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You are here: Home > Opinion & analysis

Opinion & analysis


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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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  • Two First MDR Certificates Issued – Are Floodgates Open For Mass Certifications?

    $200.00

    Two medical device manufacturers have been granted the first certificates under the EU’s new regulations that are coming into force next year. Medtech looks at whether this is a sign that the whole sector is going to be able to meet regulations.

    August 2, 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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  • UK Notified Body BSI Sets Out Clear Post-Brexit Paths As It Goes Dutch

    $200.00

    Leading UK and EU notified body BSI expects the UK to remain a full member of the EU regulatory regime post-Brexit, but it has a contingency plan. Learn what this contingency plan means for device manufacturers. Gain insights into the implications of a non-negotiated Brexit, and find out if the other notified bodies have contingency plans.

    May 25, 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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  • US FDA Commissioner: Agency Will Propose New Rule That Blends Quality System Regulation, ISO 13485

    $131.00

    The US FDA plans to “harmonize domestic and international requirements, and modernize the regulation” through a new rule that will blend its Quality System Regulation (QSR) with ISO 13485. Will FDA will swap out the QSR with ISO 13485? Probably not. Find out what it will likely do instead–and when it will do it.

    May 9, 2018
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  • US FDA Looks To Standardize Premarketing Safety Assessments

    $131.00

    A US Food and Drug Administration initiative to standardize safety assessments of new drug and biologic applications could mean changes in how sponsors classify clinical trial adverse events and the types of information companies routinely submit to the agency.

    August 2, 2019
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  • US FDA May Largely Avoid House Democrats’ Investigation Agenda

    $131.00

    As Democrats gained a majority in the House after the 2018 US midterm elections, many wonder who will be on their radar when they turn their attention to holding hearings on drug pricing. The answer? It’s not likely to be the FDA.

    November 7, 2018
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  • US FDA’s Gottlieb Shuts The Door On Exclusivity For ‘Transition’ Biologics

    $131.00

    Commissioner Scott Gottlieb announced that exclusivity for certain existing protein products will not be extended further, in remarks made at the FDA/CMS Summit. The announcement affects existing products, including insulin and human growth hormone, that, under the Public Health Service Act, are “deemed to be licensed” in 2020.

    December 11, 2018
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  • US FDA’s Office Of New Drugs Reorganization Approved, But Not Happening Overnight

    $200.00

    After more than two years of work, the US Food and Drug Administration is ready to formally begin its reorganization of the Office of New Drugs. Pink Sheet covers how this could cause signatory authority and other changes for sponsors with pending applications.

    August 2, 2019
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  • US FDA’s Rush Following Novartis’ Delay Suggests Strong Displeasure With Handling Of Zolgensma Data Manipulation

    $131.00

    The FDA’s early release of inspection findings of a testing lab’s possible involvement in data falsification in the testing (and subsequent FDA approval) of Zolgensma is unusual, signaling the likelihood that Novartis will face tough scrutiny of its actions – and perhaps stiff fines because of the fraud. Learn why one analyst is alluding to the possibility of a government investigation on the call Novartis held for the investment community, and why he’s calling for corporate officers to be held liable for statue violations, regardless of whether they knew of any wrongdoing.

    August 2, 2019
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  • US FDA’s Shutdown Offers One Possible Winner

    $131.00

    Find out the circumstances surrounding the unexpected positive results that the January 2019 US government shutdown (including the shutdown of US FDA) had on a breakthrough allergy immunotherapy in this thoughtful analysis from the industry experts at Pink Sheet.

    January 28, 2019
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  • US FDA’s Temple on Real-world Evidence: “I Find the Whole Thing Very Frustrating”

    $131.00

    At the October FDA panel discussion at the Biopharma Congress, CDER deputy director for clinical science reiterated his long-held skepticism about whether real-world evidence can be used to demonstrate efficacy claims. Pink Sheet looks deeper at his words.

    September 2, 2019
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  • US House Panel Approves Medicare Hearing, Dental And Vision Coverage; Senate Bill Introduced

    $131.00

    Three bills that would cover eye, dental and hearing examination for US Medicare beneficiaries were passed by the US House Ways and Means Committee on 22 October and there is a similar bill in the Senate. Medtech Insight looks at the next steps for these House bills and the related Senate bill.

    September 2, 2019
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  • US Office Of New Drugs Revamp Taking Shape: More Review Divisions Coming, But Who Will Lead Them?

    $200.00

    The U.S. FDA’s reorganization of its Office of New Drugs (OND) faces leadership challenges, thanks to recent departures. How will the FDA staff these new divisions? Learn more about the departures, gain insights into the agency’s options, and explore the implications for the industry.

    May 1, 2018
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  • US Zantac Sales And Distribution Continue As Sanofi Tests For NDMA

    $200.00

    Sanofi plans to continue distributing Zantac OTC heartburn remedy in the US while conducting its own tests to determine whether levels of N-nitrosodimethylamine (NDMA) in the active ingredient are above safe levels, Novartis AG, which licenses OTC Zantac, has said it stopped distribution worldwide.

    August 2, 2019
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  • Vanda Warning Letter From US FDA Leaves Firm “Puzzled”

    $131.00

    A recent letter to Vanda from the US FDA regarding the firm’s listing of indications without corresponding safety information on the company’s website left Vanda’s CEO confounded as to the reasoning behind this action, even as the firm moved to take corrective action.

    November 5, 2018
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  • Verseon Playing The Long Game To Level Up Drug Discovery

    $200.00

    Verseon’s computational drug-discovery platform designs candidates that probably wouldn’t be found with conventional methods, according to CEO Adityo Prakash. Discover why he believes Verseon’s approach is paving the way for next-level drug discovery. Gain insights into his refusal to license Verseon’s technology and learn about the company’s blockchain-based subsidiary, BlockRules.

    February 11, 2019
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  • Virtual AI Nurses And The Future Of Chronic Disease Management

    $200.00

    What’s in store for chronic disease management in the future? Tap into this informal discussion with health entrepreneur Julia Hu, founder of Lark Health, for a look at her views of what’s to come, including the use of artificial intelligence nursing.

    March 6, 2019
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  • Want To Add A Drug Coating To Your Device? Check FDA’s New Guide

    $131.00

    FDA draft guidance on combination products provides some insights, but its seven-page annex provides details on regulatory considerations for adding a drug coating to an existing device. For five common drug-coated-device scenarios, learn whether you can rely on a 510(k) submission. Discover what other related guidance is in the works.

    February 5, 2019
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  • Wearables are Transforming R&D and Care Delivery

    $2,995.00

    Wearable technologies have the potential to transform medicine and the delivery of healthcare more significantly than any other component of the digital revolution – or indeed than many other scientific advances.

    June 6, 2016
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  • What Do Cosmetics Reform Campaigners Dream Of At Night? Rep. Schakowsky Just Reintroduced It

    $131.00

    Find out more about the proposed The Safe Cosmetics and Personal Care Products Act 2018. This bill would institute a number of reforms for the industry and establish a new set of guidelines for safety, and is very similar to previous proposals for cosmetics reform submitted by Rep. Jan Schakowsky, D-Ill.

    September 29, 2018
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  • What Does 2019 Hold For Biopharma?

    $200.00

    What will be the biggest trends in biopharma during 2019? In Vivo brings you the predictions of various industry experts, who weigh in on their predictions for what 2019 may hold for R&D, market access, digital and AI, and the organizations and people who play a key role in the industry.

    January 23, 2019
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  • What Does It Take To Launch And Lead An Oncology Biotech Today?

    $200.00

    Oncolytic virus company Theolytics has emerged ready to raise a series A round and get its preclinical assets into human trials by 2021. CEO Charlotte Casebourne talks to In Vivo about the challenge of standing out from the crowd in oncology, how viruses have evolved as a treatment approach in cancer, and how oncolytic viruses might be the answer to the cancer drug pricing conundrum. Learn what this young CEO (at age 26) has to say about the skills required to be a biotech CEO today, the concerning issue of access to novel personalized cancer treatments, and the biggest challenges she sees in cancer drug development today.

    August 12, 2019
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  • What GSK’s Immunology Chief Did Next

    $200.00

    Paul Peter Tak, formerly of GlaxoSmithKline, is “following the science.” He’s joined Flagship Pioneering as a venture partner and is already CEO of an “undisclosed biotech start-up operating in stealth mode.” Learn more about Flagship’s approach–creating think tanks to build companies from scratch around important unmet challenges–and why Tak finds that so appealing.

    February 5, 2019
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  • What Should You Be Earning? Salary Benchmarks And Hiring Trends In Regulatory Affairs

    $131.00

    Tap into the findings of the latest Regulatory Affairs Professionals Society Overall Compensation & Scope of Practice Survey, a comprehensive study of the salaries, hiring trends, and other noteworthy data for regulatory professionals in 64 countries around the globe.

    October 12, 2018
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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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  • Why Deals Fail: The Reasons May Be Clinical, Economic Or Strategic

    $131.00

    Acquisitions and licensing are core to pharma and big biotech growth as pipelines thin and assets lose patent protection. Looking back at significantly sized acquisitions over just five years reveals that half of 2014’s acquisitions can already be judged as outright failures or, at best, questionable. But some lessons can be learned from dud deals. This article from In Vivo
    Examines deal failures, from the most surprising to the most expected, given the level of risk at stake. If past Is prologue, dealmakers would be wise to look back and consider these lessons of the past.

    August 1, 2019
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  • You Work In The Pharmaceutical Industry; Here’s Why You Should Care About The Novartis Payments

    $200.00

    Novartis AG’s involvement–however tangential–in the Donald Trump/Michael Cohen/Stormy Daniels scandal is just the latest incident to tarnish the pharmaceutical industry’s public image. Explore how negative public perception could accelerate the move to price controls–and why it’s an industry-wide problem.

    May 9, 2018
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