News and views from day two of the BIO International Convention: US FDA's Sharpless decries the focus on the price of "medical miracle" Zolgensma; CBER Director Marks talks about how his division will staff up to review cell and gene therapy candidates; and Takeda explains why its business development philosophy leads to the valuation seen in the Ariad buyout.
During his first two months on the job, US Food and Drug Administration acting commissioner Ned Sharpless generally has come across as unflappable in his public appearances. However, press coverage of the approval of Novartis AG’s gene therapy Zolgensma (onasemnogene abeparvovec-xioi) for spinal muscular atrophy (SMA) has got him riled up.
Following the agency’s 24 May approval, many of the headlines focused on the therapeutic’s $2.1m price tag, as well as...
Doctors are increasingly falling victim to financial scams due to their high incomes, busy schedules, and trust in professional networks. Recognizing the tactics scammers use and the reasons behind physicians’ susceptibility is essential for protecting medical professionals.
Senate HELP Committee chair Sanders trying to broker a deal between Novo Nordisk and the major pharmacy benefit managers that will lead to lower list prices.
Alternatives to the top pharmacy benefits managers argue health plan-PBM integration is leading to anti-competitive tactics that make it impossible for some employers to switch PBMs.
An effort to change the US Food and Drug Administration’s conclusion that its obesity treatment candidate retatrutide is a drug and not a biologic could give the product more time with unrestricted pricing in Medicare, among other benefits.
Pharmacy benefit manager sues Federal Trade Commission claiming chair Khan has orchestrated a campaign against PBMs that is not based in fact.
Alternatives to the top pharmacy benefits managers argue health plan-PBM integration is leading to anti-competitive tactics that make it impossible for some employers to switch PBMs.
The UK regulator approved 16 medicines containing a new active substance in the first half of this year, while the European Commission issued marketing authorizations for 20 NAS-containing drugs.
