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You are here: Home > Opinion & analysis

Opinion & analysis


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  • Neuroscience Is The Next Oncology: Why Biogen Is Doubling Down

    $131.00

    Other big names may be withdrawing from neuroscience R&D, but Biogen has seen opportunity in the area, choosing to go in big, filling the space left by the recent GlaxoSmithKline PLC, Pfizer Inc., AstraZeneca PLC, Novartis AG, and Sanofi neuroscience exodus.

    November 23, 2018
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  • Luxturna Approved In EU: Novartis Outlines Lessons For Gene Therapy Strategies

    $131.00

    Novartis/Spark Therapeutics readies the launch of its first-ever gene therapy, thanks to approval from the European Commission. Luxturna marks the start of a new strategy for the Swiss drug giant, as Novartis AG’s Global Head of Product and Portfolio Strategy told Scrip in an exclusive interview.

    November 23, 2018
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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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  • Accenture Prescribes A New Data Management Future For Medtechs

    $200.00

    In Vivo examines efforts by Accenture Life Sciences to survey medtech CEOs on their digital preparedness as leaders look to build new revenue streams from innovative business models by effectively managing data. Discover what trends they uncovered in this illuminating article from In Vivo.

    November 21, 2018
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  • Device Sector Braces For Investigative Stories Critical Of Industry

    $131.00

    Rumblings of a series of reports and broadcasts from the International Consortium of Investigative Journalists (ICIJ) have gotten louder in the past few months, as the industry braces itself for the release of these sprawling investigations, believed to be highly critical of the medical devices industry.

    November 21, 2018
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  • Kratom Industry Offers Own Standards As Another Firm Warned About FDA Rules

    $200.00

    On the same day the American Kratom Association published its own standards for safety, the FDA coincidentally released the contents of a warning letter to Avalon Packaging, Inc., a kratom contract manufacturer, citing concerns about the manufacturing process and salmonella contamination.

    November 20, 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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  • 116th Congress Could Test Cosmetic Industry’s Commitment To Reg Reform, Preemption Viability

    $200.00

    With Democrats taking control of the US House of Representatives in the fall of 2018, the future of proposed legislation to update cosmetics industry regulations is hazy, but likely to result in stricter regulations for products sold in the United States.

    November 19, 2018
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  • R&D Heads At GSK & AZ Say Key To Success Lies In Smart Risk Taking

    $131.00

    What’s the secret to successfully transforming research and development innovation into drug launches? Taking risks, but doing so in a focused, smarter way, say the heads of Britain’s two largest pharma companies. Read more about the secrets to their success here.

    November 15, 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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  • 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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  • BSI Is Designated In Netherlands, Giving Clients Go-Ahead To Start Transfer Of Certificates

    $131.00

    With the details of Brexit as yet unresolved, UK standards and certification body BSI has successfully achieved a notified body designation in the Netherlands, securing a more stable future by allowing certificate holders to migrate UK conformity assessment certificates from the UK to the Netherlands if they wish.

    November 13, 2018
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  • New Year Present For Takeda As Shire Close Nears?

    $131.00

    The wheels are turning for Takeda’s huge acquisition of Shire, assuming the European Commission’s approval on antitrust concerns, and the approval of the respective companies’ stakeholders. The $62.4b deal is the biggest overseas M&A deal in Japanese history, and brings with it speculation of future divestments by Takeda.

    November 12, 2018
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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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  • The Oncology Burden Of Proof: Learning From The PD-1 Market

    $200.00

    In Vivo interviews Eva Marchese, VP at consulting group Charles River Associates, for insights into the challenges facing the PD-1/LD1 European market’s reimbursement and access schemes for IO products. Gain insights into the sustainability obstacles for immuno-oncology products in this vital interview.

    November 7, 2018
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  • FDA Plans Consumer Survey To Better Understand Cosmetics Allergy Prevalence

    $131.00

    An FDA 2019 online survey is aimed at collecting data from 1,000 targeted respondents regarding their experiences with allergens in cosmetics. This survey marks the US FDA’s first efforts in four decades to document the possible link between an overall rise in allergies and the cosmetics industry.

    November 7, 2018
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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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  • 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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  • Infant Formula Production Stalls On Reckitt Benckiser’s Latest Stumble

    $200.00

    “Technical problems” interrupted infant formula production at Reckitt Benckiser’s Netherlands plant, resulting in an 8% decrease in 2018 third quarter revenue from Enfamil and other brand formulas, a dip that is expected to have repercussions well into 2019.

    November 5, 2018
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  • AbbVie Hit Harder By EU Humira Biosimilars Than Projected

    $131.00

    AbbieVie’s Q3 earnings call was a chance for analysts and investors to ask tough questions about the worse-than-projected impact of the first adalimumab (Humira) biosimilars to hit the European markets. Executives remained optimistic for the future of the blockbuster drug and the financial well-being of the company.

    November 2, 2018
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  • ISO Wants To Tinker With Quality Systems Standard 13485:2016. Let ISO Know What You Think By Nov. 9

    $131.00

    The most recent version of International Standardization Organization’s ISO 13485 hasn’t even gone into effect yet and already the Technical Management Board is looking for a rewrite, calling for the standard to be rewritten in a “high-level” format. Find out more here.

    November 2, 2018
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  • Focus More On Patients, Less On Hospitals, Experts Tell Device Companies

    $131.00

    Several medtech industry experts sat down with Medtech Insight to share their views on how the medical devices industry can remain competitive in a shifting healthcare climate by moving its focus to serving patients, rather than catering to doctors and hospitals.

    November 1, 2018
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  • The Emergence Of IO

    $131.00

    Immuno-oncology: spurred by the approval of first-generation checkpoint inhibitors in 2014, this important market has continued to grow exponentially, as deals are made not only around checkpoint inhibitors themselves, but also for related molecules and technologies to be used in synergy with them. Examine the origins of this important and growing area in this essential In Vivo report.

    October 24, 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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  • Immuno-Oncology: Unicorns, China And The Perfect Storm

    $200.00

    Immuo-oncology is proving to be that rare animal for investors in pharma, where return on invested capital doesn’t seem necessarily tied to risk, with mature assets returning liquidity similar to those of early assets.  Examine transaction trends, investor activity, and the exit landscape for this important area.

    October 24, 2018
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  • Drug/Software Combo Platform Coming Soon To US FDA, Gottlieb Says

    $131.00

    Explore the details behind the FDA digital health tools platform set for release in the fall of 2018, an initiative designed to allow health software applications and accompanying new drugs to be approved concurrently, further streamlining the approval process for certain combination products.

    October 24, 2018
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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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  • 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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  • Part B Payment Model Indexing Commercial Discounts Proposed By Genentech

    $131.00

    Stay aware of proposed changes to the existing Medicare Part B average sales price (ASP) payment  system. Explore Genetech’s “Market-based Pricing Model”, as well as changes to the existing competitive acquisition program, and the possibility of moving Part B drug coverage to Part D in this essential article.

    October 23, 2018
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  • Investigator Horror Stories 3: Boozing On The Job? Yup, That Happened – As Have These Other Shocking Tales Of Irregular FDA Inspections

    $200.00

    Medtech Insight’s Compliance Corner is back for the final installment of the three-part series on Investigator Horror Stories. Tap into the recollections of top industry insiders for a jaw-dropping look at some of the more outrageous tales from the world of compliance.

    October 22, 2018
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  • FDA Ban On Flavoring Ingredients Should Prompt Removal From Fragrances – WVE

    $131.00

    NGO Women’s Voices for the Earth recently called for a ban of five ingredients used in fragrances for personal-care products. These ingredients were recently removed from the safe food additives list by the FDA, despite the FDA’s claims that they pose no risk to public health. Go deeper into this clash between hazard and risk ideologies in this informative article.

    October 18, 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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  • European Commission Sheds Light On MDR/IVDR Progress In Vital Update

    $131.00

    The European Commission has finally released some long-awaited and eagerly anticipated deadlines for Medical Device Regulations and In Vitro Device Regulations implementation measures. The deadlines shed light on progress made by the EU Commission in this area, as application dates for regulations are quickly approaching.

    October 18, 2018
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  • As Humira Biosimilars Arrive, Battle Lines Shift From Education To Sustainability

    $200.00

    As a European wave of Humira biosimilars challenges the best-selling drug in the world, the question of how biosimilars will affect the market, from payers, to practitioners, to patients, comes to the forefront. Examine how biosimilars are poised to change the landscape as focus shifts from whether to adopt their use to how to actually use them effectively.

    October 15, 2018
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  • Nail Polishes Contain Undeclared DEHP, Among Other ‘Regrettable Substitutions’ – Study

    $200.00

    Plasticizer Dibutyl phthalate (DBP) is said to have been phased out of use in nail polishes, but a recent study by Harvard public health researchers wonders what is being used to replace the ingredient, and whether it is any safer than DBP.

    October 12, 2018
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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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  • 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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  • Biosimilar Suffixes Appear Superfluous In Adverse Event Reporting

    $200.00

    Is a suffix that distinguishes biosimilars and other biologic products necessary in adverse event reporting? The US FDA says yes, although to date, nearly every adverse event report received by the FDA have identified biosimilars simply by their brand names.

    October 10, 2018
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  • DECIEM, Truly ‘The Abnormal Beauty Company,’ Faces Uncertain Future

    $131.00

    “Almost everyone at Deciem has been involved in a major criminal activity.” So claimed Deciem Inc. founder Brandon Truaxe on an October 8 Instagram post in which he also announced the controversial Estee Lauder Companies-backed startup would be ceasing operations “until further notice.” Find out more here.

    October 9, 2018
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  • Cell And Gene Therapies Test New Waters In Pricing And Reimbursement

    $200.00

    At the annual Alliance for Regenerative Medicine’s Cell and Gene Meeting on the Mesa in San Diego, the struggles of setting pricing and reimbursement for these new, one-time treatments, and the opportunities to influence how these new treatments are paid, were a recurring theme.

    October 5, 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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  • Adaptive Clinical Trial Designs: US FDA Provides Checklist To Begin Study

    $130.00

    On September 28, 2018, the US FDA issued new draft guidelines for adaptive clinical trial designs, as well as additional guidance updates. Tap into these important updates, which replace draft guidance issued by the agency in 2010.

    September 30, 2018
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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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  • CMS Actively Looking For New Reimbursement Pathway For Innovative Devices

    $131.00

    The US Centers for Medicare and Medicaid Services (CMS) say they are seeking to improve medical devices reimbursement procedures as the device industry looks for a policy to help breakthrough devices receive temporary and automatic Medicare and Medicaid coverage. Read more here.

    September 28, 2018
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  • Moving Medical Affairs To The Pharma Forefront

    $200.00

    Senior medical affairs officials sat down at a roundtable discussion facilitated by the Boston Consulting Group to discuss the role of medical affairs along the pharma value chain. Take a look at the outcome of this discussion and explore the role and challenges of medical affairs in pharma.

    August 29, 2018
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