Drugindustrydaily

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April 18, 2019

Vol. 18
No. 75

Headlines

Editor’s Note

In observance of spring holidays, Drug Industry Daily will not be published Friday, April 19. The next issue will be published Monday, April 22. Read More

Cummings Presses Ahead on Drug Pricing Investigation

In an open letter on Wednesday to his Republican counterpart on the House Committee on Oversight and Reform, Chairman Elijah Cummings (D-Md.) said he will give drugmakers the committee’s protocol for guarding their potentially sensitive internal documents. Read More

European Parliament Evens Scales for Generics Makers With New SPC Waivers

European drugmakers will be allowed to make generics and biosimilars after the European Parliament on Wednesday voted in favor of manufacturing waivers that will allow their export. Read More

CBER Touts Gene Therapy, Vaccine Approvals in FY2018

CBER Director Peter Marks highlighted two gene therapy approvals in a report on the center’s achievements for fiscal 2018, released on Wednesday. Read More

Canada Issues Guidance on Abbreviated New Drug Submissions

Health Canada released two draft guidances to clarify proposed changes to the agency’s abbreviated new drug submission (ANDS) pathway for generics. Read More