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1058 Total results for product and free and sample content found

Medtech Insight:世界の医療機器に特化したニュース配信

Proposed 510(k) Changes Elicit Some Industry Skepticism

By elizabeth-orr 18 Oct 2018

Two 510(k) pilots from US FDA indicate the agency's desire for faster, easier clearances. But some observers aren’t sure if they’ll lead to real improvements.

Topic fda

Pink Sheet:世界の薬事規制と承認審査に関するニュース

DTC Advertising: The 'Kick Me' Sign On Big Pharma's Backs

By Michael McCaughan 18 Oct 2018

Treating mandatory wholesale acquisition cost disclosure in TV ads as a major drug pricing reform is close to ludicrous. But the broad approval of the action is an important sign of the continued public image cost of the ads to the drug companies.

Topic drug-approval drug-review

Pink Sheet:世界の薬事規制と承認審査に関するニュース

Humira Under Pressure As NHS England Invites 'Competitive Prices' For Biosimilars

By Ian Schofield 18 Oct 2018

Companies wanting to compete in the newly off-patent adalimumab market in England have until Oct. 22 to submit their bids. They will need to offer “competitive prices” if they are to secure the highest share of sales to the national health service. At the same time, NHS trusts and clinical commissioning groups have been warned not to accept discounted interim offers from suppliers keen to get a foot in the door.

Topic business-strategies company-analysis

Medtech Insight:世界の医療機器に特化したニュース配信

US FDA Shelves Proposal To Mandate Home-Use Device E-Labeling

18 Oct 2018

A controversial 2016 proposed rule that would have required manufacturers of many class II and class III home-use devices to electronically submit device labeling information to US FDA will not be finalized, the agency affirmed in the Oct. 17 HHS Unified Agenda document. The agency also signaled plans to imminently finalize a broad device classification rule, and other updates.

Topic medtech


Industry Makes A Drug Price Transparency Push In DTC Ads, But Is It Too Little Too Late?

18 Oct 2018

PhRMA unveiled a voluntary policy under which drug makers will provide information in DTC ads about how to access drug prices and cost information. But hours later HHS issued a proposed rule on the same topic, only requiring drug makers to include WAC prices in TV ads.

Topic drug-approval drug-review


Not To Be Sniffed At: Dupixent Success In Rhinosinusitis Could Open Up Large Additional Market

18 Oct 2018

On the brink of an expanded US approval for asthma, Sanofi/Regeneron’s interleukin-4 receptor blocker Dupixent has produced positive topline Phase III data in a lucrative third indication, rhinosinusitis with nasal polyps.

Topic influenza-virus

Stand Out as a Thought Leader with Pharma Intelligence Marketing Services: Watch the Video

15 Oct 2018

Marketing Services from Informa Pharma Intelligence connects you to the key decision makers you need to reach. Boasting the most accurate and trusted pharma and medtech intelligence in the industry.

Biomedtracker: 開発中医薬品をFDA承認確率で評価

Pharma Partnering Trends Revealed Whitepaper

12 Oct 2018

Make the most of BIO-Europe 2018 with essential partnering information from Informa Pharma Intelligence. Our insightful whitepaper, Pharma Partnering Trends Revealed: 2018 Edition, contains critical information on the landscape for biotech partnerships, and is now available for you to download – free.

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