Hoping to dislodge patent trolls, the Senate Judiciary Committee passed a bipartisan patent reform bill Thursday that attempts to thwart frivolous lawsuits while balancing the interests of various industry sectors. But the PATENT Act has a ways to go before it's stamped with the life science industry's seal of approval.
Since biosimilars are not generics, they should not be labeled like generic drugs, Abbvie Inc. said in a citizen petition asking the FDA to approve labeling clearly stating that a drug is a biosimilar.
Rather than going to trial Monday, Teva Pharmaceutical Industries Ltd. agreed to pay at least $1.2 billion to settle a 2008 FTC lawsuit challenging pay-for-delay agreements Cephalon Inc. used to fend off generic competition to its blockbuster sleep-disorder drug Provigil.
What do the Boston Marathon bombing and the Ebola epidemic have in common? The lessons learned in responding to the attack and the viral epidemic will help advance medical countermeasures (MCMs) and future emergency responses.
While it's not a death knell for the life cycle approach of building a drug franchise, an appellate court ruling in People of the State of New York v. Actavis plc could kill one tactic a few drugmakers have used to protect a blockbuster franchise from generic competition: forced switching to the next-generation product.
In a self-declared "love fest," the House Energy and Commerce Committee put aside partisan politics Thursday, voting 51-0 to pass the 21st Century Cures Act, H.R. 6, in the hope of streamlining the process of developing and approving new medical treatments.
Defending patents for drugs and medical devices is part of the stakes of an R&D budget, but the size of that stake could increase significantly if a hedge fund manager wins his inter partes review (IPR) challenge of selected drug patents.