After months of investigation, the U.S. Food and Drug Administration will not bring any penalties against Novartis over the data manipulation of the gene therapy Zolgensma, a multi-million dollar treatment for spinal muscular atrophy.
With the 2020 elections looming though, and lawmakers across the country drafting legislation aimed at curbing price increases, some companies are carefully examining the landscape as they approach pricing.
Although there were some deals announced at the ongoing J.P. Morgan Healthcare Conference, biotech stocks appeared to slide slightly at the overall lack of business transactions, at least during the first day or two.
An unnamed Novartis executive sold 925,400 Swiss francs ($946,000) worth of shares less than three weeks before the U.S. Food and Drug Administration announced data from tests of the company’s gene therapy Zolgensma had been manipulated.
Days after the U.S. FDA revealed data manipulation was involved in the early studies of Novartis’ multi-million dollar gene therapy for SMA, U.S. Senate members demanded the regulatory agency take action against AveXis, the company that developed Zolgensma.
The U.S. Food and Drug Administration revealed that data manipulation was involved in the preclinical process for Novartis’ gene therapy Zolgensma as a one-time treatment for spinal muscular atrophy, but suggests that the therapy remain on the market.
Novartis AG, which previously announced positive interim trial results for the company’s experimental gene therapy for spinal muscular atrophy, said an investigation is underway into whether a second trial death could be related to the treatment.
Biogen Inc. should slash the price of the spinal muscular atrophy (SMA) drug Spinraza, and the $4 million to $5 million Novartis has said the company’s experimental gene therapy Zolgensma for the disease is worth is excessive, an independent U.S. organization that reviews the value of medical treatments said.
Here are seven trends most likely to be hitting the news cycle in 2019 according to BioSpace.
Express Scripts Holding Co. built a multi-billion enterprise pressuring drug companies to lower their prices for U.S. patients. Now the pharmacy benefit manager is quietly building a side business: getting paid to help drug companies dispense a new generation of high-priced drugs.