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  • Regulatory NewsRegulatory News

    Do People Understand Cancer Drug Ads on TV? Drugmakers Weigh in on FDA Research

    As television ads for cancer drugs pose the question, “Who wouldn’t want a chance to live longer?” or present statements like: “Living longer is possible,” the US Food and Drug Administration’s (FDA) Office of Prescription Drug Promotion (OPDP) is trying to figure out if consumers can understand these drugs’ specific and often complicated indications supported by different types of endpoints. And now drugmakers Novartis, Merck and Eli Lilly are seeking modifications to ...
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    Australia and Canada Jointly Approve Breast Cancer Drug

    As part of a push toward regulatory convergence, Health Canada and Australia’s Therapeutic Goods Administration (TGA) last week jointly approved Eli Lilly’s Verzenio (abemaciclib) for the treatment of metastatic breast cancer. Each regulator evaluated different parts of the regulatory submission dossier, although both made independent decisions regarding approval. Health Canada also worked with the Canadian Agency for Drugs and Technologies in Health (CADTH) on the appr...
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    Senators Seek Changes to FDA Guidance to Speed Entry of Insulin Biosimilars

    As Eli Lilly announced Monday that it would introduce an authorized generic version of its Humalog insulin at half the original price, four senators on both sides of the aisle are seeking tweaks to recent US Food and Drug Administration (FDA) guidance to speed up the marketing of new biosimilar insulin products. The guidance is part of FDA’s work to begin, starting in March 2020, transitioning approved marketing applications for a subset of products, including insulin...
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    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...
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    FDA Denies Amneal Petition Seeking to Block Generic Versions of Osteoporosis Treatment

    Capping a string of recent citizen petition denials, the US Food and Drug Administration (FDA) has rejected Amneal Pharmaceuticals' citizen petition asking the agency to refrain from approving any abbreviated new drug applications (ANDAs) for the blockbuster osteoporosis treatment Forteo (teriparatide). The decision by FDA was not unexpected and followed recent denials of citizen petitions filed by Novo Nordisk and Allergan . Bernstein biotech analyst Ronny ...
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    Updated: The 505(b)(2) Pathway and Why Some Follow-on Insulins Aren’t Yet Biosimilars in the US

    Why has the European Medicines Agency (EMA) approved follow-on insulin products as biosimilars while the US Food and Drug Administration (FDA) has not? A look at several recent examples shows what is happening and what will change in the US over the next several years. In September, FDA granted tentative approval for Sanofi’s Admelog (insulin lispro injection), a rapid-acting human insulin analog. On 11 December, Admelog received full approval from FDA. In the EU, howe...
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    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...
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    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...
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    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...
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    TransCelerate Progress on Trial Efficiencies Unimpeded by Pharma Regulators

    The joint efforts of 18 biopharmaceutical companies, under the umbrella of TransCelerate BioPharma, are continuing to advance their efforts in sharing data, making clinical trials more efficient and working with drug regulators around the world to ensure that progress enables change that can help patients. The group is working to leverage the data and best practices of its members, such as Pfizer, Amgen, AstraZeneca, Merck and Roche, across a wide swath of trial-relate...
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    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...