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You are here: Home > Opinion & analysis

Opinion & analysis


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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  • FDA’s Withdrawn Reg On Data Fraud Hangs Over Zolgensma Incident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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  • Contamination In Common OTC Antacid Adds To FDA’s API Impurity Concerns

    $131.00

    The US Food and Drug Administration is considering how to respond after a contaminant was found in drugs containing, ranitidine, the active ingredient in Sanofi’s Zantac OTC heartburn remedy and multiple generic equivalents. HBW also looks at similar investigations in Europe

    August 2, 2019
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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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  • 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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  • 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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  • 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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  • Orphan Drug Pricing And Reimbursement: Challenges To Patient Access

    $131.00

    While the drug industry and patient advocacy groups have worried about price controls or reimbursement restrictions for drugs that treat orphan diseases, a review of formulary data shows that patient access to high-priced drugs has not been severely hampered despite some payer pushback.

    August 2, 2019
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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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  • FDA Announces More Actions On Drug-Coated Devices

    $131.00

    Based on a meta-analysis of randomized trials for paclitaxel-coated devices, the FDA is concerned that they may not be safe to use, as they may be linked to mortality. Until further information is available, the FDA is recommending doctors prescribe these devices on a case-by-case basis only.

    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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  • 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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  • 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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  • Novo Nordisk’s Oral Rybelsus Priced On Par With Injectable GLP-1s, But Big Discounts May Be Needed

    $200.00

    While a 30-day supply of the first oral GLP-1 agonist will cost $772.43, similar to the injectable version, this is still steeper than oral diabetes medicines and Scrip looks at how deep discounts may be needed to secure market access.

    August 2, 2019
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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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  • 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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  • ‘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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  • 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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  • 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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  • EU Post-Market Clinical Follow Up: What Manufacturers Need To Know

    $131.00

    Consultant Sarah Sorrell offers insights on the EU’s new medtech regulations that have introduced much more comprehensive post-market clinical follow-up requirements for device and diagnostics companies. Medtech interviewed her about what the requirements entail and problems with understanding them.

    August 2, 2019
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  • FDA’s Quality System Regulation Is Mapped To International Standard ISO 13485 – And Vice Versa – In New Report From AAMI

    $200.00

    A new Technical Information Report from the Association for the Advancement of Medical Instrumentation aims to help befuddled US device makers that operate under the FDA’s QSR ensure they are compliant with standard from the ISO.

    August 2, 2019
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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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  • Commission Looks Set To Expand MDR Extension So Notified Bodies Can Focus On High-Risk Devices

    $200.00

    The European Commission seems like it will widen the grace period for MDD-approved products to comply with the new Medical Device Regulation (MDR), including Class I medical devices that have never before been reviewed by notified bodies. This extension will allow notified bodies to focus on higher-risk products.

    August 2, 2019
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  • EU Post-Market Clinical Follow Up: What Manufacturers Need To Know

    $200.00

    The post-market clinical follow-up requirements for device and diagnostics companies based on the new medtech regulations are complex. They contain vague terms that need clarification for companies to understand how to comply. Expert and consultant Sarah Sorrel provides her interpretation in this interview with Medtech Insight. 

    August 2, 2019
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  • European Commission Highlights Medtech Notified Bodies Giving It Cause For Concern

    $131.00

    With higher standards and new, demanding regulations for EU notified bodies, six notified bodies have been called into question by the European Commission. All are listed with warnings on the Commission’s Nando database. Some of those six offer testing in other medtech directives, and in those other directives, they remain competent.

    August 2, 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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  • Novartis’s Zolgensma Loses EU Accelerated Assessment

    $200.00

    Novartis’s Zolgensma losing EU accelerated assessment serves as a warning to other companies. This Scrip story covers a half dozen other examples of companies and drugs who are now forced to slow their development pace—opening room for competitive threats.

    July 26, 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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  • Big Pharma CEOs Get Ready To Testify: Preparing For A No-Win Situation

    $131.00

    Leading pharmaceutical executives called to testify before a Senate Finance Committee hearing on drug prices were likely the first of many to be summoned. It’s a no-win situation, but preparation can help. Find out why changing the subject can be a smart tactic. Discover how some senators may try to lure execs into inadvertently lying–and learn how to avoid it.

    May 13, 2019
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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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  • 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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  • 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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  • 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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  • Going Generic: Big Brands Poised To Lose Marketing Exclusivity In The US In 2019

    $200.00

    2019 should be a big year for the generics and biosimilars industries, as a sizable number of blockbuster drugs are losing their market exclusivity. Find out which drugs will see their first generic and biosimilar versions this year and what the repercussions will likely be.

    March 15, 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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  • The Knowledge Within: An Interview With Merck KGaA’s R&D Chief

    $200.00

    Merck KGaA’s head of global research and development, Luciano Rossetti, sat down with In Vivo to discuss the track the German company is taking toward becoming a major player in global immuno-oncology. Tap in to his insights and opinions in this essential interview.

    March 11, 2019
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  • Breakthrough Designation Rescissions: Who Might US FDA Drop Next?

    $200.00

    Several drugs recently lost their Breakthrough Therapy Designations (BTDs), and Pink Sheet has identified others in the pipeline that might suffer the same fate soon. Take a look at the therapies possibly on the chopping block and the reasons behind it in this informative article.

    March 10, 2019
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  • How Roche Won The Bidding Battle For Spark

    $131.00

    Go behind the scenes with Scrip, as expert analysts examine the machinations of Roche’s acquisition of Spark Therapeutics, Inc. Find out in this informative article how Roche secured the deal in the face of strong competition from three other rival companies.

    March 8, 2019
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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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  • 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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This is operated by Pharma Intelligence UK Limited, a company registered in England and Wales with company number 13787459 whose registered office is 5 Howick Place, London SW1P 1WG. The Pharma Intelligence group is owned by Caerus Topco S.à r.l. and all copyright resides with the group.
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