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Opinion & analysis


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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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  • Missed Opportunities: 10 Questions We Wish Senators Had Asked At The Drug Pricing Hearing

    $200.00

    When the US Senate Finance Committee met recently with seven top pharma industry leaders to discuss drug pricing topics, they hit on some key issues, but left other items out of the discussion. Pink Sheet’s industry experts discuss what they wish would have been addressed during this unusual opportunity.

    March 7, 2019
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  • Patient-Specific Drive Takes Ortho Group Corin Into TKR Robotics With Omni Purchase

    $131.00

    Knee and hip replacement company Corin Group PLC has acquired Omni Orthopedics Inc. The acquisition of Omni, which specializes in robotic-assisted total knee replacement, marks another major step in the company’s expansion in the orthopedic market.

    March 6, 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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  • Gottlieb’s Short Tenure Will Be Felt Long After He Leaves US FDA

    $200.00

    Tap into Pink Sheet’s look back on Scott Gottlieb’s nearly two year tenure as Commissioner of the US FDA. Examine the legacy of his short-lived, yet productive stint, and look back on his list of accomplishments as leader of the agency.

    March 6, 2019
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  • EMA Issues Guidance On Medical Devices That Are Integral To Pharma Products

    $131.00

    With its first issue of guidance for the EU Medical Devices Regulation (MDR), the European Medicines Agency has focused on products that contain an “integral medical device” component, such as pre-filled syringes. Find out more about the guidance here.

    March 5, 2019
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  • Scott Gottlieb Calls It Quits After An Active Tenure At US FDA

    $200.00

    In an announcement that came as a surprise to industry experts, Scott Gottlieb announced his resignation as head of the US FDA after only a 22-month tenure. See what his legacy will be, and what his departure means for pilot projects currently in the works.

    March 5, 2019
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  • Novartis Can’t Halt Janssen’s Promo Comparing Their Psoriasis Drugs

    $131.00

    A US district court judge recently denied a request from Novartis for a temporary restraining order against Janssen. Novartis was railing against Janssen’s promotional claims that Novartis’ IL-17A inhibitor Cosentyx (secukinumab) compares unfavorably to Janssen’s IL-23 inhibitor Tremfya (guselkumab) in safety tests. Find out more here.

    March 5, 2019
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  • AbbVie’s Skyrizi Poised To Enter Packed Psoriasis Market

    $200.00

    AbbeVie is banking on the success of a possible simultaneous European/US launch of Skyrizi, its psoriasis drug, to bolster the company’s declining revenues in Europe. Read about how the company plans to use Skyrizi to bounce back from the genericization of its blockbuster Humira in this informative article.

    March 4, 2019
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  • Gene Therapy Investment At All Time High, Commercialization Challenges Noted

    $131.00

    Gene therapy continues to be a hot area of investment, even as the inevitable challenges concerning manufacturing and reimbursement remain a concern. Take a look at the major deals in this area with expert reporting from Scrip.

    March 1, 2019
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  • Innovations In Market Access: The Will, But Not The Way?

    $200.00

    An informal round table discussion among more than 20 key market access leaders in biopharma convened by the Boston Consulting Group (BCG) yielded some interesting insights into the innovations that are forcing changes to the way the industry runs.

    March 1, 2019
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  • Goodbye To All That: EMA Leaves London After 24 years

    $131.00

    The European Medicines Agency is in the midst of huge changes as it relocates its headquarters from London to Amsterdam, effective March 1. Find out more about the move, spurred by the UK’s impending exodus from the EU, in this informative Pink Sheet article.

    March 1, 2019
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  • Eudamed – A Moving Target But On Track For March 2020 Partial Go-Live

    $131.00

    In a recent update of the European Commission’s Rolling Plan, the Commission noted that while Eudamed, the EU’s databank on medical devices, is due to go live in March of 2020, some essential portions of the database may experience a delay in availability.

    March 1, 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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  • Sanofi Releases Annual Drug Price Report Ahead Of Senate Hearing

    $131.00

    Sanofi’s recently released drug-price increase report reveals that the company’s average U.S. list prices increased 4.6% in 2018. That increase was offset by rebates, resulting in a net decline of 8%. Find out what the report had to say about its insulin pricing rationale, including for Admelog (insulin lispro). See how Sanofi is responding to outrage over drug prices, and learn about its patient-assistance programs.

    February 21, 2019
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  • ‘Data Gaps’ Keep 12 Ingredients Off FDA’s Proposed OTC Sunscreen Monograph

    $200.00

    Time to change sunscreen? Only two of 16 current sunscreen ingredients have been “generally recognized as safe and effective” (GRASE) in the FDA’s proposed final sunscreen monograph–zinc oxide and titanium dioxide. Learn which popular form of sunscreen has been singled out for additional testing and whether sunscreen powders are viable. Read what industry leaders and environmental groups have to say about the FDA’s approach.

    February 21, 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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  • Annuity Payment Model For Cures May Get Test Drive In Massachusetts

    $131.00

    Commercial payers in Massachusetts and AveXis may soon pilot an annuity payment model for Zolgensma. This would spread out insurance payments for the high-cost treatment over years to reduce the burden on payers. The pilot will likely involve a performance component. Learn who the players are and what they stand to gain–and what they risk. Find out how the annuity model would work in practice.

    February 19, 2019
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  • FDA’s Proposed Sunscreen Rule Could Bring SPFs Back Down To Earth, Deter SPF Fraud Suits

    $200.00

    FDA’s proposed SPF rule would cap sunscreen claims at SPF 60+ and establish new broad-spectrum requirements for most sunscreen products, among a host of other changes. Find out how these changes could create a more even playing field among OTC sunscreen marketers and help to deter lawsuits alleging SPF fraud. Gain insights into stakeholder and environmental group perspectives.

    February 19, 2019
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  • ECHA’s Microplastic Ban Proposal Is ‘Brutally Misinformed’ – Cosmetics Europe

    $200.00

    ECHA’s plan to ban the use of intentionally added microplastics in cosmetics is based on “a whole clutch of errors and misunderstandings,” according to Cosmetics Europe’s Director-General John Chave. Find out why the industry is worried about this ban–and why they consider it unfair. Gain insights into which solutions would satisfy the industry, and learn why biodegradable plastics–which represent a potential win-win for industry and environmental advocates–may not be viable.

    February 19, 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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  • From Device Centric To Disease Management: Ascensia Commits To Deeper Role In Diabetes

    $200.00

    Find out how Ascensia’s jump from blood glucose monitoring technology to continuous glucose monitoring has moved the company into the disease management space. Learn how the company is expanding into largely untapped global markets, including India and China. Discover how Ascensia plans to become a one-stop-shop for diabetes management solutions and why it’s placing greater emphasis on the patient voice.

    February 14, 2019
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  • Deals Shaping The Medical Industry, February 2019

    $200.00

    Bristol-Myers Squibb’s acquisition of Celgene wasn’t the only big news in January. Read this brief for a comprehensive review of announcements from diagnostic, device and biopharma companies. Gain insights into both business and clinical developments, and get a peek into the in vitro diagnostics, medical devices and pharmaceuticals pipelines.

    February 13, 2019
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  • Real-World Evidence Takes Courage: A Conversation With IQVIA’s Nancy Dreyer

    $200.00

    The 21st Century Cures Act’s call for the use of real-world evidence (RWE) is slowly moving toward reality. But hurdles abound, warns IQVIA’s Nancy Dreyer. For instance, the FDA–which is behind the EMA in this area–appears split. Privacy concerns and lack of interoperability hinder progress. Learn why this sometimes-muddied distinction between randomized clinical trial data and RWE is so important, and find out RWE’s role in label expansions.

    February 11, 2019
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  • Modernizing FDA’s Supplement Industry Regulation Mapped Out In Five-Point Plan

    $200.00

    Before stepping down as FDA commissioner, Scott Gottlieb announced “one of the most significant modernizations of dietary supplement regulation and oversight in more than 25 years.” Through warning letters and advisory letters, the agency is already signaling a move toward more aggressive enforcement. Find out about the agency’s five-point plan and how FDA plans to balance innovation with regulation.

    February 11, 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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  • Surprise As UK Notified Bodies Lose Major Part Of Their UK Role In Devices From March 29

    $131.00

    UK notified bodies would have had their conformity assessment roles temporarily withdrawn in the event of a no-deal Brexit in March. Learn what this move would have meant to UK start-ups. Read the MHRA response to a Medtech Insight inquiry about the role of UK notified bodies after Brexit.

    February 11, 2019
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  • Verseon Playing The Long Game To Level Up Drug Discovery

    $200.00

    Verseon’s computational drug-discovery platform designs candidates that probably wouldn’t be found with conventional methods, according to CEO Adityo Prakash. Discover why he believes Verseon’s approach is paving the way for next-level drug discovery. Gain insights into his refusal to license Verseon’s technology and learn about the company’s blockchain-based subsidiary, BlockRules.

    February 11, 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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  • Want To Add A Drug Coating To Your Device? Check FDA’s New Guide

    $131.00

    FDA draft guidance on combination products provides some insights, but its seven-page annex provides details on regulatory considerations for adding a drug coating to an existing device. For five common drug-coated-device scenarios, learn whether you can rely on a 510(k) submission. Discover what other related guidance is in the works.

    February 5, 2019
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  • BSI Touts ‘Very Short’ Waiting Times For Migrating Certificates From UK To Netherlands

    $131.00

    UK notified bodies would have had their conformity assessment roles temporarily withdrawn in the event of a no-deal Brexit in March. Learn what this move would have meant to UK start-ups. Read the MHRA response to a Medtech Insight inquiry about the role of UK notified bodies after Brexit.

    February 5, 2019
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  • ‘UKCA Mark’ To Replace CE Marking In UK Now, Or Eventually?

    $131.00

    UK notified bodies would have had their conformity assessment roles temporarily withdrawn in the event of a no-deal Brexit, according to guidance issued in February. BBC said the guidance represented a plan “to replace the CE safety symbol on products in the event of a no-deal Brexit.” Is this actually the case? Find out what the UK Association of British HealthTech Industries (ABHI) had to say.

    February 4, 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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  • How To Read The UK’s New Medical Device Regulations: MHRA Explains The Main Points

    $200.00

    Reading the UK’s 2019 medtech regulations–created in anticipation of a no-deal Brexit at the end of March–is a tough slog. So Medtech Insight spoke directly to the Medicines and Healthcare products Regulatory Agency to find out the essentials. What are the key takeaways? Learn what changes would enable UK medtech rules to fully function after a no-deal Brexit.

    February 1, 2019
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  • No More Rebates: HHS Proposed Rule Revises AntiKickback Safe Harbor

    $131.00

    A proposal from the HHS Office of Inspector General to amend the safe harbors-provision in the Anti-Kickback statute could save billions. It would exclude some rebates used by biopharma companies from safe-harbor protection in an effort to reduce prescription costs. Find out how PhRMA and the PBM trade group reacted. Learn how much the proposed change would save. Gain insights into the OIG’s thinking and see what the proposed rule includes.

    January 31, 2019
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  • US FDA’s Shutdown Offers One Possible Winner

    $131.00

    Find out the circumstances surrounding the unexpected positive results that the January 2019 US government shutdown (including the shutdown of US FDA) had on a breakthrough allergy immunotherapy in this thoughtful analysis from the industry experts at Pink Sheet.

    January 28, 2019
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  • Going ‘Beyond The Pill’ – Sanofi To Partner With Digital Health Start-ups In Europe

    $131.00

    Sanofi and the Plug and Play venture fund are teaming up to explore digital technologies in the areas of nutrition and allergies. HBW Insight takes a deeper look at this partnership, as the pharma giant looks to take a lead role in European digital health innovation.

    January 24, 2019
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  • What Does 2019 Hold For Biopharma?

    $200.00

    What will be the biggest trends in biopharma during 2019? In Vivo brings you the predictions of various industry experts, who weigh in on their predictions for what 2019 may hold for R&D, market access, digital and AI, and the organizations and people who play a key role in the industry.

    January 23, 2019
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  • EU Beats Predicted Timelines And Appoints First UK Notified Body Against MDR

    $131.00

    Months ahead of schedule, the EU Medical Devices Regulation has succeeded in designating its first notified body. BSI UK achieved designated status much sooner than anticipated, but does that mean the road ahead for other designations will be as smooth?

    January 22, 2019
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  • Standards, Not Predicates, Emphasized In Finalized Alternative 510(k) Pathway

    $131.00

    As part of an ongoing effort to update and transform its 501(K) pathway, US FDA finalized guidance that stresses the use of consensus standards. This guidance de-emphasizes predicate comparisons with a “Safety and Performance-Based Pathway”, according to FDA.

    January 22, 2019
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  • Cancer Drug Combination Pricing: Genentech Offers Model For Tecentriq, Avastin

    $131.00

    Go behind the scenes for the details on Genetech’s proposed “Combination Pricing Pilot” plan, which offers a discount for Avastin and Tecentriq when the two drugs are used in conjunction to treat patients with lung cancer. Pink Sheet brings you the details about the proposal, which ties into the company’s Medicare Part B interests.

    January 22, 2019
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  • Global Biopharma R&D Productivity And Growth Rankings

    $200.00

    Do trends indicating the decline of R&D productivity amid the biggest names in pharma portend more of the same to come? In Vivo takes a look at the data behind the continuing dip in R&D productivity across pharma and examines what it could mean for the future.

    January 16, 2019
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  • Novartis R&D Chief Tsai On 2019 Goals, Priorities, BD And Digital Advances

    $200.00

    Scrip interviewed Novartis AG’s Head of Global Drug Development at the 2019 J.P. Morgan Healthcare Conference to get his views on how his past experience has prepared him for the job, and where he plans on taking Novartis, especially in regards to business development and digital technology.

    January 16, 2019
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  • The Gene Therapies Are Coming – And So Are New Ways To Pay For Them

    $200.00

    At the 2019 J.P. Morgan Healthcare Conference, bluebird bio Inc. became the first company to propose a 5-year annual installment payment plan for its gene therapy Lentiglobin, the first such payment plan proposal of its kind. Hear more about the reaction to the proposal from other pharma players and from insurers in this informative Scrip article.

    January 15, 2019
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