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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
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