Policy & Regulation
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Year in PreviewPharma’s forecast for 2025: Sowing seeds of a rebound
Despite regulatory uncertainty, pharma is bouncing back from a market slump and is being fueled by innovation.
By Meagan Parrish • Jan. 31, 2025 -
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Is federal funding frozen? Has it already thawed? Flip-flop leaves biopharma on edge
NIH grants that help fund drug development were caught in the mix of confusing executive orders this week.
By Amy Baxter • Jan. 31, 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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RFK Jr. faces reconciliation of past vaccine statements at Senate HHS hearing
“Are you supportive of these onesies?” Sen. Bernie Sanders asked Kennedy, pointing to infant clothing stamped with anti-vaccine slogans — and more from yesterday’s confirmation hearing.
By Michael Gibney • Jan. 30, 2025 -
Courtesy of Vertex Pharmaceuticals
A long-awaited alternative to opioids is on the FDA doorstep. Can Vertex seal the deal?
Vertex Pharmaceuticals’ non-opioid pain medication is up for FDA approval this week. Other drugmakers have found safer alternatives to expand the pain management landscape.
By Amy Baxter • Jan. 29, 2025 -
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Bringing drugs to market has ‘never been more challenging,’ and pharma is learning to adapt
As changes to the U.S. regulatory foundation take hold, pharmas need to change their strategies to keep innovation — and the bottom line — above the surface.
By Michael Gibney • Jan. 28, 2025 -
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In pharma’s competitive climate, companies need evidence beyond clinical trials
Early planning and market research are crucial in an era of rising cost pressures.
By Kelly Bilodeau • Jan. 21, 2025 -
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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 -
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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
