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You are here: Home > Opinion & analysis

Opinion & analysis


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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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  • EMA under Pressure again as Staff Losses Worsen

    $131.00

    Higher than expected staff losses at the European Medicines Agency due to the relocations to Amsterdam are posing challenges to implement new EU legislation. While the planned move to a permanent HQ in the Dutch capital has led to a decrease in staff, the agency is having to further prioritize its business activities.

    September 2, 2019
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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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  • 86% Rise In GMDN Usage Heralds New Era Of Postmarket Data Analytics

    $200.00

    The Global Medical Device Nomenclature is emblematic of the global trend toward building high-quality data sets in the public arena to derive better information about how medical devices perform. Medtech Insight covers that the new chair of the agency saying how the GMDN usage is poised to explode.

    September 2, 2019
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  • US House Panel Approves Medicare Hearing, Dental And Vision Coverage; Senate Bill Introduced

    $131.00

    Three bills that would cover eye, dental and hearing examination for US Medicare beneficiaries were passed by the US House Ways and Means Committee on 22 October and there is a similar bill in the Senate. Medtech Insight looks at the next steps for these House bills and the related Senate bill.

    September 2, 2019
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  • Six Key New Commission Documents Relating To EU Directives And New Regulations

    $131.00

    To help companies respond and adapt the processes they may have in place as rapid EU regulatory activity continues, Medtech Insight summarizes the six documents that have recently appeared on the European Commission’s medtech website.

    September 2, 2019
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  • Drug/Device Combinations: Shock For Pharma As It Seeks Notified Body Resources Too

    $131.00

    The delivery of drugs via medical devices being commonplace and introduction of new EU rules for these products via the MDR has the pharma industry dismayed at the uncertainty ahead and searching for notified body capacity. Medtech Insight look at the ongoing uncertainty and the state of Europe’s healthcare regulations.

    September 2, 2019
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  • Abbott Launches New App To Keep Heart Failure Patients Out Of The Hospital

    $131.00

    Abbott’s Merlin patient care network works with the CardioMEMS HF sensor system. The Merlin 10.0 update to the network allows physicians to share custom messages directly with their patients. Medtech Insight looks closer at the software and its intended benefits.

    September 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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  • 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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  • 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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  • 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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  • Amarin CEO Thero On Gearing Up For Success Ahead Of The Big Vascepa Ad Comm

    $131.00

    Speaking with Scrip recently, Amarin CEO, John Thero talked about the upcoming US advisory committee meeting for Vascepa and commercial expansion plans and deflected questions about a big pharma buyout. What he did say was that, “We’re planning for success.

    September 2, 2019
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  • Schakowsky’s Loaded Cosmetics Bill Described as ‘Floor, Not a Ceiling’ for States to Build On

    $200.00

    The Safe Cosmetics and Personal Care Products Act reintroduced to the US House of Representatives calls for greater duties and resource demands on companies and the FDA than the proposed Personal Care Act in the Senate and allows room for states to impose more stringent regulations.

    September 2, 2019
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  • A Hangover Is A Disease, German Court Rules

    $131.00

    Alcohol-related hangovers are genuine illnesses according to a recent ruling by a high-level German court. HBW looks at the case against a German wellness manufacturer for health claims made for its “anti-hangover” supplements and how deeming hangover’s a disease affects the outcome of the case.

    September 2, 2019
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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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