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A health plan for a carpenters’ union filed a class action lawsuit against Celgene, claiming the drugmaker engaged in anti-competitive practices to maintain its monopoly on Thalomid (thalidomide) and Revlimid (lenalidomide). 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
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
The FDA is streamlining its communications with generics manufacturers, and outlined its procedures for relaying the status of an ANDA review in a new manual for staff. Read More
The Federal Circuit eased the ability for patent holders to amend their claims when challenged under inter partes review — a hurdle that pharmaceutical industry trade groups had previously described as unfair, ambiguous and impractical. 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The FDA published a draft guidance explaining the new GDUFA fee structure and the types of fees that took effect Oct. 1.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 FDA published a new manual of policies and procedures for reviewing staff, detailing how the agency will communicate ANDA deficiencies with applicants — meeting one of its first commitments for the next generation of GDUFA. Read More
In a significant policy shift, China plans to accept data from foreign clinical trials in its drug approval process if the drug is already approved overseas. Read More
An FDA advisory committee voted 10-0 in favor of the efficacy of a drug candidate for treatment of glaucoma and ocular hypertension based on data from efficacy trials. Read More