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    Janssen Questions Literature Review on Biosimilar Switching Studies as Authors Defend it

    Three employees of Johnson & Johnson’s Janssen Pharmaceuticals, which has not publicly disclosed that it is developing any biosimilars, urged caution Tuesday on a literature review of biosimilar switching studies and said additional studies are necessary, though authors of the review also pushed back. The letter to editor from Janssen’s Antonio Pires, integrated evidence team leader, Kavitha Goyal, senior director for Remicade development, and Andrew Greenspan, VP of ...
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    Recon: Inside Pfizer’s Drug Supply Problem

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. In Focus: US Critical Condition: Inside Pfizer’s Drug Supply Problem ( Fortune ) New Vermont Law Seeks to Allow Wholesale Importation of Drugs from Canada ( FDA Law Blog ) Right to try legislation comes to the House floor ( House Daily Schedule ) ( Baltimore Sun ) Allergan doubles down on NMDA depression drug development efforts, bagging an option to a small molecule followup...
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    Alzheimer’s Disease: Companies Weigh Revised FDA Draft Guidance

    Companies developing treatments for early Alzheimer’s Disease submitted another round of positive comments last week on US Food and Drug Administration (FDA) draft guidance, offering a hint of optimism in a space where no company has seen success. With setbacks and failures in the development of Alzheimer’s treatments from Merck, Eli Lilly, AstraZeneca and others, it should come as no surprise that companies are interested in this latest revised draft and happy that the...
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    EC Targets Biosimilars With Clarifications on Duplicate Marketing Authorizations

    The European Commission late last week sought consultation on proposed clarifications for handling duplicate marketing authorizations (MAs). As readers of Focus remember from last March (when two Humira (adalimumab) biosimilars were granted duplicate authorizations), the EC is allowed, under certain circumstances, to issue duplicate MAs when issues with existing patents in certain Member States crop up and for other public health reasons. Requests for duplicate ma...
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    Bioanalytical Method Validation: FDA Finalizes Guidance From 2013

    The US Food and Drug Administration (FDA) on Monday finalized guidance revised in 2013 to help companies validate bioanalytical methods used in human clinical pharmacology, bioavailability (BA) and bioequivalence (BE) studies that require pharmacokinetic, toxicokinetic or biomarker concentration evaluation. Differences between the draft and final guidance, which is 10 pages longer, include a re-working of the text, a new title for Section III, which was previously named...
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    Recon: Ebola Vaccine Arrives in DRC

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. In Focus: US ALS patients losing time and hope as they wait for insurers to cover a pricey new drug ( Stat ) Nabriva goes 2 for 2 in Phase III antibiotic program, scoring on a key catalyst and teeing up an FDA pitch for lefamulin ( Endpoints ) ( Reuters ) ( Fierce ) FDA approves new drug for patients with chronic liver disease ( FDA ) Biosimilar Approval: Better, Stronger, Fa...
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    Tight Deadlines for EU MDR, IVDR Generate Questions for EC, Competent Authorities

    Medical device and in vitro diagnostic (IVD) manufacturers on Thursday peppered representatives from the European Commission (EC) and Ireland’s Health Products Regulatory Authority (HPRA) with questions about the upcoming deadlines, implementing acts and guidance related to the new EU device and IVD regulations. Erik Hansson, deputy head of the EC’s Health Technology and Cosmetics Unit, offered a high-level overview of the new regulations to attendees of RAPS’ worksh...
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    EU MDR, IVDR Transition: One Year in, Lots of Guidance Still to Come

    One year into the transition periods for the new EU medical device and in vitro diagnostic (IVD) regulations, and not a whole lot has occurred to help companies implement the new regulations, experts said Wednesday in Brussels at RAPS'  workshop . The three-year countdown to the new EU Medical Devices Regulation’s (MDR) full application in 2020 (and five years for IVDs) has created an anxious environment for companies, particularly as for most legacy devices (CE marke...
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    PIC/S Adopts New Guidance on GMP Inspections

    The Pharmaceutical Inspection Co-operation Scheme (PIC/S) announced this month that it has adopted new guidance on good manufacturing practice (GMP) inspections, outlining a process for “desk-top assessment” of overseas facilities to identify instances when an acceptable level of GMP compliance can be confirmed and assured without on-site inspections. Based on a draft from the International Coalition of Medicines Regulatory Authorities (ICMRA), PIC/S said the guidance p...
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    FDA Finalizes Outsourcing Facility Guidance

    The US Food and Drug Administration (FDA) on Thursday finalized guidance to help outsourcing facilities register with FDA. FDA said it received 19 comments on the draft. “In response to received comments, FDA made certain changes,” the agency said . “In particular, FDA revised the guidance to provide for a compounder seeking to operate under section 503A of the FD&C Act (21 U.S.C. 353a) to be located next to an outsourcing facility provided that there is complete segre...
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    FDA Denies Mylan Petition on Advair Generics

    The US Food and Drug Administration (FDA) announced Thursday that it has denied Mylan’s petition that sought to block certain generic applications for Advair (fluticasone propionate and salmeterol). After receiving a complete response letter (CRL) for its generic Advair in March 2017, Mylan had argued in a December 2017 petition that FDA refrain from approving generic versions of Advair, which are inhalers for asthma and COPD made by GlaxoSmithKline, if they rely on mul...
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    Updated: Off-Label Promotion: Are FDA’s Rules About to Unravel?

    State and federal legislators are prepping changes that would give wider latitude to pharmaceutical manufacturers and unravel FDA rules on off-label promotion, according to a new editorial in PLOS Medicine from Drs. Michael Sinha and Aaron Kesselheim of the Program On Regulation, Therapeutics, And Law (PORTAL), Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women’s Hospital and Harvard Medical School. The editorial coincides ...