The latest drug development news and highlights from our US FDA Performance Tracker.

Community Oncology Alliance proposes updates to the Oncology Care Model demonstration project, including a sharper focus on lowering prescription drug costs.

Recent and upcoming US FDA advisory committee meetings and a summary of topics covered.

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.

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.

There are now just two European countries left to join the agreement between the EU and the US on recognizing the findings of inspectorates in each other’s jurisdictions.

US FDA official says that the complexities involved in producing cell and gene therapies necessitate a “new manufacturing paradigm” in evaluating biologics license applications. For such therapies, the agency is willing to grant regulatory flexibility in certain areas of its chemistry, manufacturing and controls review.