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A California judge has ruled that Sandoz must file an application with the FDA for approval of a biosimilar referencing Amgen’s biologic arthritis drug Enbrel before it can challenge the brand drug’s patents. Read More
FDA advisers overwhelmingly voted Thursday to recommend approval of Vanda’s sleep drug tasimelteon for the visually impaired despite some concern over a clinical trial’s primary endpoint. Read More
The FDA may extend comment deadlines for certain drug-related regulations and guidance because the system through which online comments are submitted, Regulations.gov, was down for several days earlier this month. Read More
The Government Accountability Office (GAO) has been asked by a bipartisan group of six senators to analyze and report on current federal activities impacting regenerative medicines. Read More
The FDA is requesting that certain OTC topical antiseptic drugs be repackaged with updated labeling to decrease the risk of infection resulting from their improper use. Read More
Australia’s Therapeutic Goods Administration (TGA) is offering drugmakers a more streamlined approach for reporting adverse events in an effort to reduce manual data entry and the possible double handling of information. Read More
Alexion’s recall and replacement of vials of its rare disease drug Soliris could cost the company between $10 and $25 million in the fourth quarter, the drugmaker says in a Tuesday SEC filing. Read More
The FDA has delayed Sarepta Therapeutics’ NDA submission for its Duchenne muscular dystrophy (DMD) drug because of a failure in trials of a similar drug. Read More
GlaxoSmithKline’s experimental coronary heart disease drug darapladib failed to reduce heart attacks, strokes and major cardiovascular events in a closely watched Phase III clinical trial, deflating some expectations for GSK’s Phase III pipeline. Read More
A bill that will require drugmakers to establish a pedigree system for pharmaceuticals within one year is expected to reach President Obama’s desk this Friday. Read More
The FDA says someone hacked into CBER’s online submission system last month and may have put users in danger of having their online personal identity stolen. Read More
The UK’s National Institute for Health and Care Excellence (NICE) has asked Janssen for more information on its multiple myeloma treatment Velcade before an appraisal committee can make final recommendations on its use in patients untreatable with high-dose chemotherapy and haematopoietic stem cell transplant. Read More
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