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Petitions to override Astellas' cancer drug patent because of cost rejected by NIH

FDLI SmartBrief | Jun 21, 2016

The NIH turned down requests by several consumer groups to use its march-in rights to override the patent rights on Astellas Pharma's prostate cancer drug Xtandi, noting that the drug is not in limited supply. The consumer groups argued that the unreasonably high price of the drug limits patient access, saying it costs about two to four times more in the US than in other high-income countries. STAT (06/20)


Cheryl Laboratories gets red-listed by FDA due to inspection refusal

FDLI SmartBrief | Jun 21, 2016

GVHD drug from Incyte gains FDA breakthrough status

FDLI SmartBrief | Jun 24, 2016

FDA to review Mitsubishi Tanabe's ALS treatment

FDLI SmartBrief | Jun 22, 2016

Single IRB policy to eliminate duplicate reviews finalized by NIH

FDLI SmartBrief | Jun 21, 2016

FDA pulls document regarding suffix listing on biosimilar naming

FDLI SmartBrief | Jun 22, 2016

Ariad seeks FDA approval of lung cancer drug with rolling NDA submission

FDLI SmartBrief | Jun 20, 2016

200 pharma facilities in India under scrutiny over poor manufacturing practices

FDLI SmartBrief | Jun 22, 2016

FDA releases technical specifications for ICSR submissions for drugs, biologics

FDLI SmartBrief | Jun 23, 2016

Human testing of CRISPR gene editing to be reviewed by NIH

FDLI SmartBrief | Jun 20, 2016


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Introduction to Food Law and Regulation Course, July 28-29, Chicago

FDLI SmartBrief | Jun 27, 2016

Focused Strategies to Protect Food Against Intentional Adulteration: Key Takeaways and Interactions between FSMA’s Final Rules, June 28 webinar

FDLI SmartBrief | Jun 27, 2016

Food and Drug Law Journal Symposium's call for abstracts, deadline: July 11

FDLI SmartBrief | Jun 24, 2016

Introduction to E-Cigs and Vapor Products Law and Regulation Course, July 21, Los Angeles -- early registration ends today, June 23

FDLI SmartBrief | Jun 23, 2016

Food Advertising, Labeling and Litigation Conference, Sept. 14-15, Washington, D.C.

FDLI SmartBrief | Jun 23, 2016




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