StemImmune signs deal with Accurexa for cancer immunotherapy development | Shire updates Vyvanse label to add long-term efficacy data | Intercept's PBC treatment gains EMA conditional approval
October 18, 2016
Bio SmartBrief
Today's Top Story
StemImmune signs deal with Accurexa for cancer immunotherapy development
StemImmune and Accurexa will collaborate on the development of a stem cell-mediated cancer immunotherapy using StemImmune's immunotherapy, which targets cancer using the patient's stem cells, and Accurexa's targeted therapy delivery methods. Financial terms of the deal were not disclosed.
Genetic Engineering & Biotechnology News (10/17) 
LinkedIn Twitter Facebook Google+ Email
Health Care & Policy
Shire updates Vyvanse label to add long-term efficacy data
A supplemental new drug application was approved for Shire's Vyvanse, or lisdexamfetamine dimesylate, updating the drug's label to include longer-term maintenance of efficacy data from a late-stage study of adults with moderate to severe binge-eating disorder. The drug is indicated as a treatment for attention-deficit/hyperactivity disorder and moderate to severe binge-eating disorder in adults. (10/17) 
LinkedIn Twitter Facebook Google+ Email
Intercept's PBC treatment gains EMA conditional approval
Intercept Pharmaceuticals has received conditional approval from the European Medicines Agency for Ocaliva, or obeticholic acid, as a treatment for primary biliary cholangitis in combination with ursodeoxycholic acid for adults whose treatment with UDCA is inadequate or as a monotherapy for adults who can't tolerate UDCA.
Medscape (free registration) (10/14) 
LinkedIn Twitter Facebook Google+ Email
Allergan's sNDA for Avycaz in complicated UTI accepted for FDA review
Allergan's supplemental new drug application to update labeling for Avycaz, a combination of ceftazidime and avibactam, has been accepted for review by the FDA with a decision expected by the first quarter of next year. The firm seeks to expand the current product label with trial findings that show the safety and efficacy of the drug to treat patients with complicated urinary tract infections caused by designated susceptible pathogens. (10/14) 
LinkedIn Twitter Facebook Google+ Email
EMA panel supports approval of 8 new drugs
The European Medicines Agency's Committee for Medicinal Products for Human Use has recommended the approval of eight new drugs, including Ferring Pharmaceuticals' Rekovelle for controlled ovarian stimulation in assisted reproduction, Orphan Europe's Cystadrops for treating corneal cystine crystal deposits in cystinosis and three generic drugs to treat HIV infection in adults. The panel also endorsed the authorization of Advanced Accelerator Applications' SomaKit-TOC for use in diagnosing gastroenteropancreatic neuroendrocrine tumors.
PharmaTimes (U.K.) (10/17) 
LinkedIn Twitter Facebook Google+ Email
Company & Financial News
Public offering could bring in $10M for Biocept
A public offering of common stock and warrants has been priced by Biocept in hopes of obtaining about $10 million in gross proceeds. The company, which makes liquid biopsy assays for cancer, did not disclose how it intends to use the proceeds.
GenomeWeb Daily News (free registration) (10/14) 
LinkedIn Twitter Facebook Google+ Email
The Latest From BIO ...
Are you looking for top biotech talent? Or looking for a biotech job?
Whether you are looking for a new job or a new addition to your team, Bio Jobs makes it easier than ever to find opportunities for talent in the biotech industry. Learn more at
LinkedIn Twitter Facebook Google+ Email
Learn more about BIO:
Conferences | Join Bio | Media | Issues | Industry
Global Developments
Cipla to build biosimilars facility in South Africa
Indian drugmaker Cipla has signed an agreement to build a biosimilars manufacturing plant in South Africa, with construction beginning in 2017 and operations projected to begin in the third quarter of 2018.
The Economic Times (India) (10/16) 
LinkedIn Twitter Facebook Google+ Email
Food & Agriculture
Research greenhouse for corn breeding to be built by Monsanto
Monsanto plans to build a 7-acre greenhouse research facility in Marana, Ariz., for biotech corn breeding and trait integration. The facility is for advanced germplasm development and will support the production of biotech and conventional corn inbreds, according to Monsanto.
Western Farm Press (10/15) 
LinkedIn Twitter Facebook Google+ Email
Industrial & Environmental
JetBlue signs long-term, global biofuel deal, one of largest in aviation history
JetBlue has signed a historic agreement making SG Preston its biofuel supplier for the next decade. "This marks the largest, long-term, commitment globally by any airline for a jet fuel based on fatty acids, a way to extract carbon to burn for energy," writes Sophia Mendelsohn, JetBlue's head of sustainability.
Global Traveler online (10/15), (10/13) 
LinkedIn Twitter Facebook Google+ Email
News From BIO
Save on shipping with FedEx®
BIO Business Solutions® has teamed up with FedEx® to provide discounted pricing on select FedEx® services, including express, ground and freight delivery. FedEx offers packaging, monitoring and distribution services designed to meet your life sciences shipping needs. Save from 15% to 33% on commonly used shipping services, with additional discounts for members that average more than $20,000 in annual shipping with FedEx. Whether you're shipping biologics, pharmaceuticals, lab samples or other critical life science items, you can count on FedEx®. Enroll and start saving!
LinkedIn Twitter Facebook Google+ Email
Learn more about BIO:
Conferences | Join Bio | Media | Issues | Industry
The Talent Hub for Biotech
powered by
Director, Membership
BIO - Dist. Columbia
Upstream/Production Scientist
PACIFICGMP DBA ABZENA - San Diego, California
Vice President, Corporate Finance & Strategy
Director, Healthcare Policy, Federal Programs
BIO - Dist. Columbia
We must not say every mistake is a foolish one.
LinkedIn Twitter Facebook Google+ Email
The news summaries appearing in BIO SmartBrief are based on original information from news organizations and are produced by SmartBrief, Inc., an independent e-mail newsletter publisher. The information is not compiled or summarized by BIO. Questions and comments should be directed to SmartBrief at
Sign Up
SmartBrief offers 200+ newsletters
Learn more about the SmartBrief audience
Subscriber Tools:
Contact Us:
Advertising  -  Meryl Harold
P: 202.407.7828
Editor  -  Tara Rosenzweig
Mailing Address:
SmartBrief, Inc.®, 555 11th ST NW, Suite 600, Washington, DC 20004
© 1999-2016 SmartBrief, Inc.®
Privacy policy |  Legal Information