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You are here: Home > Opinion & analysis

Opinion & analysis


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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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  • Trump’s Drug Pricing ‘Dream Team’ And Prospects For Change

    $131.00

    The US Department of Health and Human Services is hoping for stability in its ranks in order to move its drug pricing reform policy forward, according to HHS Deputy Secretary Eric Hargan. Find out more about anticipated personnel adjustments to the HHS in this Pink Sheet article.

    November 24, 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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  • 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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  • 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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  • 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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  • 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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  • 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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  • 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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  • US Office Of New Drugs Revamp Taking Shape: More Review Divisions Coming, But Who Will Lead Them?

    $200.00

    The U.S. FDA’s reorganization of its Office of New Drugs (OND) faces leadership challenges, thanks to recent departures. How will the FDA staff these new divisions? Learn more about the departures, gain insights into the agency’s options, and explore the implications for the industry.

    May 1, 2018
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  • A World Without Rebates: Is FDA’s Gottlieb Offering New Vision?

    $200.00

    Will drug rebates become illegal? U.S. FDA Commissioner Scott Gottlieb has suggested as much, and PBMs, among others, are paying close attention. Explore the implications–especially for PBMs–and find out why this is historically such a hot-button policy issue.

    May 9, 2018
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  • Trump Drug Pricing Plan Includes Part D Surprises, Challenges PBM Business Model

    $200.00

    The Trump Administration’s “Blueprint to Lower Prices and Reduce Out-of-Pocket Costs” includes dramatic changes to protected classes, rebates and PBM reimbursement. Discover why the blueprint has industry leaders worried. Explore the implications for biopharmas and PBMs in particular and the healthcare industry in general.

    May 11, 2018
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  • Takeda/Shire Merger: Five Things To Worry About

    $131.00

    The Takeda/Shire merger will catapult the new company to the “top 10” pharma list, but greater size brings greater challenges, including manufacturing glitches and review issues. Explore the challenges each company brought to the merger and the new ones the merged faces today.

    May 16, 2018
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  • You Work In The Pharmaceutical Industry; Here’s Why You Should Care About The Novartis Payments

    $200.00

    Novartis AG’s involvement–however tangential–in the Donald Trump/Michael Cohen/Stormy Daniels scandal is just the latest incident to tarnish the pharmaceutical industry’s public image. Explore how negative public perception could accelerate the move to price controls–and why it’s an industry-wide problem.

    May 9, 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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  • 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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  • 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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  • 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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  • 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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  • 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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  • The Implant Files: EU Blamed For Regulatory Inadequacies The World Over While ‘Wrath’- Behrendt Fumes

    $131.00

    In the wake of scathing investigative reports from over 250 journalists from the International Consortium of Investigative Journalists (ICIJ) regarding the safety and oversight of implanted medical devices, this article examines the situation from a uniquely EU perspective.

    November 26, 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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  • 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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  • 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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  • New Reasons Not To Use EU MDR’s Four-Year Extension, But Comply Earlier Or Retire Products Instead

    $200.00

    The new EU Medical Device Regulation (MDR) includes an option to market CE-marked devices for an extra four years. That extension may sound tempting, but experts advise against it. Learn about their concerns and gain insights into howto prepare for compliance under MDR.

    June 13, 2018
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  • EMA To Re-Prioritize Tasks To Cope With ‘Higher Than Expected’ Staff Losses

    $131.00

    Although original estimates put staff losses at the European Medicines Agency at about 19% due to the EMA’s relocation from London to Amsterdam, the EMA reports that these losses may actually be much higher, forcing the agency to take a hard look at its most pressing priorities moving forward.

    June 8, 2018
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  • Gottlieb Uses ASCO Platform To Unveil Two Pilot Programs To Speed Drug Review

    $200.00

    During the opening session of the American Society of Clinical Oncology’s annual meeting, FDA Commissioner Scott Gottlieb announced the agency’s commitment to moving drugs through faster to market, and unveiled two pilot programs the FDA is initiating with the goal of speeding up the drug review process.

    June 3, 2018
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  • Office Of New Drugs Reorg Is Bigger Than Expected: US FDA Adds 11 Review Divisions

    $200.00

    Changes are coming to the structure of the FDA’s Center for Drug Evaluation and Research division the Office of New Drugs. This long-planned reorganization is still in the nascent stages, but expected to bring a more modern approach that, along with IT improvements and other streamlined processes, will make drug reviews more efficient.

    June 4, 2018
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  • GE Healthcare’s New Value Proposition: The Strategic Language Of Software

    $200.00

    Access this exclusive In Vivo interview with Tom McGuinness, President and CEO, Imaging at GE Healthcare. He reveals GE’s secret to success in speed-to-market product launches, and explains how GE is using data analytics and software innovations to reach patients, faster.

    February 21, 2018
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  • State Of Pharma R&D: Ex-Takeda’s Yamada Takes The Long View

    $200.00

    Biopharma industry veteran Tadataka “Tachi” Yamada sits down with In Vivo for an exclusive interview that draws on his years of experience in many roles across the R&D ecosystem to explore the state of today’s biopharma R&D enterprise.

    April 9, 2018
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