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Teva is expanding its footprint in the central nervous system treatment market with the $3.2 billion purchase of movement disorders drugmaker Auspex Pharmaceuticals. Read More
The FDA has reopened the comment period on a guidance meant to make it easier for drugmakers to test products containing live biotherapeutics. Read More
Consumer group Public Citizen is calling on the FDA to send warning letters to four drugmakers to withdraw ads for five Type 2 diabetes drugs promoting off-label uses for weight loss or blood pressure reduction. Read More
European regulators singled out timely access to novel drugs and assuring product, supply chain and data integrity as some of the main goals in a newly released draft common strategy to 2020. Read More
Otsuka is suing to block the FDA from allowing generic versions of its blockbuster antipsychotic Abilify years before the drug’s orphan product exclusivity runs out. Read More
The FDA has laid out the procedures drugmakers should follow in preparing for critical path innovation meetings designed to bring drugmakers, patient groups and regulators together to decide how to use experimental and untested methodologies that can advance drug development. Read More
FDA Office of Generic Drugs Director Kathleen “Cook” Uhl is stepping down for several months to undergo treatment for colorectal cancer. She will be replaced in the interim by John Peters, head of OGD’s Office of Bioequivalence. Read More
The U.S. Supreme Court has rejected another generics liability petition, this one from PLIVA seeking to appeal an Iowa Supreme Court ruling finding the drugmaker open to failure-to-warn claims. Read More