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You are here: Home > Opinion & analysis

Opinion & analysis


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  • Estee Lauder Is Revising Claims, Retesting Products After Internal Breakdown

    $131.00

    Estée Lauder’s CEO revealed that “a small group of employees” was responsible for intentionally altering test results behind product claims. The shocking disclosure was mitigated by the fact that the problem was discovered internally. Nevertheless, stock tumbled following the announcement–but has largely recovered. Find out how the disclosure may affect Lauder moving forward, and learn how analysts reacted

    May 16, 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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  • 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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  • Pfizer’s Reference Point on Trial Innovation : Ask the Patient

    $200.00

    In this interview with Pfizer’s head of clinical innovation, Craig Lipset, learn why clinical trial innovation requires a patient-centered approach and how Pfizer is making this happen. Learn why patient-centricity matters. Explore how the digital revolution is reshaping patient engagement, data collection and the shape of clinical trials.

    May 9, 2018
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  • US FDA Commissioner: Agency Will Propose New Rule That Blends Quality System Regulation, ISO 13485

    $131.00

    The US FDA plans to “harmonize domestic and international requirements, and modernize the regulation” through a new rule that will blend its Quality System Regulation (QSR) with ISO 13485. Will FDA will swap out the QSR with ISO 13485? Probably not. Find out what it will likely do instead–and when it will do it.

    May 9, 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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  • 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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  • Rodan + Fields Concealed Prostaglandin Risks From Lash Boost Users – Class Action

    $200.00

    A federal class-action suit alleges Rodan + Fields hid prostaglandin risks from consumers using Lash Boost. The lawsuit will likely draw attention to prostaglandin analogs in eyelash enhancers. Find out what this means for the lash-enhancement market in terms of litigation and regulatory activity.

    May 7, 2018
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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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  • Suns Sets In Hawaii On Sunscreens Containing Octinoxate, Oxybenzone

    $131.00

    Hawaii’s ban on the sale of sunscreens containing octinoxate and oxybenzone is expected to go into effect in 2021. It’s intended to protect marine ecosystems–in particular, coral. Opponents of the law included the Consumer Healthcare Product Association and the Hawaii Medical Association. Find out how manufacturers will adjust, and gain insights into the U.S. FDA’s perspective on regulating certain sunscreen ingredients.

    May 2, 2018
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  • Let’s Make A Deal: Sanofi Regeneron Extend A Hand On Praluent, Express Scripts Takes It

    $131.00

    Sanofi and Regeneron made an offer: They would drop the cost of their PCSK9 inhibitor Praluent (alirocumab) for improved access. Express Scripts took them up on it. Learn whether this deal will affect the high rejection rate for PCSK9 drugs. Find out whether this deal is a one-off or the start of a trend.

    May 1, 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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  • GSK’s Head Of Artificial Intelligence Unveils R&D Goals

    $131.00

    In this interview, John Baldoni describes GlaxoSmithKline’s artificial intelligence efforts. Baldoni, who leads GSK’s AI initiative, discusses the company’s machine-driven discovery and development methods and how they can cut time and costs. Gain insights into the AI team’s timeline and what it has accomplished already. Discover who GSK’s AI partners are–and why such deals are “tricky.”

    April 30, 2018
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  • AHPA Backs NDI Filing For Kratom, Experts Question FDA Enforcement

    $200.00

    AHPA called on FDA to regulate kratom as an NDI to avoid a patchwork of state regulations. Kratom, used to manage opioid withdrawal, garnered unwelcome scrutiny after being linked to a salmonella outbreak. Will the FDA treat it like any other dietary ingredient? Find out what may lie ahead for this herbal extract.

    April 30, 2018
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  • State Of Pharma R&D: Ex-Takeda’s Yamada Takes The Long View

    $200.00

    What’s the ultimate task of an R&D organization? Industry veteran Tadataka Yamada shares his insights, offering a big-picture take on the state of the pharma R&D enterprise. Discover which areas most excite–and concern–him, and learn why “de-risking” the pipeline is harder than ever.

    April 9, 2018
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