GSK's triple COPD combo needs Phase III trial using comparators with same active ingredients and applying factorial design, BI contends in citizen petition to US FDA.
Boehringer Ingelheim Corp. contends that the study GlaxoSmithKline PLC conducted to support approval of its triple combination therapy for chronic obstructive pulmonary disease (COPD) is inadequate since it used a comparator with different active ingredients and a different delivery device than GSK's proposed product.
In a June 9 citizen petition, BI asks the US FDA not to approve any new drug application...
The FDA is testing a new artificial intelligence tool to help generic drug developers automate maximum daily dose calculations.
Biogen has U-turned on its original decision not to file Qalsody for marketing approval in the UK for treating certain patients with amyotrophic lateral sclerosis. The move appears to have been triggered by a change in the reimbursement pathway agreed for the product.
The Danish Medicines Agency is requesting that data from bioequivalence studies to be submitted in the CDISC format in addition to the current eCTD format. It believes the move will make it easier for the agency claims to access and analyze data and will reduce the burden for applicants.
The US FDA says its release of complete response letters for products subsequently approved by the agency is just a first step toward releasing rejection letters when they are issued, assuming legal issues can be resolved.
The FDA is testing a new artificial intelligence tool to help generic drug developers automate maximum daily dose calculations.
Canadian politicians must “move quickly” to introduce policies that will speed up access to medicines, such as by broadening criteria for the temporary reimbursement of medicines, the Canadian Chamber of Commerce says.
Arimoclomol, Zevra Therapeutics's treatment for Niemann-Pick disease Type C, is among the latest products that have been filed for review by the European Medicines Agency for potential EU marketing approval.
