R&D
Gilead wins case that scrutinized pace of drug development
The California Supreme Court yesteday sided with Gilead in a closely watched case brought by thousands of patients who argued the company was negligent for slow-walking development of an HIV medicine that was safer than another drug it was already selling.
It's a win for Gilead and for the broader drug industry, which feared that an opposite ruling would lead to fears of legal liability shaping development decisions, STAT's Ed Silverman writes.
In this case, patients alleged they unnecessarily suffered kidney injury and bone loss from Gilead's older HIV drug, called TDF. They claimed Gilead stalled the development of a new, safer treatment until shortly before the patents for TDF expired, so the company could switch patients to the new medicine and crowd out generic rivals.
One professor said this was “a pretty terrible decision. What I fear is that this will become a typical life cycle management strategy” used by pharmaceutical companies to extend the ability of their medicines to generate profits.
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drug pricing
Sandoz settles price-fixing allegations with states
Sandoz, a generic drugmaker, agreed to pay $478.5 million to settle allegations by dozens of states that the company engaged in a widespread conspiracy to artificially inflate and prices of generic drugs and harmed consumers by reducing competition.
It's the latest development in a long-running battle between states and large players in the generic drug industry accused of fixing prices, STAT's Ed Silverman writes.
In building their cases, federal and state authorities amassed tens of millions of documents containing detailed records in which companies allegedly colluded at industry dinners, “girls nights out,” lunches, cocktail parties, and golf outings.
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