• Regulatory NewsRegulatory News

    Lilly 483 report offers insights from site making COVID antibodies

    The US Food and Drug Administration (FDA) on 12 August released a Form 483 report to Eli Lilly’s sterile injectables site in Indianapolis, noting multiple quality lapses.   The observations follow a February to March 2021 inspection at the site, which makes several medications: bamlanivimab and etesevimab for COVID-19, glucagon for treating severe hypoglycemia in diabetic patients, and ramucirumab for non-small cell lung cancer.   One of the seven observations wa...
  • Regulatory NewsRegulatory News

    House E&C Questions Insulin Manufacturers

    The House Committee on Energy and Commerce (E&C) on Wednesday sent letters to the three insulin manufacturers serving the US: Eli Lilly, Novo Nordisk and Sanofi, seeking more information on the root causes of the rising cost of insulin. First discovered more than 100 years ago, average insulin prices nearly tripled between 2002 and 2013 and then nearly doubled between 2012 and 2016, with patients bearing the brunt of those price spikes. Now, just a day after two moth...
  • Regulatory NewsRegulatory News

    Trump: Former Eli Lilly Exec to be Nominated as Next HHS Secretary

    President Donald Trump on Monday morning announced via Twitter his intention to nominate Alex Azar, former president at Eli Lilly and deputy HHS secretary under President George W. Bush, to be the next HHS secretary. If confirmed by the Senate, Azar would step into a cabinet position left vacant after Tom Price resigned following numerous questions related to his use of private jets and their mounting cost to the US taxpayer. "He will be a star for better health...
  • Regulatory NewsRegulatory News

    FTC: Shire ViroPharma Abused FDA Citizen Petition Process, Delaying Generics

    The US Federal Trade Commission (FTC) on Tuesday filed a complaint against Shire ViroPharma for blocking and delaying the marketing of generic versions of its antibiotic Vancocin (vancomycin), which first won FDA approval in 1986. “Facing the threat of generic competition to its lucrative franchise, ViroPharma inundated the FDA with regulatory and court filings—forty-six in all—to delay the FDA’s approval of generic Vancocin Capsules. That number is, by far, the mo...
  • Regulatory NewsRegulatory News

    Why Don’t People Like Pharma Companies? Pfizer and Regeneron CEOs Discuss

    At the end of Thursday's Forbes healthcare summit in New York, some of the pharmaceutical and biotech industries’ top executives – from Pfizer, Regeneron, Eli Lilly, Gilead and Astellas – sat down and were presented with a simple question: Why don’t people like you? At first the conversation dovetailed away from the question, with John Milligan, CEO of Gilead, discussing his company’s hepatitis C cure Sovaldi (sofosbuvir) and the rapid increases in demand. “What happen...
  • Regulatory NewsRegulatory News

    FDA Offers New Draft Guidance on Bioequivalence Studies for 19 Generics, 19 Revisions

    The US Food and Drug Administration (FDA) on Thursday released 38 new and revised draft guidance documents for drugmakers looking to begin research and development for new generics, including for some blockbuster drugs that have not yet lost patent protection. The new draft documents focus on what types of bioequivalence (BE) studies may need to be conducted to obtain abbreviated new drug application (ANDA) approval. Each document also contains information on what analyt...
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    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...