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You are here: Home > Opinion & analysis

Opinion & analysis


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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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  • 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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  • 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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  • Novo Nordisk’s Oral Rybelsus Priced On Par With Injectable GLP-1s, But Big Discounts May Be Needed

    $200.00

    While a 30-day supply of the first oral GLP-1 agonist will cost $772.43, similar to the injectable version, this is still steeper than oral diabetes medicines and Scrip looks at how deep discounts may be needed to secure market access.

    August 2, 2019
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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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  • US FDA’s Temple on Real-world Evidence: “I Find the Whole Thing Very Frustrating”

    $131.00

    At the October FDA panel discussion at the Biopharma Congress, CDER deputy director for clinical science reiterated his long-held skepticism about whether real-world evidence can be used to demonstrate efficacy claims. Pink Sheet looks deeper at his words.

    September 2, 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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  • Pharma’s New R&D Models: Federating Innovation

    $200.00

    As ROI across R&D investments in big phama declines, companies look for new and innovative ways to access and nurture innovation via partnerships and through the use of new data types.  In the process, the business models, products, and role of big pharma in healthcare is changing.

    June 20, 2018
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  • Sanofi’s New CEO Paul Hudson Poised To Write The Next Chapter

    $200.00

    Less than one month into his new job, Sanofi CEO Paul Hudson shared his perspective on how he plans to build on Sanofi’s strengths and deliver needed changes. Scrip shares details about Sanofi’s leadership history and Hudson’s early priorities at the helm.

    September 2, 2019
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  • FDA’s Quality System Regulation Is Mapped To International Standard ISO 13485 – And Vice Versa – In New Report From AAMI

    $200.00

    A new Technical Information Report from the Association for the Advancement of Medical Instrumentation aims to help befuddled US device makers that operate under the FDA’s QSR ensure they are compliant with standard from the ISO.

    August 2, 2019
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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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  • Novartis Battens Down Hatches Over Falsified Zolgensma Data

    $131.00

    The FDA is investigating data manipulation issues associated with Novartis’s filing for their type 1 spinal muscular atrophy drug, Zolgensma. This Scrip story looks at the claims, background on the issue, and the Swiss manufacturer’s recent response.

    August 7, 2019
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  • Pfizer Price Increases Underscore Rebate Problem, HHS’ Hargan Says

    $131.00

    At December’s FDA/CMS Summit in Washington, Health and Human Services Secretary Eric Hargan used Pfizer’s recent price hike of 41 of its products as evidence that higher drug costs are a direct result of the rebate system, a viewpoint touted by the Trump administration in their quest to lower drug prices.

    December 12, 2018
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  • Farxiga Data Change Heart Failure Treatment Outlook

    $200.00

    AstraZeneca’s Farxiga (dapagliflozin) appears set to become new standard or care in the treatment of hear failure based on results of the DAPA-HF Phase III trial present at the European Society of Cardiology Congress on 1 September. Scrip looks at Farxiga and its nearest competitors.

    August 2, 2019
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  • Eight Talking Points from ESMO

    $200.00

    At the 2019 congress in Barcelona from 27 September to 1 October, the European Society for Medical Oncology (ESMO) proved once again it is a match for ASCO. Scrip shares the main points of the event including Seattle Genetics victory for mid-caps.

    September 2, 2019
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