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Medtech Insight
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
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
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.
Medtech Insight
By David Filmore 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
Scrip
By Jessica Merrill 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
Scrip
By Alexandra Shimmings 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
Research and Development Strategy Solutions
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
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.
Medtech Insight
12 Oct 2018
The inaugural Medtech Insight Awards took place on September 23 in Philadelphia. It was an exciting evening of celebration, camaraderie and spirit, and the participation and enthusiasm of everyone present helped make the event a rousing success.
Informatics Solutions
09 Oct 2018
Pharma Intelligence Informatic solutions transform how you access information and make critical business decisions, delivering trusted data on your terms, the way you want it.
Topic Strategy
Scrip
03 Oct 2018
The 2015 Scrip Lifetime Achievement Award was given to Sir Gregory Winter, Master of Trinity College, Cambridge (UK). Founder of Cambridge Antibody Technology (acquired by AstraZeneca), Domantis (acquired by GlaxoSmithKline) and Bicycle Therapeutics, he is best known for his pioneering research into humanizing antibodies. His findings led to the development of the first human antibody, Humira (adalimumab), until very recently the world's top-selling drug.
Scrip
By Jo Shorthouse 03 Oct 2018
Biochemist Greg Winter has scientifically contributed to some of the pharmaceutical industry's biggest commercial and therapeutic success stories. He tells Scrip how he feels about being labelled a pioneer and why he is still wary of the boardroom.
Topic Cancer
Scrip
By Mandy Jackson 03 Oct 2018
The average return for the 54 drug developers that went public in the US during first three quarters of 2018 was 13.6% as of Oct. 1 versus 16.9% as of Aug. 31 for the 47 biopharma firms that launched IPOs during the first eight months of this year. September had seven new offerings after just two in August.
Scrip
By Jessica Merrill 03 Oct 2018
CEO Craig Wheeler talked toScripabout the challenging biosimilar market dynamics and the company's decision to end most biosimilar drug development. The path to value creation in biosimilars is not clear, he said.
Pink Sheet
By Cathy Kelly 26 Sep 2018
Approach has been endorsed by Express Scripts as more workable solution than trying to cut list prices for drugs already on the market.
Scrip
18 Oct 2018
Pink Sheet
18 Oct 2018
Scrip
18 Oct 2018
Medtech Insight
18 Oct 2018
Pink Sheet
18 Oct 2018
Scrip
18 Oct 2018
Medtech Insight
18 Oct 2018
Pink Sheet
18 Oct 2018
Scrip
18 Oct 2018
Pink Sheet
18 Oct 2018
Pink Sheet
18 Oct 2018
Scrip
18 Oct 2018
Medtech Insight
18 Oct 2018
Medtech Insight
18 Oct 2018
Pink Sheet
18 Oct 2018
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