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…

An FDA advisory panel voted unanimously Thursday to recommend that the agency establish patient-focused dissolution standards for extended-release solid oral dosage forms. Source: Drug Industry Daily

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to submit trial data to ClinicalTrials.gov on time could cost drugmakers up to $10,000 per violation, the FDA said in draft guidance issued Thursday. Source: Drug Industry Daily

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…

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. Source: Drug Industry Daily

The FDA Wednesday issued guidance on labeling and safety testing for heparin-containing combination products, finalizing the agency’s 2015 draft. Source: Drug Industry Daily

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. Source: Drug Industry Daily

The FDA hit Rotterdam, Netherlands-based drugmaker Fagron for inadequate drug product storage and procedures for controlling recalled products at the firm’s Saint Paul, Minn., facility. Source: Drug Industry Daily

The Senate passed legislation Monday that would bar PBMs or insurers from including gag clauses in their contracts with pharmacies, sending the bill to the House by a vote of…

Lawmakers are hoping to quickly reconcile the Senate’s newly-passed Opioid Crisis Response Act (S. 2680) with the package the House passed as soon as Friday and vote through a final…