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A federal judge blocked Aegerion’s proposed $36 million deal to settle claims of illegal marketing tactics for its cholesterol drug Juxtapid, ordering the case to trial. Read More
Genentech filed a lawsuit aiming to stop Pfizer’s proposed Herceptin biosimilar from reaching the market — asking the court to compensate for losses in sales should the copy launch before 2019, when several patents are set to expire. Read More
The European Medicines Agency revised two guidelines on the development and labeling of factor VIII products used to treat hemophilia A, removing requirements for sponsors to conduct clinical trials in previously untreated patients. Read More
Finger-pointing abounded during a Senate hearing on prescription drug prices, where branded and generic industry representatives testified alongside pharmacy, wholesale distributor and benefit manager groups. Read More
The FDA continues to work to restore drug manufacturing crippled by hurricane Maria in Puerto Rico, with special response teams set up to tackle the job, but none of the plants has reached 70 percent of its pre-storm capacity, FDA Commissioner Scott Gottlieb told a congressional committee. Read More
A federal judge refused to dismiss a false advertising lawsuit filed by Allergan against drug compounder Imprimis Pharmaceuticals concerning its dry-eye drug Klarity, meant to compete with Allergan’s Restasis. 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
FDA Commissioner Scott Gottlieb told lawmakers the agency will work to break the stigma associated with medication-assisted treatments for opioid dependence and addiction. Read More
The FDA published a draft guidance explaining the new GDUFA fee structure and the types of fees that took effect Oct. 1. The draft also covers how to submit payments to the agency, the consequences for failing to pay, and how to request reconsiderations of user fee assessments. Read More
The PTO’s Patent Trial and Appeal Board issued a final rule clarifying when attorney-client privilege is recognized during the inter partes review process — as well as which communications are protected when seeking patents at the PTO or at foreign intellectual property offices. Read More