Latest News & Analysis
Biogen presented highly anticipated data in Alzheimer’s disease at CTAD for its Phase III EMERGE and ENGAGE studies, but one major question remains unanswered: will the FDA approve the drug?
Amgen exec calls for more informal agency feedback and alignment between review divisions in understanding design methodologies.
Keeping Track Of Thanksgiving Leftovers: Risdiplam, Artesunate Highlight Glut Of Submissions/Filings
Yes, we know they should be out of the fridge by now, but here are the highlights of submissions and filings during the Thanksgiving week.
Agency wants to ensure patients ‘aren’t unnecessarily or unfairly scared off or intimidated’ from taking biosimilars, Office of Therapeutic Biologics and Biosimilars' acting policy director Eva Temkin tells the FDA/CMS Summit; Temkin says recent guidance on biosimilar insulins shows agency is trying to be flexible on interchangeability data requirements.
Prices for retail drugs across US payers decreased for the first time in years, driven by a drop in generic prices and “little to no growth” in prices for brands.
Stay up to date on regulatory guidelines from around the world with the Pink Sheet's Guidance Tracker. The complete Global Pharma Guidance Tracker, with sortable and searchable listings going back to 2014, is available online.
The new EU commissioner for health has been given a number of high-priority tasks, including medicines supply and tackling antimicrobial resistance. These topics will be taken up by the European Commission’s advisory body, the Pharmaceutical Committee, in its new work plan.
Plans for EU-wide Joint Clinical assessments will come under scrutiny at an EU council meeting next week.
Proposal could yield a bounty of new options for innovative drug delivery systems.
CDER Director Woodcock says generic approvals remain inflated by applications that languished before FDA’s user fee program began, but as sponsors work through their own backlog of FDA responses, the number of ANDAs cleared by the agency appears likely to fall.
Accelerating post-approval change oversight by focusing on ‘established conditions’ means trusting pharmaceutical quality management systems. But how?
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