Federal Appeals Court Grants Reprieve To Sanofi And Regeneron In Cholesterol-Drug Battle
In other pharmaceutical industry news, Gilead Sciences' revenue problem, a status check of Food and Drug Administration user fees and Vice President Mike Pence's position on right-to-try laws.
Sanofi And Regeneron Win A Reprieve In Cholesterol Drug Battle
In a dramatic development, Sanofi and Regeneron Pharmaceuticals can continue selling their cholesterol medicine while they fight an injunction that might force their drug off the market permanently, according to a federal appeals court ruling. The court suspended a permanent injunction that was issued last month by a lower court, and would have prevented the companies from marketing Praluent, a new type of cholesterol treatment. The injunction was issued in response to a jury verdict last year that found the drug infringed on patents held by Amgen, which sells a rival medicine called Repatha. (Silverman, 2/8)
The Wall Street Journal:
Gilead’s Boom Fades And Bust Will Linger
Gilead Sciences, perhaps the company most responsible for powering the last biotech bull market, has a revenue problem on its hands. Its struggles highlight how quickly the moment of opportunity can pass for research-focused drug companies. Gilead announced Tuesday it expects between $7.5 billion and $9 billion in sales for its hepatitis C franchise this year, well below analyst expectations. Hitting the high end of that forecast would mark a 40% annual sales decline. As a result, total company revenues could be down more than 20% in 2017 from a year ago. (Grant, 2/8)
CQ Roll Call:
FDA User Fees On Track Despite Health Law 'Chaos'
Lawmakers are feeling pressure to turn to Food and Drug Administration legislation that Republicans and Democrats alike hope can be cleared quickly and with limited controversy, despite partisan debate over changes to the broader health system. Every five years Congress must renew the FDA’s ability to collect fees from some of the industries it regulates. The current authorization expires at the end of September. The fees total about $2 billion of the FDA’s $5 billion annual budget. (Siddons, 2/9)
Dying Patients Have Pence’s Backing On ‘Right To Try’ Policy
Vice President Mike Pence may have just picked another fight with pharmaceutical companies -- one that doesn’t involve drug prices. Pence is pushing for a nationwide law that would give terminally ill patients expanded access to experimental drugs that haven’t been approved yet but have made it through the first of three approval phases. The vice president had championed the so-called right-to-try issue while governor of Indiana and later on the campaign trail. (Edney, 2/8)