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You are here: Home > Opinion & analysis

Opinion & analysis


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  • Ranbaxy Brothers Arrested, Downward Spiral Intensifies

    $131.00

    With the Singh brothers of Ranbaxy being arrested over allegations of financial fraud, Scrip looks at the history of issues at the company and how things appear headed even further downhill with Daiichi Sankyo also separately pursuing enforcement of damages against the brothers.

    September 2, 2019
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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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  • Probiotic Safety Latest Target Of Supplement Regulation Critic Cohen

    $131.00

    Probiotic labeling came under fire in a recent opinion piece published in JAMA Internal Medicine, which called for more detailed and extensive labeling for probiotic supplements, as well as improved good manufacturing practices (GMP) as they pertain to the production of products containing live microorganisms.

    December 5, 2018
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  • Poseida, Legend/Janssen Look To Snag Celgene/ Bluebird’s BCMA Crown

    $200.00

    The BCMA CAR-T therapies gap between industry leaders Celgene and bluebird bio and their competition in the space is closing, according to data released at the December 2018 American Society of Hematology (ASH) meeting in San Diego.

    December 4, 2018
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  • Philips To Create More Context, Connectedness And Continuity And Shift Sick Care To Health Care

    $100.00

    Connected care technologies play an important role in disease prevention, but are still not used as widely as they should be. Philips’ second Future Health Index study surveyed 33,000 participants in 19 countries to compare perceptions and experiences of healthcare users across three areas – access to care, integration of health systems and adoption of connected care technologies.

    February 15, 2018
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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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  • Pharma Intelligence Report Store Article: Collection Cybersecurity

    $300.00

    Preventing cyberattacks on medical technology occupies the waking thoughts of device software manufacturers, but the global ransomware episode in mid-May shows that companies must also be alive to threat posed to their provider customers.

    May 19, 2017
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  • Pharma Intelligence Report Store Article Collection Innovation, Data and Machine Learning Report 2

    $500.00

    OTC drug firms should offer more digital tools that guide consumers in product purchases, says a health care marketing executive. The American Pharmacists Association suggests firms also strengthen outreach with pharmacists.

    March 16, 2017
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  • Pharma Intelligence Report Store Article Collection Innovation, Data and Machine Learning Report 1

    $500.00

    Real-world evidence promises to solve many problems inherent in getting a drug to patients at a good price. It could slash development costs and help make the reimbursement case to payers. But there are challenges for companies that want to exploit real-world evidence to get their drug to patients in Europe.

    November 22, 2016
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  • Pharma Intelligence Report Store Article Collection Digital Policy & Regulation Report 2

    $300.00

    Funding is taking a long time to come through for the UK NHS’s digital health care transformation, but as the national provider’s head of technology strategy, Dr Paul Rice says, “We can’t afford to remain non-digital.”

    July 21, 2017
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  • Pharma Intelligence Report Store Article Collection Digital Policy & Regulation Report 1

    $400.00

    The digital medtech sector is growing fast. As new companies enter the space, they are going to face oversight from a slew of government agencies and statutes.

    March 31, 2017
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  • Pharma Intelligence Report Store Article Collection Digital Patient Management

    $200.00

    The digitalization of health care has been much talked about over the last decade or so. But activity among the medical device manufacturers and service providers has only just recently accelerated as they start overcoming barriers and resistance to this new way of delivering health care.

    April 25, 2017
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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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  • 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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  • Petition Suggests Environmental Laws Compel FDA To Ban Oxybenzone, Octinoxate In Sunscreens

    $131.00

    Citing the negative impact on both coral reefs and human health, the citizen-led Center for Biological Diversity has officially petitioned the US FDA to ban the use of oxybenzone and octinoxate, reportedly present in over 3,500 sunscreens on the market today.

    May 31, 2018
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  • Peter Stein Takes Short Path To Director Of US FDA Drug Office

    $131.00

    After only a short stint at the US FDA as Deputy Director of the Office of New Drugs, industry veteran Peter Stein was appointed to his permanent post as Director of the OND in December of 2018, filling a role that sat vacant for nearly two years.

    December 9, 2018
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  • Paying for Pharmaceutical Value: The Problem of a One-Size-Fits-All Definition

    $200.00

    In Vivo takes a look at the hot-button topic of drug value in this thought-provoking article, which examines the role of ICER (Institute for Clinical and Economic Review) and wonders if a more sophisticated method of assigning value in the US market is necessary.

    March 20, 2019
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  • Paying For Gene Therapy: Will Pharma Be First In Line?

    $200.00

    In considering pricing models for the increasingly important area of gene therapy, what are the options facing biopharma? This article from In Vivo explores the question of how to pay for gene therapy in a way that’s sustainable to developers of these potentially curative therapies, while ensuring patient access.

    June 12, 2018
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  • Patients’ Preferred Endpoints May Not Satisfy Regulatory Needs, US FDA Says

    $200.00

    At a meeting of mitochondrial disease drug development, officials of US Food and Drug Administration said that just because a measure is relevant to the patient community does not mean it can capture meaningful change in a clinical trial. Pink Sheet looks at the implications to sponsors.

    August 2, 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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  • Part B Payment Model Indexing Commercial Discounts Proposed By Genentech

    $131.00

    Stay aware of proposed changes to the existing Medicare Part B average sales price (ASP) payment  system. Explore Genetech’s “Market-based Pricing Model”, as well as changes to the existing competitive acquisition program, and the possibility of moving Part B drug coverage to Part D in this essential article.

    October 23, 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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  • OTC Marketing Awards 2019 Winners Announced – GSK Crowned Company Of The Year, Pfizer’s Viagra Takes Best Brand

    $131.00

    Find out who the big winners were at the 24th annual OTC Marketing Awards. This article contains highlights from the gala awards evening, as well as a full list of all winners announced at the event, which celebrates the best in the British OTC industry.

    March 8, 2019
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  • OTC Distribution in Europe – The New Global Agenda

    $2,845.00

    This comprehensive study identifies key factors driving change in the channels through which non-prescription/OTC medicines are distributed in Europe (18 main EU markets, plus Norway and Switzerland) and highlights the challenges facing suppliers in an ever-changing market.

    January 18, 2016
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  • Orphan Drug Pricing And Reimbursement: Challenges To Patient Access

    $131.00

    While the drug industry and patient advocacy groups have worried about price controls or reimbursement restrictions for drugs that treat orphan diseases, a review of formulary data shows that patient access to high-priced drugs has not been severely hampered despite some payer pushback.

    August 2, 2019
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  • One Cancer Start-Up’s Resolve To Crack The Mystery Of Metastasis

    $131.00

    Rgenix, founded by three brothers who are prominent physician researchers, sees itself at the forefront of cancer treatment. They are finding drugs that shut off metastasis rather than the more common goal of using the immune system to destroy cancer receptors.

    September 24, 2019
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  • Oncology Leader Liz Barrett Joins UroGen As CEO As It Heads Towards Commercial Stage

    $131.00

    There is new leadership at UroGen Pharma, Ltd., as Novartis AG Oncology’s former Oncology CEO takes the helm. Scrip sat down to talk to Liz Barrett about her plans as CEO of UroGen, including assuming the tasks of ushering the company’s lead asset through the FDA approval and launch processes.

    January 9, 2019
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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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  • 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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  • Novartis’s Zolgensma Loses EU Accelerated Assessment

    $200.00

    Novartis’s Zolgensma losing EU accelerated assessment serves as a warning to other companies. This Scrip story covers a half dozen other examples of companies and drugs who are now forced to slow their development pace—opening room for competitive threats.

    July 26, 2019
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  • Novartis’ Zolgensma Had Manipulated Data In Application, US FDA Says

    $200.00

    The gene therapy Zolgensma will remain on the market, but Novartis and subsidiary AveXis Inc. may face civil or criminal action after revelations by the FDA that data used for approval had been manipulated. In fact, the drug giant knew about the problem months before Zolgensma was approved and said nothing. Learn what happened, why the FDA still asserts confidence in its approval of Zolgensma, and what these events could mean to Novartis and the gene therapy industry moving forward.

    August 3, 2019
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  • Novartis’ New Oncology CEO Liz Barrett Charts A Course, But It Will Require Jump-Starting New Brands

    $200.00

    Novartis Oncology CEO and newcomer to the company, Liz Bennett, sat down with Scrip ad talked about her plans for an organization currently in transition, and her strategy for moving new blockbusters forward. Access her insights into the future of Novartis Oncology in this illuminating interview.

    June 6, 2018
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  • Novartis Swaps Two AveXis Executives For One Following Zolgensma Data Manipulation

    $200.00

    AveXis co-founder and CSO Brian Kaspar and his brother are no longer with Novartis, the Swiss manufacturer who acquired AveXis and its Zolgensma drug in 2018. After disclosing data manipulation to the FDA earlier this year about Zolgensma filings, Novartis announced two employees would exit the company.

    August 14, 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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  • Novartis Pruned Pipeline Producing Attractive Respiratory And Neurology Fruits

    $200.00

    In the wake of new CEO Vas Narasimhan, and like several of its peers in the industry, Novartis AG recently announced it was paring back their pipeline, from 430 products to 340. Find out which products got the axe and what the focus of the company will be in the months and years to come in this illuminating article from Scrip.

    December 13, 2018
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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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  • Novartis CEO Explains Delay In Telling US FDA About Zolgensma Data Fraud: We Wanted To Understand It First

    $200.00

    Novartis AG tried to squash any murmurings that it had a disreputable intent in not disclosing the data fraud it knew about before approval of its gene therapy Zolgensma, saying the company wanted a full understanding of the issue first before bringing it to the attention of regulators. In a recent conference call with analysts, Novartis execs were bombarded with questions about their “prescribed process” of internal investigation, and when exactly they knew about the fraud. Find out how the pharma giant is handling such close scrutiny, how they are dealing with the AveXis scientists involved in the “data inaccuracies,” and the recent EMA decision to downgrade Zolgensma’s accelerated assessment.

    August 2, 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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  • 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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  • Notified Bodies And EU Industry Voice Separate, But Aligned Frustrations Over Slow Progress In NB Designations

    $131.00

    EU notified bodies associations are sounding the alarm that delays in designation could result in a host of problems in making medical devices available. They warn that designation delays represent the largest hurdle in keeping products on the market after the Medicines Device Regulation (MDR)’s May 2020 deadline.

    January 10, 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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  • Nitrosamine Episode Could Lead To Paradigm Shift In Quality

    $131.00

    The detection of cancer-causing impurities in drugs with well-established safety profiles may call for regulators across the globe to revise their approach for evaluating quality. Pink Sheet looks at whether or not companies seem to know their own products.

    September 2, 2019
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  • Next-Generation Roche: How Data Analytics Will Keep It In The Lead In Oncology

    $200.00

    At Roche’s on-site investors briefing at ASCO in 2018, company execs unveiled the oncology leader’s strategy for staying ahead in the market: heavy investment in digital and personalized healthcare. Read more about the company’s plans in this illuminating article from Scrip.

    June 8, 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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  • 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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This is operated by Pharma Intelligence UK Limited, a company registered in England and Wales with company number 13787459 whose registered office is 5 Howick Place, London SW1P 1WG. The Pharma Intelligence group is owned by Caerus Topco S.à r.l. and all copyright resides with the group.
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