Policy & Regulation: Page 2
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The key factors shaping China’s biopharma boom
Chinese companies are involved in one-fifth of pharma’s clinical development programs, but trade wars and regulatory hurdles could stymie dealmaking.
By Alexandra Pecci • March 19, 2025 -
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Lawmakers tease out pharma’s influence over RFK Jr. through probe into Mar-a-Lago meetings
HHS head Robert F. Kennedy Jr. has long been an opponent of pharma influence in government. U.S. lawmakers are asking whether unofficial Mar-a-Lago meetings point to a change of heart.
By Michael Gibney • March 13, 2025 -
Explore the Trendline➔
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TrendlineRare diseases
As drug developers find promise in the rare diseases, deals and treatments are on the rise
By PharmaVoice staff -
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IRA reforms, including a small molecule fix, could be on the table. Will Trump and the GOP make the leap?
Industry insiders are pushing to fix the small molecule ‘penalty’ by setting their hopes on a Republican majority.
By Amy Baxter • March 12, 2025 -
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Pricing transparency is in the spotlight — and that could be good news for drugmakers
An opaque system of rebates and discounts makes understanding a drug’s true price near impossible, even for experts. Can efforts to bring transparency into that system now pan out?
By Michael Gibney • March 11, 2025 -
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As tariffs loom over pharma manufacturing, a reshoring effort is underway — but not without challenges
Experts say cost and other barriers present challenges to returning to U.S. shores.
By Kelly Bilodeau • March 10, 2025 -
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How will Makary lead FDA amid workforce cuts and RFK Jr.s’ influence?
With President Trump’s nominee for FDA commissioner in Senate confirmation hearings, his approach to workforce cuts and other policies is under scrutiny.
By Amy Baxter • March 7, 2025 -
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The top 3 impacts of Trump’s health data purge
Interrupted access to health-related data has already led to worse outcomes and could undermine faith in the U.S. healthcare system, experts say.
By Michael Brady • March 6, 2025 -
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Incentivizing rare disease R&D is getting tougher, but revamped policies could turn the tide
Orphan drug development has long been incentivized by government policy. But as the financial math shifts, so do the risks of bringing rare disease drugs to market.
By Michael Gibney • Feb. 25, 2025 -
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Kennedy’s MAHA agenda is tackling ‘conflicts of interest’ — and could take aim at FDA adcomms
Health agency job cuts and a newly-established MAHA commission leave many unanswered questions about potential reforms and impact on drug approvals.
By Amy Baxter • Feb. 24, 2025 -
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In FDA job cuts, experts see threat of far-reaching impact
"Any place that gets cut, it's going to have an impact, because there's not any spare personnel at FDA,” said former agency commissioner Robert Califf, of the layoffs.
By Jonathan Gardner , Delilah Alvarado • Feb. 21, 2025 -
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A look at Trump’s healthcare cuts — so far
How the federal workforce crackdown has impacted the agencies that oversee pharma and healthcare.
By Meagan Parrish • Feb. 21, 2025 -
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Medicare’s next list of drugs for price negotiation could get ‘very interesting’ — and have a bigger impact on pharma
The Biden-era law is now in the hands of a new administration, and drugmakers are scanning the horizon for hints of a massive overhaul or incremental change.
By Michael Gibney • Feb. 11, 2025 -
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Tariffs raise concern among generic drugmakers, and advocacy groups are seeking exemptions
While the 10% tariff on Chinese goods won’t have too much impact on branded drugs, generics are struggling to pivot.
By Kelly Bilodeau • Feb. 7, 2025 -
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RFK Jr. will face these critical tests if confirmed as head of the HHS
After a Senate committee advanced President Trump’s nominee to lead HHS, Robert F. Kennedy Jr. is poised to secure the top job at the nation’s healthcare agency.
By Amy Baxter • Feb. 5, 2025 -
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Looming USAID shutdown threatens global health presence and a legacy of medical foreign aid
As President Trump and his cohorts plan to shut down the U.S. Agency for International Development, here’s what that could mean for global health and the drugmaking industry.
By Michael Gibney • Feb. 4, 2025 -
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What should pharma make of the FDA going dark on DEI?
After a series of potent executive orders last week, the FDA removed draft guidance on diversity in clinical trials.
By Meagan Parrish • Feb. 4, 2025 -
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Drugmakers prep for bird flu outbreak, despite continued low risk
While the virus hasn’t made a sustained leap into humans, vaccines and treatments are coming through the pipes if it does.
By Kelly Bilodeau • Feb. 3, 2025 -
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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 -
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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 • Updated Feb. 4, 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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