Policy & Regulation: Page 7
-
Getty Images
The ability to pivot will be ‘key’ as pharma’s tariff threat looms
Companies are looking to new countries like Vietnam for manufacturing needs, but change comes at a cost.
By Kelly Bilodeau • Jan. 13, 2025 -
Sarah Silbiger via Getty Images
FDA ‘stuck to its corner’ with AI draft guidance, leaving plenty of questions unanswered
The first draft guidance provides an initial framework for how the agency will assess AI models in drug development, but the industry is still looking for more.
By Amy Baxter • Jan. 13, 2025 -
Explore the Trendline➔
Getty Images
TrendlineArtificial intelligence & machine learning
After years of excited buzz around the potential of artificial intelligence and machine learning, pharma has begun to realize the true implications and potential value of these technologies.
By PharmaVoice staff -
Getty Images
Opinion // Year in PreviewPharmaVoice’s Crystal Ball: Industry shifts in R&D, policy and clinical trials
Coming changes that could impact pharma from drug development to launch.
By Meagan Parrish • Jan. 10, 2025 -
Getty Images
Opinion // Year in PreviewPharmaVoice’s Crystal Ball: The industry’s AI future
How AI will further transform the business of drug discovery and development in 2025.
By Meagan Parrish • Jan. 7, 2025 -
Getty Images
4 closely watched FDA approval dates in 2025 from J&J, Novo and more
A first-in-class pain med and blockbusters with new indications are just a few of the possible approvals to keep an eye on in the new year.
By Alexandra Pecci • Jan. 6, 2025 -
Chip Somodevilla via Getty Images
PBMs have evaded lawmakers’ reform attempts so far. Could 2025 turn the tide?
How regulators could hit PBMs from multiple sides in the coming year.
By Amy Baxter • Jan. 6, 2025 -
Sarah Silbiger via Getty Images
FDA approves drugs from Vertex, Novo, Bristol Myers to wrap 2024
The agency’s main drug review office cleared 50 novel medicines last year, short of 2018’s record total but on the higher end of recent annual tallies.
By Ben Fidler • Jan. 3, 2025 -
Permission granted by Merck Archives
How pharma was instrumental in President Jimmy Carter’s global health efforts
Pharma companies stepped up to support The Carter Center and provide access to life-saving treatments.
By Michael Gibney • Jan. 3, 2025 -
Getty Images
10 of our most read articles of 2024
The high drama of an election year, industry layoffs, patent cliff strategies and other key trends that shaped pharma in 2024.
By Meagan Parrish • Dec. 20, 2024 -
Sarah Silbiger via Getty Images
Zepbound, Mounjaro shortages are resolved, FDA confirms
The FDA’s decision will close a lucrative market opportunity for compounding pharmacies, although the agency will give a limited grace period before taking any enforcement actions.
By Ned Pagliarulo • Dec. 20, 2024 -
Scott Olson via Getty Images
Big Pharma’s new DTC play: partnering with digital health providers
The pharma giant is looking for another edge in the competitive weight loss market through DTC expansion.
By Amy Baxter • Dec. 18, 2024 -
Getty Images
Maternal mortality trends remain dire — and researchers face an uphill battle to solve them
Rising maternal mortality, particularly among vulnerable populations, stems in part from a lack of research in pregnant women.
By Michael Gibney • Dec. 17, 2024 -
Getty Images
Oncology, obesity and more: Where pharma R&D is headed in 2025
With a little more certainty coming to the market, the R&D environment in 2025 will be about pipeline prioritization and accelerating M&A.
By Amy Baxter • Dec. 16, 2024 -
Getty Images
Will the ‘anti-woke’ movement derail DEI efforts in pharma?
Amid the DEI backlash in corporate America, pharma leaders are quietly adjusting tactics.
By Meagan Parrish • Dec. 13, 2024 -
Courtesy of Eli Lilly
GLP-1 compounding is still in limbo. Will the FDA leave it for the next administration?
The agency has yet to make a decision about keeping tirzepatide on or off of its shortage list — letting compound pharmacies continue their lucrative operations for now.
By Amy Baxter • Dec. 11, 2024 -
Getty Images
Psychedelics haven’t fulfilled clinical expectations, but new trial strategies could turn the tide
Leading companies in the psychedelics space have had trouble crossing the regulatory threshold. Here’s where they’re going wrong — and how to fix it.
By Kelly Bilodeau • Dec. 9, 2024 -
Getty Images
Trump’s tariffs could put more pressure on the U.S. to produce generic drugs. Are we ready?
The push to bring generic drug production back home has failed to reach a critical mass.
By Meagan Parrish • Dec. 6, 2024 -
Noam Galai via Getty Images
With Makary set to face FDA commissioner hearings, how deep do his industry ties run?
Dr. Marty Makary’s conflicts of interest could come into question before he is confirmed as the next FDA commissioner.
By Amy Baxter • Dec. 4, 2024 -
Kevin Dietsch / Staff via Getty Images
How the incoming administration could impact FTC’s approach to pharma M&A
Pharma companies looking to get a break from the FTC under a new administration may be out of luck.
By Kelly Bilodeau • Nov. 26, 2024 -
Noam Galai via Getty Images
Johns Hopkins surgeon Makary is Trump’s pick to lead FDA
A prolific medical research and author, Martin Makary criticized the FDA and CDC for their decision-making during the pandemic, although he describes himself as pro-vaccine.
By Jonathan Gardner , Ned Pagliarulo • Nov. 25, 2024 -
Win McNamee via Getty Images
Trump nominees want to slash and burn agencies. Will RFK Jr. and Oz do the same in healthcare?
Both Trump appointees have promised to bring sweeping changes to several healthcare agencies.
By Amy Baxter • Nov. 25, 2024 -
Chip Somodevilla via Getty Images
What might a Trump administration mean for the Biosecure Act?
It’s still likely U.S. biotechs and pharmas will have to cut ties with key Chinese partners — it’s just a matter of when.
By Amy Baxter • Nov. 20, 2024 -
Rebecca Noble via Getty Images
Trump names RFK Jr. as his pick to lead HHS
If confirmed to the role, Robert F. Kennedy Jr. would oversee the country's top health agencies, including the Food and Drug Administration and the Centers for Disease Control and Prevention.
By Ned Pagliarulo • Updated Nov. 14, 2024 -
Permission granted by Pfizer
Pfizer and Lilly’s telehealth prescribing platforms draw Senate scrutiny for ‘potential fraud’
As Big Pharma embraces telehealth to sell medicines directly to patients, lawmakers wonder whether the programs skirt anti-kickback rules.
By Kelly Bilodeau • Nov. 12, 2024 -
Michael M. Santiago via Getty Images
What RFK Jr.’s influence could mean for pharma
Past comments hint at the changes Robert F. Kennedy Jr. could make across the various sectors of healthcare.
By Amy Baxter • Nov. 8, 2024
Previous
