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You are here: Home > Opinion & analysis

Opinion & analysis


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  • The Case For CAR-T Grows As Responses Hold Up Longer Term

    $200.00

    Scrip speaks with Pascal Touchon, Senior Vice President and Global Head, Cell & Gene Therapy at Novartis AG about the company’s encouraging successes with CAR-T therapies, as evidenced by 18-month data released during the December 2018 meeting of the American Society of Hematology.

    December 20, 2018
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  • The Case For Agile Innovation In Health Care

    $131.00

    According to a recent Bain & Company survey, while nearly 80% of health care executives said they needed to be more agile, more than half said they were not familiar with formal agile methodologies and tools and were not using them in their companies.

    September 2, 2019
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  • The Blockbusters No One Talks About

    $131.00

    Although their patent protection has expired, big-name blockbusters continue to produce huge revenues for the pharmaceutical companies that produce them. Take a look at how some well-known drugs may no longer be making headlines, but continue to be big earners.

    June 21, 2018
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  • The Advantages Of Providing Access To Unlicensed Medicines

    $200.00

    As pharma companies increasingly include access to unlicensed medicines as part of their commercialization game plans, new challenges – and opportunities – are born. In this informative article, In Vivo examines both the potential pitfalls and probable triumphs of incorporating unlicensed medicines into commercial strategies.

    November 5, 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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  • Telehealth, Wearables and Apps – Report 3

    $300.00

    >  Reckitt Reaps ROI Reward In Geo-Targeted Symptoms App Promoting Mucinex, Delsym
    >  Biogen CMO Notes iPhone’s Potential For Early Detection of Alzheimer’s
    >  Interview: Philips Plugs Into Patient Connectivity

    December 1, 2017
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  • Telehealth, Wearables and Apps – Report 2

    $400.00

    > Behind The Scenes Of Digital Health: Medtech Players And Partners
    >  Philips To Create More Context, Connectedness And Continuity And Shift Sick Care To Health Care
    >  New Data Gives Adherium Fuel To Accelerate Digital Tech Adoption in Drug Sector
    >  Siemens Healthineers To Launch Digital ‘One-Stop-Shop’

    December 1, 2017
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  • Telehealth, Wearables and Apps – Report 1

    $400.00

    > Engaging Patients and Navigating Laws: What To Consider When Developing Health Apps
    > Telehealth Reforms Praised At Senate Hearing
    > Philips’ Survey Highlights Gaps In Perceptions Of Health Care
    > Game On For Akili’s Cognitive Control Tech

    December 1, 2017
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  • Telehealth Reforms Praised At Senate Hearing

    $100.00

    Insurers and a neurologist testifying at a May 16 Senate Finance Committee hearing on the CHRONIC Care Act praised the bill’s telehealth provisions. Committee Chairman Orrin Hatch, R-Utah, says he plans to mark up the bill, which has been under development for two years, this week.

    February 15, 2018
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  • Technology Gap Separates OTC Drug Firms From SelfCare Sales Growth

    $100.00

    OTC drug firms should offer more digital tools that guide consumers in product purchases, says a health care marketing executive. The American Pharmacists Association suggests firms also strengthen outreach with pharmacists.

    February 15, 2018
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  • Takeda/Shire Merger: Five Things To Worry About

    $131.00

    The Takeda/Shire merger will catapult the new company to the “top 10” pharma list, but greater size brings greater challenges, including manufacturing glitches and review issues. Explore the challenges each company brought to the merger and the new ones the merged faces today.

    May 16, 2018
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  • Takeda To Press On With Core R&D Strategy Post-Shire

    $200.00

    Tap into the state of Takeda’s R&D strategy and how it might change in the wake of their Shire acquisition, due to take place in 2019 to the tune of $62.4b. Find out more about Takeda’s new rare diseases therapeutic areas unit, their partnering efforts to build out the pipeline, near term highlights, progress in penetrating Chinese markets, and more.

    October 2, 2018
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  • Swiss Regulatory Change Takes Over 500 OTCs Out Of Pharmacy

    $131.00

    Swissmedic, Switzerland’s medicines authority, recently completed a full review of Switzerland’s classification system for medicines, deeming 500 OTCs previously available only in pharmacies now suitable for marketing in drugstores, as well. Read more about this sweeping change and how it is affecting hundreds of OTC medicines in Switzerland.

    December 13, 2018
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  • Surprise As UK Notified Bodies Lose Major Part Of Their UK Role In Devices From March 29

    $131.00

    UK notified bodies would have had their conformity assessment roles temporarily withdrawn in the event of a no-deal Brexit in March. Learn what this move would have meant to UK start-ups. Read the MHRA response to a Medtech Insight inquiry about the role of UK notified bodies after Brexit.

    February 11, 2019
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  • Sunshine rules in the EU: Implications of a piecemeal approach

    $200.00

    The EU’s piecemeal approach to transparency makes compliance harder, but this expert advice can smooth the path forward. Learn about implications of these”sunshine”rules in the EU and U.S., how they differ,and what the EU can learn from the U.S.

    June 1, 2018
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  • Sunscreen Test Lab Used Fewer Subjects Than Reported, US Prosecutors Allege

    $131.00

    The owner of AMA Labs, which provides testing for cosmetic, drug, medical device and other products, was arrested on charges of wire fraud and conspiracy following an indictment in New York federal court. The firm that bills itself as “the premier sunscreen testing laboratory” falsified results for 30 years by testing products on fewer subjects than it reported, federal prosecutors allege. Letzia pleaded not guilty but four AMA Labs employees pleaded guilty to similar charges in May. Get the whole story, and what this could mean for the approval or compliance status of products tested by AMA that are currently available.

    August 2, 2019
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  • Suns Sets In Hawaii On Sunscreens Containing Octinoxate, Oxybenzone

    $131.00

    Hawaii’s ban on the sale of sunscreens containing octinoxate and oxybenzone is expected to go into effect in 2021. It’s intended to protect marine ecosystems–in particular, coral. Opponents of the law included the Consumer Healthcare Product Association and the Hawaii Medical Association. Find out how manufacturers will adjust, and gain insights into the U.S. FDA’s perspective on regulating certain sunscreen ingredients.

    May 2, 2018
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  • Strategy At Novartis: Culture Change As The ‘How’ Behind The ‘What’

    $200.00

    Go behind the scenes at Novartis via an In Vivo interview with the company’s Global Head of Strategy, Stephen Moran. Moran discusses the secret behind effective strategy planning, as Novartis navigates a new era of culture change, enhanced risk management, and functional integration.

    November 19, 2018
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  • Sterilization Facility Shutdowns Could Spell Medical Device Shortage; FDA Urges Firms To Assess ‘Downstream Impacts’

    $131.00

    Explore the repercussions of two medical device sterilization plant closings in this informative Medtech Insight article. Closed due to environmental and health concerns, the plants’ cessation of operations could mean medical device shortages, while opening the door to new sterilization innovations.

    March 26, 2019
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  • State Of Pharma R&D: Ex-Takeda’s Yamada Takes The Long View

    $200.00

    Biopharma industry veteran Tadataka “Tachi” Yamada sits down with In Vivo for an exclusive interview that draws on his years of experience in many roles across the R&D ecosystem to explore the state of today’s biopharma R&D enterprise.

    April 9, 2018
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  • State Of Pharma R&D: Ex-Takeda’s Yamada Takes The Long View

    $200.00

    What’s the ultimate task of an R&D organization? Industry veteran Tadataka Yamada shares his insights, offering a big-picture take on the state of the pharma R&D enterprise. Discover which areas most excite–and concern–him, and learn why “de-risking” the pipeline is harder than ever.

    April 9, 2018
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  • Standards, Not Predicates, Emphasized In Finalized Alternative 510(k) Pathway

    $131.00

    As part of an ongoing effort to update and transform its 501(K) pathway, US FDA finalized guidance that stresses the use of consensus standards. This guidance de-emphasizes predicate comparisons with a “Safety and Performance-Based Pathway”, according to FDA.

    January 22, 2019
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  • Special Report: The Intersection Between Tech and Pharma (Part 1. Google)

    $3,000.00

    In January 2015, Fortune reported that at $2.9tn, the state of the US healthcare industry is very strong and continues to grow.

    January 2, 2016
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  • Six Questions For McKinsey Executives On Pharma’s Digital Experience

    $200.00

    Scrip sat down with the heads of McKinsey & Company for an informative Q&A about pharma’s efforts to expand and update in the areas of advanced analytics and digitization. Tap into their insights about where the industry is now, and where it may soon be heading.

    March 8, 2019
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  • Six Key New Commission Documents Relating To EU Directives And New Regulations

    $131.00

    To help companies respond and adapt the processes they may have in place as rapid EU regulatory activity continues, Medtech Insight summarizes the six documents that have recently appeared on the European Commission’s medtech website.

    September 2, 2019
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  • Serious Skin Reactions Reported with Ibuprofen Use in Europe

    $131.00

    The European Medicines Agency’s Pharmacovigilance Risk Assessment Committee advises ibuprofen manufacturers to add warnings on patient information leaflets concerning acute generalized exanthematous pustulosis associated with use of the drug. HBW provides details about the skin reaction being noted and the informational changes required.

    September 2, 2019
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  • Scott Gottlieb Calls It Quits After An Active Tenure At US FDA

    $200.00

    In an announcement that came as a surprise to industry experts, Scott Gottlieb announced his resignation as head of the US FDA after only a 22-month tenure. See what his legacy will be, and what his departure means for pilot projects currently in the works.

    March 5, 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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  • Schakowsky’s Loaded Cosmetics Bill Described as ‘Floor, Not a Ceiling’ for States to Build On

    $200.00

    The Safe Cosmetics and Personal Care Products Act reintroduced to the US House of Representatives calls for greater duties and resource demands on companies and the FDA than the proposed Personal Care Act in the Senate and allows room for states to impose more stringent regulations.

    September 2, 2019
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  • Sanofi’s New CEO Paul Hudson Poised To Write The Next Chapter

    $200.00

    Less than one month into his new job, Sanofi CEO Paul Hudson shared his perspective on how he plans to build on Sanofi’s strengths and deliver needed changes. Scrip shares details about Sanofi’s leadership history and Hudson’s early priorities at the helm.

    September 2, 2019
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  • Sanofi Releases Annual Drug Price Report Ahead Of Senate Hearing

    $131.00

    Sanofi’s recently released drug-price increase report reveals that the company’s average U.S. list prices increased 4.6% in 2018. That increase was offset by rebates, resulting in a net decline of 8%. Find out what the report had to say about its insulin pricing rationale, including for Admelog (insulin lispro). See how Sanofi is responding to outrage over drug prices, and learn about its patient-assistance programs.

    February 21, 2019
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  • Sanofi Prioritizes Cancer And Rare Diseases In Pipeline Shake-Up

    $200.00

    Shortly after US FDA approval of its blood-disorder drug Cablivi, Sanofi announced “a rigorous pipeline prioritization review.” It’s fast-tracking 17 programs and discontinuing 13 development and 25 research projects. What’s left? Will Sanofi divest its animal health and/or consumer healthcare units? Find out what experts are saying.

    February 7, 2019
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  • Sanofi Offloads Two German OTC Brands, New CEO Prepares To Make Mark

    $200.00

    Sanofi signaled earlier this year it would continue to rationalize its Consumer Healthcare portfolio and focus on several priority brands and categories. Now they have divested two brands in Germany and Austria. HBW covers the details including plans of the firm’s CEO.

    August 2, 2019
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  • Rodan + Fields Concealed Prostaglandin Risks From Lash Boost Users – Class Action

    $200.00

    A federal class-action suit alleges Rodan + Fields hid prostaglandin risks from consumers using Lash Boost. The lawsuit will likely draw attention to prostaglandin analogs in eyelash enhancers. Find out what this means for the lash-enhancement market in terms of litigation and regulatory activity.

    May 7, 2018
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  • Roche’s External Control Arms Show What Real-World Evidence Can Look Like In Practice

    $131.00

    Roche is leading the charge in the emerging field of using real-world evidence (RWE) with its recent acquisition of Flatiron Health, Inc. and Flatiron’s electronic health records database. Take a closer look at the use of RWE in actual practice in this illuminating article from Pink Sheet.

    June 14, 2018
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  • Roche: We’ve Abandoned Budgets And It’s Liberated Employees

    $200.00

    Imagine what would happen if a huge corporation abandoned the core competency of controlling its multi-million-dollar budgets and accelerating processes across R&D and commercial divisions. Would it survive? Would it actually thrive? Scrip talks to one CEO who knows.

    August 2, 2019
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  • Roche: We’ve Abandoned Budgets And It’s Liberated Employees

    $131.00

    Imagine what would happen if a huge corporation abandoned the core competency of controlling its multi-million-dollar budgets and accelerating processes across R&D and commercial divisions. Would it survive? Would it actually thrive? In Vivo talks to one CEO who knows.

    September 2, 2019
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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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  • 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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  • Reckitt Shaking Up Brain Health Market With Neuriva Dietary Supplement And Mobile App Launch In US

    $131.00

    Reckitt Benckiser Group PLC is looking to become the leader in the booming brain health segment with its release of Neuriva, a dietary supplement whose main ingredient is coffee berry, and whose efficacy, the company says, is backed by a double-blind clinical study.

    February 25, 2019
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  • Reckitt Reaps ROI Reward In Geo-Targeted Symptoms App Promoting Mucinex, Delsym

    $100.00

    RB’s spending on the WebMD-hosted Cold & Flu Tracker app generated an ROI three times greater than traditional digital marketing, says marketing executive Emma Howe. Similar campaigns are gaining momentum, with WebMD and Walgreens launching “Relief Advisor.”

    February 15, 2018
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  • Reckitt Invests In AI Symptom Checker To ‘Unlock Self-Care’

    $131.00

    Reckitt Benckiser has invested in ‘doctor in your pocket’ app Your.MD in response to consumers’ increasing demand for “personal, always-on mobile and data-driven” digital healthcare – that according to Aditya Sehgal, RB Health’s chief operating officer. The app’s AI-powered symptom checker claims to diagnose with high accuracy a range of medical conditions. For its part, Your.MD believes the tie-up with RB will be a game-changer for the firm. Will the new infusion of capital fulfill the goal of Your.MD to put a doctor in the pocket of every citizen in the world?

    August 2, 2019
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  • Real-World Evidence: US FDA’s Prucalopride Review Shows Datasets’ Utility And Limitations

    $131.00

    Although criticism was leveled at the use of real-world datasets in the US FDA advisory committee review of Shire PLC’s constipation drug Motegrity (prucalopride) with worries raised over its lack of race-related patient information, a European pharmacoepidemiology study allayed concerns regarding its cardiovascular safety.

    October 23, 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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  • Ranitidine Recalls Begin In Europe As Regulators Take Action

    $200.00

    Over the counter products are among the first to be recalled in Europe following the discovery of a human carcinogen in ranitidine-based drugs. HBW covers how investigations are underway worldwide while regulators across Europe are divided between “take immediate action” and “wait and see”.

    August 3, 2019
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