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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 federal judge in Pennsylvania threw out AbbVie’s patent suits against generic competitors, strengthening the Federal Trade Commission’s pay-for-delay case against the drugmaker. Read More
The U.S. government sided with Sandoz on the residual claims from the biosimilar manufacturer’s Supreme Court case with Amgen — arguing the federal law outlining the biosimilar approval process should preempt state laws on the topic. 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
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
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
It would be obvious to treat a patient with folic acid before administering Lilly’s antifoliate chemotherapy drug Alimta (pemetrexed) to reduce Alimta’s toxic effects, the PTO’s Patent Trial and Appeals Board ruled in a challenge to Lilly. 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
Amgen leveled new biosimilar patent infringement litigation against Mylan, after the generics manufacturer submitted an FDA application for its version of the company’s Neulasta (pegfilgrastim) therapy earlier this year. Read More
A federal judge declined to block Maryland’s new law on generic drug price-gouging that went into effect Oct. 1, but said a challenge based on the law’s vagueness can proceed. Read More