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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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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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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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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 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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Ranitidine Recalls Begin In Europe As Regulators Take Action

$200.00

Over the counter products are among the first to be recalled in Europe following the discovery of a human carcinogen in ranitidine-based drugs. HBW covers how investigations are underway worldwide while regulators across Europe are divided between “take immediate action” and “wait and see”.
August 3, 2019
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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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How To Pay For The New Wave Of Gene Therapies

$200.00

Paul Goudreau, executive director & head of Phase IV Solutions at the CRO Covance, recently told Scrip, “an ongoing and wide-ranging discussion is needed about assessment, payment and reimbursement of innovative products, as well as the evidence that supports them.”
August 2, 2019
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Roche: We’ve Abandoned Budgets And It’s Liberated Employees

$200.00

Imagine what would happen if a huge corporation abandoned the core competency of controlling its multi-million-dollar budgets and accelerating processes across R&D and commercial divisions. Would it survive? Would it actually thrive? Scrip talks to one CEO who knows.
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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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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ECHA’s Microplastic Ban Proposal Is ‘Brutally Misinformed’ – Cosmetics Europe

$200.00

ECHA’s plan to ban the use of intentionally added microplastics in cosmetics is based on “a whole clutch of errors and misunderstandings,” according to Cosmetics Europe’s Director-General John Chave. Find out why the industry is worried about this ban–and why they consider it unfair. Gain insights into which solutions would satisfy the industry, and learn why biodegradable plastics–which represent a potential win-win for industry and environmental advocates–may not be viable.
February 19, 2019
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What GSK’s Immunology Chief Did Next

$200.00

Paul Peter Tak, formerly of GlaxoSmithKline, is “following the science.” He’s joined Flagship Pioneering as a venture partner and is already CEO of an “undisclosed biotech start-up operating in stealth mode.” Learn more about Flagship’s approach–creating think tanks to build companies from scratch around important unmet challenges–and why Tak finds that so appealing.
February 5, 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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