeted, precision medicines. Understanding the biological basis and natural history of a complex disease, such as cancer, unlocks the potential for new treatment options. In particular, novel-nov...
  • Bill Introduced to Speed Development and Review of Breakthrough Therapies

    A bipartisan bill introduced in the House of Representatives would work to speed up the development and review of some drugs intended to treat life-threatening diseases by creating a new "breakthrough therapy" designation at the US Food and Drug Administration (FDA). The bill, To amend chapter V of the Federal Food, Drug, and Cosmetic Act (FD&C Act) to expedite the development and review of breakthrough therapies , would amend the FD&C Act  to include pr...
  • EMA Releases Paper on Advanced Therapies to Assist Sponsors

    The European Medicines Agency (EMA) has released a new reflection paper on the classification of advanced-therapy medical products (ATMPs)-therapies made from genes and cells-which aims to clarify the legal basis for the classification of advanced therapies and provide information to applicants on how to submit applications for approval to EMA. In particular, the paper "provides information on how these medicines are classified as gene therapy, somatic-cell therapy, tiss...
  • Texas Approves New Stem Cell Therapies, Setting up Possible FDA Showdown

    The state of Texas approved new-and controversial-rules to allow doctors to use adult stem cells to conduct institutional review board (IRB)-approved procedures on patients, reports The New York Times . The changes, instituted 13 April by the Texas Medical Board, were reportedly spearheaded by Texas Governor and former Republican presidential nominee Rick Perry, who has said he experienced relief from the procedures, reports The Times . Some researchers, however, are ...
  • Paper: Small Companies Need Regulatory Assistance from EMA

    The European Medicines Agency (EMA) needs to assist companies-particularly small businesses, academic institutions and charities-in the development of advanced-therapy medicines, claims a new paper written by members of the Committee for Advanced Therapies (CAT) in the journal Molecular Therapies . These smaller drug development entities often lack the resources necessary to "navigate regulatory procedures," including clinical trials and application submissions. The pa...
  • Bill Would Encourage FDA to Seek Expert Advice About Rare Diseases

    Proposed legislation introduced in Congress on 7 March would encourage the US Food and Drug Administration (FDA) to seek and receive advice from experts in the field of rare diseases. The Expanding and Promoting Expertise in Review of Rare Treatments Act of 2012 ( EXPERRT Act ) would allow a consultation programs to be established for the purpose of allowing an exchange of expert information. The goal of the program is to allow FDA staff to better inform and strengthen...
  • Draft Guideline Released on Assessing Risk of Advanced Therapy Medicinal Products in Europe

    The European Medicines Agency (EMA) released a new draft guideline on 24 January assessing Advanced Therapy Medicinal Products (ATMPs) using a risk-based approach. ATMPs are biological medicinal products such as gene therapy, somatic cell therapy or tissue-engineered products. According to EMA , ATMPs contain an active substance which contains or consists of a recombinant nucleic acid used in or administered to human beings with a view to regulating, repairing, replac...