Legal
Fidelta Ltd is pleased to announce that it has signed an integrated drug discovery agreement with Galapagos based on Fidelta’s macrocyclic platform.
Axovant Sciences, announced that it has licensed exclusive worldwide rights for the development and commercialization of two novel gene therapy programs to address GM1 gangliosidosis and GM2 gangliosidosis from the University of Massachusetts (UMass) Medical School.
In writing literally hundreds of stories this year, two BioSpace writers, Alex Keown and Mark Terry, found certain stories particularly intriguing or impactful. Some of those were such big topics that they were covered over a series of stories. Looking back at 2018, here are their Top 10.
Lawsuit Charges FDA, NIH With Failing to Follow Established Law for Reporting of Clinical Trial Data
The lawsuit alleges that the government is letting a number of researchers off the hook of reporting clinical data.
It apparently began with a 2016 federal lawsuit. At that time, 20 state attorneys general filed a federal lawsuit alleging that six generic drug makers artificially inflated and manipulated prices for an antibiotic and an oral diabetes drug. The goal was to reduce competition.
Although a moderate presence in Europe, with about 25 biosimilars approved and on the market, they haven’t gained traction in the U.S. Even though at least 11 have been approved in the U.S., only about three are available, largely because of business tactics branded drug companies are using to slow down the competition to their typically very high-priced biologic drugs.
The government alleged Actelion provided money to a nonprofit to cover copay costs for Medicare drugs, a violation of the False Claims Act.
Positive interim analysis demonstrated proof-of-biology and proof-of-concept for BIIB067
Medtronic is notifying customers worldwide of a voluntary field corrective action for its Puritan Bennett(TM) 980 (PB980) ventilator series. Medtronic initiated this field action on September 19, 2018.
Ingenza is pleased to announce that Syngenta is exercising its commercial licensing option for a technology that enables the development of innovative crop protection products.
PRESS RELEASES