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Opinion & analysis


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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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  • NASH: Flying The Plane While Building It

    $200.00

    Investors are showing interest in the development of treatments for NASH (nonalcoholic steatohepatitis), a type of liver disease, as the pipeline for the disease develops in parallel with those R&D efforts. Get a full view of the promising market for NASH in this article from In Vivo.

    July 25, 2018
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  • P&G Grooming Quits Counting Blades, Innovates In New Directions While Battling DTC Disruptors

    $200.00

    In the wake of the disruptive influence of Dollar Shave Club, Proctor & Gamble’s Grooming business is making progress in its efforts to win back market share, slowly, but surely. During an Investor Day presentation, P&G’s global division president also warned that there were likely to be hiccups during the recovery process.

    November 13, 2018
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  • CAR-T Label Update Could Address Medicare Coverage Challenges, FDA’s Gottlieb Suggests

    $131.00

    Lifesaving chimeric antigen receptor T-cell (CAR-T) therapies could soon move to outpatient settings, easing the financial burden currently felt by providers, according to US FDA Commissioner Scott Gottlieb, who said a label change to allow for outpatient treatment under Medicare Part B is in the works.

    November 13, 2018
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  • Interventional Cardiology: Implantable Cardioverter Defibrillators

    Interventional Cardiology: Implantable Cardioverter Defibrillators

    $4,750.00

    The ICD market alone lost nearly $1bn from $8.3bn in 2019 to $7.4bn in 2020 due to a combination of lockdowns, supply chain disruptions, and logistical strain in the healthcare space. The global market for ICD devices, along with many other medical devices, is currently recovering from a major economic downturn. Therefore, to provide context as to the nature of this market recovery and what exactly it is recovering from, data from 2019 are included. Types of cardiac defibrillators covered by the scope of this report include ICDs, subcutaneous ICDs (S-ICDs), and cardiac resynchronization therapy defibrillators (CRT-Ds). The regions covered by this report are the US, the 5 major European economies (UK, France, Spain, Italy, Germany), Japan, and the rest of the world. The forecast range is 2020-2025.

    December 21, 2021
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  • Merck Steps Out Of Insulin Glargine Market, But Says It Remains Committed To Biosimilars

    $131.00

    Despite a recent decision not to commercialize their version of Sanofi’s Lantus (insulin glargine), Merk & Co. Inc. says they remain committed to oncology and immunology biosimilars. The decision to withhold their insulin glargine biosimilar (known as Lusduna) from the US market comes even as the copy already received tentative approval by the US FDA in 2017.

    October 11, 2018
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  • Patients’ Preferred Endpoints May Not Satisfy Regulatory Needs, US FDA Says

    $200.00

    At a meeting of mitochondrial disease drug development, officials of US Food and Drug Administration said that just because a measure is relevant to the patient community does not mean it can capture meaningful change in a clinical trial. Pink Sheet looks at the implications to sponsors.

    August 2, 2019
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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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  • Never Mind Next-Gen UV Filters; Existing Sunscreen Ingredients’ GRASE Status May Be In Danger

    $131.00

    Later this year, FDA is expected to publish a final monograph for OTC sunscreens. Meanwhile, applications submitted for next-generation UV filters all remain pending. It’s increasingly clear that FDA will not be determining whether any new sunscreen ingredients are “generally recognized as safe and effective” (GRASE) without additional data. Find out what new data the FDA will be requesting. Learn how the industry is responding.

    February 11, 2019
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  • Farxiga Data Change Heart Failure Treatment Outlook

    $200.00

    AstraZeneca’s Farxiga (dapagliflozin) appears set to become new standard or care in the treatment of hear failure based on results of the DAPA-HF Phase III trial present at the European Society of Cardiology Congress on 1 September. Scrip looks at Farxiga and its nearest competitors.

    August 2, 2019
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  • Novartis Pharma CEO Sees Zolgensma Supplanting Spinraza

    $131.00

    Will Novartis’ Zolgensma or Biogen’s Spinraza be the standard of care for spinal muscular atrophy? Novartis shared its perspective with Scrip. Find out what Biogen had to say about the competition during an earnings call–and read how Novartis’ Paul Hudson responded. Learn how Novartis plans to handle payments for the expensive therapy. Is it considering outcomes-based payments? Gain insights into the clinical benefits of both medications and learn what’s next.

    February 1, 2019
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  • L’Oréal E-Commerce Growth Approaches 50%: ‘We Are Now Clearly A Digital-First Company’

    $131.00

    Beauty products leader L’Oréal has enjoyed much success thanks to E-commerce, the Asian market and travel retail continue to fuel gains at L’Oréal, which just posted its strongest first half like for-like growth in more than a decade. Skin care remains a key driver as well, offsetting a global slowdown in makeup that has hit the firm’s US business hardest, with little improvement expected this year. Will all this be enough to make up for sluggish conditions in North America and the US in particular, where more than half of L’Oréal’s sales are in makeup? Read the article to find out what else the company is banking on.

    August 2, 2019
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  • EMA Set For More Staff Losses & Activity Cuts Next Year

    $131.00

    The European Medicines Agency braces itself for a major reduction in staff and decrease in activities. The move is a reaction to Brexit and the agency’s move from London to the Netherlands. The cuts are the latest challenge presented by Brexit, as the EMA braces for an overall 30% loss of staff.

    December 11, 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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  • 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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  • 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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  • 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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  • New Age Thinking: US FDA’s Temple Sees Third Era Of Drug Development

    $131.00

    Robert Temple, the FDA’s voice of institutional memory, believes drug regulation has quietly entered a third era: the “Age of Individualization.” Unlike the prior eras of safety and efficacy, there is no milestone legislation to set the ground rules. But, Temple stressed, there have been significant changes in areas like the assessment of drug-drug interactions, metabolic response to therapeutics, and in the FDA’s willingness for sub-population analyses. Is there a change in the air that will result in further change in drug development as it relates to the Age of the Individual?

    August 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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  • 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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  • Pharma Intelligence Report Store Article Collection Digital Policy & Regulation Report 2

    $300.00

    Funding is taking a long time to come through for the UK NHS’s digital health care transformation, but as the national provider’s head of technology strategy, Dr Paul Rice says, “We can’t afford to remain non-digital.”

    July 21, 2017
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  • Brexit At The 11th Hour: UK Refreshes No-Deal Guidance For Medtech

    $200.00

    As Brexit looms and a no-deal scenario becomes increasingly a possibility, the UK Medicines and Healthcare products Regulatory Agency (MHRA) has updated their guidance on how to respond should no deal with Europe be reached. What does it mean for Medtech? Find out here.

     

    January 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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  • 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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  • 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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  • Eight Things To Know From Novartis’ Third Quarter Call

    $200.00

    Capture the key takeaways from Novartis’ third quarter call in this illuminating article from Scrip. Eight Things To Know From Novartis’ Third Quarter Call brings you the most important developments from the third quarter earnings call that occurred on October 18. Gain insight into the progress on new launches, regulatory developments, and more.

    October 18, 2018
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  • Top 10 Drugs: Weighing Pharma’s Golden Eggs

    $131.00

    A relatively small number of costly drugs account for a sizable portion of pharma industry revenues. This informative and easily scannable Scrip infographic shows which drugs are the golden eggs, which companies are behind them, and how the landscape has changed in the past decade.

    August 6, 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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  • GSK’s Head Of Artificial Intelligence Unveils R&D Goals

    $131.00

    In this interview, John Baldoni describes GlaxoSmithKline’s artificial intelligence efforts. Baldoni, who leads GSK’s AI initiative, discusses the company’s machine-driven discovery and development methods and how they can cut time and costs. Gain insights into the AI team’s timeline and what it has accomplished already. Discover who GSK’s AI partners are–and why such deals are “tricky.”

    April 30, 2018
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  • How To Pay For The New Wave Of Gene Therapies

    $200.00

    Paul Goudreau, executive director & head of Phase IV Solutions at the CRO Covance, recently told Scrip, “an ongoing and wide-ranging discussion is needed about assessment, payment and reimbursement of innovative products, as well as the evidence that supports them.”

    August 2, 2019
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