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    FDA Drafts Guidance to Help Address Blood Pressure Effects in Drug Development

    The US Food and Drug Administration (FDA) on Wednesday released draft guidance to help biopharma companies address the precision of blood pressure measurements in the assessment of the effects of a drug in development. The 11-page draft recommends “systemic characterization of the effect of a drug on blood pressure during drug development.” While noting that nearly every drug development program has “some assessment of the effect of a drug on blood pressure, the meth...
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    FTC Charges Against Generic Company in Pay-for-Delay Case Dismissed

    Chief Administrative Law Judge D. Michael Chappell last week dismissed antitrust charges from the Federal Trade Commission (FTC) against generic drugmaker Impax Laboratories, arguing that earlier entry to market for the generic “was unlikely,” even though Impax was paid $112 million by the brand name drugmaker Endo Pharmaceuticals. The FTC had filed an administrative complaint against Impax, charging that in 2010, Impax and Endo Pharmaceuticals illegally agreed that Imp...
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    European Commission Aims to Boost Generic, Biosimilar Manufacturing

    The European Commission on Monday released a proposal aiming to boost investment and create more than 20,000 new jobs over 10 years in the production of generics and biosimilars in the EU by introducing a manufacturing waiver for exports. The proposal is meant to tackle problems the EU has faced in terms of the loss of exports because its supplementary protection certificate (SPC) system can restrict manufacturers from making product for non-EU-based countries. Backgr...
  • Cancer Cell Therapy Trials Spike in Last Six Months, New Report Finds

    In just the six months from last September to March, the number of cancer cell therapies in development has increased by 87%, though about half of the total tallied is in the preclinical phase, according to a new report from the non-profit Cancer Research Institute in Nature Reviews Drug Discovery . The Cancer Research Institute’s database is now tracking 753 cell therapies, pursuing 113 different targets, and of which 375 are in clinical trials and 378 are in the prec...
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    Senate Committee Advances Bill Boosting FDA’s FY2019 Budget by $159M

    The Senate Appropriations Committee on Thursday signed off on a $159 million increase in discretionary funding for the US Food and Drug Administration (FDA), though that increase was about $150 million less than the increase proposed in the House.   According to the Alliance for a Stronger FDA, the additional funds requested by FDA are planned to promote domestic manufacturing (House committee bill has about $27 million more in it for this), expand FDA engagement with ...
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    Kickback Allegation Settlements Pile Up for Pharmaceutical Companies

    Fresh off the Novartis scandal, in which the company paid President Donal Trump's lawyer, the Department of Justice (DOJ) on Thursday announced that Pfizer agreed to pay $23.85 million to resolve claims that it used a foundation as a conduit to help pay the copays of Medicare patients using three of its drugs. But Pfizer is just one of many pharmaceutical companies paying tens or even hundreds of millions to settle these allegations. In explaining why a company would he...
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    UK Prepping for Different Brexit Scenarios

    Sounding a note of optimism, the UK government released a report Wednesday calling again for the nation to remain a part of the European Medicines Agency (EMA) in some form, adding that “the prospect of a ‘no deal’ scenario is highly unlikely and therefore we are in a strong position from which to seek to agree a mutually beneficial way forward.” “The safety of patients is of paramount importance to the Government’s exit negotiations for medicines, medical devices and s...
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    Health Canada to Transition to Global Medical Device Nomenclature

    Health Canada announced Tuesday that it is initiating a transition from its current medical device categorization method to the Global Medical Device Nomenclature (GMDN), as part of a push to improve the availability, access to and quality of information available on medical devices in Canada. Later this month, Health Canada says it will provide manufacturers with a list of their medical devices associated with active medical device licenses. “Manufacturers will be i...
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    EMA Begins Public Consultation on Draft Guideline for Handling and Shipping Investigational Medicines

    The European Medicines Agency (EMA) on Wednesday opened for consultation a guideline laying out the principles for managing investigational medicinal products for use in a clinical trial and in accordance with Good Clinical Practices (GCPs) and Good Manufacturing Practice (GMPs). The guideline says investigational medicines should remain under the control of the sponsor until after completion of a two-step procedure, which consists of the batch certification by the Qual...
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    Recon: Former Valeant Exec Found Guilty in Kickback Scheme

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. In Focus: US Congress OKs letting terminal patients try unapproved drugs ( AP ) ( Washington Post -$) ( NYT -$) ( Focus ) ( LA Times ) A Preferable Path For Thwarting Pharmaceutical Product Hopping ( Health Affairs ) Patient and Prescriber Outreach Materials for Biosimilars ( FDA ) FDA warns teething medicines unsafe, wants them off shelves ( AP ) Gene Therapies That Could T...
  • House Passes Bill Allowing Terminally Ill to Ask Companies to Use Experimental Treatments Outside of FDA Purview

    The House on Tuesday afternoon passed a Senate-passed version of a bill, known as “Right-to-Try,” and President Donald Trump has indicated he will sign it – further proof that the Koch brothers-backed Goldwater Institute’s politicization of the US Food and Drug Administration (FDA) is just beginning. Riding on the backs of terminally ill patients who have run out of options, Republicans pegged the bill as a last-ditch effort to “try anything.” At an earlier hearing, Re...
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    Gottlieb: FDA Prepping for Push of New Gene and Cell Therapies

    In addition to new draft guidance documents on gene therapy-related issues, the US Food and Drug Administration (FDA) will also release guidance on the clinical development of gene and cell therapies, FDA Commissioner Scott Gottlieb said at the Alliance for Regenerative Medicine's annual board meeting on Tuesday. The first therapeutic area he said FDA will focus on, in terms of offering "potential accelerated approval endpoints for certain gene therapy products, is hem...