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In another blow to Allergan’s efforts to retain exclusivity for its dry-eye drug Restasis, the U.S. Patent Trials and Appeals Board said Allergan’s transfer of the patents to the St. Regis Mohawk tribe last year conferred only “illusory rights” and denied the company’s motion to terminate Mylan’s challenge to six of its patents. Read More
The FDA plans to launch a new pilot program to improve the efficiency of orphan designation submissions and reviews, Commissioner Scott Gottlieb announced Monday. Read More
HHS Secretary Alex Azar said the FDA plans to expand the use of medication-assisted treatments for opioid addiction and will soon issue two new guidances on the topic. Read More
Aevi Genomic Medicine commented that “the proposed remedy is likely to impede and delay development of important new medicines for children.” Read More
The FDA observed GMP deficiencies in an inspection of a Legacy Pharmaceuticals Switzerland facility, including problems with sterility, maintenance and discrepancy investigations. Read More
The FDA issued U.K. drug manufacturer Bray Group a Form 483 after finding numerous violations during an inspection of the firm’s Faringdon, Oxfordshire facility, including problems with validations, sample testing, cleaning and maintenance. Read More
The FDA slapped TrueCare Biomedix with a Form 483 for numerous procedural issues and violations observed during a November inspection of its facility in Gujarat, India. Read More
The FDA finalized a Q&A guidance clarifying the International Council for Harmonization’s November 2012 Q11 guidance on development and manufacture of drug substances — giving recommendations for information that should be provided in authorization applications for starting materials. Read More