FDA Launches Device Software Pre-certification Pilot
The FDA’s new pilot program for pre-certifying software for digital medical devices is up and running and companies can now apply to take part in the program. The goal of…
Lilly Settles on Cialis Patent, Pushing Generics to September 2018
Eli Lilly & Co. settled with several generic companies to resolve pending litigation over a unit dose patent for Cialis (tadalafil), delaying potential ANDA competition. Source: Generic Line
Avastin, Herceptin Biosimilars Get OKs From FDA Advisory Committee
An FDA advisory panel unanimously recommended that the agency approve two biosimilars for the cancer treatments Avastin (bevacizumab) and Herceptin (trastuzumab). Source: Generic Line
Merck and Samsung Bioepis Launch Biosimilar Early, After SCOTUS Ruling
Samsung Bioepis and Merck announced the U.S. launch of Renflexis (infliximab-abda), a biosimilar of Janssen’s Remicade (infliximab). Source: Generic Line
GlaxoSmithKline to Shift Neuro R&D Out of China to Philadelphia Research Hub
<IMG SRC"http://enewsletters.biospace.com/images/news/biospace-news-815x400-glaxosmithkline.jpg" NAME"GlaxoSmithKline to Shift Neuro R&D Out of China to Philadelphia Research Hub" ALT"GlaxoSmithKline to Shift Neuro R&D Out of China to Philadelphia Research Hub"August 4, 2017By Mark Terry,…
Pharma Scores Big Win: to Ink FDA User Fee Bill, Saving 5,000 Jobs
<IMG SRC"http://enewsletters.biospace.com/images/news/biospace-news-815x450-fda.jpg" NAME"Pharma Scores Big Win: Trump to Ink FDA User Fee Bill, Saving 5,000 Jobs" ALT"Pharma Scores Big Win: Trump to Ink FDA User Fee Bill, Saving 5,000 Jobs"August…
Mirati Therapeutics Reports Second Quarter 2017 Financial Results
Life Sciences Jobs ... Source: BioSpace
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