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The PTO’s Patent Trial and Appeals Board invalidated Aventis Pharma’s patent for the chemotherapy drug Jevtana (cabazitaxel), following a challenge from Mylan. Read More
A Pennsylvania federal judge dismissed a class-action lawsuit against more than 10 drugmakers that accused them of misrepresenting facts to inflate generic drug prices. Read More
Following the destruction brought by Hurricane Maria in Puerto Rico, FDA Commissioner Scott Gottlieb said one of the agency’s main goals in the recovery effort is to bring the island’s medical product manufacturing plants back into operation. Read More
Aegerion Pharmaceuticals pleaded guilty to two criminal misdemeanor violations of the FD&C Act, for failing to comply with REMS requirements for its Juxtapid (lomitapide) cholesterol therapy. Read More
The FDA has cracked down on a host of operators peddling prescription drugs online, claiming the vendors are selling the drugs without a prescription, or marketing the drugs in a way that is not approved by the agency, or both. Read More
A new pricing agreement will allow a leading HIV regimen to be rolled out in more than 90 low- to middle-income countries, at an average cost of $75 per patient, per year. Read More
The FDA has cracked down on a host of operators peddling prescription drugs online, claiming the vendors are selling the drugs without a prescription, or marketing the drugs in a way that is not approved by the agency, or both. Read More
Pfizer is suing Johnson & Johnson over its contracts and rebate policies with insurers and hospitals, saying they are designed to block sales of a biosimilar for J&J’s blockbuster Remicade therapy. Read More
New guidance from the UK’s National Institute of Health and Care Excellence links the cost-effectiveness of different bisphosphonate medications for osteoporosis with a patient’s 10-year risk of bone fractures. Read More