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Opinion & analysis


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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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  • Biogen CMO Notes iPhone’s Potential For Early Detection of Alzheimer’s

    $100.00

    Biogen’s chief medical officer says iPhone technology should in future be used for early warning diagnosis of Alzheimer’s Disease. Biogen CMO Alfred Sandrock has told a London neuroscience forum that constraints impeding CNS drug development include the fact diagnosis needs to be done earlier but that barrier could be mitigated in future by digital health solutions such iPhones used as “early warning” diagnostics, notably in Alzheimer’s Disease.

    February 5, 2018
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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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  • 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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  • 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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  • 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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  • Brexit At The 11th Hour: UK Refreshes No-Deal Guidance For Medtech

    $200.00

    As Brexit looms and a no-deal scenario becomes increasingly a possibility, the UK Medicines and Healthcare products Regulatory Agency (MHRA) has updated their guidance on how to respond should no deal with Europe be reached. What does it mean for Medtech? Find out here.

     

    January 4, 2019
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  • Bristol-Myers, Celgene and The Perils Of The US Drug Pricing Environment

    $131.00

    Pink Sheet brings you a look at the effects of the Bristol-Celgene merger on the public and political perceptions of the companies, with an examination of how pricing for Revlimid has affected Celgene’s public image and stock pricing.

    January 6, 2019
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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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  • 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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  • Burt’s Bees Hopes Third Time’s A Charm For Toothpaste, This One With P&G

    $131.00

    Burt’s Bees is making another foray into the toothpaste category with a line for adults and children and a strategic licensing partnership with Procter & Gamble, makers of Crest. Discover the details of this third attempt to successfully enter the oral care space by the Clorox-owned Burt’s Bees.

    January 5, 2019
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  • Bye-Bye QSR? FDA May Swap Its Quality System Regulation For ISO 13485 ‘In The Coming Years,’ Official Says

    $131.00

    Global regulators are looking to converge–or at least align–various requirements, and the US FDA is no exception. Officials have strongly suggested that the agency will replace its Quality System Regulation with ISO 13485. It won’t be simple. Discover the implications for device makers, and find out what’s involved in making this dramatic change.

    May 4, 2018
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  • Can Novartis Reclaim Pioneering Role In Transplantation?

    $131.00

    Novartis is developing a new type of immunosuppressive agent, an anti-CD40 monoclonal antibody, which might allow organ transplants to last longer in recipients, reduce pressure on transplant waiting lists, and improve long-term outcomes. In Vivo interviewed Novartis’ Head of Immunology, Hepatology and Dermatology.

    September 2, 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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  • Cancer’s New Patient Demographic; Will Survivorship Change The Face Of Cancer Care?

    $200.00

    As the number of cancer survivors increases, they are reshaping cancer research and clinical practice. Find out how–and discover the impact it will have on the allocation of research dollars. Learn how the looming physician shortage has implications for the emergence and increasing use of complex immunotherapy drugs.

    August 6, 2018
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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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  • 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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  • 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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  • 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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  • Cell And Gene Therapy Logistics Requires Early Planning

    $131.00

    Traditionally, the subject of logistics has not been considered until late in the development process for cell and gene therapy. Industry experts at the October 2018 Cell and Gene Meeting on the Mesa in San Diego suggest that considering logistics early in the planning stages for cell and gene therapy is a critically important move.

    December 7, 2018
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  • CEO-To-Worker Pay Ratios Averaged 150-1 At Six Top Medtech Companies In 2017

    $131.00

    CEOs earned 32- to 215- times that of the median worker at six device companies. Find out which CEO earned $10.8 billion–215 times the median salary–and see how company revenues compare to the CEO/worker pay ratio. The average ratio for the six firms is 150-1: Discover how this compares to other public companies across industries.

    April 9, 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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  • 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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  • Commission Addresses Non-EU/EEA Authorities To Set Record Straight On New EU Regs

    $131.00

    Hoping to head off possible rejection of IVDs and medical devices by other countries for items receiving CE marks under the European Union’s Directives for medical devices, the European Commission has issued a fact sheet for third-countries that explains the issue.

    December 5, 2018
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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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  • Commission Would Back Limited Expansion Of Products Covered By MDR Grace Period

    $200.00

    After much speculation and urges of caution related to whether the European Commission would support a proposal to expand the range of products covered by the Medical Device Regulation’s four-year grace period, the European Commission has now said it will support it.

    August 3, 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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  • Cosmetic Preservatives Crisis Creeping Into CIR Program

    $131.00

    The assessment of cosmetic preservative safety continues to be complex and fraught with controversy, as some in the industry look to the Cosmetic Ingredient Review (CIR) program to set the record straight about the use of certain cosmetic preservative ingredients.

    June 10, 2018
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  • Countdown To Transition: US FDA Says 91 Drugs Will Become Biologics In March 2020

    $131.00

    A Pink Sheet infographic shows how insulins account for the largest category of transition products, with 27 NDAs that will be deemed BLAs in six months as the FDA is addressing the transition of authorized generic insulins to regulation under the PHS act.

    September 2, 2019
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  • Culture Change At GSK: ‘We’re Doing What We Said We’d Do’

    $131.00

    Hal Barron, Chief scientific officer at GSK recently spoke about winning the hearts and minds of 10,000 R&D employees and adopting practices from acquired company, Tesaro. Scrip covers the talk topics including how doubters are coming around amid recent successful approvals

    September 2, 2019
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