Merck's Keytruda approved for cancer patients with certain genetic traits | Genmab/Janssen to launch 3 studies for multiple myeloma drug Darzalex | US FDA approves memantine HCl tablets from Strides Shasun
May 25, 2017
DIA Global SmartBrief
News on diagnostic and therapeutic innovations and regulatory science
SIGN UP ⋅   FORWARD
Top Story
Merck's Keytruda approved for cancer patients with certain genetic traits
The FDA has granted accelerated approval to Merck's Keytruda, or pembrolizumab, as a treatment for patients with solid tumor cancer who have the microsatellite instability-high biomarker or mismatch repair deficient, and who are not eligible for surgery. The decision marks the first approval of a cancer drug based on genetic traits.
Reuters (5/23) 
LinkedIn Twitter Facebook Google+ Email
Europe
Genmab/Janssen to launch 3 studies for multiple myeloma drug Darzalex
Three clinical trials will be launched between July 2017 and early 2018 in a joint venture between Genmab and Janssen Biotech to test the efficacy of Janssen's drug Darzalex, or daratumumab, in patients with multiple myeloma. The planned trials -- two Phase III and one Phase II -- "emphasize the commitment to test daratumumab broadly in many different clinical settings, which hopefully results in better treatment options for patients," said Genmab CEO Jan van de Winkel.
Myeloma Research News (5/19) 
LinkedIn Twitter Facebook Google+ Email
Asia Pacific
US FDA approves memantine HCl tablets from Strides Shasun
India-based Strides Shasun has been given approval by the US FDA for its memantine hydrochloride tablets USP, 5 mg and 10 mg, for the treatment of moderate to severe Alzheimer-type dementia. The company's facility in Bengaluru, India, will produce the drug, while Strides Pharma will commercialize it in the US.
PharmaBiz (India) (5/24) 
LinkedIn Twitter Facebook Google+ Email
Hypertension, diabetes generics from Aurobindo get FDA OK in US
Aurobindo Pharma's generic amlodipine and olmesartan medoxomil tablets, 5 mg/20 mg, 5 mg/40 mg, 10 mg/20 mg, and 10 mg/40 mg, have been approved by the US FDA as a treatment for patients with hypertension as the generic equivalent to the reference drug, Daiichi Sankyo's Azor. Aurobindo's Glipizide extended-release tablets, 2.5 mg, 5 mg and 10 mg, were also granted FDA approval for diabetes indication as a generic equivalent to Pfizer's Glucotrol XL.
Drug Store News (5/22) 
LinkedIn Twitter Facebook Google+ Email
Xynomic, UCSF join forces for clinical trial of abexinostat
US-China oncology firm Xynomic Pharma is teaming up with the University of California at San Francisco on a Phase II/III clinical trial of its leading drug, abexinostat, an HDAC inhibitor used to fight chemotherapy resistance that has been tested globally in 17 early- and midstage trials. The study will build on positive clinical data from a new UCSF Phase Ib clinical trial sponsored by the National Cancer Institute.
BioSpectrum Asia (5/24) 
LinkedIn Twitter Facebook Google+ Email
Summit on Marketing Authorization Holder program slated for June in Shanghai
WuXi App Tec subsidiary STA Pharmaceutical, the Shanghai Municipal FDA and the Jinshan government will co-host a summit focusing on China's recently initiated Marketing Authorization Holder pilot program on June 22 in Shanghai. The program permits license holders to sell pharmaceuticals in China through contract manufacturers, speeding time to market and enhancing local innovation.
BioSpectrum Asia (5/24) 
LinkedIn Twitter Facebook Google+ Email
North America
Pfizer's anemia biosimilar on track for FDA approval
An FDA committee determined that the biosimilar developed by Hospira is close enough to Amgen's anemia drug Epogen and could gain approval after an upcoming panel review. Regulators rejected the initial filing for the biosimilar made in 2015.
Endpoints News (5/23) 
LinkedIn Twitter Facebook Google+ Email
Achaogen's plazomicin wins FDA breakthrough status
The FDA has granted breakthrough therapy designation to Achaogen's antibiotic plazomicin, intended to treat serious bacterial infections caused by multidrug-resistant Enterobacteriaceae and carbapenem-resistant Enterobacteriaceae. Achaogen plans to file a new-drug application to the agency in the second half of this year.
Reuters (5/23),  Business Insider/RTT News (5/24) 
LinkedIn Twitter Facebook Google+ Email
Global
FDA approves rheumatoid arthritis drug from Sanofi, Regeneron
Sanofi and Regeneron Pharmaceuticals' Kevzara, or sarilumab, has been approved by the FDA for the treatment of adult patients with moderate to severe rheumatoid arthritis. The companies anticipate European approval of Kevzara in the next few months.
Reuters (5/22) 
LinkedIn Twitter Facebook Google+ Email
DIA News
Must-add events for your calendar!
LinkedIn Twitter Facebook Google+ Email
Learn more about DIA:
About DIA | Meetings & Trainings | News & Publications | Membership
Editor's Note
DIA Global SmartBrief will not publish May 30
In observance of Memorial Day in the US, DIA Global SmartBrief will not publish on Tuesday, May 30. Publication will resume Thursday, June 1.
LinkedIn Twitter Facebook Google+ Email
SmartBrief Terms of Use and Privacy Policy
We are updating our Terms of Use and Privacy Policy and we want to share the details with you.

Effective May 18, 2017, updates will go into effect for SmartBrief's Terms of Use and Privacy Policy. You may view the updated documents by selecting the following links.
For your convenience, the following is a summary of the important changes. We recommend reviewing each document fully.

Terms of Use
  • Allows us to notify you of changes to our Terms of Use by posting a notice on our website.
  • Updates the license you grant us to use content that you provide to us.
Privacy Policy
  • Updates to address how we share information with our social media partners and other service providers.
  • Includes information for California residents on their state privacy rights.
LinkedIn Twitter Facebook Google+ Email
  
  
Restlessness is discontent -- and discontent is the first necessity of progress.
Thomas Edison,
inventor
LinkedIn Twitter Facebook Google+ Email
  
  
Sign Up
SmartBrief offers 200+ newsletters
Advertise
Learn more about the SmartBrief audience
Subscriber Tools:
Contact Us:
Advertising  -  Wynn Hansen
P: 202.470.1149
Editor  -  Lisa Gough
Mailing Address:
SmartBrief, Inc.®, 555 11th ST NW, Suite 600, Washington, DC 20004
© 1999-2017 SmartBrief, Inc.®
Privacy policy |  Legal Information