Biogen's MS patent struck down in court

A federal court has invalidated Biogen’s patent on its blockbuster multiple sclerosis drug, STAT’s Adam Feuerstein writes. Per the ruling, Mylan could launch its own generic version of the medicine within days — though Biogen said it plans to file an appeal.

Tecfidera is responsible for about one-third of Biogen’s total revenue, totaling $4.43 billion in sales last year. The company’s shares fell 6% to $264 on the news, while Mylan’s rose 3% to $16.

“This morning’s news is a disappointment which will likely shave a number of years off of Tecfidera’s U.S. commercial life,” one Cowen analyst wrote in a research note.

Can a vaccine be an October surprise?

Are journal publishers running a racket? And why is genetics so white? We discuss all that and more this week on “The Readout LOUD,” STAT’s biotech podcast.

First, we run through a busy week in news, discussing the results of a major study on a Covid-19 treatment, an escalating fight in the publishing world, and a record-breaking biopharma IPO. Then, physician and health care policy expert Ezekiel Emanuel joins us to discuss his nightmare scenario: President Trump, desperate for re-election, forces the approval of an ineffective coronavirus vaccine.

Finally, we talk to geneticist Tshaka Cunningham about the deep racial inequities in the field of genomics and what can be done to correct them.

Listen here.

Clinical trials aren't all that expensive

The biopharma industry has long claimed that clinical trials are costly — and contribute ultimately to high drug prices. But a new BMJ Open study, which pored over the 101 new medicines approved by the FDA between 2015 and 2017, finds that the cost to run a clinical trial is actually somewhat modest.

The median cost for trials was $48 million per drug, STAT’s Ed Silverman reports. The biggest factor driving that cost: the number of patients required to establish whether a drug worked.

But there's still a hotly contested debate about the overall cost to develop a drug, which an analysis earlier this year estimated at $1.3 billion.

Research on cellular compartments suggests a way make chemo more effective

New research suggests chemotherapy drugs could be fine-tuned to hit smaller targets in cells, which might in turn make them more effective. Researchers at the Whitehead Institute found that cancer drugs accumulate in small cellular compartments called condensates. In experiments in cell culture, they found that how well two cancer drugs work — and whether cells develop resistance against them — depends on which condensates they end up in, STAT’s Elizabeth Cooney writes.

But scientists still don't know much about how condensates work.

“If we knew more about the chemistry of condensates, and if there were a way to engineer a drug so that it could concentrate into a condensate but could not diffuse out again, that could be a useful trick for selectively enriching a drug and a potential target in the same place at high concentrations,” one researcher told STAT.