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  • Regulatory NewsRegulatory News

    European Regulatory Roundup: Lilly May Move API Production Outside EU Due to REACH Regulations (17 March 2016)

    Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news. Eli Lilly Threatens to Move API Production out of the EU in Broadside Against REACH Eli Lilly has warned it may move production of certain active pharmaceutical ingredients (APIs) out of the European Union because of REACH regulations. The production of two of Lilly’s veterinary APIs is tied to the availability of cobalt salts, something it says is becoming a “significant pr...
  • Feature ArticlesFeature Articles

    Case Study: Regulatory Advertising and Promotion From a Fellow’s Perspective

    This article discusses three components of Purdue University’s Regulatory Pharmaceutical Fellowship from a current fellow’s perspective followed by a candid interview. Introduction The professional field of regulatory advertising and promotion has become increasingly essential to pharmaceutical companies because of the increased volume of advertisements and promotional materials available to them as well as accessibility to a wide variety of different advertisi...
  • Warning Letter to Eli Lilly Focuses on Use of Color Images in Marketing Materials

    The US Food and Drug Administration (FDA) has sent a warning letter to pharmaceutical manufacturer Eli Lilly over alleged deficiencies present in marketing materials distributed by the company through its website, FDA announced on 10 September. The letter, posted on FDA's website by the Office of Prescription Drug Promotion (OPDP), references marketing materials published for Amyvid (Florbetapir F 18 Injection), a positron emission tomography (PET) drug used to help eval...
  • Companion Diagnostic Test, Drug Get Concurrent Approval from FDA

    A companion diagnostic test developed by Manchester, England-based QIAGEN and marketed by Bristol-Myers Squibb and Eli Lilly and Company has won approval from the US Food and Drug Administration (FDA) for determining whether the anti-colorectal cancer (CRC) drug Erbitux (cetuximab) will be effective in patients. The product, known as the Therascreen KRAS RSQ PCR Kit, screens patients for the presence or absence of a particular mutation in the KRAS gene. If the KRAS gene ...
  • Suspects Nabbed in Record-Setting Pharmaceutical Heist

    • 08 May 2012
    A pharmaceutical robbery in 2010 had all the trappings of a Hollywood-inspired heist: thieves breaking into a secure facility, tens of millions of dollars in stolen product and a cold trail. Now, that heist is getting something else: an ending. Authorities had been left stunned after a March 2010 heist in Connecticut left $80 million in pharmaceutical products from an Eli Lilly warehouse missing-a heist so large it may be the largest theft of pharmaceutical products in U...
  • NIH Launches New Program to Share Drug Compounds

    • 04 May 2012
    The National Institutes of Health's (NIH) new National Center for Advancing Translational Sciences (NCATS) said it will launch a new pilot program to partner with a number of pharmaceutical manufacturers in an effort to look for new uses for some of their existing compounds. NCATS, currently under the temporary leadership of Thomas Insel , was formed in late 2011 to spur the development of new therapies by focusing on ways to bridge the so-called "valley of death" betwe...
  • Eli Lilly's Lechleiter Replaces Sanofi's Veibacher as PhRMA Chairman

    • 16 April 2012
    The Pharmaceutical Researchers and Manufactuers of America (PhRMA), the powerful trade organization of the pharmaceutical industry, announced at its annual meeting its members have elected John C. Lechleiter, CEO of Eli Lilly and Co., as its next chairman. Lechleiter will replace outgoing Chairman Christopher Veichbacher, CEO of Sanofi, who has served the organization since 2008. The Chairman of the PhRMA Board-along with PhRMA's President, currently John Castellani-has...
  • FDA Guidance on Veterinary Antibiotic Use Prompts Compliance, Criticism

    Shortly after the US Food and Drug Administration (FDA) released new rules to curtail the "injudicious" use of antibiotics in food-producing animals , three pharmaceutical manufacturers said they were agreeing to change the labeling on their veterinary antibiotics to exclude indications for food-producing animals, reports Bloomberg . FDA Deputy Commissioner for Foods Michael Taylor said he has assurances from Pfizer Inc., Eli Lilly & Co. and Merck & Co.-three o...
  • Eli Lilly Gets Approval for Brain Plaque Test

    • 09 April 2012
    The US Food and Drug Administration (FDA) has approved a test that would help doctors detect brain plaque to rule out Alzheimer's disease in patients, according to a Reuters report. The radioactive dye, called Amyvid, attaches to clumps of beta amyloid, a toxic protein accumulating in the brains of Alzheimer's patients. The report said doctors can see the plaque light up due to the dye on a positron emission tomography (PET) scan. Eli Lilly and Co. said the test should ...
  • NIH, Eli Lilly Creating Public Drug Database

    The US National Institutes of Health (NIH) and Eli Lilly and Company are working together to create a publicly available database of thousands of approved and investigational medicines and molecules. The collaboration will see NIH's new National Center for the Advancement of Translational Sciences (NCATS) working with Eli Lilly's Research Laboratories branch. NCATS already has a library of more than 3,800 medicines, which will be screened using a Phenotypic Drug Discover...