By Brenda Sandburg
State governments have found a new source of revenue for tough economic times, and they are creating aggressive and committed teams to collect the money.
States have become more aggressive in pursuing pharma for health care fraud. They are building stronger cases by teaming up with each other and the federal government to push companies to accept more onerous restrictions on their business practices.States have become more aggressive in pursuing pharma for health care fraud. They are building stronger cases by teaming up with each other and the federal government to push companies to accept more onerous restrictions on their business practices.
By Brenda Sandburg
State governments have found a new source of revenue for tough economic times, and they are creating aggressive and committed teams to collect the money.
If US tariffs on pharmaceutical supply chain products come into force they could be disruptive for companies. Ewan Townsend, of the international law firm Arnold & Porter, explains how companies can mitigate issues through negotiating with suppliers and reallocating tariff responsibilities.
Bridget Dooling, a law school professor who reviewed draft regulations from the FDA and other agencies as an OMB attorney, said prior federal court decisions suggest judges typically defer to agency decisions based in science.
The verdict by the Unified Patent Court in the dispute between Sanofi/Regeneron Pharmaceuticals and Amgen explains what companies should look out for when deciding whether infringement has taken place when it comes to second medical use patents.
A US Supreme Court ruling in favor of the agency in an e-cigarette case has implications for drugs and other medical products as the justices decided not to disturb the FDA’s ‘change in position’ authority, while also creating a complex new landscape.
Japan is cutting more drug reimbursement prices following cost effectiveness analysis and is applying the methodology to a new group of products including Wegovy and Leqembi.
Bridget Dooling, a law school professor who reviewed draft regulations from the FDA and other agencies as an OMB attorney, said prior federal court decisions suggest judges typically defer to agency decisions based in science.
The new CBER director, once best known in the pharma world for criticizing accelerated approval, committed to expediting cancer drugs with surrogate endpoints.