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1 month ago | 
insights.citeline.com | Sue Sutter |Derrick Gingery |Nancy Pham
Could Makary Face Facility Issues As US FDA Commissioner? The Department of Government Efficiency cancelled leases for FDA office and lab space at numerous sites outside the Washington, DC, area, while many buildings on the agency’s White Oak, MD, campus were included on the General Services Administration’s initial list of “non-core” government properties for disposal. The FDA's real property footprint could shrink under the second Trump Administration. (Shutterstock)
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2 months ago | 
insights.citeline.com | Joseph Haas |Nancy Pham
Biopharma Deal Metrics Declined Across The Board In 2024INFOGRAPHIC: 2024 was a particularly quiet year for biopharma M&A, with no buyouts reaching the $5bn threshold, while alliance volume and valuations declined compared to 2023, as well. Dealmaking metrics declined sharply in 2024 (Shutterstock)
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2 months ago | 
insights.citeline.com | Bridget Silverman |Nancy Pham |Kosh Naran
Novel Agents Up For US FDA Approval In 2025CBER has at least 14 and CDER another 10 novel biologics among the more than 60 candidates with a user fee goal in 2025. The FDA's 2025 user fee calendar includes a wide range of product types. (Shutterstock)
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Jan 16, 2025 | 
insights.citeline.com | Bridget Silverman |Nancy Pham
Clocking The Speed Of US FDA 2024 Novel ApprovalsReview times for all 61 novel agents the US FDA approved in 2024. The Pink Sheet calculated the review times for all the novel agents approved in 2024. (Shutterstock)
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Oct 23, 2024 | 
insights.citeline.com | Jessica Merrill |Nancy Pham
The Life Of A BlockbusterThe industry’s top-selling drugs generate billions in revenues each year. Scrip analyzed data on nearly 200 blockbuster drugs to see which are forecast to make the most at peak and over a 14-year time horizon. Scrip's deep dive into blockbuster drugs • Source: Shutterstock
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Oct 22, 2024 | 
insights.citeline.com | Nancy Pham
‘Inside Regulatory Affairs’ With Bayer Consumer Health’s Jenny HolmesIn this installment of HBW Insight’s “Inside Regulatory Affairs” series, Bayer Consumer Health’s global regulatory director, Jenny Holmes, describes how the job has changed in recent years to assume an enabling role for innovation. • Source: Citeline/Bayer Consumer Health/Shutterstock
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Oct 22, 2024 | 
insights.citeline.com | Nancy Pham
‘Inside Regulatory Affairs’ With Honey Pot Company’s Kristini MilesIn this installment of HBW Insight’s "Inside Regulatory Affairs” series, The Honey Pot Company’s Kristini Miles discusses the challenges of communicating science to today’s consumer, progress in policy benefiting historically disadvantaged communities, and the numerous other demands that occupy her day-to-day. • Source: Citeline/The Honey Pot Company/Shutterstock
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Sep 13, 2024 | 
hbw.citeline.com | Nancy Pham
Interviews
Executive Summary
In this instalment of HBW Insight’s “Inside Regulatory Affairs” series, AdverCheck managing directors Lucy Rochford and James Walmsley describe how the consumer health industry is increasingly outsourcing its advertising copy review as it moves closer to the fast-moving consumer goods sector. They also point to a worrying trend in the UK of advertising prescription-only medicines online.
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Sep 10, 2024 | 
hbw.citeline.com | Nancy Pham
Interviews
Executive Summary
In this installment of HBW Insight’s "Inside Regulatory Affairs” series, The Honey Pot Company’s Kristini Miles discusses the challenges of communicating science, including data on chemicals, to today’s consumers while helping foster innovation and improving protections for historically disadvantaged communities.
Source: Citeline/The Honey Pot Company/Shutterstock
Existing Subscriber?
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Sep 2, 2024 | 
hbw.citeline.com | Nancy Pham
Interviews
Executive Summary
In this installment of HBW Insight’s “Inside Regulatory Affairs” series, Bayer Consumer Health’s global regulatory director, Jenny Holmes, describes how the job has changed in recent years to assume an enabling role for innovation.
