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.
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.
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.
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.
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.
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.
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.
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.