Agency officials and oncologists debate considerations where a data package overwhelms non-responders in favor of a tissue-agnostic indication.

Advisory committee members are divided on whether agency should restrict access to higher dose opioids, but most want option kept on the table.

Reductions in research and development spending will be much greater than the 1% average often quoted by HHS, consultant tells the Biotechnology Innovation Organization annual convention.

Expect plenty of litigation over what constitutes infringement of a method-of-use patent even when the protected indication is not found on a biosimilar’s labeling, a panel of legal experts said at the recent BIO meeting; another area of unsettled law is the extent to which a biosimilar sponsor has satisfied the information-exchange provisions of the BPCIA ‘patent dance.’

Antibiotic developers have a blunt message for Congress: the time for action is now or never. They see a targeted reimbursement change (The DISARM Act) as vital to send a signal to investors that the sector can be saved – and don’t want to delay to debate other ideas like “subscription” models.

Recent cases of individual designed treatments have FDA playing a bit of catch up. The concept has been on the horizon, but now “bespoke therapies” are here.

The generation of more real world evidence on medicines is one of the aims of a newly announced collaboration that will see family doctors playing a bigger role in providing data for the European Medicines Agency to use in its drug evaluation activities.

News and views from day four of the BIO International Convention: Former FDA official Amy McKee said "everything worked right" with accelerated approval and removal of Lilly's Lartruvo; emerging company M&A deals nearly double in 2018; and the ASCO effect on the 3-6 June BIO meeting.

Much like Genzyme’s Ceredase did two decades ago, Novartis’ Zolgensma is setting a new pricing benchmark. The first million-dollar product is launching in the US and it will actually cost more than $2 million.

News and views from day one of the BIO International Convention: Merck reaffirms commitment to antibiotic space the same day Zerbaxa picks up a new indication; US FDA regenerative medicine advanced therapy designations now outnumber breakthrough designations for cell/gene therapies; BIO survey finds out-licensing cash for emerging firms more than doubled in 2018.

A US FDA official is exhorting the biopharmaceutical industry to adopt standards to help in developing new cell and gene therapy products, yet this may pose difficulties as there is a lack of standards in this space, particularly in areas such as cell viability, chain of identity and viral vector gene quantification.

Top officials at the US FDA explain why the agency opposes USP monographs for biological products as a Senate committee proposes to disallow them and the USP launches an advertising campaign in their favor.

The US FDA plans to give its young drug compounding oversight program new leadership and move it from the drug center director's office down to the center's compliance office. Whether this move translates into heightened enforcement of drug compounders remains to be seen.