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An EU-level court has established a precedent that would allow drugmakers to protect orphan drugs from generic competition by developing and patenting a similar drug for the same orphan indications while the original therapy still enjoys market exclusivity. Read More
Sun Pharma completed its $4 billion purchase of fellow Indian generics maker Ranbaxy March 25, shortly after the FTC signed off on a divestiture order allowing the merger as long as the companies relinquish rights to the antibiotic minocycline. Read More
Drugmakers sparred with consumer and patient advocates at a March 27 public hearing on the FDA’s proposed rule to give generics makers the ability to update label safety information independently — with generics firms opposing the rule and advocacy groups supporting it. Read More
Biosimilars makers are not required to share their applications and manufacturing processes with the biologics company whose product they are copying, the FDA says, rejecting Amgen’s argument that the law that created the biosimilars pathway mandates disclosure of that information. Read More
The U.S. government has awarded BioCryst $12.1 million for further development of its BCX4430 antiviral that targets multiple pathogens — including Ebola. Read More
Drugmakers in the European Union will pay slightly lower fees starting today, under an annual adjustment that reflects the inflation rate for the previous year. 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