• RoundupsRoundups

    Asia Regulatory Roundup: Australia Aligns Sartan Rules to EMA as Singapore Finds NDMA in Ranitidine Drugs

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia.   Australia Aligns Sartan Rules to EMA as Singapore Finds NDMA in Ranitidine Drugs   Australia’s Therapeutic Goods Administration (TGA) has aligned its requirements for sartan medicines with those adopted in Europe. The action coincided with news from Singapore about the presence of N-nitrosodimethylamine (NDMA), one of the key sartan impurities, in GlaxoSmithKline’s Z...
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    MHRA Updates on Biologics Pharmacopoeial Quality Strategy

    The UK's Medicines and Healthcare products Regulatory Agency (MHRA) on Monday provided an update on its strategy for pharmacopoeial quality standards for biological medicines.   The agency's five-year strategy for pharmacopoeial quality standards for biologics was released in 2017 following a public consultation earlier that year.   For its 2019 update, MHRA said it reviewed its strategy and work program and made editorial changes to the strategy document to br...
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    NASEM, Royal Society Consult on Human Genome Editing Framework

    The US National Academies of Sciences, Engineering and Medicine (NASEM) and the UK's Royal Society issued a call for evidence on human germline genome editing as the two scientific bodies prepare to host an international commission to develop a framework for the scientific, medical, regulatory and ethical requirements necessary for such applications.   The commission, which met for the first time in August in Washington, DC, will consider submissions to the consultat...
  • ReconRecon

    Recon: Insulin Makers Brace for Brexit; Fire at Facility Housing Smallpox Virus in Russia

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Would a Purdue Bankruptcy Protect the Sacklers? Good Question. ( NYTimes ) Purdue Pharma’s Bankruptcy Deal Has Holes the Size of 24 States ( Bloomberg ) Purdue Pharma's battle isn't over ( Politico ) Former FDA Commissioner Scott Gottlieb joins Aetion's Board of Directors ( Press ) Opioid plaintiffs fight bid to disqualify US judge before trial ( Reuters ) ...
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    FDA Awards $4M in Grants to Support Development of COAs

    As part of the US Food and Drug Administration’s (FDA) work to develop publicly available Clinical Outcome Assessments (COAs), the agency awarded three grants to researchers at Albert Einstein College of Medicine, Duke University and Northwestern University. The grants, which total about $4 million, are meant to help collect patient input to inform the selection of clinical outcomes and how data is collected. “If methodologically sound data collection tools are devel...
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    FDA Explains Plans for New Pharmaceutical Quality Assessment System

    As part of its work to improve and modernize the quality assessment of drug applications, the US Food and Drug Administration (FDA) is developing a new, more standardized system, to be known as the Knowledge-aided Assessment & Structured Application (KASA), according to an article authored by officials from FDA’s Center for Drug Evaluation and Research and published in the latest issue of the International Journal of Pharmaceutics . The authors describe KASA as a new s...
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    FDA Issues 53 Product-Specific Guidances to Help With Generic Drug Development

    The US Food and Drug Administration (FDA) on Monday released 53 product-specific guidance documents to aid generic drug development, including 34 new guidance documents, 26 guidances for treatments that lack generic competition and 16 for complex products. When finalized, the guidance documents will represent the current thinking of FDA on, among other things, the product-specific design of bioequivalence studies to support abbreviated new drug applications. Among th...
  • ReconRecon

    Recon: Lundbeck Buys Alder for $2B; Purdue Pharma Files for Bankruptcy

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US First peanut allergy treatment gains backing from FDA advisory panel ( Science ) ( Atlantic ) ( AP ) Purdue Pharma, maker of OxyContin and other drugs, files for bankruptcy ( Stat ) ( Bloomberg ) ( WSJ ) ( Guardian ) Opioid Defendants Seek to Disqualify Judge Overseeing 2,300 Cases ( NY Times ) The Startup That Manipulated Data to Get a Miracle Drug to Market ...
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    Three Breast Cancer Drugs: FDA Warns of Rare but Serious Lung Inflammation

    The US Food and Drug Administration (FDA) on Friday warned that breast cancer drugs, Ibrance (palbociclib) from Pfizer, Novartis' Kisqali (ribociclib) and Lilly's Verzenio (abemaciclib) may cause rare but severe inflammation of the lungs that could lead to death. “We have approved new warnings about this risk to the prescribing information and Patient Package Insert for the entire class of these cyclin-dependent kinase 4/6 (CDK 4/6) inhibitor medicines. The overall bene...
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    FDA Tells Company to Pull Press Release on Drinking With Female Libido Drug

    Last April, Sprout Pharmaceuticals completed postmarketing trials for its drug Addyi (flibanserin), which is used to treat decreased sexual desire in women, and the US Food and Drug Administration (FDA) said it could change the labeling of the drug to clarify that although a boxed warning is still necessary, alcohol does not have to be avoided completely. FDA’s decision on the label followed a push from Sprout to remove the warning entirely. Sprout touted newly released...
  • ReconRecon

    Recon: Biogen, Eisai Abandon Two Phase 3 Alzheimer’s Studies Over Safety Concerns

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Biogen scraps two late-stage Alzheimer's trials ( Reuters ) ( Fierce ) ( Endpoints ) ( Press ) Inside the drug industry’s plan to disarm the DEA ( Washington Post ) While battling opioid crisis, US government weighed using fentanyl for executions ( Reuters ) Purdue Pharma Made, Then Ditched, Plans for Opioid-Treatment Nonprofit ( WSJ ) Chaotic talks show chal...
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    EMA, FDA Begin Reviewing Heartburn Medicines for Carcinogen

    Following its investigation into an impurity called N-nitrosodimethylamine (NDMA) in blood pressure medicines, the European Medicines Agency (EMA) on Friday said that, at the request of the European Commission, it’s beginning a review of ranitidine medicines after tests showed that some contained the impurity. NDMA is classified as a substance that could cause cancer on the basis of animal studies, although EMA explains how it is present in some foods and in water suppl...