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Opinion & analysis


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  • IXICO Targets Go-To Status In Neuro Data Analytics Space

    $131.00

    IXICO is a neuroscience data specialist that wants to partner with large and small pharmas to help them develop better-targeted clinical trials using imaging and digital biomarkers data. In Vivo looks at the CEO’s activity planning review and subsequent leadership restructuring.

    August 2, 2019
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  • Made In China Gene Therapy A Father’s Quest To Save Son With UltraRare Condition

    $131.00

    China has the potential to be the world’s largest market for rare disease treatments but may need to develop their own gene therapies as imported products will be too costly.  Read about a father’s journey to find a gene therapy to treat his young son’s rare condition.

    August 5, 2019
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  • In Vivo’s Quick Guide To Gene Therapy

    $131.00

    In Vivo looks at how gene therapies have gone from being just implausible science fiction premises, to becoming clinical realities taking an ever-larger portion of pharma R&D attention. This article covers how gene therapies work, where the field has been and where it’s going.

    September 19, 2019
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  • Biotech CEOs: Can Scientist-Founders Remain In Charge?

    $200.00

    Founder-CEOs do not typically remain at the helm as biotechs mature, as the majority of scientist-founders lack the skills to lead a company beyond discovery and early development. Exceptions to that rule are multiplying, though, especially in Europe as companies aim directly for Nasdaq. In this fascinating read, In Vivo reviews the many, varied paths toward biotech CEO, and what it takes to lead a company to IPO and beyond.

    May 20, 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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  • 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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  • 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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  • Made In China Gene Therapy A Father’s Quest To Save Son With UltraRare Condition

    $131.00

    With a population of 1.3 billion and a large patient pool with rare genetic conditions, China has the potential to be the world’s largest market for rare disease treatments. It is believed, however, that China will need to develop its own gene therapies, given that such imported products will be simply too costly for what is a largely self-pay market.  Read about one very determined Chinese father’s journey on two continents to find a research provider with the particular expertise to find a new gene therapy to treat his young son’s very rare condition.

    August 5, 2019
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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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  • 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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  • 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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  • CBD Suits Challenge ‘THC-Free’ Claims After Users Fail Drug Tests; Plaintiffs Bar May Just Be Warming Up

    $131.00

    Attorneys are warning CBD product marketers to be on guard for litigation challenging the authenticity of their claims, the safety of their products and other aspects of their businesses – this after users in the US filed suit as a result of testing positive for THC, which they attribute to defendants’ purportedly THC-free cannabidiol products. So far, suits of this nature have been limited in the US, but the few known cases could be the first waves of an impending tsunami to come. Was it false advertising on the part of the defendants, or did they not know their claims of THC-free CBD products to be untrue? In either case, the cost of litigation could be steep.

    August 2, 2019
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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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  • Novartis CEO Explains Delay In Telling US FDA About Zolgensma Data Fraud: We Wanted To Understand It First

    $200.00

    Novartis AG tried to squash any murmurings that it had a disreputable intent in not disclosing the data fraud it knew about before approval of its gene therapy Zolgensma, saying the company wanted a full understanding of the issue first before bringing it to the attention of regulators. In a recent conference call with analysts, Novartis execs were bombarded with questions about their “prescribed process” of internal investigation, and when exactly they knew about the fraud. Find out how the pharma giant is handling such close scrutiny, how they are dealing with the AveXis scientists involved in the “data inaccuracies,” and the recent EMA decision to downgrade Zolgensma’s accelerated assessment.

    August 2, 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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  • 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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  • FDA’s Withdrawn Reg On Data Fraud Hangs Over Zolgensma Incident

    $131.00

    Democratic senators push data-challenged gene therapy Zolgensma into the center of the drug pricing debate as they press acting commissioner Sharpless to bring the hammer down on Novartis, but also question the US FDA’s decision to withdraw its proposed rule about data falsification in clinical and nonclinical studies last year. Did the FDA do the right thing by abandoning a proposed rule that, as they state, is not needed to protect research subjects or ensure integrity of clinical trial data?

    August 2, 2019
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  • Novartis’ Zolgensma Had Manipulated Data In Application, US FDA Says

    $200.00

    The gene therapy Zolgensma will remain on the market, but Novartis and subsidiary AveXis Inc. may face civil or criminal action after revelations by the FDA that data used for approval had been manipulated. In fact, the drug giant knew about the problem months before Zolgensma was approved and said nothing. Learn what happened, why the FDA still asserts confidence in its approval of Zolgensma, and what these events could mean to Novartis and the gene therapy industry moving forward.

    August 3, 2019
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  • Cannabis Industry Taking Legal Action Against EU Regulators Over CBD Novel Food Classification

    $131.00

    In response to the recent controversial European Commission decision to classify products containing cannabidiol (CBD) as “novel foods”, the Cannabis Trades Association UK has begun legal action to challenge the classification. Read more about the controversy and legal proceedings here.

    March 20, 2019
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  • FDA Determined To Update Cosmetics Regs After Claire’s Refuses To Recall Asbestos-Tainted Makeup

    $200.00

    The battle over traces of asbestos found in cosmetics products at Claire’s, a jewelry and accessories retail chain that caters to girls and young women, serves to illustrate the limitations of the US FDA’s oversight of cosmetics matters. Find out more here.

    March 7, 2019
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  • OTC Marketing Awards 2019 Winners Announced – GSK Crowned Company Of The Year, Pfizer’s Viagra Takes Best Brand

    $131.00

    Find out who the big winners were at the 24th annual OTC Marketing Awards. This article contains highlights from the gala awards evening, as well as a full list of all winners announced at the event, which celebrates the best in the British OTC industry.

    March 8, 2019
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  • House Committee Hearing Shows How Talc/Asbestos Concerns Could Be Impetus For Cosmetics Reform

    $131.00

    During the first hearing of the Subcommittee on Economic and Consumer Policy, part of the House Committee on Oversight and Reform, US lawmakers focused on the issue of the safety of talc and asbestos in personal care items.

    March 12, 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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  • 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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  • BioMarin Is Carrying The Biggest Target On Its Back, Morningstar Says

    $200.00

    Expect more industry consolidation, counsels Morningstar’s Healthcare Observer report. Among the potential deals: BioMarin is a logical acquisition target. But for whom? Find out what Morningstar’s Damien Conover predicts. Discover which companies could be targets for Pfizer, and learn what Conover thinks of Pfizer CEO Albert Bourla’s insistence that it plans to grow organically.

    February 18, 2019
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  • Mortality Signal For Pfizer’s Xeljanz In Rheumatoid Arthritis Puts A Damper On JAK Class

    $200.00

    The cardiovascular risks associated with a higher-than-approved dose of Pfizer’s JAK inhibitor Xeljanz in a long-term rheumatoid arthritis study have raised questions about its other indications. Will the risk of pulmonary embolism for a higher unapproved dose of Xeljanz in arthritis trigger a label change in the drug’s other indications? Is the JAK-inhibitor class of therapies in jeopardy? Learn what the analysts are saying.

    February 20, 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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  • 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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  • Paying for Pharmaceutical Value: The Problem of a One-Size-Fits-All Definition

    $200.00

    In Vivo takes a look at the hot-button topic of drug value in this thought-provoking article, which examines the role of ICER (Institute for Clinical and Economic Review) and wonders if a more sophisticated method of assigning value in the US market is necessary.

    March 20, 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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