Policy & Regulation
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Musk’s rare disease torpedo, hospitals’ pharma fix and other policies leaders are tracking
There’s more to pharma's regulatory story in 2025 than just the IRA.
By Meagan Parrish • Jan. 17, 2025 -
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What to expect in the sequel to Medicare’s drug price negotiation program
CMS is expected to publish up to 15 drugs for the second cycle of the program by Feb. 1, and these are some of the drugs most likely to make the list.
By Amy Baxter • Jan. 15, 2025 -
Explore the Trendline➔
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TrendlineCommercialization, marketing and social media
As the pharma industry stares down a historic patent cliff, macroeconomic headwinds and challenging R&D costs for increasingly complex medicines, nailing the launch of new medicines has become increasingly critical.
By PharmaVoice staff -
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FTC releases second report slamming pharmacy benefit managers
Agency commissioners voted unanimously on Tuesday to publish the report, which makes similar allegations against the controversial drug middlemen as the agency’s first report released last summer — but relies on more data.
By Rebecca Pifer • Updated Jan. 14, 2025 -
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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 -
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FDA ‘stuck to its corner’ with AI draft guidance, leaving plenty of questions unanswered
The first draft guidance provides an initial framework for how the agency will assess AI models in drug development, but the industry is still looking for more.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 -
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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 -
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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 -
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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 -
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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 -
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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 -
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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 -
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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 -
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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 -
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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 -
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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 -
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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 -
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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 -
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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 -
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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 -
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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 -
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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 -
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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 -
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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 -
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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
