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    FDA Consults on Abuse-Deterrent CNS Stimulants

    The US Food and Drug Administration (FDA) on Thursday opened a public consultation to gather input on the development and evaluation of abuse-deterrent formulations (ADF) of central nervous system (CNS) stimulants.   The agency also says it is seeking comments on whether such formulations could help to reduce prescription stimulant misuse and abuse.   According to FDA, most currently marketed prescription CNS stimulants are amphetamine salts and other similar compo...
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    EMA's CHMP Recommends Three New Medicines

    The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) on Friday recommended the approval of three new medicines, including one orphan product, and recommended extending the indication for eight other drugs.   The newly recommended medicines include Astellas' acute myeloid leukemia drug Xospata (gilteritinib), which was granted orphan designation and was reviewed under EMA's accelerated assessment program. The recommendation comes l...
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    Recon: Drug Suppliers Say Brexit Freight Plans Urgently Needed; Philippines Prepares Vaccination Campaign After Polio Reemerges

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Pelosi Unveils Plan to Lower Prescription Drug Prices ( Focus ) US House speaker: Drug pricing plan should be priority for White House ( Reuters ) Democrats' drug pricing proposal 'dead on arrival' in Senate: leading Republican ( Reuters ) ( Politico ) Trump says he likes a Republican drug bill after Democratic alternative unveiled ( Reuters ) How An 'Interna...
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    FDA Develops Tool to Simulate Immune Response to Biologics

    Researchers at the US Food and Drug Administration (FDA) have developed a new computational tool to predict whether the body will mount an immune response that blocks the activity of biological drugs.   Specifically, the tool, dubbed TCPro, simulates how the body's CD4+ T cells will respond to biotherapeutics, and predicts whether the body will produce anti-drug antibodies.   "TCPro can be used to assess the potential for antibody formation even before the laborato...
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    FDA Calls on Compounders to be More Diligent About Their Bulk Suppliers

    The US Food and Drug Administration (FDA) is calling on drug compounders to be more diligent with their suppliers to ensure that bulk active pharmaceutical ingredients (API) they receive have been tested and properly handled throughout the supply chain.   "The agency urges compounders to know your bulk supplier and know if they are testing the drugs before you purchase bulks for patient use," FDA writes.   The advisory comes after drug repacker Darmerica LLC last w...
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    Recon: FDA Panel Backs GSK's OTC Nicotine Spray; Swiss Competition Watchdog Raids Makers of Stomach Drug

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Industry groups push back against ‘troubling’ FDA crackdown on genetic tests used to predict response to drugs ( STAT ) GSK's over-the-counter nicotine oral spray gets FDA panel backing ( Reuters ) Ginkgo Bioworks scores an eye-popping valuation with latest fundraise ( STAT ) Insys Bankruptcy Plan Comes Up Short in Paying Justice Department ( WSJ ) Bristol jo...
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    Recon: Senators Urge More FTC Scrutiny for Pharma Mega-Mergers; WHO Panel Warns on Pandemic Risk

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Grassley's fight to win over GOP on drug prices ( Politico ) Hearing on "Profits Over Consumers: Exposing How Pharmaceutical Companies Game The System" ( House E&C ) Medicare Part D rebates ‘substantially’ reduced drug spending, but not enough to offset price hikes ( STAT ) US Senators urge FTC to scrutinize multi-billion dollar pharma mergers ( Reuters ) ( ST...
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    OGD Explains How it Reviews and Conducts Pre-ANDA Meetings

    In a newly issued manual of policies and procedures (MAPP), the US Food and Drug Administration's (FDA) Office of Generic Drugs (OGD) explains how it evaluates and conducts two types of meetings under its pre-abbreviated new drug application (ANDA) program.   In the eight-page MAPP, the office explains its criteria for granting or denying product development and pre-submission pre-ANDA meetings. The MAPP also provides timeframes for how the agency conducts those meetin...
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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...
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    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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    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...