Policy & Regulation: Page 2
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‘Chaos’ in the biotech market has dampened hopes of a rebound. What does that mean for dealmaking and IPOs?
The biotech market is taking a beating amid Trump’s turbulent economic policies.
By Amy Baxter • April 15, 2025 -
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Pharma’s capital allocation could shift as tariffs threaten an already fragile profit model
Major changes to the dynamics of the pharmaceutical ecosystem are making executive decisions even tougher.
By Michael Gibney • April 14, 2025 -
Explore the Trendline➔
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TrendlineEmerging biotech
After years of financial turmoil, the biotech market is turning the page. Strong fundamentals, including solid clinical data, are key for biotechs hoping to capitalize on the improving conditions.
By PharmaVoice staff -
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Pharma’s US manufacturing moment: Where companies are making the biggest moves
The tariff war has prompted new calls to reshore manufacturing. Several large pharmas have already made the leap.
By Meagan Parrish • April 11, 2025 -
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Trump’s tariff tirade and sudden calm keep Big Pharma on its toes
A wild ride in an escalating trade war has torn at Big Pharma’s shares while global markets flag in the back-and-forth winds.
By Michael Gibney • April 10, 2025 -
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US risks losing biotech edge to China, report warns
“There will be a ChatGPT moment for biotechnology,” a bipartisan commission wrote in the new report, which calls for the U.S. to invest at least $15 billion into the sector over the next five years.
By Ned Pagliarulo • April 9, 2025 -
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US vs. EU: When it comes to novel Alzheimer’s drugs, regulators can’t seem to agree
The FDA is much more flexible in approving first-in-class drugs compared to European regulators.
By Amy Baxter • April 7, 2025 -
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Dr. Oz confirmed to lead CMS
Dr. Mehmet Oz, a physician and TV personality, will lead the agency during a turbulent time for federal health programs as the HHS lays off thousands of staffers and Republicans float potential cuts to Medicaid.
By Emily Olsen • April 4, 2025 -
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OpinionIndustry leaders react to HHS being ‘reduced to a shell’
What healthcare watchdogs have said about the far-reaching job cuts this week.
By Meagan Parrish and Amy Baxter • April 3, 2025 -
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With government health info in limbo, drugmakers lose credible sources
The lack of clear communication from the government could spark wide-ranging issues in pharma — from sowing confusion about clinical trial design to further eroding public trust.
By Alexandra Pecci • April 1, 2025 -
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FDA’s ‘mixed signals’ on diversity have entangled clinical trials. Here’s how pharma can push ahead.
The agency is still unclear about where it will stand on clinical trial diversity, but companies are looking for answers and leaning toward good science.
By Meagan Parrish • March 28, 2025 -
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HHS announces sweeping reorganization, including cuts of 10K workers
Along with shrinking the HHS’ workforce further, the reorganization announced Thursday will cut the department from 28 divisions to 15, and close five regional offices.
By Rebecca Pifer • March 27, 2025 -
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Rx-to-OTC rule gets pushed back — again
A delay of the prescription-to-OTC rule signals health agencies’ ongoing reluctance to implement new regulations.
By Amy Baxter • March 26, 2025 -
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Lilly, Novo expand DTC reach of obesity meds after compound win
The FDA delisted semaglutide and tirzepatide from its shortage list, putting an end to copycat GLP-1s.
By Amy Baxter • March 24, 2025 -
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How pharma could feel the pain of a recession
Pharma has long been considered “recession proof,” but an economic downturn could still hurt the industry in numerous ways.
By Meagan Parrish • March 21, 2025 -
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Vaccine makers face mRNA backlash as states seek further restrictions
A handful of states are targeting the technology at the same time the Trump administration is cutting research funding and revoking vaccine contracts.
By Amy Baxter • March 19, 2025 -
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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 -
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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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