August 1, 2023

New re­search pub­lished Fri­day in JA­MA Net­work Open es­ti­mates that up­wards of $50 bil­lion to $60 bil­lion is spent an­nu­al­ly by bio­phar­ma com­pa­nies on failed

The FDA un­veiled its user fee rates for pre­scrip­tion drugs, biosim­i­lars, gener­ics and med­ical de­vices last Fri­day — and with the ex­cep­tion of biosim­i­lar ap­pli­cants,

The FDA is seek­ing more col­lab­o­ra­tions with dif­fer­ent glob­al agen­cies when it comes to in­spec­tions. The agency re­cent­ly inked an agree­ment with the Swiss Agency

Bris­tol My­ers Squibb, John­son & John­son and the US gov­ern­ment agreed that the two com­pa­nies can con­sol­i­date their briefs to­geth­er in their cas­es against the

As­traZeneca’s block­buster asth­ma and COPD drug Sym­bi­cort, which brought in $2.5 bil­lion for the phar­ma gi­ant in 2022, now has a gener­ics com­peti­tor from Vi­a­tris.

GSK’s new can­cer drug Jem­per­li (dostar­limab) won an FDA ap­proval on Mon­day, al­most two months ahead of its PDU­FA date, for use in cer­tain front­line

Pur­due Phar­ma’s role in the opi­oid epi­dem­ic is get­ting an­oth­er Hol­ly­wood as­sess­ment, this time on Net­flix with a cast led by Matthew Brod­er­ick as Richard

What’s next for two of biotech’s once-cool, now-hot com­pa­nies? Hot on the heels of crit­i­cal da­ta read­outs, Roivant Sci­ences and Bridge­Bio Phar­ma are en­joy­ing two

In May, An­nex­on’s drug can­di­date ANX007 did not prove bet­ter at re­duc­ing the le­sion growth in a lead­ing cause of blind­ness. Now more da­ta have

Pe­ter Hecht and his crew are ready to re­veal the name be­hind their new start­up and dis­close the iden­ti­ty of an­oth­er VC in­vestor be­hind their