Now that the European Commission has finally given the go-ahead to Ocrevus, regarded by multiple sclerosis specialists as a game changer especially for the primary progressive form of the disease, observers will be watching to see what pricing strategy Roche adopts.
Some 19 months after being validated for review, Roche's multiple sclerosis Ocrevus (ocrelizumab), already nearing blockbuster status in the US, has finally been given the green light in Europe.
Following a positive opinion in November 2017 from the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP),...
The agency gave accelerated approval to the BCMAxCD3-directed bispecific antibody, which had been the subject of an August 2024 CRL.
Pipeline Watch is a weekly snapshot of selected late-stage clinical trial events and approvals announced by pharmaceutical and biotech companies at medical and industry conferences, in financial and company presentations, and in company releases and statements.
Many assets underperform their pre-launch sales predictions, which can be disastrous to their developers and marketers. In this article, Scrip highlights several historic examples and the factors that influenced their poorer-than-expected performance.
Pipeline Watch is a weekly snapshot of selected late-stage clinical trial events and approvals announced by pharmaceutical and biotech companies at medical and industry conferences, in financial and company presentations, and in company releases and statements.
The merger with a fellow Norwegian biotech comes a few months after its lead asset, bemcentinib, bit the dust.
Data from a second pivotal trial support a filing in the US for Opus Genetics’ phentolamine ophthalmic solution, to treat presbyopia.
BlissBio is to single-handedly move BB-1701, its eribulin-containing, HER2-targeting antibody-drug conjugate, into a global pivotal Phase II/III program for HER2-expressing, Enhertu-resistant breast cancer.
