Gilead is defending a suite of patents for its profitable hepatitis C antivirals from challenges by a non-profit group petitioning the PTO’s Patent Trial and Appeal Board. Source: Drug Industry…
The PTO’s Patent Trials and Appeals Board reversed course last week, granting inter partes review of a Herceptin patent that it previously refused, following challenges from Hospira. Source: Drug Industry…
A worker benefits fund filed a lawsuit against Johnson & Johnson this week for allegedly maintaining an illegal monopoly for its Crohn’s disease drug Remicade. Source: Drug Industry Daily
The European Medicines Agency is already changing its procedures in advance of the UK’s departure from the European Union in 2019, with the pending withdrawal affecting which experts the agency…
FDA advisory committee members overwhelmingly recommended approval of Indivior’s RBP-6000, an extended-release reformulation of buprenorphine for the treatment of opioid abuse. Source: Drug Industry Daily
The FDA will begin to recognize manufacturing facility inspections conducted by drug regulatory authorities in Austria, Croatia, France, Italy, Malta, Spain, Sweden and the U.K as capable of meeting the…
The Crestwood, KY-based company plans to raise $150M by offering 10.7 million shares at a price range of $13 to $15. Source: BioSpace
Investors and analysts are wondering if the company should buy a biotech to bolster its pipeline and bottom line. Source: BioSpace
Dupilumab added to standard therapies significantly reduced the use of maintenance oral corticosteroids (OCS) by 70% on average. Source: BioSpace
Shares of Voyager have fallen more than 12 percent in premarket trading after Sanofi Genzyme walked away from its $845M gene therapy treatment for Parkinson’s disease. Source: BioSpace