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You are here: Home > Opinion & analysis

Opinion & analysis


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  • ‘Something’s Going To Happen’: Former FDAer John Bailey On Cosmetics Reform Legislation

    $200.00

    Don’t dismiss cosmetics reform efforts underway in Washington, former FDA official John Bailey warned an Independent Cosmetic Manufacturers and Distributors workshop. At the same gathering, Linda Katz, director of FDA’s Office of Cosmetics and Colors, hinted broadly at what’s ahead. Find out what she had to say and gain insights into what’s expected to be the first major regulatory/legislative overhaul in decades

    May 21, 2018
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  • FDA Announces More Actions On Drug-Coated Devices

    $131.00

    Based on a meta-analysis of randomized trials for paclitaxel-coated devices, the FDA is concerned that they may not be safe to use, as they may be linked to mortality. Until further information is available, the FDA is recommending doctors prescribe these devices on a case-by-case basis only.

    August 2, 2019
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  • Oncology Leader Liz Barrett Joins UroGen As CEO As It Heads Towards Commercial Stage

    $131.00

    There is new leadership at UroGen Pharma, Ltd., as Novartis AG Oncology’s former Oncology CEO takes the helm. Scrip sat down to talk to Liz Barrett about her plans as CEO of UroGen, including assuming the tasks of ushering the company’s lead asset through the FDA approval and launch processes.

    January 9, 2019
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  • The Knowledge Within: An Interview With Merck KGaA’s R&D Chief

    $200.00

    Merck KGaA’s head of global research and development, Luciano Rossetti, sat down with In Vivo to discuss the track the German company is taking toward becoming a major player in global immuno-oncology. Tap in to his insights and opinions in this essential interview.

    March 11, 2019
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  • The Implant Files: EU Blamed For Regulatory Inadequacies The World Over While ‘Wrath’- Behrendt Fumes

    $131.00

    In the wake of scathing investigative reports from over 250 journalists from the International Consortium of Investigative Journalists (ICIJ) regarding the safety and oversight of implanted medical devices, this article examines the situation from a uniquely EU perspective.

    November 26, 2018
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  • J.P. Morgan Notebook Day 2: Biogen, GSK, Bluebird, Roche, Amgen, Biohaven And Lilly

    $200.00

    The second day of the 2019 JP Morgan Healthcare Conference has concluded, and Pink Sheet was there to bring you all of the breaking news, major announcements, and insights from the largest investment healthcare symposium in the world.

    January 9, 2019
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  • Pharma Intelligence Report Store Article Collection Digital Patient Management

    $200.00

    The digitalization of health care has been much talked about over the last decade or so. But activity among the medical device manufacturers and service providers has only just recently accelerated as they start overcoming barriers and resistance to this new way of delivering health care.

    April 25, 2017
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  • Repositioning Market Access: A Function Fit For Purpose In A New Era Of Costly Cures

    $200.00

    Explore the findings of an October 2018 panel discussion of market analysts and market access specialists as they discuss the question: As new cures and treatments for patients develop, how does the conversation shift from delivering market access to products to focusing on patient access to progress?

    November 28, 2018
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  • GSK And Pfizer Assemble Consumer Healthcare Leadership Team As JV Closes

    $131.00

    GlaxoSmithKline PLC and Pfizer Inc. have closed their consumer health joint venture to create the “global leader in OTC products.” Operating under the GSK Consumer Healthcare name, the joint venture – announced in December last year – has around a 7.3% share of the global consumer health market, well ahead of the next competitor, Johnson & Johnson, at 4.1%. Under the leadership of Brian McNamara, the new company has begun to assemble a management team that combines talent from both GSK and Pfizer. Who’s on the dream team, and what’s on the horizon for this new superpower?

    August 2, 2019
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  • Schleifer, Yancopoulos And The $36 Billion Friendship

    $200.00

    Examine the 30-year friendship that built Regeneron in In Vivo’s interview with company leaders Len Schleifer and George Yancopoulos. The two reflect back on the company’s beginnings and take a look at what’s in store for the future in this insightful – and often funny – interview.

    November 23, 2018
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  • 86% Rise In GMDN Usage Heralds New Era Of Postmarket Data Analytics

    $200.00

    The Global Medical Device Nomenclature is emblematic of the global trend toward building high-quality data sets in the public arena to derive better information about how medical devices perform. Medtech Insight covers that the new chair of the agency saying how the GMDN usage is poised to explode.

    September 2, 2019
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  • New Reasons Not To Use EU MDR’s Four-Year Extension, But Comply Earlier Or Retire Products Instead

    $200.00

    The new EU Medical Device Regulation (MDR) includes an option to market CE-marked devices for an extra four years. That extension may sound tempting, but experts advise against it. Learn about their concerns and gain insights into howto prepare for compliance under MDR.

    June 13, 2018
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  • EMA To Re-Prioritize Tasks To Cope With ‘Higher Than Expected’ Staff Losses

    $131.00

    Although original estimates put staff losses at the European Medicines Agency at about 19% due to the EMA’s relocation from London to Amsterdam, the EMA reports that these losses may actually be much higher, forcing the agency to take a hard look at its most pressing priorities moving forward.

    June 8, 2018
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  • J.P. Morgan Notebook Day 2: Biogen, GSK, Bluebird, Roche, Amgen, Biohaven, Lilly And FDA’s Gottlieb

    $200.00

    Scrip reports from Day 2 of the 2019 J.P. Morgan Healthcare Conference, bringing you the highlights to come out of the San Francisco meeting. Read the most important news from Day 2, including the latest from Biogen, updates on GSK’s oncology efforts, deal developments for bluebird and Lilly, and more.

    January 9, 2019
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  • Regulatory headaches: Brexit’s not the only thing you need to worry about

    $131.00

    A no-deal Brexit would dramatically affect regulatory alignment and trade, but it’s far from the only regulatory concern in the medtech industry. Learn about the various challenges, including GDPR and the uncertainty around the new Medical Device and IVD Regulations.

    June 5, 2018
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  • Unilever Seeks End To Litigation Over St. Ives Scrub, Plaintiffs’ ‘Fake Medical Condition’

    $131.00

    “Junk science” is being blamed for a lawsuit filed against Unilever for alleged “micro-tears” caused by their St. Ives Apricot Scrub. The suit, first filed in 2016, may be coming to the end of the road, as Unilever requests a summary judgement in the matter.

    October 24, 2018
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  • Testing Ranitidine with Too Much Heat Could Generate NDMA, FDA Say

    $131.00

    The US Food and Drug Administration says reports of high levels of N-nitrosodimethylamine in the histamine-2 blocker ranitidine resulted from a third-party laboratory’s use of the incorrect test for the drug treatment. HBW covers the recommended testing method.

    September 2, 2019
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  • What’s Under The Iceberg: GE Healthcare’s Deep Dive Look At Future Of Gene Therapy

    $200.00

    As gene therapy becomes an increasingly prominent area of interest, players are formulating new strategies to enter the marketplace. In Vivo speaks with GE Healthcare’s General Manager of Cell and Gene Therapy for an inside look at the company’s plans to expand into this area.

    December 3, 2018
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  • Real-World Evidence Takes Courage: A Conversation With IQVIA’s Nancy Dreyer

    $200.00

    The 21st Century Cures Act’s call for the use of real-world evidence (RWE) is slowly moving toward reality. But hurdles abound, warns IQVIA’s Nancy Dreyer. For instance, the FDA–which is behind the EMA in this area–appears split. Privacy concerns and lack of interoperability hinder progress. Learn why this sometimes-muddied distinction between randomized clinical trial data and RWE is so important, and find out RWE’s role in label expansions.

    February 11, 2019
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  • ‘Project Orbis’ Oncology Pilot Eventually Will Target ‘Major Impact’ Applications

    $200.00

    The US Food and Drug Administration’s Oncology Center of Excellence will hand-select applications to enroll in its “Project Orbis” multi-national parallel review pilot program. Pink Sheet covers how the FDA will focus on applicants that are expected to have a major impact on the standard of care.

    August 2, 2019
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  • A Hangover Is A Disease, German Court Rules

    $131.00

    Alcohol-related hangovers are genuine illnesses according to a recent ruling by a high-level German court. HBW looks at the case against a German wellness manufacturer for health claims made for its “anti-hangover” supplements and how deeming hangover’s a disease affects the outcome of the case.

    September 2, 2019
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  • Burt’s Bees Hopes Third Time’s A Charm For Toothpaste, This One With P&G

    $131.00

    Burt’s Bees is making another foray into the toothpaste category with a line for adults and children and a strategic licensing partnership with Procter & Gamble, makers of Crest. Discover the details of this third attempt to successfully enter the oral care space by the Clorox-owned Burt’s Bees.

    January 5, 2019
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  • Novartis’s Zolgensma Loses EU Accelerated Assessment

    $200.00

    Novartis’s Zolgensma losing EU accelerated assessment serves as a warning to other companies. This Scrip story covers a half dozen other examples of companies and drugs who are now forced to slow their development pace—opening room for competitive threats.

    July 26, 2019
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  • Two EU Notified Body Frontrunners In Race For Designation Under New Regulations

    $131.00

    Names have not been made public, but two frontrunners have been chosen as contenders for notified bodies under the European Union’s new Medical Device Regulation. Find out who the frontrunners could be, and how timing is playing a critical role in this crucial announcement.

    October 24, 2018
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  • Drug/Software Combo Platform Coming Soon To US FDA, Gottlieb Says

    $131.00

    Explore the details behind the FDA digital health tools platform set for release in the fall of 2018, an initiative designed to allow health software applications and accompanying new drugs to be approved concurrently, further streamlining the approval process for certain combination products.

    October 24, 2018
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  • Top 10 Drugs: Biologic Blockbusters And The Biosimilar Threat

    $131.00

    Pharma companies faced a “patent cliff” a decade ago with generic competition threatening to slash sales of certain blockbusters. The new threat is biosimilars. Scrip shows how some mature cancer and autoimmune biologics are still the major drivers of revenues, and how biosimilars are gaining on them.

    August 9, 2019
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  • ESMO Preview: Five Key Oncology Battlegrounds To Watch

    $200.00

    With Europe’s biggest cancer congress ESMO attracting large and small companies to present the latest data readouts across a broad range of tumor types, Scrip looked at the key players and the five key battlegrounds at stake.

    August 3, 2019
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  • Two More EU Notified Bodies But Not On Nando Yet

    $131.00

    Nando has registered two new EU notified bodies as of August 2019, though the European Commission has said four notified bodies have been designated. Nando’s tardiness in updating their databases is affecting companies that need their medical products tested, especially given the huge volume of products compared to the number of notified bodies available.

    August 2, 2019
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  • Part B Payment Model Indexing Commercial Discounts Proposed By Genentech

    $131.00

    Stay aware of proposed changes to the existing Medicare Part B average sales price (ASP) payment  system. Explore Genetech’s “Market-based Pricing Model”, as well as changes to the existing competitive acquisition program, and the possibility of moving Part B drug coverage to Part D in this essential article.

    October 23, 2018
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  • Immuno-Oncology: What To Watch At ASCO 2018

    $200.00

    Immunotherapy dominated the American Society of Clinical Oncology 2018 annual meeting. PD-1/L1 inhibitors were among those taking center stage–find out which ones hold the most promise for NSCLC. Gain insights into why Jounce’s ICOS antibody JTX-2011 proved to be such a disappointment–and why this affects Celgene investors.

    May 17, 2018
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