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Sponsors of generics for Pfizer’s estrogen drug Premarin should use the “Pfizer method” for assessing sameness rather than the method recommended in FDA draft guidance, the company said in a citizen petition. Read More
Purdue agreed to pay rival opioid manufacturer Assertio Therapeutics $62 million to settle Assertio’s patent infringement lawsuit against the OyxContin maker. Read More
A federal judge in the US. District Court for the Eastern District of California threw out PhRMA’s case contesting state drug pricing legislation, but left the door open for an amended filing. Read More
In an Aug. 30 notice, the agency said meeting requests should include key features of the statistical analysis plan, as well as the simulation plan and components of the study design the sponsor believes are non-disclosable. Read More
The FDA’s ongoing investigation of Zhejiang Huahai Pharmaceuticals looked at the company’s API manufacturing process and changes made to it over time. Read More
The U.S. District Court for the District of New Jersey issued a permanent injunction barring online distributor Just Enhance from illegally selling sexual enhancement products on more than 100 websites. Read More
In the latest CMS move aimed at reducing drug prices, Administrator Seema Verma released new guidance on how Part D plan sponsors can negotiate formulary coverage based on specific indications starting in 2020. Read More