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You are here: Home > Opinion & analysis

Opinion & analysis


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  • Behind The Scenes Of Digital Health: Medtech Players And Partners

    $100.00

    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.

    February 5, 2018
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  • Bayer’s US Playbook: The Smart Way To Top-Line Growth

    $200.00

    Tap into Bayer AG’s plans to establish itself as a global innovator, particularly with their oncology, cardiovascular, and women’s health franchises. In this exclusive interview, In Vivo talks strategy with Dr. Carsten Brunn, Bayer’s Head of Pharmaceuticals, Americas Region.

    June 18, 2018
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  • Bayer’s Consumer Chief Initiates Turnaround Plan In Bid To Return Troubled Business To Growth

    $200.00

    Bayer AG is seeking to turn around its troubled Consumer Health division through implementing key portfolio changes and embracing growth-focused innovation, according to Heiko Schipper, President of Consumer Health.  Find out what’s in store for Bayer AG’s Consumer Health group, straight from its top leadership.

    December 17, 2018
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  • ASCO 2018: Optimism As Industry Resets And Looks To What Is Next

    $200.00

    The tone of the 2018 ASCO annual meeting was one of regrouping, resolve, and refinement that may have left investors apathetic, but signaled a commitment to getting it right going forward to those in pharma. Examine the key takeaways from ASCO 2018.

    June 4, 2018
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  • As Humira Biosimilars Arrive, Battle Lines Shift From Education To Sustainability

    $200.00

    As a European wave of Humira biosimilars challenges the best-selling drug in the world, the question of how biosimilars will affect the market, from payers, to practitioners, to patients, comes to the forefront. Examine how biosimilars are poised to change the landscape as focus shifts from whether to adopt their use to how to actually use them effectively.

    October 15, 2018
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  • Anti-Aging Cosmetics Or Unlawfully Marketed Drugs? Two Federal Court Cases To Watch

    $131.00

    Skin-firming and anti-wrinkle claims on products marketed as cosmetics are being tested in California federal course. The results will have considerable implications on the health, beauty and wellness industry. HBW looks at similarities and differences of the two cases.

    September 2, 2019
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  • Annuity Payment Model For Cures May Get Test Drive In Massachusetts

    $131.00

    Commercial payers in Massachusetts and AveXis may soon pilot an annuity payment model for Zolgensma. This would spread out insurance payments for the high-cost treatment over years to reduce the burden on payers. The pilot will likely involve a performance component. Learn who the players are and what they stand to gain–and what they risk. Find out how the annuity model would work in practice.

    February 19, 2019
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  • Analysts Weigh Up Benefits Of Big Bayer Restructuring

    $131.00

    The recent shakeup at Bayer AG took some observers by surprise, but was heralded by most as a much-needed measure to maintain the German giant’s viability. Find out how this restructuring will play out, and what top analysts make of the move to streamline the organization.

    November 30, 2018
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  • An FDA Age-Based Predicate Policy Would Be Arbitrary, Reg Experts Complain

    $200.00

    The US FDA intends to make changes to its 501(k) process, and is currently considering a proposal to impose an age limitation on predicate devices as a means of encouraging the use of more modern predicates. Opponents of the plan argue that such a step would do little to achieve the FDAs goals in this area.

    April 18, 2019
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  • Amarin CEO: Consumers Have Heard About Omega-3 Heart Benefits ‘Too Long’

    $200.00

    Amarin’s John Thero says the firm expects a jump in sales for Vascepa from potential label expansion allowing a larger patient groups with lower triglycerides than current label indications. At the same time, he notes competitors fail to show broader cardiovascular risk reduction.

    August 2, 2019
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  • Amarin CEO Thero On Gearing Up For Success Ahead Of The Big Vascepa Ad Comm

    $131.00

    Speaking with Scrip recently, Amarin CEO, John Thero talked about the upcoming US advisory committee meeting for Vascepa and commercial expansion plans and deflected questions about a big pharma buyout. What he did say was that, “We’re planning for success.

    September 2, 2019
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  • AHPA Backs NDI Filing For Kratom, Experts Question FDA Enforcement

    $200.00

    AHPA called on FDA to regulate kratom as an NDI to avoid a patchwork of state regulations. Kratom, used to manage opioid withdrawal, garnered unwelcome scrutiny after being linked to a salmonella outbreak. Will the FDA treat it like any other dietary ingredient? Find out what may lie ahead for this herbal extract.

    April 30, 2018
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  • Adaptive Clinical Trial Designs: US FDA Provides Checklist To Begin Study

    $130.00

    On September 28, 2018, the US FDA issued new draft guidelines for adaptive clinical trial designs, as well as additional guidance updates. Tap into these important updates, which replace draft guidance issued by the agency in 2010.

    September 30, 2018
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  • Accenture Prescribes A New Data Management Future For Medtechs

    $200.00

    In Vivo examines efforts by Accenture Life Sciences to survey medtech CEOs on their digital preparedness as leaders look to build new revenue streams from innovative business models by effectively managing data. Discover what trends they uncovered in this illuminating article from In Vivo.

    November 21, 2018
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  • AbbVie’s Skyrizi Poised To Enter Packed Psoriasis Market

    $200.00

    AbbeVie is banking on the success of a possible simultaneous European/US launch of Skyrizi, its psoriasis drug, to bolster the company’s declining revenues in Europe. Read about how the company plans to use Skyrizi to bounce back from the genericization of its blockbuster Humira in this informative article.

    March 4, 2019
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  • AbbVie Hit Harder By EU Humira Biosimilars Than Projected

    $131.00

    AbbieVie’s Q3 earnings call was a chance for analysts and investors to ask tough questions about the worse-than-projected impact of the first adalimumab (Humira) biosimilars to hit the European markets. Executives remained optimistic for the future of the blockbuster drug and the financial well-being of the company.

    November 2, 2018
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  • Abbott Launches New App To Keep Heart Failure Patients Out Of The Hospital

    $131.00

    Abbott’s Merlin patient care network works with the CardioMEMS HF sensor system. The Merlin 10.0 update to the network allows physicians to share custom messages directly with their patients. Medtech Insight looks closer at the software and its intended benefits.

    September 2, 2019
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  • A World Without Rebates: Is FDA’s Gottlieb Offering New Vision?

    $200.00

    Will drug rebates become illegal? U.S. FDA Commissioner Scott Gottlieb has suggested as much, and PBMs, among others, are paying close attention. Explore the implications–especially for PBMs–and find out why this is historically such a hot-button policy issue.

    May 9, 2018
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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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  • 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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  • 2021 J.P. Morgan Healthcare Conference Review

    $4,750.00

    The 39th annual J.P. Morgan Healthcare Conference (JPM) was held virtually from January 11-14, 2021. A list of events and catalysts that were announced or updated at the conference are included in this report. Below are some key points from company presentations.

    January 25, 2021
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  • 2018’s Top Biopharma Deal-makers

    $131.00

    How did biopharma shape up for 2018 in terms of mergers, acquisitions, and other business deals? Explore what transpired during last year for M&A in biopharma, when tax cuts were expected to spur major activity. In Vivo brings you a vital look back at the events of 2018.

    January 14, 2019
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  • 2018 Completed Clinical Trials: Change Is The New Constant

    $200.00

    Trialtrove’s 2018 Completed Trials: State of Industry-Sponsored Clinical Development report takes a detailed look at the record of completed trials over the calendar year, highlighting key trends by therapeutic area; the company sponsorship landscape; and trial phase, including progress of designated pivotal trials and success in meeting endpoints. This insightful annual review of clinical trials initiated by industry sponsors is a useful gauge of the diversity and innovative potential of biopharma’s investments in R&D. This year’s report reveals that, for all the consistencies in many aspects of the clinical trial landscape, changes are in the wind – particularly as companies outside the “Pharma Top 20” now contribute more completed trials than any other type of sponsor.

    August 21, 2019
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  • 116th Congress Could Test Cosmetic Industry’s Commitment To Reg Reform, Preemption Viability

    $200.00

    With Democrats taking control of the US House of Representatives in the fall of 2018, the future of proposed legislation to update cosmetics industry regulations is hazy, but likely to result in stricter regulations for products sold in the United States.

    November 19, 2018
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  • ‘UKCA Mark’ To Replace CE Marking In UK Now, Or Eventually?

    $131.00

    UK notified bodies would have had their conformity assessment roles temporarily withdrawn in the event of a no-deal Brexit, according to guidance issued in February. BBC said the guidance represented a plan “to replace the CE safety symbol on products in the event of a no-deal Brexit.” Is this actually the case? Find out what the UK Association of British HealthTech Industries (ABHI) had to say.

    February 4, 2019
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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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  • ‘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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  • ‘Implant Files’: New Device-Failure Database Benefits Companies And Savvy Consumers, But May Befuddle Others, Experts Say

    $200.00

    The International Consortium of Investigative Journalists (ICIJ) unveiled their International Medical Devices Database (IMDD) with the aim of alerting consumers to possibly dangerous and under-regulated medical devices, but some argue that the database could confuse laypeople who attempt to use it.

    December 19, 2018
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  • ‘Data Gaps’ Keep 12 Ingredients Off FDA’s Proposed OTC Sunscreen Monograph

    $200.00

    Time to change sunscreen? Only two of 16 current sunscreen ingredients have been “generally recognized as safe and effective” (GRASE) in the FDA’s proposed final sunscreen monograph–zinc oxide and titanium dioxide. Learn which popular form of sunscreen has been singled out for additional testing and whether sunscreen powders are viable. Read what industry leaders and environmental groups have to say about the FDA’s approach.

    February 21, 2019
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