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You are here: Home > Opinion & analysis

Opinion & analysis


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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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  • 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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  • 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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  • 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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  • 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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  • 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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  • 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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  • 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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  • Data, AI And Machine Learning Are Propelling Clinical Trials Data Analysis To New Heights

    $200.00

    At the recent Medidata NEXT London meeting, Medidata Solutions, Inc., explained their new Clinical Cloud solution, part of the new crop of clinical trials and data analysis tools that only a few years ago, seemed like a distant dream. Read how Clinical Cloud and other clinical trials tools are taking data analysis to new heights in this informative article.

    May 16, 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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  • 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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  • 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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  • 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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  • 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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  • 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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  • 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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  • 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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  • 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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  • Father of Humira, Greg Winter, Wins 2018 Nobel Prize For Chemistry

    $131.00

    The 2018 Nobel Prize for Chemistry was recently jointly awarded to George Winter and two other scientists for their pioneering work in the directed evolution of antibodies, research which led to the development of Humira, the world’s most successful drug.

    December 9, 2018
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  • Next-Generation Roche: How Data Analytics Will Keep It In The Lead In Oncology

    $200.00

    At Roche’s on-site investors briefing at ASCO in 2018, company execs unveiled the oncology leader’s strategy for staying ahead in the market: heavy investment in digital and personalized healthcare. Read more about the company’s plans in this illuminating article from Scrip.

    June 8, 2018
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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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  • ASCO 2018: Optimism As Industry Resets And Looks To What Is Next

    $200.00

    The tone of the 2018 ASCO annual meeting was one of regrouping, resolve, and refinement that may have left investors apathetic, but signaled a commitment to getting it right going forward to those in pharma. Examine the key takeaways from ASCO 2018.

    June 4, 2018
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  • Novartis’ New Oncology CEO Liz Barrett Charts A Course, But It Will Require Jump-Starting New Brands

    $200.00

    Novartis Oncology CEO and newcomer to the company, Liz Bennett, sat down with Scrip ad talked about her plans for an organization currently in transition, and her strategy for moving new blockbusters forward. Access her insights into the future of Novartis Oncology in this illuminating interview.

    June 6, 2018
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  • Lilly Prices Olumiant For JAK Battle, But Misses Approval For Higher Dose

    $200.00

    How do you compete with rheumatoid arthritis giants Humira and Xeljanz? Eli Lily & Co. is betting that pricing their janus kinase (JAK) inhibitor, Olumiant at 50% and 60% less, respectively, may just do the trick. Find out more about Lily’s gambit, even as Olumiant failed to gain FDA approval for a 4mg dose.

    June 2, 2018
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  • FDA investigator insights: Device makers forget about the humans who use their products

    $200.00

    Device makers often fail to consider what happens once their product is in a patient’s hands, says a seasoned U.S. FDA investigator. She identifies seven common human-factor–usability–problems. Learn what they are so you can enhance compliance and patient safety.

    May 31, 2018
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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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  • 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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  • Thinking about using CMMI? Here are tips from the experts

    $200.00

    Learn about the voluntary U.S. FDA pilot program that uses Capability Maturity Model Integration (CMMI) from quality,compliance and regulatory officials at three major device firms. Walk through the CMMI process,and discover why it’s nothing like a typical regulatory audit.

    June 25, 2018
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  • Colgate/Tom’s Of Maine Pays Back Unilever For ‘Naturally Dry’ Loss

    $131.00

    It’s payback time for Unilever, as the maker of Schmidt’s deodorants must re-label its products, removing reference to certain wetness-absorption claims. In 2016, Unilever was responsible for making close competitor Colgate’s Tom’s of Maine remove similar claims to their deodorant products at a self-regulatory forum.

    June 7, 2018
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