Articles By Ed Miseta

51. Johnson & Johnson To Share Clinical Trial Data With Yale School Of Medicine 1/31/2014

    In a move that is sure to be seen as a major win for advancing science and medicine, Johnson & Johnson has announced that Janssen Research and Development, LLC, has reached an agreement with the Yale School of Medicine’s Open Data Access (YODA) Project to share data from its clinical trials. According to the terms of the agreement, YODA, as an independent body, will review requests from investigators and physicians seeking access to anonymized clinical trials data from Janssen, a subsidiary of J&J. In its role, YODA will also make final decisions on data sharing. According to the company’s press release, this will mark the first time any company has collaborated in this manner with an independent third party regarding requests for clinical data.

52. Eli Lilly And Company Responds To Sanofi Lawsuit 1/31/2014

    This morning brought news that Eli Lilly and Co is being sued by Sanofi, a drug manufacturer based in France. The lawsuit alleges patent infringement on four of its patents relating to Lantus, the company’s popular treatment for diabetes. The lawsuit is expected to delay the launch of Lilly’s version of the treatment. Lilly applied to the FDA for permission to sell a biosimilar version of Lantus about a month ago.

53. InformEx Celebrates 30 Years Of Success 1/29/2014

    Thirty years of taking care of customers is a very long time, especially in the trade show business. So it is no small accomplishment that InformEx recently celebrated its 30th year of bringing together clients and manufacturers in the specialty chemical industry. Industry leaders first came together in 1984 to address the demand for a show to foster better partnering opportunities between specialty chemical manufacturers and users. In Atlanta just one year later, the first InformEx show was held. The event, a small tabletop conference, hardly resembles the much larger show we know today with the education sessions, featured speakers, mobile app, and hundreds of chemical exhibitors from around the world.

54. FDA: We Are Addressing IV Fluid Shortage 1/21/2014

    In a release from the FDA this morning, the agency is reporting that it is aware of the shortage situation existing for intravenous (IV) solutions, particularly 0.9% sodium chloride injection (i.e., saline). This solution is used to provide necessary fluids to patients with hydration and other conditions. FDA notes a range of factors may be responsible for the shortage, including increased hospital visits of patients experiencing symptions related to the current flu season.

55. Bring Down The Cost Of Clinical Trials With Improved Site Selection 12/19/2013

    With the cost of a single clinical trial costing upwards of $100 million, it’s not surprising the cost of developing a new drug has risen to more than $1 billion. The rising costs of drug development have personnel at every level of the process seeking ways to cut expenses. A recent collaboration between ViS Research and inVentiv Clinical Trial Recruitment Solutions (iCTRS) seeks to cut the cost of trials by speeding up the process of evaluating and selecting a clinical trial site.  

    “Pharma and CROs don’t have all of the information they need to properly select the right sites,” says Fabio Thiers, ViS founder and CEO. “As a result, pharma firms and CROs may well end up with centers that don’t recruit any patients, and trials that take twice as long as they should. This lack of available information on trial sites will therefore drive up the cost of trials.”

56. Acquisition Expands Phase I Capabilities 12/3/2013

    Clinical research firm PRA has announced it will be acquiring privately-held specialty research firm CRI Lifetree. CRI’s focus has been on early stage patient population studies with a focus in Human Abuse Liability (HAL), addiction, pain, psychiatry, neurology, pediatric and infectious disease services.

    With three Clinical Pharmacology Centers and over 200 beds, combined with over 20 years of clinical experience, CRI is one of the largest providers of patient population Phase I and confined Phase II-III services in the United States. 

57. FDA Presents Regulatory Challenges For Finished Dosage Manufacturers 12/1/2013

    As president of contract manufacturer Oso Biopharmaceutical Manufacturing, there are many concerns that might keep Milton Boyer awake at night. For example, he believes that, for most CMOs, every customer is always ready to leave. Therefore, manufacturers need to have a steady stream of new clients ready to fill the void. There are also cost pressures in the industry, concerns over hiring talented personnel, and internal problems that could arise and potentially derail any relationship. But when talking to Boyer, you get the feeling that no topic consumes more of his time than concern over the current regulatory environment.

58. How To Cut Clinical Time And Cost With CRO Continuity 11/27/2013

    Roxanne Tavakkol has a lengthy track record in the pharmaceutical industry. Currently the VP of Regulatory and Scientific services at clinical firm TKL Research, she began her career on the sponsor side of the house and has been involved in over 10 NDA registrations in her 20-year career in pharma. This experience has instilled in her the importance of solid data and streamlined data collection process in clinical trials.  

    “When FDA reviews an application for a registration, the primary concern to them is the risk/benefit to the patients,” she says. “That is not news to the pharmaceutical industry. We all know the quality of the data will ultimately determine whether or not a drug is approved. But I do think a lot more attention is now being paid to how the choice of a CRO can affect that the quality of the data.”

59. Overcoming Challenges In The Development Of Peptides And Oligonucleotide Therapeutics 11/7/2013

    At the 2013 Oligonucleotide & Peptide Based Therapeutics Congress, Dr. Hanjo Hennemann, co-founder and chief science officer of Nexigen, will speak on Overcoming Delivery Challenges in Peptide and Oligonucleotide Therapeutics. Dr. Hennemann is a founding member of Nexigen GmbH and has served as managing director and head of research since the company’s founding. Previously he was principal investigator at the research center caesar, Bonn, where he established the basis for the technology and the foundation of Nexigen. We spoke with him about the potential for peptides in the treatment of cancer and other diseases.

60. Januvia and Tradjenta Battle For DPP-4 Supremacy 11/7/2013

    Januvia is facing increased competition in a market space that seems to be getting evermore crowded. The DPP-4 inhibitor from Merck, which was first to market for the treatment of type 2 diabetes, racked up sales of $4 billion in 2012. However, recently released results for the third quarter of 2013 revealed an unexpectedly poor performance for the medicine. The results are being blamed on increased competition in the market, primarily from another Big Pharma titan.

    Valentina Gburcik, cardiovascular & metabolic disorders analyst for consulting firm GlobalData, notes the competition in this space is stronger than ever, with Big Pharma firms launching new therapies into this market with a force designed to sweep away existing medicines, as well as competitors. “As most therapies within one drug class hardly differentiate from each other, and the differences between entire classes are also relatively unimpressive, business strategy behind new products now means more than anything,” notes Gburcik.