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Claims that Allergan repeatedly tried to delay Restasis generics from entering the U.S. market are plausible, a U.S. District Judge ruled on Tuesday, shooting down the pharmaceutical giant’s attempts to have the multi-district litigation dismissed. Read More
An FDA advisory panel voted unanimously Thursday to recommend that the agency establish patient-focused dissolution standards for extended-release solid oral dosage forms. Read More
Failure to submit trial data to ClinicalTrials.gov on time could cost drugmakers up to $10,000 per violation, the FDA said in draft guidance issued Thursday. Read More
“With science evolving at such a fast pace, our challenge will be to achieve a balance between being agile to find solutions to emerging scientific or regulatory issues and being consistent with previous decisions,” Enzmann said. Read More
The drugmaker claimed that 60 percent of patients receiving its 500 mg dose saw targeted tumors shrink even though the efficacy rate was actually much lower. Read More
The Securities and Exchange Commission (SEC) Tuesday levied a $20.8 million fine against biopharmaceutical company Clovis Oncology and two company executives for concealing the true efficacy rate of its lung cancer drug Roci (rociletinib). Read More
California’s Department of Insurance filed suit against AbbVie Tuesday alleging the company increased Humira prescriptions through kickbacks and paid nurses to push patients to refill prescriptions. Read More
The FDA Wednesday issued guidance on labeling and safety testing for heparin-containing combination products, finalizing the agency’s 2015 draft. Read More
The FDA released a trio of guidances Wednesday on Drug Supply Chain and Security Act (DSCSA) requirements for drugmakers to attach identifiers to their prescription drugs. Read More