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A federal appeals court Monday upheld a lower court ruling that invalidated four Acorda Therapeutics patents for the multiple sclerosis drug Ampyra (dalfampridine). Read More
In comments on the FDA’s draft guidance on the Usage and Indication sections of drug labeling, Novartis and Pfizer asked the agency to clarify its thinking on limitations of use. Read More
In the latest salvo in the federal crackdown on fraud among Florida compounders, a federal jury convicted pharmacist Stephen Chalker of participating in a $5 million scheme to defraud Medicare, Medicaid and TRICARE. Read More
A California federal judge dismissed a shareholder suit against Impax Laboratories alleging price-fixing but left the door open for an amended complaint. Read More
The FDA issued guidance Monday on how sponsors of synthetic drugs should approach post-approval manufacturing process changes — listing examples of low, medium and high risk changes. Read More