Australia TGA tightens GMP clearance application rules | Post-Brexit host of EMA to be set in Nov. | Janssen shifts R&D focus from hepatitis C to hepatitis B therapies
September 14, 2017
DIA Global SmartBrief
News on diagnostic and therapeutic innovations and regulatory science
Top Story
Australia TGA tightens GMP clearance application rules
Australia's Therapeutic Goods Administration revised its policy on compliance verification applications, tightening rules on when supporting evidence may be submitted. After Sept. 26, incomplete applications will be evaluated without allowing applicants to add missing data, and if applicants fail to deliver requested information during the assessment phase by the TBA-stated deadline, the assessment will proceed without it.
Regulatory Focus (9/12) 
LinkedIn Twitter Facebook Google+ Email
Post-Brexit host of EMA to be set in Nov.
Diplomats and ministers from EU states are scheduled to decide Nov. 20 on the post-Brexit home for the European Medicines Agency. The meeting of the General Affairs Council will end more than a year of campaigning by cities that want to host the agency.
Daily Express (London) (9/11),  Politico Pro (subscription required) (9/11) 
LinkedIn Twitter Facebook Google+ Email
Janssen shifts R&D focus from hepatitis C to hepatitis B therapies
Janssen Sciences Ireland, a Johnson & Johnson unit, said it has decided to focus its research and development efforts on chronic hepatitis B therapies because of the increased availability of highly effective direct-acting antiviral therapies for hepatitis C. The company said it will discontinue further development of its hepatitis C candidate JNJ-4178, a combo drug consisting of three direct-acting antivirals, although it will complete an ongoing midstage study for the drug.
Reuters (9/11),  Healio (free registration)/HCVnext (9/11) 
LinkedIn Twitter Facebook Google+ Email
Concept Life expands operation in UK
Drug discovery firm Concept Life Sciences has expanded its laboratory space in Alderley Park at Cheshire, UK, to support the company's integrated research and discovery capacity by more than 30%.
Manufacturing Chemist (UK) (9/12) 
LinkedIn Twitter Facebook Google+ Email
Asia Pacific
Australian researchers develop AI tool for diagnosing diabetic retinopathy
The Commonwealth Scientific and Industrial Research Organization in Australia reported the success of a trial of Dr Grader, an eye-screening tool that uses artificial intelligence for early diagnosis of diabetic retinopathy. The trial, which involved 187 diabetes patients, found that the technology was as effective in identifying signs and classifying the severity of the condition as a human specialist.
ZDNet (9/11) 
LinkedIn Twitter Facebook Google+ Email
North America
FDA commissioner outlines plan for lowering drug-development costs
The FDA wants to make drug development more efficient and effective by modernizing how the agency collects and evaluates clinical information, allowing adaptive clinical trial designs and master protocols, and communicating more with clinical trial sponsors, investigators, review boards and other stakeholders, Commissioner Scott Gottlieb said.
Regulatory Focus (9/11),  Bloomberg (9/7) 
LinkedIn Twitter Facebook Google+ Email
4-drug regimen treats hard-to-cure hepatitis C genotype 3 in trial
A Canadian study found that combining Technivie, AbbVie's ombitasvir/paritaprevir/ritonavir hepatitis C drug, with Gilead's direct acting antiviral Sovaldi, or sofosbuvir, was effective for treatment-resistant HCV genotype 3, according to findings published online in the Journal of Viral Hepatology. The study authors also found that an eight-week course of the regimen was effective against HCV genotype 2.
MD Magazine online (9/12) 
LinkedIn Twitter Facebook Google+ Email
Drug-price notification bill approved by Calif. Assembly
The California State Assembly approved a bill already passed by the state Senate that would require drugmakers to notify payers at least 60 days before raising prices in excess of 16% over two years and explain the reason for the price hike.
San Jose Mercury News (Calif.)/Bay Area News Group (9/12) 
LinkedIn Twitter Facebook Google+ Email
Fujifilm Diosynth Biotechnologies launches lab in UK
A new process development laboratory in Teesside, UK, will support Fujifilm Diosynth Biotechnologies' development of monoclonal antibodies.
In-Pharma Technologist (9/13) 
LinkedIn Twitter Facebook Google+ Email
DIA News
If you have a biologic, this concerns you
The FDA's final guidance on the naming of biologics (originator and biosimilar), issued this year, is in the implementation process and will have an impact on manufacturers, supply chain, end users and safety systems. All stakeholders will need systematic approaches to ensure adherence -- both prospectively and retrospectively. How will these changes affect your systems and products? What will be your next steps? Download the Biosimilars Navigation Guide and get up to speed on the latest scientific and regulatory topics related to biosimilars.
LinkedIn Twitter Facebook Google+ Email
Upcoming DIA events
LinkedIn Twitter Facebook Google+ Email
Learn more about DIA:
About DIA | Meetings & Trainings | News & Publications | Membership
Competence, like truth, beauty and contact lenses, is in the eye of the beholder.
Laurence J. Peter,
educator and writer
LinkedIn Twitter Facebook Google+ Email
Sign Up
SmartBrief offers 200+ newsletters
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